CAD & Atherosclerosis

Just months after the MASTER DAPT trial showed that abbreviated dual-antiplatelet therapy (DAPT) lowers the risk of bleeding after stent placement in patients at high bleeding risk, a new analysis showed the favorable benefit-to-risk ratio was about the same in the subgroup who also had an acute or recent myocardial infarction.

In the new prespecified MASTER DAPT analysis, the data show that the subgroup with both an increased bleeding risk and an increased risk of ischemic events benefited much like the entire study population from a shorter DAPT duration, reported Pieter C. Smits, MD, PhD, at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

“There was no signal towards increased ischemic risk in the abbreviated DAPT population presenting with recent acute MI,” said Dr. Smits, emphasizing the consistency of results in this “bi-risk” subgroup with objective criteria for increased risks of bleeding and ischemic events.

MASTER DAPT main results published

The main results of the MASTER DAPT trial were presented at the 2021 annual meeting of the European Society of Cardiology and published recently in the New England Journal of Medicine. The trial randomized 4,434 patients who met one or more criteria for high bleeding risk. These included age of at least 75 years, documented anemia, a clinical indication for oral anticoagulants, and previous bleeding episodes requiring hospitalization.

In the trial, all patients were maintained on DAPT for 1 month after implantation of a biodegradable-polymer, sirolimus-eluting coronary stent (Ultimaster, Terumo). At the end of the month, those randomized to abbreviated DAPT started immediately on single-agent antiplatelet therapy, while those in the standard DAPT group remained on DAPT for at least 2 additional months.

Over 1 year of follow-up, the bleeding event rate was lower in the abbreviated DAPT group (6.5% vs. 9.4%; P < .0001 for superiority). The slight increase in major ischemic events among those in the abbreviated DAPT group (6.1% vs. 5.9%) was not significantly different (P = .001 for noninferiority).

When compared on the basis of net adverse clinical events (NACE), which comprised all-case death, MI, stroke, or Bleeding Academic Research Consortium (BARC) level 3 or 5 bleeding, there was a slight advantage for abbreviated DAPT (7.5% vs. 7.7%). This did not reach significance, but it was similar (P < .001 for noninferiority), favoring the abbreviated course of DAPT because of the bleeding advantage.

Recent MI vs. no MI

In the new analysis, patients in both the abbreviated and standard DAPT group were stratified into those with no major cardiovascular event within the past 12 months and those with an acute MI or acute coronary syndrome within this time. There were somewhat more patients without a history of MI within the previous 12 months in both the abbreviated DAPT (1,381 vs. 914 patients) and standard DAPT (1,418 vs. 866) groups.

In those without a recent MI, NACE rates were nearly identical over 1-year follow-up for those who received abbreviated versus standard DAPT. In both, slightly more than 6% had a NACE event, producing a hazard ratio of 1.03 for abbreviated versus standard DAPT (P = 0.85).

For those with a recent MI, event rates began to separate within 30 days. By 1 year, NACE rates exceeded 10% in those on standard DAPT, but remained below 9% for those on abbreviated DAPT. The lower hazard ratio in the abbreviated DAPT group (HR, 0.83; P = .22) did not reach statistical significance, but it did echo the larger MASTER DAPT conclusion.

“An abbreviated DAPT strategy significantly reduced clinically relevant bleeding risk in these bi-risk patients without increasing risk of ischemic events,” reported Dr. Smits, director of interventional cardiology at Maasstad Hospital, Rotterdam, the Netherlands.
 

No difference in NACE components

In fact, when the components of NACE were evaluated individually in the subgroup of patients with prior MI, both stroke (HR, 0.47; P = .16) and all-cause death (HR, 0.78; P = .28), although not significant, numerically favored abbreviated DAPT.

There was no difference between abbreviated and standard DAPT for risk of MI at 1 year (HR, 1.03; P = .92).

As in the overall MASTER DAPT results, bleeding risk (BARC 2, 3, or 5 bleeding) was significantly reduced in the substudy among those with a recent prior MI (P = .013) or those with no MI in the prior 12 months (P = .01).

In MASTER DAPT, which was an open-label study that randomized participants in 30 countries, all patients received one type of drug-eluting stent. While Dr. Smits conceded that it is not clear whether the conclusions about abbreviated DAPT can be extrapolated to other stents, he noted that recent long-term outcomes for modern drug-eluting coronary stents have been similar, suggesting these results might be more broadly applicable.

According to Dr. Smit, the consistency of this subgroup analysis with the previously published MASTER DAPT study is mutually reinforcing for a role of abbreviated DAPT in patients at high bleeding risk. Other experts agreed.

“One of the concerns that people have had is exactly what has been addressed here in this subgroup analysis. These are the patients that are not only bleeding-risk high but ischemic-risk high. The question was whether the benefit of reducing bleeding risk is offset by increasing stent thrombosis or other ischemic event outcomes, and the answer from the analysis is really clearly no,” said Philippe Gabriel Steg, MD, chief, department of cardiology, Hôpital Bichat, Paris, at the meeting, sponsored by the Cardiovascular Research Foundation.

Dr. Smits reports financial relationships with Abiomed, Abbott Vascular, Daiichi-Sankyo, Microport, Opsense, and Terumo Medical. Dr. Steg reports financial relationships with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Idorsia, Merck, Novartis, Regeneron, and Sanofi-Aventis.

Just months after the MASTER DAPT trial showed that abbreviated dual-antiplatelet therapy (DAPT) lowers the risk of bleeding after stent placement in patients at high bleeding risk, a new analysis showed the favorable benefit-to-risk ratio was about the same in the subgroup who also had an acute or recent myocardial infarction.

In the new prespecified MASTER DAPT analysis, the data show that the subgroup with both an increased bleeding risk and an increased risk of ischemic events benefited much like the entire study population from a shorter DAPT duration, reported Pieter C. Smits, MD, PhD, at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

“There was no signal towards increased ischemic risk in the abbreviated DAPT population presenting with recent acute MI,” said Dr. Smits, emphasizing the consistency of results in this “bi-risk” subgroup with objective criteria for increased risks of bleeding and ischemic events.

MASTER DAPT main results published

The main results of the MASTER DAPT trial were presented at the 2021 annual meeting of the European Society of Cardiology and published recently in the New England Journal of Medicine. The trial randomized 4,434 patients who met one or more criteria for high bleeding risk. These included age of at least 75 years, documented anemia, a clinical indication for oral anticoagulants, and previous bleeding episodes requiring hospitalization.

In the trial, all patients were maintained on DAPT for 1 month after implantation of a biodegradable-polymer, sirolimus-eluting coronary stent (Ultimaster, Terumo). At the end of the month, those randomized to abbreviated DAPT started immediately on single-agent antiplatelet therapy, while those in the standard DAPT group remained on DAPT for at least 2 additional months.

Over 1 year of follow-up, the bleeding event rate was lower in the abbreviated DAPT group (6.5% vs. 9.4%; P < .0001 for superiority). The slight increase in major ischemic events among those in the abbreviated DAPT group (6.1% vs. 5.9%) was not significantly different (P = .001 for noninferiority).

When compared on the basis of net adverse clinical events (NACE), which comprised all-case death, MI, stroke, or Bleeding Academic Research Consortium (BARC) level 3 or 5 bleeding, there was a slight advantage for abbreviated DAPT (7.5% vs. 7.7%). This did not reach significance, but it was similar (P < .001 for noninferiority), favoring the abbreviated course of DAPT because of the bleeding advantage.

Recent MI vs. no MI

In the new analysis, patients in both the abbreviated and standard DAPT group were stratified into those with no major cardiovascular event within the past 12 months and those with an acute MI or acute coronary syndrome within this time. There were somewhat more patients without a history of MI within the previous 12 months in both the abbreviated DAPT (1,381 vs. 914 patients) and standard DAPT (1,418 vs. 866) groups.

In those without a recent MI, NACE rates were nearly identical over 1-year follow-up for those who received abbreviated versus standard DAPT. In both, slightly more than 6% had a NACE event, producing a hazard ratio of 1.03 for abbreviated versus standard DAPT (P = 0.85).

For those with a recent MI, event rates began to separate within 30 days. By 1 year, NACE rates exceeded 10% in those on standard DAPT, but remained below 9% for those on abbreviated DAPT. The lower hazard ratio in the abbreviated DAPT group (HR, 0.83; P = .22) did not reach statistical significance, but it did echo the larger MASTER DAPT conclusion.

“An abbreviated DAPT strategy significantly reduced clinically relevant bleeding risk in these bi-risk patients without increasing risk of ischemic events,” reported Dr. Smits, director of interventional cardiology at Maasstad Hospital, Rotterdam, the Netherlands.
 

No difference in NACE components

In fact, when the components of NACE were evaluated individually in the subgroup of patients with prior MI, both stroke (HR, 0.47; P = .16) and all-cause death (HR, 0.78; P = .28), although not significant, numerically favored abbreviated DAPT.

There was no difference between abbreviated and standard DAPT for risk of MI at 1 year (HR, 1.03; P = .92).

As in the overall MASTER DAPT results, bleeding risk (BARC 2, 3, or 5 bleeding) was significantly reduced in the substudy among those with a recent prior MI (P = .013) or those with no MI in the prior 12 months (P = .01).

In MASTER DAPT, which was an open-label study that randomized participants in 30 countries, all patients received one type of drug-eluting stent. While Dr. Smits conceded that it is not clear whether the conclusions about abbreviated DAPT can be extrapolated to other stents, he noted that recent long-term outcomes for modern drug-eluting coronary stents have been similar, suggesting these results might be more broadly applicable.

According to Dr. Smit, the consistency of this subgroup analysis with the previously published MASTER DAPT study is mutually reinforcing for a role of abbreviated DAPT in patients at high bleeding risk. Other experts agreed.

“One of the concerns that people have had is exactly what has been addressed here in this subgroup analysis. These are the patients that are not only bleeding-risk high but ischemic-risk high. The question was whether the benefit of reducing bleeding risk is offset by increasing stent thrombosis or other ischemic event outcomes, and the answer from the analysis is really clearly no,” said Philippe Gabriel Steg, MD, chief, department of cardiology, Hôpital Bichat, Paris, at the meeting, sponsored by the Cardiovascular Research Foundation.

Dr. Smits reports financial relationships with Abiomed, Abbott Vascular, Daiichi-Sankyo, Microport, Opsense, and Terumo Medical. Dr. Steg reports financial relationships with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Idorsia, Merck, Novartis, Regeneron, and Sanofi-Aventis.

Just months after the MASTER DAPT trial showed that abbreviated dual-antiplatelet therapy (DAPT) lowers the risk of bleeding after stent placement in patients at high bleeding risk, a new analysis showed the favorable benefit-to-risk ratio was about the same in the subgroup who also had an acute or recent myocardial infarction.

In the new prespecified MASTER DAPT analysis, the data show that the subgroup with both an increased bleeding risk and an increased risk of ischemic events benefited much like the entire study population from a shorter DAPT duration, reported Pieter C. Smits, MD, PhD, at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

“There was no signal towards increased ischemic risk in the abbreviated DAPT population presenting with recent acute MI,” said Dr. Smits, emphasizing the consistency of results in this “bi-risk” subgroup with objective criteria for increased risks of bleeding and ischemic events.

MASTER DAPT main results published

The main results of the MASTER DAPT trial were presented at the 2021 annual meeting of the European Society of Cardiology and published recently in the New England Journal of Medicine. The trial randomized 4,434 patients who met one or more criteria for high bleeding risk. These included age of at least 75 years, documented anemia, a clinical indication for oral anticoagulants, and previous bleeding episodes requiring hospitalization.

In the trial, all patients were maintained on DAPT for 1 month after implantation of a biodegradable-polymer, sirolimus-eluting coronary stent (Ultimaster, Terumo). At the end of the month, those randomized to abbreviated DAPT started immediately on single-agent antiplatelet therapy, while those in the standard DAPT group remained on DAPT for at least 2 additional months.

Over 1 year of follow-up, the bleeding event rate was lower in the abbreviated DAPT group (6.5% vs. 9.4%; P < .0001 for superiority). The slight increase in major ischemic events among those in the abbreviated DAPT group (6.1% vs. 5.9%) was not significantly different (P = .001 for noninferiority).

When compared on the basis of net adverse clinical events (NACE), which comprised all-case death, MI, stroke, or Bleeding Academic Research Consortium (BARC) level 3 or 5 bleeding, there was a slight advantage for abbreviated DAPT (7.5% vs. 7.7%). This did not reach significance, but it was similar (P < .001 for noninferiority), favoring the abbreviated course of DAPT because of the bleeding advantage.

Recent MI vs. no MI

In the new analysis, patients in both the abbreviated and standard DAPT group were stratified into those with no major cardiovascular event within the past 12 months and those with an acute MI or acute coronary syndrome within this time. There were somewhat more patients without a history of MI within the previous 12 months in both the abbreviated DAPT (1,381 vs. 914 patients) and standard DAPT (1,418 vs. 866) groups.

In those without a recent MI, NACE rates were nearly identical over 1-year follow-up for those who received abbreviated versus standard DAPT. In both, slightly more than 6% had a NACE event, producing a hazard ratio of 1.03 for abbreviated versus standard DAPT (P = 0.85).

For those with a recent MI, event rates began to separate within 30 days. By 1 year, NACE rates exceeded 10% in those on standard DAPT, but remained below 9% for those on abbreviated DAPT. The lower hazard ratio in the abbreviated DAPT group (HR, 0.83; P = .22) did not reach statistical significance, but it did echo the larger MASTER DAPT conclusion.

“An abbreviated DAPT strategy significantly reduced clinically relevant bleeding risk in these bi-risk patients without increasing risk of ischemic events,” reported Dr. Smits, director of interventional cardiology at Maasstad Hospital, Rotterdam, the Netherlands.
 

No difference in NACE components

In fact, when the components of NACE were evaluated individually in the subgroup of patients with prior MI, both stroke (HR, 0.47; P = .16) and all-cause death (HR, 0.78; P = .28), although not significant, numerically favored abbreviated DAPT.

There was no difference between abbreviated and standard DAPT for risk of MI at 1 year (HR, 1.03; P = .92).

As in the overall MASTER DAPT results, bleeding risk (BARC 2, 3, or 5 bleeding) was significantly reduced in the substudy among those with a recent prior MI (P = .013) or those with no MI in the prior 12 months (P = .01).

In MASTER DAPT, which was an open-label study that randomized participants in 30 countries, all patients received one type of drug-eluting stent. While Dr. Smits conceded that it is not clear whether the conclusions about abbreviated DAPT can be extrapolated to other stents, he noted that recent long-term outcomes for modern drug-eluting coronary stents have been similar, suggesting these results might be more broadly applicable.

According to Dr. Smit, the consistency of this subgroup analysis with the previously published MASTER DAPT study is mutually reinforcing for a role of abbreviated DAPT in patients at high bleeding risk. Other experts agreed.

“One of the concerns that people have had is exactly what has been addressed here in this subgroup analysis. These are the patients that are not only bleeding-risk high but ischemic-risk high. The question was whether the benefit of reducing bleeding risk is offset by increasing stent thrombosis or other ischemic event outcomes, and the answer from the analysis is really clearly no,” said Philippe Gabriel Steg, MD, chief, department of cardiology, Hôpital Bichat, Paris, at the meeting, sponsored by the Cardiovascular Research Foundation.

Dr. Smits reports financial relationships with Abiomed, Abbott Vascular, Daiichi-Sankyo, Microport, Opsense, and Terumo Medical. Dr. Steg reports financial relationships with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Idorsia, Merck, Novartis, Regeneron, and Sanofi-Aventis.

Percutaneous coronary intervention (PCI) guided by quantitative flow ratio (QFR) lesion assessment provided better clinical outcomes than visual assessment of the angiogram in the sham-controlled FAVOR III China study.

PCI success rates were about 95% with both strategies; however, QFR guidance was associated with fewer major adverse cardiac events (MACE) at 1 year, use of fewer stents, less contrast medium exposure, and fewer procedural complications.

“The simplicity and safety of QFR compared with wire-based physiologic measurements should facilitate the adoption of physiologic lesion assessment into routine clinical practice,” co–primary investigator Bo Xu, MBBS, Fuwai Hospital, Beijing, said.

The results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held online and in Orlando, and published simultaneously in The Lancet.

Although pressure wire–based physiological assessment with fractional flow reserve (FFR) and instantaneous wave-free ratio (IFR) more accurately identify flow-limiting lesions than standard angiography and have been shown to improve outcomes after PCI, the authors note that it’s underused in practice because of prolonged procedural time, potential pressure wire complications, and side effects from hyperemic agents.

QFR, however, is derived from 3-dimensional coronary artery reconstruction and computational fluid dynamics from the angiogram, so FFR can be estimated without the need for a pressure wire or hyperemic drugs.

FAVOR III China was designed statistically for superiority and enrolled 3,847 patients with stable or unstable angina or a myocardial infarction (MI) at least 72 hours before screening if they had at least one coronary lesion with a diameter stenosis of 50% to 90% and a reference vessel diameter of at least 2.5 mm. The intention-to-treat population included 3,825 patients (mean age, 62.7 years; 29.4% female).

In the QFR group, QFR was measured in all coronary arteries with a lesion but PCI performed only in lesions with a QFR of at least 0.80 or diameter stenosis greater than 90%. Two angiographic imaging runs were taken and the data transmitted to the AngioPlus system (Pulse Medical Imaging Technology) by a local network of sites for QFR calculation.

PCI in the angiography-guided group was performed on the basis of visual angiographic assessment only. A 10-minute delay was used in both groups to preserve masking.

The primary endpoint of 1-year MACE, a composite of all-cause death, MI, or ischemia-driven revascularization, occurred in 5.8% of the QFR-guided group and 8.8% of the angiography-guided group (hazard ratio, 0.65; 95% CI, 0.51-0.83; P = .0004).

The curves separated within 48 hours, driven largely by fewer MIs (3.4% vs. 5.7%; P = .0008) and ischemia-driven revascularizations (2.0% vs. 3.1%; P = .0078) in the QFR-guided group, Mr. Xu said.

The major secondary endpoint of MACE excluding periprocedural MI occurred in 3.1% of QFR-guided patients and 4.8% of angiography-guided patients (HR, 0.64; 95% CI, 0.46-0.89; P = .0073).

The prerandomization revascularization plan was changed in 23.3% of patients with QFR and only 6.2% in the angiography group (P < .0001), mainly due to deferral of treatment of at least one vessel originally planned for PCI (19.6% vs. 5.2%; P < .0001).

“I think in the next guideline they will change the recommendation, not just to include FFR and IFR, but also to include QFR,” Giuseppe Tarantini, MD, PhD, University of Padua, Italy, said during a press briefing on the study.

“This is a milestone in our community, not only because it is easier to use compared to the other lesion-specific indexes like FFR, IFR, but also for the need to expand the use of physiology in the setting of interventional cardiology,” he added.

In an accompanying commentary, Robert A. Byrne, MBBCh, PhD, and Laurna McGovern, MBBCh, both from the Cardiovascular Research Institute Dublin, say the results are “relevant for cardiovascular disease researchers and clinicians and an important step forward for the field of angiography-derived flow measurements for guidance of PCI.”

They point out, however, that the control group did not receive pressure wire–guided PCI, which is the standard of care in contemporary practice and out of step with clinical practice guidelines, thus limiting external validity.

They also note that experiences to date suggest that up to 20% of patients may be unsuitable for the algorithm analysis because of coronary anatomy, presence of overlapping vessels, and insufficient image quality.

Commenting for this news organization, David E. Kandzari, MD, chief of the Piedmont Heart Institute, Atlanta, said “the technology isn’t readily available in catheterization labs today. Could it be assimilated into the cath labs at one point in the near term? I think absolutely, and that would be a welcome addition to expedite the procedure itself.”

Nevertheless, he said the results “need to be externally validated too, with what is the gold standard today of FFR in a larger experience.”

Session moderator Gregg W. Stone, MD, Icahn School of Medicine at Mount Sinai, New York, said FAVOR III China has “advanced our knowledge” but pointed out that the ongoing randomized FAVOR III Europe Japan study is directly comparing QFR with invasive pressure-wire assessed FFR. The estimated primary completion date for that study is Dec. 31.

The study was supported by grants from the Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital. Dr. Byrne reported institutional research or educational funding from Abbott Vascular, Biosensors, Biotronik, and Boston Scientific. Ms. McGovern has disclosed no relevant financial relationships. Dr. Kandzari reported minor consulting honoraria from the interventional device industry and institutional research grant support.

A version of this article first appeared on Medscape.com.

Percutaneous coronary intervention (PCI) guided by quantitative flow ratio (QFR) lesion assessment provided better clinical outcomes than visual assessment of the angiogram in the sham-controlled FAVOR III China study.

PCI success rates were about 95% with both strategies; however, QFR guidance was associated with fewer major adverse cardiac events (MACE) at 1 year, use of fewer stents, less contrast medium exposure, and fewer procedural complications.

“The simplicity and safety of QFR compared with wire-based physiologic measurements should facilitate the adoption of physiologic lesion assessment into routine clinical practice,” co–primary investigator Bo Xu, MBBS, Fuwai Hospital, Beijing, said.

The results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held online and in Orlando, and published simultaneously in The Lancet.

Although pressure wire–based physiological assessment with fractional flow reserve (FFR) and instantaneous wave-free ratio (IFR) more accurately identify flow-limiting lesions than standard angiography and have been shown to improve outcomes after PCI, the authors note that it’s underused in practice because of prolonged procedural time, potential pressure wire complications, and side effects from hyperemic agents.

QFR, however, is derived from 3-dimensional coronary artery reconstruction and computational fluid dynamics from the angiogram, so FFR can be estimated without the need for a pressure wire or hyperemic drugs.

FAVOR III China was designed statistically for superiority and enrolled 3,847 patients with stable or unstable angina or a myocardial infarction (MI) at least 72 hours before screening if they had at least one coronary lesion with a diameter stenosis of 50% to 90% and a reference vessel diameter of at least 2.5 mm. The intention-to-treat population included 3,825 patients (mean age, 62.7 years; 29.4% female).

In the QFR group, QFR was measured in all coronary arteries with a lesion but PCI performed only in lesions with a QFR of at least 0.80 or diameter stenosis greater than 90%. Two angiographic imaging runs were taken and the data transmitted to the AngioPlus system (Pulse Medical Imaging Technology) by a local network of sites for QFR calculation.

PCI in the angiography-guided group was performed on the basis of visual angiographic assessment only. A 10-minute delay was used in both groups to preserve masking.

The primary endpoint of 1-year MACE, a composite of all-cause death, MI, or ischemia-driven revascularization, occurred in 5.8% of the QFR-guided group and 8.8% of the angiography-guided group (hazard ratio, 0.65; 95% CI, 0.51-0.83; P = .0004).

The curves separated within 48 hours, driven largely by fewer MIs (3.4% vs. 5.7%; P = .0008) and ischemia-driven revascularizations (2.0% vs. 3.1%; P = .0078) in the QFR-guided group, Mr. Xu said.

The major secondary endpoint of MACE excluding periprocedural MI occurred in 3.1% of QFR-guided patients and 4.8% of angiography-guided patients (HR, 0.64; 95% CI, 0.46-0.89; P = .0073).

The prerandomization revascularization plan was changed in 23.3% of patients with QFR and only 6.2% in the angiography group (P < .0001), mainly due to deferral of treatment of at least one vessel originally planned for PCI (19.6% vs. 5.2%; P < .0001).

“I think in the next guideline they will change the recommendation, not just to include FFR and IFR, but also to include QFR,” Giuseppe Tarantini, MD, PhD, University of Padua, Italy, said during a press briefing on the study.

“This is a milestone in our community, not only because it is easier to use compared to the other lesion-specific indexes like FFR, IFR, but also for the need to expand the use of physiology in the setting of interventional cardiology,” he added.

In an accompanying commentary, Robert A. Byrne, MBBCh, PhD, and Laurna McGovern, MBBCh, both from the Cardiovascular Research Institute Dublin, say the results are “relevant for cardiovascular disease researchers and clinicians and an important step forward for the field of angiography-derived flow measurements for guidance of PCI.”

They point out, however, that the control group did not receive pressure wire–guided PCI, which is the standard of care in contemporary practice and out of step with clinical practice guidelines, thus limiting external validity.

They also note that experiences to date suggest that up to 20% of patients may be unsuitable for the algorithm analysis because of coronary anatomy, presence of overlapping vessels, and insufficient image quality.

Commenting for this news organization, David E. Kandzari, MD, chief of the Piedmont Heart Institute, Atlanta, said “the technology isn’t readily available in catheterization labs today. Could it be assimilated into the cath labs at one point in the near term? I think absolutely, and that would be a welcome addition to expedite the procedure itself.”

Nevertheless, he said the results “need to be externally validated too, with what is the gold standard today of FFR in a larger experience.”

Session moderator Gregg W. Stone, MD, Icahn School of Medicine at Mount Sinai, New York, said FAVOR III China has “advanced our knowledge” but pointed out that the ongoing randomized FAVOR III Europe Japan study is directly comparing QFR with invasive pressure-wire assessed FFR. The estimated primary completion date for that study is Dec. 31.

The study was supported by grants from the Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital. Dr. Byrne reported institutional research or educational funding from Abbott Vascular, Biosensors, Biotronik, and Boston Scientific. Ms. McGovern has disclosed no relevant financial relationships. Dr. Kandzari reported minor consulting honoraria from the interventional device industry and institutional research grant support.

A version of this article first appeared on Medscape.com.

Percutaneous coronary intervention (PCI) guided by quantitative flow ratio (QFR) lesion assessment provided better clinical outcomes than visual assessment of the angiogram in the sham-controlled FAVOR III China study.

PCI success rates were about 95% with both strategies; however, QFR guidance was associated with fewer major adverse cardiac events (MACE) at 1 year, use of fewer stents, less contrast medium exposure, and fewer procedural complications.

“The simplicity and safety of QFR compared with wire-based physiologic measurements should facilitate the adoption of physiologic lesion assessment into routine clinical practice,” co–primary investigator Bo Xu, MBBS, Fuwai Hospital, Beijing, said.

The results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2021, held online and in Orlando, and published simultaneously in The Lancet.

Although pressure wire–based physiological assessment with fractional flow reserve (FFR) and instantaneous wave-free ratio (IFR) more accurately identify flow-limiting lesions than standard angiography and have been shown to improve outcomes after PCI, the authors note that it’s underused in practice because of prolonged procedural time, potential pressure wire complications, and side effects from hyperemic agents.

QFR, however, is derived from 3-dimensional coronary artery reconstruction and computational fluid dynamics from the angiogram, so FFR can be estimated without the need for a pressure wire or hyperemic drugs.

FAVOR III China was designed statistically for superiority and enrolled 3,847 patients with stable or unstable angina or a myocardial infarction (MI) at least 72 hours before screening if they had at least one coronary lesion with a diameter stenosis of 50% to 90% and a reference vessel diameter of at least 2.5 mm. The intention-to-treat population included 3,825 patients (mean age, 62.7 years; 29.4% female).

In the QFR group, QFR was measured in all coronary arteries with a lesion but PCI performed only in lesions with a QFR of at least 0.80 or diameter stenosis greater than 90%. Two angiographic imaging runs were taken and the data transmitted to the AngioPlus system (Pulse Medical Imaging Technology) by a local network of sites for QFR calculation.

PCI in the angiography-guided group was performed on the basis of visual angiographic assessment only. A 10-minute delay was used in both groups to preserve masking.

The primary endpoint of 1-year MACE, a composite of all-cause death, MI, or ischemia-driven revascularization, occurred in 5.8% of the QFR-guided group and 8.8% of the angiography-guided group (hazard ratio, 0.65; 95% CI, 0.51-0.83; P = .0004).

The curves separated within 48 hours, driven largely by fewer MIs (3.4% vs. 5.7%; P = .0008) and ischemia-driven revascularizations (2.0% vs. 3.1%; P = .0078) in the QFR-guided group, Mr. Xu said.

The major secondary endpoint of MACE excluding periprocedural MI occurred in 3.1% of QFR-guided patients and 4.8% of angiography-guided patients (HR, 0.64; 95% CI, 0.46-0.89; P = .0073).

The prerandomization revascularization plan was changed in 23.3% of patients with QFR and only 6.2% in the angiography group (P < .0001), mainly due to deferral of treatment of at least one vessel originally planned for PCI (19.6% vs. 5.2%; P < .0001).

“I think in the next guideline they will change the recommendation, not just to include FFR and IFR, but also to include QFR,” Giuseppe Tarantini, MD, PhD, University of Padua, Italy, said during a press briefing on the study.

“This is a milestone in our community, not only because it is easier to use compared to the other lesion-specific indexes like FFR, IFR, but also for the need to expand the use of physiology in the setting of interventional cardiology,” he added.

In an accompanying commentary, Robert A. Byrne, MBBCh, PhD, and Laurna McGovern, MBBCh, both from the Cardiovascular Research Institute Dublin, say the results are “relevant for cardiovascular disease researchers and clinicians and an important step forward for the field of angiography-derived flow measurements for guidance of PCI.”

They point out, however, that the control group did not receive pressure wire–guided PCI, which is the standard of care in contemporary practice and out of step with clinical practice guidelines, thus limiting external validity.

They also note that experiences to date suggest that up to 20% of patients may be unsuitable for the algorithm analysis because of coronary anatomy, presence of overlapping vessels, and insufficient image quality.

Commenting for this news organization, David E. Kandzari, MD, chief of the Piedmont Heart Institute, Atlanta, said “the technology isn’t readily available in catheterization labs today. Could it be assimilated into the cath labs at one point in the near term? I think absolutely, and that would be a welcome addition to expedite the procedure itself.”

Nevertheless, he said the results “need to be externally validated too, with what is the gold standard today of FFR in a larger experience.”

Session moderator Gregg W. Stone, MD, Icahn School of Medicine at Mount Sinai, New York, said FAVOR III China has “advanced our knowledge” but pointed out that the ongoing randomized FAVOR III Europe Japan study is directly comparing QFR with invasive pressure-wire assessed FFR. The estimated primary completion date for that study is Dec. 31.

The study was supported by grants from the Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital. Dr. Byrne reported institutional research or educational funding from Abbott Vascular, Biosensors, Biotronik, and Boston Scientific. Ms. McGovern has disclosed no relevant financial relationships. Dr. Kandzari reported minor consulting honoraria from the interventional device industry and institutional research grant support.

A version of this article first appeared on Medscape.com.

More than half of people living with HIV and suppressed viral loads nonetheless had imaging-confirmed coronary artery disease – and despite longtime use of HIV drugs that have been associated with cardiovascular trouble, none of those drugs were implicated in disease risk in this study.

“Traditional risk factors and duration of HIV infection were associated with severe coronary artery disease,” said Andreas Knudsen, MD, PhD, an infectious disease provider at Copenhagen University Hospital, Hvidovre, Denmark, during his presentation at the 18th European AIDS Conference. “When we adjusted for time since diagnosis of HIV, none of the drugs remained associated with the severity of coronary artery disease.”

Notably, that included abacavir, which was found in another EACS presentation and in past research to be associated with increased rates of heart attacks. Abacavir is sold individually as a generic as well as a component of Epzicom (abacavir/lamivudine) and the single-drug regimen Triumeq (dolutegravir/abacavir/lamivudine).

The Copenhagen Comorbidity in HIV Infection (COCOMO) study enrolled 1,099 people living with HIV in the Danish capital beginning in 2015, and 705 of them had angiographies via CT available to include in the results. The participants were almost all male (89%), at a healthy weight (BMI of 25), and 96% had undetectable viral loads.

Large minorities of participants also had traditional risk factors for coronary artery disease. More than one in four smoked, one in five had high cholesterol, and 42% had high blood pressure. In addition, many had used drugs that have been associated with cardiovascular trouble, including abacavir, which 26% of participants had used; indinavir, used by 17% of participants; zidovudine/AZT, used by 47%; and didanosine, which 14% used. (While abacavir is still in use, the other three drugs are considered legacy drugs and are not in current use.)

In addition, nearly one in three (29%) were currently using a protease inhibitor, which has been associated with heart failure.

When the investigators looked at participants’ CTs, they found that, by the Coronary Artery Disease-Reporting and Data Systems (CAD-RAMS) scoring system, close to half (46%) had clear arteries with no signs of coronary artery disease. But that also meant that 54% had some blockage or stiffening of the arteries. The good news is that 27% of those people had minimal or mild coronary artery disease.

But a full 17% had confirmed obstructive coronary artery disease, and another 1 in 10 participants had the highest level of blockages. When they broke the data down by traditional and HIV medication–related risk factors for coronary artery disease, they found something interesting. Although obesity was associated with the presence of atherosclerosis, it wasn’t associated with severe disease. But diabetes was the reverse of that: It wasn’t associated with the presence of the disease, but it was associated with more severe disease.

And when they looked at abacavir, they found no relationship between the drug and atherosclerosis. “Abacavir was not associated with the presence of atherosclerosis and was also not associated with severity of disease,” said Dr. Knudsen.

Although past use of AZT, indinavir, and didanosine were associated with severity of atherosclerosis, that association went away when Dr. Knudsen and team adjusted the findings for time since diagnosis. What was associated atherosclerosis was length of time living with HIV itself. For every 5 years a person lived with HIV, the study found the risk of having any atherosclerosis increased 20% and severity increased 23%. In addition, being a man was associated with a nearly 2.5-times increased risk of having any atherosclerosis and a 96% increased chance of having more severe atherosclerosis. Having diabetes was associated with a nearly threefold increased risk of atherosclerosis, as was every additional decade of life for a person who was living with HIV.

The findings confirm the baseline data of the REPRIEVE trial, which recently released data showing similarly high rates of atherosclerotic plaque in people living with HIV who didn’t register as “at risk” for cardiovascular disease using traditional scoring methods.

“It’s important in that it’s a huge study that’s confirmatory [of] what we know, which is that there are high levels of subclinical coronary artery disease in people living with HIV,” said Steven Grinspoon, MD, professor at Harvard Medical School in Boston, Massachusetts, and principal investigator of REPRIEVE.

As for the lack of association between abacavir and cardiovascular risk, he said he’s taking the findings with a grain of salt.

“It’s hard to make a lot out of that,” he said. “It’s hard to know in a cross-sectional study. People put people on different things.”

In Spain, where Jose Ignacio Bernardino, MD, treats people living with HIV at La Paz University Hospital in Madrid, abacavir is mostly a moot point, as clinicians have long since moved away from maintaining people living with HIV on any abacavir-containing regimens. What’s more important in the study, he told this news organization, is that “worrisome” high level of risk. REPRIEVE will test whether statins can reduce heart disease events in people living with HIV. But in the meantime, he said the take-away for clinicians from the study is the primary importance of traditional cardiovascular risk factors.

“We have to acknowledge that the major cardiovascular risk factor is age,” he said. “When patients are approaching their 50s, I usually try to stress a lot about cardiovascular risk factors in general. I stress healthy lifestyle – get physical exercise, hypertension, glucose, lipids – in every single patient.”

Dr. Knudsen and Dr. Bernardino have disclosed no relevant financial relationships. Dr. Grinspoon reports receiving personal and consulting fees from Theratechnologies and ViiV Healthcare.

A version of this article first appeared on Medscape.com.

More than half of people living with HIV and suppressed viral loads nonetheless had imaging-confirmed coronary artery disease – and despite longtime use of HIV drugs that have been associated with cardiovascular trouble, none of those drugs were implicated in disease risk in this study.

“Traditional risk factors and duration of HIV infection were associated with severe coronary artery disease,” said Andreas Knudsen, MD, PhD, an infectious disease provider at Copenhagen University Hospital, Hvidovre, Denmark, during his presentation at the 18th European AIDS Conference. “When we adjusted for time since diagnosis of HIV, none of the drugs remained associated with the severity of coronary artery disease.”

Notably, that included abacavir, which was found in another EACS presentation and in past research to be associated with increased rates of heart attacks. Abacavir is sold individually as a generic as well as a component of Epzicom (abacavir/lamivudine) and the single-drug regimen Triumeq (dolutegravir/abacavir/lamivudine).

The Copenhagen Comorbidity in HIV Infection (COCOMO) study enrolled 1,099 people living with HIV in the Danish capital beginning in 2015, and 705 of them had angiographies via CT available to include in the results. The participants were almost all male (89%), at a healthy weight (BMI of 25), and 96% had undetectable viral loads.

Large minorities of participants also had traditional risk factors for coronary artery disease. More than one in four smoked, one in five had high cholesterol, and 42% had high blood pressure. In addition, many had used drugs that have been associated with cardiovascular trouble, including abacavir, which 26% of participants had used; indinavir, used by 17% of participants; zidovudine/AZT, used by 47%; and didanosine, which 14% used. (While abacavir is still in use, the other three drugs are considered legacy drugs and are not in current use.)

In addition, nearly one in three (29%) were currently using a protease inhibitor, which has been associated with heart failure.

When the investigators looked at participants’ CTs, they found that, by the Coronary Artery Disease-Reporting and Data Systems (CAD-RAMS) scoring system, close to half (46%) had clear arteries with no signs of coronary artery disease. But that also meant that 54% had some blockage or stiffening of the arteries. The good news is that 27% of those people had minimal or mild coronary artery disease.

But a full 17% had confirmed obstructive coronary artery disease, and another 1 in 10 participants had the highest level of blockages. When they broke the data down by traditional and HIV medication–related risk factors for coronary artery disease, they found something interesting. Although obesity was associated with the presence of atherosclerosis, it wasn’t associated with severe disease. But diabetes was the reverse of that: It wasn’t associated with the presence of the disease, but it was associated with more severe disease.

And when they looked at abacavir, they found no relationship between the drug and atherosclerosis. “Abacavir was not associated with the presence of atherosclerosis and was also not associated with severity of disease,” said Dr. Knudsen.

Although past use of AZT, indinavir, and didanosine were associated with severity of atherosclerosis, that association went away when Dr. Knudsen and team adjusted the findings for time since diagnosis. What was associated atherosclerosis was length of time living with HIV itself. For every 5 years a person lived with HIV, the study found the risk of having any atherosclerosis increased 20% and severity increased 23%. In addition, being a man was associated with a nearly 2.5-times increased risk of having any atherosclerosis and a 96% increased chance of having more severe atherosclerosis. Having diabetes was associated with a nearly threefold increased risk of atherosclerosis, as was every additional decade of life for a person who was living with HIV.

The findings confirm the baseline data of the REPRIEVE trial, which recently released data showing similarly high rates of atherosclerotic plaque in people living with HIV who didn’t register as “at risk” for cardiovascular disease using traditional scoring methods.

“It’s important in that it’s a huge study that’s confirmatory [of] what we know, which is that there are high levels of subclinical coronary artery disease in people living with HIV,” said Steven Grinspoon, MD, professor at Harvard Medical School in Boston, Massachusetts, and principal investigator of REPRIEVE.

As for the lack of association between abacavir and cardiovascular risk, he said he’s taking the findings with a grain of salt.

“It’s hard to make a lot out of that,” he said. “It’s hard to know in a cross-sectional study. People put people on different things.”

In Spain, where Jose Ignacio Bernardino, MD, treats people living with HIV at La Paz University Hospital in Madrid, abacavir is mostly a moot point, as clinicians have long since moved away from maintaining people living with HIV on any abacavir-containing regimens. What’s more important in the study, he told this news organization, is that “worrisome” high level of risk. REPRIEVE will test whether statins can reduce heart disease events in people living with HIV. But in the meantime, he said the take-away for clinicians from the study is the primary importance of traditional cardiovascular risk factors.

“We have to acknowledge that the major cardiovascular risk factor is age,” he said. “When patients are approaching their 50s, I usually try to stress a lot about cardiovascular risk factors in general. I stress healthy lifestyle – get physical exercise, hypertension, glucose, lipids – in every single patient.”

Dr. Knudsen and Dr. Bernardino have disclosed no relevant financial relationships. Dr. Grinspoon reports receiving personal and consulting fees from Theratechnologies and ViiV Healthcare.

A version of this article first appeared on Medscape.com.

More than half of people living with HIV and suppressed viral loads nonetheless had imaging-confirmed coronary artery disease – and despite longtime use of HIV drugs that have been associated with cardiovascular trouble, none of those drugs were implicated in disease risk in this study.

“Traditional risk factors and duration of HIV infection were associated with severe coronary artery disease,” said Andreas Knudsen, MD, PhD, an infectious disease provider at Copenhagen University Hospital, Hvidovre, Denmark, during his presentation at the 18th European AIDS Conference. “When we adjusted for time since diagnosis of HIV, none of the drugs remained associated with the severity of coronary artery disease.”

Notably, that included abacavir, which was found in another EACS presentation and in past research to be associated with increased rates of heart attacks. Abacavir is sold individually as a generic as well as a component of Epzicom (abacavir/lamivudine) and the single-drug regimen Triumeq (dolutegravir/abacavir/lamivudine).

The Copenhagen Comorbidity in HIV Infection (COCOMO) study enrolled 1,099 people living with HIV in the Danish capital beginning in 2015, and 705 of them had angiographies via CT available to include in the results. The participants were almost all male (89%), at a healthy weight (BMI of 25), and 96% had undetectable viral loads.

Large minorities of participants also had traditional risk factors for coronary artery disease. More than one in four smoked, one in five had high cholesterol, and 42% had high blood pressure. In addition, many had used drugs that have been associated with cardiovascular trouble, including abacavir, which 26% of participants had used; indinavir, used by 17% of participants; zidovudine/AZT, used by 47%; and didanosine, which 14% used. (While abacavir is still in use, the other three drugs are considered legacy drugs and are not in current use.)

In addition, nearly one in three (29%) were currently using a protease inhibitor, which has been associated with heart failure.

When the investigators looked at participants’ CTs, they found that, by the Coronary Artery Disease-Reporting and Data Systems (CAD-RAMS) scoring system, close to half (46%) had clear arteries with no signs of coronary artery disease. But that also meant that 54% had some blockage or stiffening of the arteries. The good news is that 27% of those people had minimal or mild coronary artery disease.

But a full 17% had confirmed obstructive coronary artery disease, and another 1 in 10 participants had the highest level of blockages. When they broke the data down by traditional and HIV medication–related risk factors for coronary artery disease, they found something interesting. Although obesity was associated with the presence of atherosclerosis, it wasn’t associated with severe disease. But diabetes was the reverse of that: It wasn’t associated with the presence of the disease, but it was associated with more severe disease.

And when they looked at abacavir, they found no relationship between the drug and atherosclerosis. “Abacavir was not associated with the presence of atherosclerosis and was also not associated with severity of disease,” said Dr. Knudsen.

Although past use of AZT, indinavir, and didanosine were associated with severity of atherosclerosis, that association went away when Dr. Knudsen and team adjusted the findings for time since diagnosis. What was associated atherosclerosis was length of time living with HIV itself. For every 5 years a person lived with HIV, the study found the risk of having any atherosclerosis increased 20% and severity increased 23%. In addition, being a man was associated with a nearly 2.5-times increased risk of having any atherosclerosis and a 96% increased chance of having more severe atherosclerosis. Having diabetes was associated with a nearly threefold increased risk of atherosclerosis, as was every additional decade of life for a person who was living with HIV.

The findings confirm the baseline data of the REPRIEVE trial, which recently released data showing similarly high rates of atherosclerotic plaque in people living with HIV who didn’t register as “at risk” for cardiovascular disease using traditional scoring methods.

“It’s important in that it’s a huge study that’s confirmatory [of] what we know, which is that there are high levels of subclinical coronary artery disease in people living with HIV,” said Steven Grinspoon, MD, professor at Harvard Medical School in Boston, Massachusetts, and principal investigator of REPRIEVE.

As for the lack of association between abacavir and cardiovascular risk, he said he’s taking the findings with a grain of salt.

“It’s hard to make a lot out of that,” he said. “It’s hard to know in a cross-sectional study. People put people on different things.”

In Spain, where Jose Ignacio Bernardino, MD, treats people living with HIV at La Paz University Hospital in Madrid, abacavir is mostly a moot point, as clinicians have long since moved away from maintaining people living with HIV on any abacavir-containing regimens. What’s more important in the study, he told this news organization, is that “worrisome” high level of risk. REPRIEVE will test whether statins can reduce heart disease events in people living with HIV. But in the meantime, he said the take-away for clinicians from the study is the primary importance of traditional cardiovascular risk factors.

“We have to acknowledge that the major cardiovascular risk factor is age,” he said. “When patients are approaching their 50s, I usually try to stress a lot about cardiovascular risk factors in general. I stress healthy lifestyle – get physical exercise, hypertension, glucose, lipids – in every single patient.”

Dr. Knudsen and Dr. Bernardino have disclosed no relevant financial relationships. Dr. Grinspoon reports receiving personal and consulting fees from Theratechnologies and ViiV Healthcare.

A version of this article first appeared on Medscape.com.

The applicability of the results of the ISCHEMIA trial to real-world clinical practice in the United States has been called into question by a new study showing that less than a third of U.S. patients with stable ischemic heart disease (IHD) who currently undergo intervention would meet the trial’s inclusion criteria.

The ISCHEMIA trial, first reported in 2019, showed that, for stable patients with moderate to severe ischemia, an invasive approach using percutaneous coronary intervention (PCI) did not significantly reduce major cardiovascular events after a median 3.2 years of follow-up, compared with a conservative medical strategy.

For the current study, a group of interventionalists analyzed contemporary U.S. data on patients undergoing PCI and found that a large proportion of patients receiving PCI for stable ischemic heart disease in the United States would not have met criteria of the ISCHEMIA trial population.

The study was published online Nov. 1 in JACC: Cardiovascular Interventions).  

“While ISCHEMIA was a very well-conducted trial, our results show that it only applies to about one-third of stable IHD patients undergoing intervention in U.S. clinical practice in the real world. In this group, while ISCHEMIA did not show a reduction in event rate in the intervention group, there was a reduction in symptoms,” lead author Saurav Chatterjee, MD, Long Island Jewish Medical Center, New York, told this news organization.

“But ISCHEMIA did not really answer the question for 67% of stable IHD in current U.S. practice. We may be abIe to defer PCI in these patients, but we don’t know that from the ISCHEMIA trial, as these patients were not included in the trial,” Chatterjee said.  

“There is some concern that people will accept the ISCHEMIA results as being universal, but we cannot apply these results to all stable IHD patients who currently undergo intervention,” he added. “We believe that patients who do not fall into the ISCHEMIA population need a nuanced individual approach, taking into account symptom burden and patient preferences.”

In the new report, Dr. Chatterjee and associates note that the applicability of the ISCHEMIA findings to contemporary practice has been questioned by some, because of the exclusion of a significant proportion of patients that are routinely considered for revascularization, both within and outside of the United States.

They point out that the ISCHEMIA trial recruited 16.5% of its participants from the United States, and the proportion of patients in contemporary U.S. practice that would have qualified for the trial is not clear.

They therefore examined the proportion of stable IHD patients meeting inclusion criteria for the ISCHEMIA trial in a U.S. nationwide PCI registry.

The researchers used data from the National Cardiovascular Data Registry (NCDR) CathPCI Registry, which includes patients undergoing PCI at 1,662 institutions and accounts for more than 90% of PCI-capable hospitals in the United States.

All PCI procedures performed at institutions participating in the NCDR CathPCI Registry from October 2017 to June 2019 were identified. Patients presenting with acute coronary syndrome (ACS), cardiogenic shock, or cardiac arrest were excluded, as there is significant evidence in favor of revascularization in these groups, and they were not included in the ISCHEMIA trial.

Subsequently, all remaining stable IHD patients were classified into one of four groups.

• ISCHEMIA-like: These patients had intermediate- or high-risk findings on a stress test but no high-risk features that would have excluded enrollment into the ISCHEMIA trial
• High risk: This group comprised patients with stable IHD and left ventricular ejection fraction less than 35%, significant unprotected left main stenosis (>50%), preexisting dialysis, recent heart-failure exacerbation, or heart transplant. These patients would have met exclusion criteria for the ISCHEMIA trial
• Low risk: This group included patients with stable and negative or low-risk findings on stress test and would have met exclusion criteria for the ISCHEMIA trial
• Not classifiable: This group comprised patients with stable IHD not fitting any of the other cohorts, including no stress test or extent of ischemia not reported on stress testing. These patients would have not had enough information to clearly meet inclusion or exclusion criteria for the ISCHEMIA trial

Results showed that during the study period 927,011 patients underwent PCI as recorded in the NCDR CathPCI Registry. Of these, 58% had ACS, cardiogenic shock, or cardiac arrest and were excluded; the remaining 388,212 patients who underwent PCI for stable IHD comprised the study population.

Of these, 125,302 (32.28%) had a moderate- or high-risk stress test without high-risk anatomic or clinical features and met ISCHEMIA trial inclusion criteria.

Among stable IHD patients not meeting ISCHEMIA trial inclusion criteria, 71,852 (18.51%) had high-risk criteria that would have excluded them from the ISCHEMIA trial, a total of 67,159 (17.29%) patients had low-risk criteria that would have excluded them from the ISCHEMIA trial, and 123,899 (31.92%) were unclassifiable, either owing to lack of stress testing or the extent of ischemia not being reported on stress testing.

The authors suggest that the unclassifiable patients appear to represent a “higher-risk” population than those closely resembling the ISCHEMIA trial population, with more prior myocardial infarction and heart failure.
 

ISCHEMIA investigators respond

In an accompanying editorial, ISCHEMIA investigators David J. Maron, MD, Stanford (Calif.) University, and Sripal Bangalore, MD, and Judith S. Hochman, MD, New York University, argue that many of the patients highlighted by Dr. Chatterjee and associates were excluded from the ISCHEMIA trial for good reason.

They explain that ISCHEMIA was designed under the premise that prior stable IHD strategy trials such as COURAGE and BARI 2D included lower-risk patients, and the remaining gap was to evaluate the utility of invasive management in those at higher risk with moderate or severe stress-induced ischemia.

They point out that, among the NCDR patients with stable IHD in the current study by Dr. Chatterjee and associates who did not meet ISCHEMIA entry criteria, 18.5% had high-risk features, including 35.2% with left main coronary artery disease, 43.7% with left ventricular systolic dysfunction, and 16.8% with end-stage renal disease.

Although ISCHEMIA results do not apply to patients who were excluded from the trial, there is little controversy regarding the benefit of revascularization in patients with stable IHD with left main coronary artery disease or left ventricular ejection fraction <35%, which is why they were excluded from ISCHEMIA, the editorialists note.  

They also report that patients with end-stage renal disease, who were also designated as not meeting ISCHEMIA inclusion criteria, were included in the companion ISCHEMIA CKD trial.

They further point out that, at the other end of the risk spectrum, 17.3% of stable IHD patients in the current analysis had negative or low-risk functional testing, and these patients were excluded from ISCHEMIA because they were shown in COURAGE and BARI 2D to not benefit from revascularization, and they do not meet guideline recommendations for elective PCI in the absence of symptoms.

Of the 31.9% of stable IHD patients who had missing data on ischemic burden, the ISCHEMIA investigators say that some of these would have qualified for the trial, although it is not possible to say how many. They suggest a conservative estimate of 50%.

Taking these arguments into account, the editorialists recalculated the proportion of NCDR PCI patients with stable IHD who would have been included in ISCHEMIA as between 62.1% and 68.6% of patients.

They say the current NCDR analysis by Dr. Chatterjee and associates should be interpreted as indicating, at worst, that the ISCHEMIA trial results apply to only 32% of patients undergoing elective PCI in the United States, and at best “that the results apply to a far higher proportion, excluding only those at high risk (18.5%) or with unacceptable symptoms despite maximal medical therapy (percentage unknown), for whom PCI is clearly indicated.”

The editorialists conclude: “The purpose of the analysis by Chatterjee et al. is to inform the cardiovascular community of the proportion of patients with stable IHD in clinical practice who would have been excluded from ISCHEMIA without regard for the logic of each exclusion criterion. The purpose of this editorial is to provide context for the analysis, admittedly from the perspective of ISCHEMIA investigators, with the hope that this helps readers clearly see the relevance of the trial to patients under their care.”

They add: “For practical and ethical reasons, ISCHEMIA excluded stable patients with high-risk features, angina inadequately controlled by medication, and low-risk features who do not meet evidence-based guidelines for revascularization. That leaves a large percentage of patients for whom the ISCHEMIA trial is highly relevant; exactly what percentage on the basis of NCDR data is hard to say.”

The ISCHEMIA trial was supported by the National Heart, Lung, and Blood Institute.

A version of this article first appeared on Medscape.com.

The applicability of the results of the ISCHEMIA trial to real-world clinical practice in the United States has been called into question by a new study showing that less than a third of U.S. patients with stable ischemic heart disease (IHD) who currently undergo intervention would meet the trial’s inclusion criteria.

The ISCHEMIA trial, first reported in 2019, showed that, for stable patients with moderate to severe ischemia, an invasive approach using percutaneous coronary intervention (PCI) did not significantly reduce major cardiovascular events after a median 3.2 years of follow-up, compared with a conservative medical strategy.

For the current study, a group of interventionalists analyzed contemporary U.S. data on patients undergoing PCI and found that a large proportion of patients receiving PCI for stable ischemic heart disease in the United States would not have met criteria of the ISCHEMIA trial population.

The study was published online Nov. 1 in JACC: Cardiovascular Interventions).  

“While ISCHEMIA was a very well-conducted trial, our results show that it only applies to about one-third of stable IHD patients undergoing intervention in U.S. clinical practice in the real world. In this group, while ISCHEMIA did not show a reduction in event rate in the intervention group, there was a reduction in symptoms,” lead author Saurav Chatterjee, MD, Long Island Jewish Medical Center, New York, told this news organization.

“But ISCHEMIA did not really answer the question for 67% of stable IHD in current U.S. practice. We may be abIe to defer PCI in these patients, but we don’t know that from the ISCHEMIA trial, as these patients were not included in the trial,” Chatterjee said.  

“There is some concern that people will accept the ISCHEMIA results as being universal, but we cannot apply these results to all stable IHD patients who currently undergo intervention,” he added. “We believe that patients who do not fall into the ISCHEMIA population need a nuanced individual approach, taking into account symptom burden and patient preferences.”

In the new report, Dr. Chatterjee and associates note that the applicability of the ISCHEMIA findings to contemporary practice has been questioned by some, because of the exclusion of a significant proportion of patients that are routinely considered for revascularization, both within and outside of the United States.

They point out that the ISCHEMIA trial recruited 16.5% of its participants from the United States, and the proportion of patients in contemporary U.S. practice that would have qualified for the trial is not clear.

They therefore examined the proportion of stable IHD patients meeting inclusion criteria for the ISCHEMIA trial in a U.S. nationwide PCI registry.

The researchers used data from the National Cardiovascular Data Registry (NCDR) CathPCI Registry, which includes patients undergoing PCI at 1,662 institutions and accounts for more than 90% of PCI-capable hospitals in the United States.

All PCI procedures performed at institutions participating in the NCDR CathPCI Registry from October 2017 to June 2019 were identified. Patients presenting with acute coronary syndrome (ACS), cardiogenic shock, or cardiac arrest were excluded, as there is significant evidence in favor of revascularization in these groups, and they were not included in the ISCHEMIA trial.

Subsequently, all remaining stable IHD patients were classified into one of four groups.

• ISCHEMIA-like: These patients had intermediate- or high-risk findings on a stress test but no high-risk features that would have excluded enrollment into the ISCHEMIA trial
• High risk: This group comprised patients with stable IHD and left ventricular ejection fraction less than 35%, significant unprotected left main stenosis (>50%), preexisting dialysis, recent heart-failure exacerbation, or heart transplant. These patients would have met exclusion criteria for the ISCHEMIA trial
• Low risk: This group included patients with stable and negative or low-risk findings on stress test and would have met exclusion criteria for the ISCHEMIA trial
• Not classifiable: This group comprised patients with stable IHD not fitting any of the other cohorts, including no stress test or extent of ischemia not reported on stress testing. These patients would have not had enough information to clearly meet inclusion or exclusion criteria for the ISCHEMIA trial

Results showed that during the study period 927,011 patients underwent PCI as recorded in the NCDR CathPCI Registry. Of these, 58% had ACS, cardiogenic shock, or cardiac arrest and were excluded; the remaining 388,212 patients who underwent PCI for stable IHD comprised the study population.

Of these, 125,302 (32.28%) had a moderate- or high-risk stress test without high-risk anatomic or clinical features and met ISCHEMIA trial inclusion criteria.

Among stable IHD patients not meeting ISCHEMIA trial inclusion criteria, 71,852 (18.51%) had high-risk criteria that would have excluded them from the ISCHEMIA trial, a total of 67,159 (17.29%) patients had low-risk criteria that would have excluded them from the ISCHEMIA trial, and 123,899 (31.92%) were unclassifiable, either owing to lack of stress testing or the extent of ischemia not being reported on stress testing.

The authors suggest that the unclassifiable patients appear to represent a “higher-risk” population than those closely resembling the ISCHEMIA trial population, with more prior myocardial infarction and heart failure.
 

ISCHEMIA investigators respond

In an accompanying editorial, ISCHEMIA investigators David J. Maron, MD, Stanford (Calif.) University, and Sripal Bangalore, MD, and Judith S. Hochman, MD, New York University, argue that many of the patients highlighted by Dr. Chatterjee and associates were excluded from the ISCHEMIA trial for good reason.

They explain that ISCHEMIA was designed under the premise that prior stable IHD strategy trials such as COURAGE and BARI 2D included lower-risk patients, and the remaining gap was to evaluate the utility of invasive management in those at higher risk with moderate or severe stress-induced ischemia.

They point out that, among the NCDR patients with stable IHD in the current study by Dr. Chatterjee and associates who did not meet ISCHEMIA entry criteria, 18.5% had high-risk features, including 35.2% with left main coronary artery disease, 43.7% with left ventricular systolic dysfunction, and 16.8% with end-stage renal disease.

Although ISCHEMIA results do not apply to patients who were excluded from the trial, there is little controversy regarding the benefit of revascularization in patients with stable IHD with left main coronary artery disease or left ventricular ejection fraction <35%, which is why they were excluded from ISCHEMIA, the editorialists note.  

They also report that patients with end-stage renal disease, who were also designated as not meeting ISCHEMIA inclusion criteria, were included in the companion ISCHEMIA CKD trial.

They further point out that, at the other end of the risk spectrum, 17.3% of stable IHD patients in the current analysis had negative or low-risk functional testing, and these patients were excluded from ISCHEMIA because they were shown in COURAGE and BARI 2D to not benefit from revascularization, and they do not meet guideline recommendations for elective PCI in the absence of symptoms.

Of the 31.9% of stable IHD patients who had missing data on ischemic burden, the ISCHEMIA investigators say that some of these would have qualified for the trial, although it is not possible to say how many. They suggest a conservative estimate of 50%.

Taking these arguments into account, the editorialists recalculated the proportion of NCDR PCI patients with stable IHD who would have been included in ISCHEMIA as between 62.1% and 68.6% of patients.

They say the current NCDR analysis by Dr. Chatterjee and associates should be interpreted as indicating, at worst, that the ISCHEMIA trial results apply to only 32% of patients undergoing elective PCI in the United States, and at best “that the results apply to a far higher proportion, excluding only those at high risk (18.5%) or with unacceptable symptoms despite maximal medical therapy (percentage unknown), for whom PCI is clearly indicated.”

The editorialists conclude: “The purpose of the analysis by Chatterjee et al. is to inform the cardiovascular community of the proportion of patients with stable IHD in clinical practice who would have been excluded from ISCHEMIA without regard for the logic of each exclusion criterion. The purpose of this editorial is to provide context for the analysis, admittedly from the perspective of ISCHEMIA investigators, with the hope that this helps readers clearly see the relevance of the trial to patients under their care.”

They add: “For practical and ethical reasons, ISCHEMIA excluded stable patients with high-risk features, angina inadequately controlled by medication, and low-risk features who do not meet evidence-based guidelines for revascularization. That leaves a large percentage of patients for whom the ISCHEMIA trial is highly relevant; exactly what percentage on the basis of NCDR data is hard to say.”

The ISCHEMIA trial was supported by the National Heart, Lung, and Blood Institute.

A version of this article first appeared on Medscape.com.

The applicability of the results of the ISCHEMIA trial to real-world clinical practice in the United States has been called into question by a new study showing that less than a third of U.S. patients with stable ischemic heart disease (IHD) who currently undergo intervention would meet the trial’s inclusion criteria.

The ISCHEMIA trial, first reported in 2019, showed that, for stable patients with moderate to severe ischemia, an invasive approach using percutaneous coronary intervention (PCI) did not significantly reduce major cardiovascular events after a median 3.2 years of follow-up, compared with a conservative medical strategy.

For the current study, a group of interventionalists analyzed contemporary U.S. data on patients undergoing PCI and found that a large proportion of patients receiving PCI for stable ischemic heart disease in the United States would not have met criteria of the ISCHEMIA trial population.

The study was published online Nov. 1 in JACC: Cardiovascular Interventions).  

“While ISCHEMIA was a very well-conducted trial, our results show that it only applies to about one-third of stable IHD patients undergoing intervention in U.S. clinical practice in the real world. In this group, while ISCHEMIA did not show a reduction in event rate in the intervention group, there was a reduction in symptoms,” lead author Saurav Chatterjee, MD, Long Island Jewish Medical Center, New York, told this news organization.

“But ISCHEMIA did not really answer the question for 67% of stable IHD in current U.S. practice. We may be abIe to defer PCI in these patients, but we don’t know that from the ISCHEMIA trial, as these patients were not included in the trial,” Chatterjee said.  

“There is some concern that people will accept the ISCHEMIA results as being universal, but we cannot apply these results to all stable IHD patients who currently undergo intervention,” he added. “We believe that patients who do not fall into the ISCHEMIA population need a nuanced individual approach, taking into account symptom burden and patient preferences.”

In the new report, Dr. Chatterjee and associates note that the applicability of the ISCHEMIA findings to contemporary practice has been questioned by some, because of the exclusion of a significant proportion of patients that are routinely considered for revascularization, both within and outside of the United States.

They point out that the ISCHEMIA trial recruited 16.5% of its participants from the United States, and the proportion of patients in contemporary U.S. practice that would have qualified for the trial is not clear.

They therefore examined the proportion of stable IHD patients meeting inclusion criteria for the ISCHEMIA trial in a U.S. nationwide PCI registry.

The researchers used data from the National Cardiovascular Data Registry (NCDR) CathPCI Registry, which includes patients undergoing PCI at 1,662 institutions and accounts for more than 90% of PCI-capable hospitals in the United States.

All PCI procedures performed at institutions participating in the NCDR CathPCI Registry from October 2017 to June 2019 were identified. Patients presenting with acute coronary syndrome (ACS), cardiogenic shock, or cardiac arrest were excluded, as there is significant evidence in favor of revascularization in these groups, and they were not included in the ISCHEMIA trial.

Subsequently, all remaining stable IHD patients were classified into one of four groups.

• ISCHEMIA-like: These patients had intermediate- or high-risk findings on a stress test but no high-risk features that would have excluded enrollment into the ISCHEMIA trial
• High risk: This group comprised patients with stable IHD and left ventricular ejection fraction less than 35%, significant unprotected left main stenosis (>50%), preexisting dialysis, recent heart-failure exacerbation, or heart transplant. These patients would have met exclusion criteria for the ISCHEMIA trial
• Low risk: This group included patients with stable and negative or low-risk findings on stress test and would have met exclusion criteria for the ISCHEMIA trial
• Not classifiable: This group comprised patients with stable IHD not fitting any of the other cohorts, including no stress test or extent of ischemia not reported on stress testing. These patients would have not had enough information to clearly meet inclusion or exclusion criteria for the ISCHEMIA trial

Results showed that during the study period 927,011 patients underwent PCI as recorded in the NCDR CathPCI Registry. Of these, 58% had ACS, cardiogenic shock, or cardiac arrest and were excluded; the remaining 388,212 patients who underwent PCI for stable IHD comprised the study population.

Of these, 125,302 (32.28%) had a moderate- or high-risk stress test without high-risk anatomic or clinical features and met ISCHEMIA trial inclusion criteria.

Among stable IHD patients not meeting ISCHEMIA trial inclusion criteria, 71,852 (18.51%) had high-risk criteria that would have excluded them from the ISCHEMIA trial, a total of 67,159 (17.29%) patients had low-risk criteria that would have excluded them from the ISCHEMIA trial, and 123,899 (31.92%) were unclassifiable, either owing to lack of stress testing or the extent of ischemia not being reported on stress testing.

The authors suggest that the unclassifiable patients appear to represent a “higher-risk” population than those closely resembling the ISCHEMIA trial population, with more prior myocardial infarction and heart failure.
 

ISCHEMIA investigators respond

In an accompanying editorial, ISCHEMIA investigators David J. Maron, MD, Stanford (Calif.) University, and Sripal Bangalore, MD, and Judith S. Hochman, MD, New York University, argue that many of the patients highlighted by Dr. Chatterjee and associates were excluded from the ISCHEMIA trial for good reason.

They explain that ISCHEMIA was designed under the premise that prior stable IHD strategy trials such as COURAGE and BARI 2D included lower-risk patients, and the remaining gap was to evaluate the utility of invasive management in those at higher risk with moderate or severe stress-induced ischemia.

They point out that, among the NCDR patients with stable IHD in the current study by Dr. Chatterjee and associates who did not meet ISCHEMIA entry criteria, 18.5% had high-risk features, including 35.2% with left main coronary artery disease, 43.7% with left ventricular systolic dysfunction, and 16.8% with end-stage renal disease.

Although ISCHEMIA results do not apply to patients who were excluded from the trial, there is little controversy regarding the benefit of revascularization in patients with stable IHD with left main coronary artery disease or left ventricular ejection fraction <35%, which is why they were excluded from ISCHEMIA, the editorialists note.  

They also report that patients with end-stage renal disease, who were also designated as not meeting ISCHEMIA inclusion criteria, were included in the companion ISCHEMIA CKD trial.

They further point out that, at the other end of the risk spectrum, 17.3% of stable IHD patients in the current analysis had negative or low-risk functional testing, and these patients were excluded from ISCHEMIA because they were shown in COURAGE and BARI 2D to not benefit from revascularization, and they do not meet guideline recommendations for elective PCI in the absence of symptoms.

Of the 31.9% of stable IHD patients who had missing data on ischemic burden, the ISCHEMIA investigators say that some of these would have qualified for the trial, although it is not possible to say how many. They suggest a conservative estimate of 50%.

Taking these arguments into account, the editorialists recalculated the proportion of NCDR PCI patients with stable IHD who would have been included in ISCHEMIA as between 62.1% and 68.6% of patients.

They say the current NCDR analysis by Dr. Chatterjee and associates should be interpreted as indicating, at worst, that the ISCHEMIA trial results apply to only 32% of patients undergoing elective PCI in the United States, and at best “that the results apply to a far higher proportion, excluding only those at high risk (18.5%) or with unacceptable symptoms despite maximal medical therapy (percentage unknown), for whom PCI is clearly indicated.”

The editorialists conclude: “The purpose of the analysis by Chatterjee et al. is to inform the cardiovascular community of the proportion of patients with stable IHD in clinical practice who would have been excluded from ISCHEMIA without regard for the logic of each exclusion criterion. The purpose of this editorial is to provide context for the analysis, admittedly from the perspective of ISCHEMIA investigators, with the hope that this helps readers clearly see the relevance of the trial to patients under their care.”

They add: “For practical and ethical reasons, ISCHEMIA excluded stable patients with high-risk features, angina inadequately controlled by medication, and low-risk features who do not meet evidence-based guidelines for revascularization. That leaves a large percentage of patients for whom the ISCHEMIA trial is highly relevant; exactly what percentage on the basis of NCDR data is hard to say.”

The ISCHEMIA trial was supported by the National Heart, Lung, and Blood Institute.

A version of this article first appeared on Medscape.com.

Coronary stenting guided by fractional flow reserve (FFR) readings, considered to reflect the targeted lesion’s functional impact, was no match for coronary bypass surgery (CABG) in patients with multivessel disease (MVD) in a major international randomized trial.

M. Alexander Otto/MDedge News

Indeed, FFR-guided percutaneous coronary intervention (PCI) using one of the latest drug-eluting stents (DES) seemed to perform poorly in the trial, compared with surgery, apparently upping the risk for clinical events by 50% over 1 year.

Designed statistically for noninferiority, the third Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME 3) trial, with 1,500 randomized patients, showed that FFR-guided PCI was “not noninferior” to CABG. Of those randomized to PCI, 10.6% met the 1-year primary endpoint of major adverse cardiac or cerebrovascular events (MACCE), compared with only 6.9% of patients assigned to CABG.

The trial enrolled only patients with three-vessel coronary disease with no left-main coronary artery involvement, who were declared by their institution’s multidisciplinary heart team to be appropriate for either form of revascularization.

One of the roles of FFR for PCI guidance is to identify significant lesions “that are underrecognized by the angiogram,” which is less likely to happen in patients with very complex coronary anatomy, study chair William F. Fearon, MD, Stanford (Calif.) University, said in an interview.

“That’s what we saw in a subgroup analysis based on SYNTAX score,” an index of lesion complexity. “In patients with very high SYNTAX scores, CABG outperformed FFR-guided PCI. But if you look at patients with low SYNTAX scores, actually, FFR-guided PCI outperformed CABG for 1-year MACCE.”

Dr. Fearon is lead author on the study’s Nov. 4, 2021, publication in the New England Journal of Medicine, its release timed to coincide with his presentation of the trial at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

He noted that FAME-3 “wasn’t designed or powered to test for superiority,” so its results do not imply CABG is superior to FFR-PCI in patients with MVD, and remains “inconclusive” on that question.

“I think what this study does is provide both the physician and patients more contemporary data and information on options and expected outcomes in multivessel disease. So if you are a patient who has less complex disease, I think you can feel comfortable that you will get an equivalent result with FFR-guided PCI.” But, at least based on FAME-3, Dr. Fearon said, CABG provides better outcomes in patients with more complex disease.

“I think there are still patients that look at trade-offs. Some patients will accept a higher event rate in order to avoid a long recovery, and vice versa.” So the trial may allow patients and physicians to make more informed decisions, he said.

A main message of FAME-3 “is that we’re getting very good results with three-vessel PCI, but better results with surgery,” Ran Kornowski, MD, Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, said as a discussant following Dr. Fearon’s presentation of the trial. The subanalysis by SYNTAX score, he agreed, probably could be used as part of shared decision-making with patients.

Not all that surprising

“It’s a well-designed study, with a lot of patients,” said surgeon Frank W. Sellke, MD, of Rhode Island Hospital, Miriam Hospital, and Brown University, all in Providence.

“I don’t think it’s all that surprising,” he said in an interview. “It’s very consistent with what other studies have shown, that for three-vessel disease, surgery tends to have the edge,” even when pitted against FFR-guided PCI.

Indeed, pressure-wire FFR-PCI has a spotty history, even as an alternative to standard angiography-based PCI. For example, it has performed well in registry and other cohort studies but showed no advantage in the all-comers RIPCORD-2 trial or in the setting of complete revascularization PCI for acute MI in FLOWER-MI. And it emitted an increased-mortality signal in the prematurely halted FUTURE trial.

In FAME-3, “the 1-year follow-up was the best chance for FFR-PCI to be noninferior to CABG. The CABG advantage is only going to get better with time if prior experience and pathobiology is true,” Sanjay Kaul, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

Overall, “the quality and quantity of evidence is insufficient to support FFR-guided PCI” in patients with complex coronary artery disease (CAD), he said. “I would also argue that the evidence for FFR-guided PCI for simple CAD is also not high quality.”

Dr. Kaul also blasted the claim that FFR-PCI was seen to perform better against CABG in patients with low SYNTAX scores. “In general, one cannot use a positive subgroup in a null or negative trial, as is the case with FAME-3, to ‘rescue’ the treatment intervention.” Such a positive subgroup finding, he said, “would at best be deemed hypothesis-generating and not hypothesis validating.”

Dr. Fearon agreed that the subgroup analysis by SYNTAX score, though prespecified, was only hypothesis generating. “But I think that other studies have shown the same thing – that in less complex disease, the two strategies appear to perform in a similar fashion.”

The FAME-3 trial’s 1,500 patients were randomly assigned at 48 centers to undergo standard CABG or FFR-guided PCI with Resolute Integrity (Medtronic) zotarolimus-eluting DES. Lesions with a pressure-wire FFR of 0.80 or less were stented and those with higher FFR readings were deferred.

The 1-year hazard ratio for the primary endpoint—a composite of death from any cause, MI, stroke, or repeat revascularization – was 1.5 (95% confidence interval, 1.1-2.2) with a noninferiority P value of .35 for the comparison of FFR-PCI versus CABG.

FFR-guided PCI fared significantly better than CABG for some safety endpoints, including major bleeding (1.6% vs 3.8%, P < .01), arrhythmia including atrial fibrillation (2.4% vs. 14.1%, P < .001), acute kidney injury (0.1% vs 0.9%, P < .04), and 30-day rehospitalization (5.5% vs 10.2%, P < .001).
 

Did the primary endpoint favor CABG?

At a media briefing prior to Dr. Fearon’s TCT 2021 presentation of the trail, Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, proposed that the inclusion of repeat revascularization in the trial’s composite primary endpoint tilted the outcome in favor of CABG. “To me, the FAME-3 results are predictable because repeat revascularization is in the equation.”

M. Alexander Otto, MDedge News

It’s well recognized that the endpoint is less likely after CABG than PCI. The latter treats focal lesions that are a limited part of a coronary artery in which CAD is still likely progressing. CABG, on the other hand, can bypass longer segments of diseased artery.

Indeed, as Dr. Fearon reported, the rates of death, MI, or stroke excluding repeat revascularization were 7.3% with FFR-PCI and 5.2% for CABG, for an HR of 1.4 (95% CI, 0.9-2.1).

Dr. Mehran also proposed that intravascular-ultrasound (IVUS) guidance, had it been part of the trial, could potentially have boosted the performance of FFR-PCI.

Repeat revascularization, Dr. Kaul agreed, “should not have been included” in the trial’s primary endpoint. It had been added “to amplify events and to minimize sample size. Not including revascularization would render the sample size prohibitive. There is always give and take in designing clinical trials.”

And he agreed that “IVUS-based PCI optimization would have further improved PCI outcomes.” However, “IVUS plus FFR adds to the procedural burden and limited resources available.” Dr. Fearon said when interviewed that the trial’s definition of procedural MI, a component of the primary endpoint, might potentially be seen as controversial. Procedural MIs in both the PCI and CABG groups were required to meet the standards of CABG-related type-5 MI according to the third and fourth Universal Definitions. The had also had to be accompanied by “a significant finding like new Q waves or a new wall-motion abnormality on echocardiography,” he said.

“That’s fairly strict. Because of that, we had a low rate of periprocedural MI and it was similar between the two groups, around 1.5% in both arms.”

FAME-3 was funded by Medtronic and Abbott Vascular. Dr. Kaul disclosed no relevant financial relationships. Dr. Kornowsky receives royalties from or holds intellectual property rights with CathWorks. Dr. Mehran disclosed financial ties to numerous pharmaceutical and device companies, and that she, her spouse, or her institution hold equity in Elixir Medical, Applied Therapeutics, and ControlRad.

A version of this article first appeared on Medscape.com.

Coronary stenting guided by fractional flow reserve (FFR) readings, considered to reflect the targeted lesion’s functional impact, was no match for coronary bypass surgery (CABG) in patients with multivessel disease (MVD) in a major international randomized trial.

M. Alexander Otto/MDedge News

Indeed, FFR-guided percutaneous coronary intervention (PCI) using one of the latest drug-eluting stents (DES) seemed to perform poorly in the trial, compared with surgery, apparently upping the risk for clinical events by 50% over 1 year.

Designed statistically for noninferiority, the third Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME 3) trial, with 1,500 randomized patients, showed that FFR-guided PCI was “not noninferior” to CABG. Of those randomized to PCI, 10.6% met the 1-year primary endpoint of major adverse cardiac or cerebrovascular events (MACCE), compared with only 6.9% of patients assigned to CABG.

The trial enrolled only patients with three-vessel coronary disease with no left-main coronary artery involvement, who were declared by their institution’s multidisciplinary heart team to be appropriate for either form of revascularization.

One of the roles of FFR for PCI guidance is to identify significant lesions “that are underrecognized by the angiogram,” which is less likely to happen in patients with very complex coronary anatomy, study chair William F. Fearon, MD, Stanford (Calif.) University, said in an interview.

“That’s what we saw in a subgroup analysis based on SYNTAX score,” an index of lesion complexity. “In patients with very high SYNTAX scores, CABG outperformed FFR-guided PCI. But if you look at patients with low SYNTAX scores, actually, FFR-guided PCI outperformed CABG for 1-year MACCE.”

Dr. Fearon is lead author on the study’s Nov. 4, 2021, publication in the New England Journal of Medicine, its release timed to coincide with his presentation of the trial at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

He noted that FAME-3 “wasn’t designed or powered to test for superiority,” so its results do not imply CABG is superior to FFR-PCI in patients with MVD, and remains “inconclusive” on that question.

“I think what this study does is provide both the physician and patients more contemporary data and information on options and expected outcomes in multivessel disease. So if you are a patient who has less complex disease, I think you can feel comfortable that you will get an equivalent result with FFR-guided PCI.” But, at least based on FAME-3, Dr. Fearon said, CABG provides better outcomes in patients with more complex disease.

“I think there are still patients that look at trade-offs. Some patients will accept a higher event rate in order to avoid a long recovery, and vice versa.” So the trial may allow patients and physicians to make more informed decisions, he said.

A main message of FAME-3 “is that we’re getting very good results with three-vessel PCI, but better results with surgery,” Ran Kornowski, MD, Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, said as a discussant following Dr. Fearon’s presentation of the trial. The subanalysis by SYNTAX score, he agreed, probably could be used as part of shared decision-making with patients.

Not all that surprising

“It’s a well-designed study, with a lot of patients,” said surgeon Frank W. Sellke, MD, of Rhode Island Hospital, Miriam Hospital, and Brown University, all in Providence.

“I don’t think it’s all that surprising,” he said in an interview. “It’s very consistent with what other studies have shown, that for three-vessel disease, surgery tends to have the edge,” even when pitted against FFR-guided PCI.

Indeed, pressure-wire FFR-PCI has a spotty history, even as an alternative to standard angiography-based PCI. For example, it has performed well in registry and other cohort studies but showed no advantage in the all-comers RIPCORD-2 trial or in the setting of complete revascularization PCI for acute MI in FLOWER-MI. And it emitted an increased-mortality signal in the prematurely halted FUTURE trial.

In FAME-3, “the 1-year follow-up was the best chance for FFR-PCI to be noninferior to CABG. The CABG advantage is only going to get better with time if prior experience and pathobiology is true,” Sanjay Kaul, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

Overall, “the quality and quantity of evidence is insufficient to support FFR-guided PCI” in patients with complex coronary artery disease (CAD), he said. “I would also argue that the evidence for FFR-guided PCI for simple CAD is also not high quality.”

Dr. Kaul also blasted the claim that FFR-PCI was seen to perform better against CABG in patients with low SYNTAX scores. “In general, one cannot use a positive subgroup in a null or negative trial, as is the case with FAME-3, to ‘rescue’ the treatment intervention.” Such a positive subgroup finding, he said, “would at best be deemed hypothesis-generating and not hypothesis validating.”

Dr. Fearon agreed that the subgroup analysis by SYNTAX score, though prespecified, was only hypothesis generating. “But I think that other studies have shown the same thing – that in less complex disease, the two strategies appear to perform in a similar fashion.”

The FAME-3 trial’s 1,500 patients were randomly assigned at 48 centers to undergo standard CABG or FFR-guided PCI with Resolute Integrity (Medtronic) zotarolimus-eluting DES. Lesions with a pressure-wire FFR of 0.80 or less were stented and those with higher FFR readings were deferred.

The 1-year hazard ratio for the primary endpoint—a composite of death from any cause, MI, stroke, or repeat revascularization – was 1.5 (95% confidence interval, 1.1-2.2) with a noninferiority P value of .35 for the comparison of FFR-PCI versus CABG.

FFR-guided PCI fared significantly better than CABG for some safety endpoints, including major bleeding (1.6% vs 3.8%, P < .01), arrhythmia including atrial fibrillation (2.4% vs. 14.1%, P < .001), acute kidney injury (0.1% vs 0.9%, P < .04), and 30-day rehospitalization (5.5% vs 10.2%, P < .001).
 

Did the primary endpoint favor CABG?

At a media briefing prior to Dr. Fearon’s TCT 2021 presentation of the trail, Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, proposed that the inclusion of repeat revascularization in the trial’s composite primary endpoint tilted the outcome in favor of CABG. “To me, the FAME-3 results are predictable because repeat revascularization is in the equation.”

M. Alexander Otto, MDedge News

It’s well recognized that the endpoint is less likely after CABG than PCI. The latter treats focal lesions that are a limited part of a coronary artery in which CAD is still likely progressing. CABG, on the other hand, can bypass longer segments of diseased artery.

Indeed, as Dr. Fearon reported, the rates of death, MI, or stroke excluding repeat revascularization were 7.3% with FFR-PCI and 5.2% for CABG, for an HR of 1.4 (95% CI, 0.9-2.1).

Dr. Mehran also proposed that intravascular-ultrasound (IVUS) guidance, had it been part of the trial, could potentially have boosted the performance of FFR-PCI.

Repeat revascularization, Dr. Kaul agreed, “should not have been included” in the trial’s primary endpoint. It had been added “to amplify events and to minimize sample size. Not including revascularization would render the sample size prohibitive. There is always give and take in designing clinical trials.”

And he agreed that “IVUS-based PCI optimization would have further improved PCI outcomes.” However, “IVUS plus FFR adds to the procedural burden and limited resources available.” Dr. Fearon said when interviewed that the trial’s definition of procedural MI, a component of the primary endpoint, might potentially be seen as controversial. Procedural MIs in both the PCI and CABG groups were required to meet the standards of CABG-related type-5 MI according to the third and fourth Universal Definitions. The had also had to be accompanied by “a significant finding like new Q waves or a new wall-motion abnormality on echocardiography,” he said.

“That’s fairly strict. Because of that, we had a low rate of periprocedural MI and it was similar between the two groups, around 1.5% in both arms.”

FAME-3 was funded by Medtronic and Abbott Vascular. Dr. Kaul disclosed no relevant financial relationships. Dr. Kornowsky receives royalties from or holds intellectual property rights with CathWorks. Dr. Mehran disclosed financial ties to numerous pharmaceutical and device companies, and that she, her spouse, or her institution hold equity in Elixir Medical, Applied Therapeutics, and ControlRad.

A version of this article first appeared on Medscape.com.

Coronary stenting guided by fractional flow reserve (FFR) readings, considered to reflect the targeted lesion’s functional impact, was no match for coronary bypass surgery (CABG) in patients with multivessel disease (MVD) in a major international randomized trial.

M. Alexander Otto/MDedge News

Indeed, FFR-guided percutaneous coronary intervention (PCI) using one of the latest drug-eluting stents (DES) seemed to perform poorly in the trial, compared with surgery, apparently upping the risk for clinical events by 50% over 1 year.

Designed statistically for noninferiority, the third Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME 3) trial, with 1,500 randomized patients, showed that FFR-guided PCI was “not noninferior” to CABG. Of those randomized to PCI, 10.6% met the 1-year primary endpoint of major adverse cardiac or cerebrovascular events (MACCE), compared with only 6.9% of patients assigned to CABG.

The trial enrolled only patients with three-vessel coronary disease with no left-main coronary artery involvement, who were declared by their institution’s multidisciplinary heart team to be appropriate for either form of revascularization.

One of the roles of FFR for PCI guidance is to identify significant lesions “that are underrecognized by the angiogram,” which is less likely to happen in patients with very complex coronary anatomy, study chair William F. Fearon, MD, Stanford (Calif.) University, said in an interview.

“That’s what we saw in a subgroup analysis based on SYNTAX score,” an index of lesion complexity. “In patients with very high SYNTAX scores, CABG outperformed FFR-guided PCI. But if you look at patients with low SYNTAX scores, actually, FFR-guided PCI outperformed CABG for 1-year MACCE.”

Dr. Fearon is lead author on the study’s Nov. 4, 2021, publication in the New England Journal of Medicine, its release timed to coincide with his presentation of the trial at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

He noted that FAME-3 “wasn’t designed or powered to test for superiority,” so its results do not imply CABG is superior to FFR-PCI in patients with MVD, and remains “inconclusive” on that question.

“I think what this study does is provide both the physician and patients more contemporary data and information on options and expected outcomes in multivessel disease. So if you are a patient who has less complex disease, I think you can feel comfortable that you will get an equivalent result with FFR-guided PCI.” But, at least based on FAME-3, Dr. Fearon said, CABG provides better outcomes in patients with more complex disease.

“I think there are still patients that look at trade-offs. Some patients will accept a higher event rate in order to avoid a long recovery, and vice versa.” So the trial may allow patients and physicians to make more informed decisions, he said.

A main message of FAME-3 “is that we’re getting very good results with three-vessel PCI, but better results with surgery,” Ran Kornowski, MD, Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, said as a discussant following Dr. Fearon’s presentation of the trial. The subanalysis by SYNTAX score, he agreed, probably could be used as part of shared decision-making with patients.

Not all that surprising

“It’s a well-designed study, with a lot of patients,” said surgeon Frank W. Sellke, MD, of Rhode Island Hospital, Miriam Hospital, and Brown University, all in Providence.

“I don’t think it’s all that surprising,” he said in an interview. “It’s very consistent with what other studies have shown, that for three-vessel disease, surgery tends to have the edge,” even when pitted against FFR-guided PCI.

Indeed, pressure-wire FFR-PCI has a spotty history, even as an alternative to standard angiography-based PCI. For example, it has performed well in registry and other cohort studies but showed no advantage in the all-comers RIPCORD-2 trial or in the setting of complete revascularization PCI for acute MI in FLOWER-MI. And it emitted an increased-mortality signal in the prematurely halted FUTURE trial.

In FAME-3, “the 1-year follow-up was the best chance for FFR-PCI to be noninferior to CABG. The CABG advantage is only going to get better with time if prior experience and pathobiology is true,” Sanjay Kaul, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

Overall, “the quality and quantity of evidence is insufficient to support FFR-guided PCI” in patients with complex coronary artery disease (CAD), he said. “I would also argue that the evidence for FFR-guided PCI for simple CAD is also not high quality.”

Dr. Kaul also blasted the claim that FFR-PCI was seen to perform better against CABG in patients with low SYNTAX scores. “In general, one cannot use a positive subgroup in a null or negative trial, as is the case with FAME-3, to ‘rescue’ the treatment intervention.” Such a positive subgroup finding, he said, “would at best be deemed hypothesis-generating and not hypothesis validating.”

Dr. Fearon agreed that the subgroup analysis by SYNTAX score, though prespecified, was only hypothesis generating. “But I think that other studies have shown the same thing – that in less complex disease, the two strategies appear to perform in a similar fashion.”

The FAME-3 trial’s 1,500 patients were randomly assigned at 48 centers to undergo standard CABG or FFR-guided PCI with Resolute Integrity (Medtronic) zotarolimus-eluting DES. Lesions with a pressure-wire FFR of 0.80 or less were stented and those with higher FFR readings were deferred.

The 1-year hazard ratio for the primary endpoint—a composite of death from any cause, MI, stroke, or repeat revascularization – was 1.5 (95% confidence interval, 1.1-2.2) with a noninferiority P value of .35 for the comparison of FFR-PCI versus CABG.

FFR-guided PCI fared significantly better than CABG for some safety endpoints, including major bleeding (1.6% vs 3.8%, P < .01), arrhythmia including atrial fibrillation (2.4% vs. 14.1%, P < .001), acute kidney injury (0.1% vs 0.9%, P < .04), and 30-day rehospitalization (5.5% vs 10.2%, P < .001).
 

Did the primary endpoint favor CABG?

At a media briefing prior to Dr. Fearon’s TCT 2021 presentation of the trail, Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, New York, proposed that the inclusion of repeat revascularization in the trial’s composite primary endpoint tilted the outcome in favor of CABG. “To me, the FAME-3 results are predictable because repeat revascularization is in the equation.”

M. Alexander Otto, MDedge News

It’s well recognized that the endpoint is less likely after CABG than PCI. The latter treats focal lesions that are a limited part of a coronary artery in which CAD is still likely progressing. CABG, on the other hand, can bypass longer segments of diseased artery.

Indeed, as Dr. Fearon reported, the rates of death, MI, or stroke excluding repeat revascularization were 7.3% with FFR-PCI and 5.2% for CABG, for an HR of 1.4 (95% CI, 0.9-2.1).

Dr. Mehran also proposed that intravascular-ultrasound (IVUS) guidance, had it been part of the trial, could potentially have boosted the performance of FFR-PCI.

Repeat revascularization, Dr. Kaul agreed, “should not have been included” in the trial’s primary endpoint. It had been added “to amplify events and to minimize sample size. Not including revascularization would render the sample size prohibitive. There is always give and take in designing clinical trials.”

And he agreed that “IVUS-based PCI optimization would have further improved PCI outcomes.” However, “IVUS plus FFR adds to the procedural burden and limited resources available.” Dr. Fearon said when interviewed that the trial’s definition of procedural MI, a component of the primary endpoint, might potentially be seen as controversial. Procedural MIs in both the PCI and CABG groups were required to meet the standards of CABG-related type-5 MI according to the third and fourth Universal Definitions. The had also had to be accompanied by “a significant finding like new Q waves or a new wall-motion abnormality on echocardiography,” he said.

“That’s fairly strict. Because of that, we had a low rate of periprocedural MI and it was similar between the two groups, around 1.5% in both arms.”

FAME-3 was funded by Medtronic and Abbott Vascular. Dr. Kaul disclosed no relevant financial relationships. Dr. Kornowsky receives royalties from or holds intellectual property rights with CathWorks. Dr. Mehran disclosed financial ties to numerous pharmaceutical and device companies, and that she, her spouse, or her institution hold equity in Elixir Medical, Applied Therapeutics, and ControlRad.

A version of this article first appeared on Medscape.com.

Designed to show noninferiority for treatment of coronary artery disease (CAD) in patients with diabetes, a head-to-head comparison of contemporary stents ended up showing that one was superior to the for the primary endpoint of target lesion failure (TLF).

HandmadePictures/Thinkstock

In the superiority analysis, the 35% relative reduction in the risk of TLF at 1 year for the Cre8 EVO (Alvimedica) stent relative to the Resolute Onyx (Medtronic) device reached significance, according to Rafael Romaguera, MD, PhD, an interventional cardiologist at the Bellvitge University Hospital, Barcelona.

At 1 year, the rates of TLF were 7.2% and 10.5% for the Cre8 EVO and Resolute Onyx stents, respectively. On the basis of noninferiority, the 3.73% reduction in TLF at 1 year among those receiving the Cre8 EVO device provided a highly significant confirmation of noninferiority (P < .001) and triggered the preplanned superiority analysis.

When the significant advantage on the TLF endpoint (P = .03) was broken down into its components, the Cre8 EVO stent was linked to numerically lower rates of cardiac death (2.1% vs. 2.7%), target vessel MI (5.3% vs. 7.2%), and target lesion revascularization (2.4% vs. 3.9%), according to the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes) trial results presented at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

In a previous study comparing these devices, called the ReCre8 trial, the rates of TLF in an all-comer CAD population were similar at 1 year. When an updated 3-year analysis was presented earlier in 2021 at the Cardiovascular Research Technologies meeting, they remained similar.
 

Diabetes-centered trial was unmet need

The rationale for conducting a new trial limited to patients with diabetes was based on the greater risk in this population, according to Dr. Romaguera. He cited data that indicate the risk of major adverse cardiac events are about two times higher 2 years after stent implantation in patients with diabetes relative to those without, even when contemporary drug-eluting stents are used.

Both the Cre8 EVO and Resolute Onyx stent are drug eluting and employ contemporary architecture that provides the basis for marketing claims that they are suitable for complex patients; but they have differences.

“There are three features that I think differentiate the Cre8 EVO stent,” Dr. Romaguera reported at the meeting, sponsored by the Cardiovascular Research Foundation.

One is the absence of polymer, which contrasts with the permanent polymer of the Resolute device. This feature affects the dissolution of the anti-inflammatory drug and might be one explanation for the greater protection from ischemic events, according to Dr. Romaguera.

Another is the thickness of the struts, which range from 70 to 80 mm for the Cre8 EVO device and from 92 to 102 mm for the Resolute Onyx device. In experimental studies, strut thickness has been associated with greater risk of thrombus formation, although it is unclear if this modest difference is clinically significant.

Also important, the Cre8 EVO device employs sirolimus for an anti-inflammatory effect, while the Resolute Onyx elutes zotarolimus. Again, experimental evidence suggests a greater anti-inflammatory effect reduces the need for dual-antiplatelet therapy (DAPT); that might offer a relative advantage in patients with an elevated risk of bleeding.

It is not clear whether all of these features contribute to the better results observed in this trial in diabetes patients, but Dr. Romaguera indicated that the lower risk of TLF with Cre8 EVO is not just statistically significant but also clinically meaningful.

In SUGAR, which included 23 centers in Spain, 1,175 patients with confirmed diabetes scheduled for percutaneous intervention (PCI) were randomized to one of the two stents. The study was purposely designed with very few exclusion criteria.
 

SUGAR trial employed all-comer design

“This was an all-comer design and there was no limitation in regard to clinical presentation, complexity, number of lesions, or other disease features,” said Dr. Romaguera. The major exclusions were a life expectancy of less than 2 years and a contraindication to taking DAPT for at least 1 month,

The patients were almost equally divided between those who had a non–ST-segment elevation MI) and those with chronic coronary artery disease, but patients with a STEMI, representing about 12% of the population, were included. Almost all of the patients (about 95%) had type 2 diabetes; nearly one-third were on insulin at the time of randomization.

According to Dr. Romaguera, “SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes,” and he emphasized the all-comer design in supporting its clinical relevance.

Several of those participating in discussion of the trial during the late-breaker session agreed. Although the moderator, Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, expressed surprise that the trial “actually demonstrated superiority” given the difficulty of showing a difference between modern stents, he called the findings “remarkable.”

Others seemed to suggest that it would alter their practice.

“This study is sweet like sugar for us, because now we have a stent that is dedicated and fitted for the diabetic population,” said Gennaro Sardella, MD, of Sapienza University of Rome.

For Marc Etienne Jolicoeur, MD, an interventional cardiologist associated with Duke University, Durham, N.C., one of the impressive findings was the early separation of the curves in favor of Cre8 EVO. Calling SUGAR a “fantastic trial,” he indicated that the progressive advantage over time reinforced his impression that the difference is real.

However, David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta, was more circumspect. He did not express any criticisms of the trial, but he called for “a larger evidence base” before declaring the Cre8 EVO device a standard of care for patients with diabetes undergoing PCI.

The SUGAR results were published in the European Heart Journal at the time of presentation at the meeting.

The trial was funded by the Spanish Society of Cardiology. Dr. Romaguera reported financial relationships with Biotronik and Boston Scientific. Dr. Stone, has financial relationships with more than 10 pharmaceutical companies, including those developing devices used in PCI. Dr. Sardella and Dr. Jolicoeur reported no financial relationships relevant to this topic. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Designed to show noninferiority for treatment of coronary artery disease (CAD) in patients with diabetes, a head-to-head comparison of contemporary stents ended up showing that one was superior to the for the primary endpoint of target lesion failure (TLF).

HandmadePictures/Thinkstock

In the superiority analysis, the 35% relative reduction in the risk of TLF at 1 year for the Cre8 EVO (Alvimedica) stent relative to the Resolute Onyx (Medtronic) device reached significance, according to Rafael Romaguera, MD, PhD, an interventional cardiologist at the Bellvitge University Hospital, Barcelona.

At 1 year, the rates of TLF were 7.2% and 10.5% for the Cre8 EVO and Resolute Onyx stents, respectively. On the basis of noninferiority, the 3.73% reduction in TLF at 1 year among those receiving the Cre8 EVO device provided a highly significant confirmation of noninferiority (P < .001) and triggered the preplanned superiority analysis.

When the significant advantage on the TLF endpoint (P = .03) was broken down into its components, the Cre8 EVO stent was linked to numerically lower rates of cardiac death (2.1% vs. 2.7%), target vessel MI (5.3% vs. 7.2%), and target lesion revascularization (2.4% vs. 3.9%), according to the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes) trial results presented at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

In a previous study comparing these devices, called the ReCre8 trial, the rates of TLF in an all-comer CAD population were similar at 1 year. When an updated 3-year analysis was presented earlier in 2021 at the Cardiovascular Research Technologies meeting, they remained similar.
 

Diabetes-centered trial was unmet need

The rationale for conducting a new trial limited to patients with diabetes was based on the greater risk in this population, according to Dr. Romaguera. He cited data that indicate the risk of major adverse cardiac events are about two times higher 2 years after stent implantation in patients with diabetes relative to those without, even when contemporary drug-eluting stents are used.

Both the Cre8 EVO and Resolute Onyx stent are drug eluting and employ contemporary architecture that provides the basis for marketing claims that they are suitable for complex patients; but they have differences.

“There are three features that I think differentiate the Cre8 EVO stent,” Dr. Romaguera reported at the meeting, sponsored by the Cardiovascular Research Foundation.

One is the absence of polymer, which contrasts with the permanent polymer of the Resolute device. This feature affects the dissolution of the anti-inflammatory drug and might be one explanation for the greater protection from ischemic events, according to Dr. Romaguera.

Another is the thickness of the struts, which range from 70 to 80 mm for the Cre8 EVO device and from 92 to 102 mm for the Resolute Onyx device. In experimental studies, strut thickness has been associated with greater risk of thrombus formation, although it is unclear if this modest difference is clinically significant.

Also important, the Cre8 EVO device employs sirolimus for an anti-inflammatory effect, while the Resolute Onyx elutes zotarolimus. Again, experimental evidence suggests a greater anti-inflammatory effect reduces the need for dual-antiplatelet therapy (DAPT); that might offer a relative advantage in patients with an elevated risk of bleeding.

It is not clear whether all of these features contribute to the better results observed in this trial in diabetes patients, but Dr. Romaguera indicated that the lower risk of TLF with Cre8 EVO is not just statistically significant but also clinically meaningful.

In SUGAR, which included 23 centers in Spain, 1,175 patients with confirmed diabetes scheduled for percutaneous intervention (PCI) were randomized to one of the two stents. The study was purposely designed with very few exclusion criteria.
 

SUGAR trial employed all-comer design

“This was an all-comer design and there was no limitation in regard to clinical presentation, complexity, number of lesions, or other disease features,” said Dr. Romaguera. The major exclusions were a life expectancy of less than 2 years and a contraindication to taking DAPT for at least 1 month,

The patients were almost equally divided between those who had a non–ST-segment elevation MI) and those with chronic coronary artery disease, but patients with a STEMI, representing about 12% of the population, were included. Almost all of the patients (about 95%) had type 2 diabetes; nearly one-third were on insulin at the time of randomization.

According to Dr. Romaguera, “SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes,” and he emphasized the all-comer design in supporting its clinical relevance.

Several of those participating in discussion of the trial during the late-breaker session agreed. Although the moderator, Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, expressed surprise that the trial “actually demonstrated superiority” given the difficulty of showing a difference between modern stents, he called the findings “remarkable.”

Others seemed to suggest that it would alter their practice.

“This study is sweet like sugar for us, because now we have a stent that is dedicated and fitted for the diabetic population,” said Gennaro Sardella, MD, of Sapienza University of Rome.

For Marc Etienne Jolicoeur, MD, an interventional cardiologist associated with Duke University, Durham, N.C., one of the impressive findings was the early separation of the curves in favor of Cre8 EVO. Calling SUGAR a “fantastic trial,” he indicated that the progressive advantage over time reinforced his impression that the difference is real.

However, David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta, was more circumspect. He did not express any criticisms of the trial, but he called for “a larger evidence base” before declaring the Cre8 EVO device a standard of care for patients with diabetes undergoing PCI.

The SUGAR results were published in the European Heart Journal at the time of presentation at the meeting.

The trial was funded by the Spanish Society of Cardiology. Dr. Romaguera reported financial relationships with Biotronik and Boston Scientific. Dr. Stone, has financial relationships with more than 10 pharmaceutical companies, including those developing devices used in PCI. Dr. Sardella and Dr. Jolicoeur reported no financial relationships relevant to this topic. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Designed to show noninferiority for treatment of coronary artery disease (CAD) in patients with diabetes, a head-to-head comparison of contemporary stents ended up showing that one was superior to the for the primary endpoint of target lesion failure (TLF).

HandmadePictures/Thinkstock

In the superiority analysis, the 35% relative reduction in the risk of TLF at 1 year for the Cre8 EVO (Alvimedica) stent relative to the Resolute Onyx (Medtronic) device reached significance, according to Rafael Romaguera, MD, PhD, an interventional cardiologist at the Bellvitge University Hospital, Barcelona.

At 1 year, the rates of TLF were 7.2% and 10.5% for the Cre8 EVO and Resolute Onyx stents, respectively. On the basis of noninferiority, the 3.73% reduction in TLF at 1 year among those receiving the Cre8 EVO device provided a highly significant confirmation of noninferiority (P < .001) and triggered the preplanned superiority analysis.

When the significant advantage on the TLF endpoint (P = .03) was broken down into its components, the Cre8 EVO stent was linked to numerically lower rates of cardiac death (2.1% vs. 2.7%), target vessel MI (5.3% vs. 7.2%), and target lesion revascularization (2.4% vs. 3.9%), according to the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes) trial results presented at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

In a previous study comparing these devices, called the ReCre8 trial, the rates of TLF in an all-comer CAD population were similar at 1 year. When an updated 3-year analysis was presented earlier in 2021 at the Cardiovascular Research Technologies meeting, they remained similar.
 

Diabetes-centered trial was unmet need

The rationale for conducting a new trial limited to patients with diabetes was based on the greater risk in this population, according to Dr. Romaguera. He cited data that indicate the risk of major adverse cardiac events are about two times higher 2 years after stent implantation in patients with diabetes relative to those without, even when contemporary drug-eluting stents are used.

Both the Cre8 EVO and Resolute Onyx stent are drug eluting and employ contemporary architecture that provides the basis for marketing claims that they are suitable for complex patients; but they have differences.

“There are three features that I think differentiate the Cre8 EVO stent,” Dr. Romaguera reported at the meeting, sponsored by the Cardiovascular Research Foundation.

One is the absence of polymer, which contrasts with the permanent polymer of the Resolute device. This feature affects the dissolution of the anti-inflammatory drug and might be one explanation for the greater protection from ischemic events, according to Dr. Romaguera.

Another is the thickness of the struts, which range from 70 to 80 mm for the Cre8 EVO device and from 92 to 102 mm for the Resolute Onyx device. In experimental studies, strut thickness has been associated with greater risk of thrombus formation, although it is unclear if this modest difference is clinically significant.

Also important, the Cre8 EVO device employs sirolimus for an anti-inflammatory effect, while the Resolute Onyx elutes zotarolimus. Again, experimental evidence suggests a greater anti-inflammatory effect reduces the need for dual-antiplatelet therapy (DAPT); that might offer a relative advantage in patients with an elevated risk of bleeding.

It is not clear whether all of these features contribute to the better results observed in this trial in diabetes patients, but Dr. Romaguera indicated that the lower risk of TLF with Cre8 EVO is not just statistically significant but also clinically meaningful.

In SUGAR, which included 23 centers in Spain, 1,175 patients with confirmed diabetes scheduled for percutaneous intervention (PCI) were randomized to one of the two stents. The study was purposely designed with very few exclusion criteria.
 

SUGAR trial employed all-comer design

“This was an all-comer design and there was no limitation in regard to clinical presentation, complexity, number of lesions, or other disease features,” said Dr. Romaguera. The major exclusions were a life expectancy of less than 2 years and a contraindication to taking DAPT for at least 1 month,

The patients were almost equally divided between those who had a non–ST-segment elevation MI) and those with chronic coronary artery disease, but patients with a STEMI, representing about 12% of the population, were included. Almost all of the patients (about 95%) had type 2 diabetes; nearly one-third were on insulin at the time of randomization.

According to Dr. Romaguera, “SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes,” and he emphasized the all-comer design in supporting its clinical relevance.

Several of those participating in discussion of the trial during the late-breaker session agreed. Although the moderator, Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, expressed surprise that the trial “actually demonstrated superiority” given the difficulty of showing a difference between modern stents, he called the findings “remarkable.”

Others seemed to suggest that it would alter their practice.

“This study is sweet like sugar for us, because now we have a stent that is dedicated and fitted for the diabetic population,” said Gennaro Sardella, MD, of Sapienza University of Rome.

For Marc Etienne Jolicoeur, MD, an interventional cardiologist associated with Duke University, Durham, N.C., one of the impressive findings was the early separation of the curves in favor of Cre8 EVO. Calling SUGAR a “fantastic trial,” he indicated that the progressive advantage over time reinforced his impression that the difference is real.

However, David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta, was more circumspect. He did not express any criticisms of the trial, but he called for “a larger evidence base” before declaring the Cre8 EVO device a standard of care for patients with diabetes undergoing PCI.

The SUGAR results were published in the European Heart Journal at the time of presentation at the meeting.

The trial was funded by the Spanish Society of Cardiology. Dr. Romaguera reported financial relationships with Biotronik and Boston Scientific. Dr. Stone, has financial relationships with more than 10 pharmaceutical companies, including those developing devices used in PCI. Dr. Sardella and Dr. Jolicoeur reported no financial relationships relevant to this topic. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

• Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
• Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
• Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
• Choose healthy sources of protein, mostly from plants (legumes and nuts).
• Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
• Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
• Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
• Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
• Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
• If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
• While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
• Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

• Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
• Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
• Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
• Choose healthy sources of protein, mostly from plants (legumes and nuts).
• Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
• Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
• Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
• Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
• Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
• If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
• While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
• Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

• Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
• Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
• Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
• Choose healthy sources of protein, mostly from plants (legumes and nuts).
• Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
• Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
• Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
• Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
• Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
• If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
• While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
• Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

“Short-term hospitalization [for reasons other than diabetes] may not be the time to intervene in long-term diabetes management,” researchers conclude.

They found that, in a national cohort of older almost entirely male veterans with non–insulin-treated type 2 diabetes who were hospitalized for non–diabetes-related common medical conditions, intensified diabetes treatment on hospital discharge was linked to an increased risk of severe hypoglycemia in the immediate postdischarge period.

However, diabetes treatment intensification – that is, receiving a prescription for a new or higher dose of diabetes medicine – was not associated with decreased risks of severe hyperglycemia or with improved glycemic (hemoglobin A1c) control at 30 days or 1 year, according to study results, published in JAMA Network Open.

“We didn’t see a reduction in diabetes emergencies in more intensively treated patients,” lead investigator Timothy S. Anderson, MD, said in an interview.

Also, importantly, there was a low rate of persistence with the new treatment. “Half of the patients were no longer taking these [intensified diabetes medicines] at 1 year, which tells me that context is key,” he pointed out. “If a patient is in the hospital for diabetes [unlike the patients in this study], I think it makes a lot of sense to modify and adjust their regimen to try to help them right then and there.”

The overall risk of severe hyperglycemia or severe hypoglycemia was pretty small in the overall cohort, Dr. Anderson noted, “but we do put people at risk of leaving the hospital and ending up back in the hospital with low blood sugar when we intensify medications, and there’s not necessarily a good signal to suggest that it’s all that urgent to change these medicines.”

Instead, the “safer path” may be to make recommendations to the patient’s outpatient physician and also inform the patient – for example, “We saw some concerns about your diabetes while you were in the hospital, and this is really something that should be looked at when you’re recovered and feeling better from the rest of your health standpoint” – rather than making a diabetes medication change while the person is acutely ill or recovering from illness, said Dr. Anderson, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston.

The researchers also found an “unexpected” significant decrease in 30-day mortality in the patients with intensified diabetes treatment, which was probably because of confounding that was not accounted for, Dr. Anderson speculated, since clinical trials have consistently shown that benefits from diabetes medications take a longer time to show an effect.
 

‘Important study,’ but lacked newer meds

This is an “important” study for primary care and in-hospital physicians that shows that “hospitalization is really not the time and the place” to intensify diabetes medication, Rozalina G. McCoy, MD, coauthor of an invited commentary, told this news organization in an interview.

“While overcoming treatment inertia is important, [it should be] done appropriately, so that we don’t overtreat patients,” Dr. McCoy, of the Mayo Clinic in Rochester, Minn., stressed.

The very low rate of persistence of taking intensified medications is a major finding, she agreed. Hospitalized patients “are not in their usual state of health, so if we make long-term treatment decisions based on their acute abnormal situation, that may not be appropriate.”

However, patients with high A1c may benefit from a change at hospital discharge rather than when they see their primary care provider, with the caveat that they need close follow-up as an outpatient.

The study emphasizes the “need for longitudinal patient care rather than episodic patches,” according to Dr. McCoy.

For example, a patient who is hospitalized for a chronic obstructive pulmonary disease or asthma exacerbation may be receiving steroids that cause high blood glucose levels but as soon as they’re done with their steroid course, blood glucose will decrease, so the “need for close outpatient follow-up is very important.”

One limitation of the current work is that an earlier study in the same population by the research group showed that 49% of patients whose treatment regimens were intensified had limited life expectancy or were at or below their A1c goal, so they would not have benefited from the stepped-up treatment, she noted.

Another limitation is that the findings cannot be generalized to women or younger patients, or to patients treated with glucagonlike peptide 1 (GLP-1)–receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors.

The study patients were seen in the U.S. Veterans Health Administration health system when these newer agents were not used. Three-quarters of patients received intensified treatment with sulfonylurea or insulin, and only one patient received a new GLP-1–receptor agonist.

Ideally, Dr. McCoy said, patients should have been prescribed a GLP-1–receptor agonist if they had atherosclerotic cardiovascular disease or kidney disease, or an SGLT2 inhibitor if they had kidney disease or heart failure, which may have led to different results, and would need to be determined in further study.

Dr. Anderson agreed that “SGLT2 inhibitors and GLP1 agonists are broadly much safer than the older diabetes medicines, at least when it comes to risk of hypoglycemia, and may have more clear benefits in heart disease and mortality. So I would not want to extrapolate our findings to those new classes,” he said. “A similar set of studies would need to be done.”
 

Study rationale and findings

Hospitalized older adults with diabetes commonly have transiently elevated blood glucose levels that might lead clinicians to discharge them from hospital with a prescription for more intensive diabetes medications than they were on before they were hospitalized, but it is not clear if these diabetes medication changes would improve outcomes.

To investigate this, the researchers analyzed data from patients with diabetes who were 65 and older and hospitalized for common medical conditions in VHA hospitals during January 2011–September 2016, and then discharged to the community.

They excluded patients who were hospitalized for things that require immediate change in diabetes treatment and patients who were using insulin before their hospitalization (because instructions to modify insulin dosing frequently don’t have a new prescription).

The researchers identified 28,198 adults with diabetes who were not on insulin and were hospitalized in the VHA health system for heart failure (18%), coronary artery disease (13%), chronic obstructive pulmonary disease (10%), pneumonia (9.6%), and urinary tract infection (7.5%), and less often and not in decreasing order, for acute coronary syndrome, arrhythmia, asthma, chest pain, conduction disorders, heart valve disorders, sepsis, skin infection, stroke, and transient ischemic attack.

Of these patients, 2,768 patients (9.8%) received diabetes medication intensification, and the researchers matched 2,648 of these patients with an equal number of patients who did not receive this treatment intensification.

The patients in each group had a mean age of 73 and 98.5% were male; 78% were White.

They had a mean A1c of 7.9%. Most were receiving sulfonylurea (43%) or metformin (39%), and few were receiving thiazolidinediones (4.1%), alpha-glucosidase inhibitors (2.7%), dipeptidyl peptidase 4 inhibitors (2.0%), or other types of diabetes drugs (0.1%).

Of the 2,768 patients who received intensified diabetes medication, most received a prescription for insulin (51%) or sulfonylurea (23%).

In the propensity-matched cohort, patients with intensified diabetes medication had a higher rate of severe hypoglycemia at 30 days (1% vs. 0.5%), which translated into a significant twofold higher risk (hazard ratio, 2.17).

The rates of severe hypoglycemia at 1 year were similar in both groups (3.1% and 2.9%).

The incidence of severe hyperglycemia was the same in both groups at 30 days (0.3%) and 1 year (1.3%).

In secondary outcomes, at 1 year, 48% of new oral diabetes medications and 39% of new insulin prescriptions were no longer being filled.

Overall, patients who were discharged with intensified diabetes medication were significantly less likely to die within 30 days than the other patients (1.3% vs. 2.4%; HR, 0.55).

However, this mortality benefit was found only in the subgroup of 2,524 patients who had uncontrolled diabetes when they were admitted to hospital (A1c >7.5%; mean A1c, 9.1%), and not in the propensity-matched subgroup of 2,672 patients who had controlled diabetes then (A1c up to 7.5%; mean A1c, 6.8%).

There was no significant difference in 1-year mortality in patients with versus without intensified treatment (15.8% vs. 17.8%).

There were also no significant between-group difference in rates of hospital readmission at 30 days (roughly 17%) or 1 year (roughly 51%).

The decreases in mean A1c from hospital discharge to 1 year later were also the same in both groups (going from 7.9% to 7.7%).

The study was funded by grants from the National Institute on Aging and the American College of Cardiology. Dr. Anderson has no relevant financial disclosures. Dr. McCoy reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases, AARP, and the Patient-Centered Outcomes Research Institute outside the submitted work. The disclosures of the other authors and the editorial coauthor are available with the article and commentary.

“Short-term hospitalization [for reasons other than diabetes] may not be the time to intervene in long-term diabetes management,” researchers conclude.

They found that, in a national cohort of older almost entirely male veterans with non–insulin-treated type 2 diabetes who were hospitalized for non–diabetes-related common medical conditions, intensified diabetes treatment on hospital discharge was linked to an increased risk of severe hypoglycemia in the immediate postdischarge period.

However, diabetes treatment intensification – that is, receiving a prescription for a new or higher dose of diabetes medicine – was not associated with decreased risks of severe hyperglycemia or with improved glycemic (hemoglobin A1c) control at 30 days or 1 year, according to study results, published in JAMA Network Open.

“We didn’t see a reduction in diabetes emergencies in more intensively treated patients,” lead investigator Timothy S. Anderson, MD, said in an interview.

Also, importantly, there was a low rate of persistence with the new treatment. “Half of the patients were no longer taking these [intensified diabetes medicines] at 1 year, which tells me that context is key,” he pointed out. “If a patient is in the hospital for diabetes [unlike the patients in this study], I think it makes a lot of sense to modify and adjust their regimen to try to help them right then and there.”

The overall risk of severe hyperglycemia or severe hypoglycemia was pretty small in the overall cohort, Dr. Anderson noted, “but we do put people at risk of leaving the hospital and ending up back in the hospital with low blood sugar when we intensify medications, and there’s not necessarily a good signal to suggest that it’s all that urgent to change these medicines.”

Instead, the “safer path” may be to make recommendations to the patient’s outpatient physician and also inform the patient – for example, “We saw some concerns about your diabetes while you were in the hospital, and this is really something that should be looked at when you’re recovered and feeling better from the rest of your health standpoint” – rather than making a diabetes medication change while the person is acutely ill or recovering from illness, said Dr. Anderson, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston.

The researchers also found an “unexpected” significant decrease in 30-day mortality in the patients with intensified diabetes treatment, which was probably because of confounding that was not accounted for, Dr. Anderson speculated, since clinical trials have consistently shown that benefits from diabetes medications take a longer time to show an effect.
 

‘Important study,’ but lacked newer meds

This is an “important” study for primary care and in-hospital physicians that shows that “hospitalization is really not the time and the place” to intensify diabetes medication, Rozalina G. McCoy, MD, coauthor of an invited commentary, told this news organization in an interview.

“While overcoming treatment inertia is important, [it should be] done appropriately, so that we don’t overtreat patients,” Dr. McCoy, of the Mayo Clinic in Rochester, Minn., stressed.

The very low rate of persistence of taking intensified medications is a major finding, she agreed. Hospitalized patients “are not in their usual state of health, so if we make long-term treatment decisions based on their acute abnormal situation, that may not be appropriate.”

However, patients with high A1c may benefit from a change at hospital discharge rather than when they see their primary care provider, with the caveat that they need close follow-up as an outpatient.

The study emphasizes the “need for longitudinal patient care rather than episodic patches,” according to Dr. McCoy.

For example, a patient who is hospitalized for a chronic obstructive pulmonary disease or asthma exacerbation may be receiving steroids that cause high blood glucose levels but as soon as they’re done with their steroid course, blood glucose will decrease, so the “need for close outpatient follow-up is very important.”

One limitation of the current work is that an earlier study in the same population by the research group showed that 49% of patients whose treatment regimens were intensified had limited life expectancy or were at or below their A1c goal, so they would not have benefited from the stepped-up treatment, she noted.

Another limitation is that the findings cannot be generalized to women or younger patients, or to patients treated with glucagonlike peptide 1 (GLP-1)–receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors.

The study patients were seen in the U.S. Veterans Health Administration health system when these newer agents were not used. Three-quarters of patients received intensified treatment with sulfonylurea or insulin, and only one patient received a new GLP-1–receptor agonist.

Ideally, Dr. McCoy said, patients should have been prescribed a GLP-1–receptor agonist if they had atherosclerotic cardiovascular disease or kidney disease, or an SGLT2 inhibitor if they had kidney disease or heart failure, which may have led to different results, and would need to be determined in further study.

Dr. Anderson agreed that “SGLT2 inhibitors and GLP1 agonists are broadly much safer than the older diabetes medicines, at least when it comes to risk of hypoglycemia, and may have more clear benefits in heart disease and mortality. So I would not want to extrapolate our findings to those new classes,” he said. “A similar set of studies would need to be done.”
 

Study rationale and findings

Hospitalized older adults with diabetes commonly have transiently elevated blood glucose levels that might lead clinicians to discharge them from hospital with a prescription for more intensive diabetes medications than they were on before they were hospitalized, but it is not clear if these diabetes medication changes would improve outcomes.

To investigate this, the researchers analyzed data from patients with diabetes who were 65 and older and hospitalized for common medical conditions in VHA hospitals during January 2011–September 2016, and then discharged to the community.

They excluded patients who were hospitalized for things that require immediate change in diabetes treatment and patients who were using insulin before their hospitalization (because instructions to modify insulin dosing frequently don’t have a new prescription).

The researchers identified 28,198 adults with diabetes who were not on insulin and were hospitalized in the VHA health system for heart failure (18%), coronary artery disease (13%), chronic obstructive pulmonary disease (10%), pneumonia (9.6%), and urinary tract infection (7.5%), and less often and not in decreasing order, for acute coronary syndrome, arrhythmia, asthma, chest pain, conduction disorders, heart valve disorders, sepsis, skin infection, stroke, and transient ischemic attack.

Of these patients, 2,768 patients (9.8%) received diabetes medication intensification, and the researchers matched 2,648 of these patients with an equal number of patients who did not receive this treatment intensification.

The patients in each group had a mean age of 73 and 98.5% were male; 78% were White.

They had a mean A1c of 7.9%. Most were receiving sulfonylurea (43%) or metformin (39%), and few were receiving thiazolidinediones (4.1%), alpha-glucosidase inhibitors (2.7%), dipeptidyl peptidase 4 inhibitors (2.0%), or other types of diabetes drugs (0.1%).

Of the 2,768 patients who received intensified diabetes medication, most received a prescription for insulin (51%) or sulfonylurea (23%).

In the propensity-matched cohort, patients with intensified diabetes medication had a higher rate of severe hypoglycemia at 30 days (1% vs. 0.5%), which translated into a significant twofold higher risk (hazard ratio, 2.17).

The rates of severe hypoglycemia at 1 year were similar in both groups (3.1% and 2.9%).

The incidence of severe hyperglycemia was the same in both groups at 30 days (0.3%) and 1 year (1.3%).

In secondary outcomes, at 1 year, 48% of new oral diabetes medications and 39% of new insulin prescriptions were no longer being filled.

Overall, patients who were discharged with intensified diabetes medication were significantly less likely to die within 30 days than the other patients (1.3% vs. 2.4%; HR, 0.55).

However, this mortality benefit was found only in the subgroup of 2,524 patients who had uncontrolled diabetes when they were admitted to hospital (A1c >7.5%; mean A1c, 9.1%), and not in the propensity-matched subgroup of 2,672 patients who had controlled diabetes then (A1c up to 7.5%; mean A1c, 6.8%).

There was no significant difference in 1-year mortality in patients with versus without intensified treatment (15.8% vs. 17.8%).

There were also no significant between-group difference in rates of hospital readmission at 30 days (roughly 17%) or 1 year (roughly 51%).

The decreases in mean A1c from hospital discharge to 1 year later were also the same in both groups (going from 7.9% to 7.7%).

The study was funded by grants from the National Institute on Aging and the American College of Cardiology. Dr. Anderson has no relevant financial disclosures. Dr. McCoy reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases, AARP, and the Patient-Centered Outcomes Research Institute outside the submitted work. The disclosures of the other authors and the editorial coauthor are available with the article and commentary.

“Short-term hospitalization [for reasons other than diabetes] may not be the time to intervene in long-term diabetes management,” researchers conclude.

They found that, in a national cohort of older almost entirely male veterans with non–insulin-treated type 2 diabetes who were hospitalized for non–diabetes-related common medical conditions, intensified diabetes treatment on hospital discharge was linked to an increased risk of severe hypoglycemia in the immediate postdischarge period.

However, diabetes treatment intensification – that is, receiving a prescription for a new or higher dose of diabetes medicine – was not associated with decreased risks of severe hyperglycemia or with improved glycemic (hemoglobin A1c) control at 30 days or 1 year, according to study results, published in JAMA Network Open.

“We didn’t see a reduction in diabetes emergencies in more intensively treated patients,” lead investigator Timothy S. Anderson, MD, said in an interview.

Also, importantly, there was a low rate of persistence with the new treatment. “Half of the patients were no longer taking these [intensified diabetes medicines] at 1 year, which tells me that context is key,” he pointed out. “If a patient is in the hospital for diabetes [unlike the patients in this study], I think it makes a lot of sense to modify and adjust their regimen to try to help them right then and there.”

The overall risk of severe hyperglycemia or severe hypoglycemia was pretty small in the overall cohort, Dr. Anderson noted, “but we do put people at risk of leaving the hospital and ending up back in the hospital with low blood sugar when we intensify medications, and there’s not necessarily a good signal to suggest that it’s all that urgent to change these medicines.”

Instead, the “safer path” may be to make recommendations to the patient’s outpatient physician and also inform the patient – for example, “We saw some concerns about your diabetes while you were in the hospital, and this is really something that should be looked at when you’re recovered and feeling better from the rest of your health standpoint” – rather than making a diabetes medication change while the person is acutely ill or recovering from illness, said Dr. Anderson, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston.

The researchers also found an “unexpected” significant decrease in 30-day mortality in the patients with intensified diabetes treatment, which was probably because of confounding that was not accounted for, Dr. Anderson speculated, since clinical trials have consistently shown that benefits from diabetes medications take a longer time to show an effect.
 

‘Important study,’ but lacked newer meds

This is an “important” study for primary care and in-hospital physicians that shows that “hospitalization is really not the time and the place” to intensify diabetes medication, Rozalina G. McCoy, MD, coauthor of an invited commentary, told this news organization in an interview.

“While overcoming treatment inertia is important, [it should be] done appropriately, so that we don’t overtreat patients,” Dr. McCoy, of the Mayo Clinic in Rochester, Minn., stressed.

The very low rate of persistence of taking intensified medications is a major finding, she agreed. Hospitalized patients “are not in their usual state of health, so if we make long-term treatment decisions based on their acute abnormal situation, that may not be appropriate.”

However, patients with high A1c may benefit from a change at hospital discharge rather than when they see their primary care provider, with the caveat that they need close follow-up as an outpatient.

The study emphasizes the “need for longitudinal patient care rather than episodic patches,” according to Dr. McCoy.

For example, a patient who is hospitalized for a chronic obstructive pulmonary disease or asthma exacerbation may be receiving steroids that cause high blood glucose levels but as soon as they’re done with their steroid course, blood glucose will decrease, so the “need for close outpatient follow-up is very important.”

One limitation of the current work is that an earlier study in the same population by the research group showed that 49% of patients whose treatment regimens were intensified had limited life expectancy or were at or below their A1c goal, so they would not have benefited from the stepped-up treatment, she noted.

Another limitation is that the findings cannot be generalized to women or younger patients, or to patients treated with glucagonlike peptide 1 (GLP-1)–receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors.

The study patients were seen in the U.S. Veterans Health Administration health system when these newer agents were not used. Three-quarters of patients received intensified treatment with sulfonylurea or insulin, and only one patient received a new GLP-1–receptor agonist.

Ideally, Dr. McCoy said, patients should have been prescribed a GLP-1–receptor agonist if they had atherosclerotic cardiovascular disease or kidney disease, or an SGLT2 inhibitor if they had kidney disease or heart failure, which may have led to different results, and would need to be determined in further study.

Dr. Anderson agreed that “SGLT2 inhibitors and GLP1 agonists are broadly much safer than the older diabetes medicines, at least when it comes to risk of hypoglycemia, and may have more clear benefits in heart disease and mortality. So I would not want to extrapolate our findings to those new classes,” he said. “A similar set of studies would need to be done.”
 

Study rationale and findings

Hospitalized older adults with diabetes commonly have transiently elevated blood glucose levels that might lead clinicians to discharge them from hospital with a prescription for more intensive diabetes medications than they were on before they were hospitalized, but it is not clear if these diabetes medication changes would improve outcomes.

To investigate this, the researchers analyzed data from patients with diabetes who were 65 and older and hospitalized for common medical conditions in VHA hospitals during January 2011–September 2016, and then discharged to the community.

They excluded patients who were hospitalized for things that require immediate change in diabetes treatment and patients who were using insulin before their hospitalization (because instructions to modify insulin dosing frequently don’t have a new prescription).

The researchers identified 28,198 adults with diabetes who were not on insulin and were hospitalized in the VHA health system for heart failure (18%), coronary artery disease (13%), chronic obstructive pulmonary disease (10%), pneumonia (9.6%), and urinary tract infection (7.5%), and less often and not in decreasing order, for acute coronary syndrome, arrhythmia, asthma, chest pain, conduction disorders, heart valve disorders, sepsis, skin infection, stroke, and transient ischemic attack.

Of these patients, 2,768 patients (9.8%) received diabetes medication intensification, and the researchers matched 2,648 of these patients with an equal number of patients who did not receive this treatment intensification.

The patients in each group had a mean age of 73 and 98.5% were male; 78% were White.

They had a mean A1c of 7.9%. Most were receiving sulfonylurea (43%) or metformin (39%), and few were receiving thiazolidinediones (4.1%), alpha-glucosidase inhibitors (2.7%), dipeptidyl peptidase 4 inhibitors (2.0%), or other types of diabetes drugs (0.1%).

Of the 2,768 patients who received intensified diabetes medication, most received a prescription for insulin (51%) or sulfonylurea (23%).

In the propensity-matched cohort, patients with intensified diabetes medication had a higher rate of severe hypoglycemia at 30 days (1% vs. 0.5%), which translated into a significant twofold higher risk (hazard ratio, 2.17).

The rates of severe hypoglycemia at 1 year were similar in both groups (3.1% and 2.9%).

The incidence of severe hyperglycemia was the same in both groups at 30 days (0.3%) and 1 year (1.3%).

In secondary outcomes, at 1 year, 48% of new oral diabetes medications and 39% of new insulin prescriptions were no longer being filled.

Overall, patients who were discharged with intensified diabetes medication were significantly less likely to die within 30 days than the other patients (1.3% vs. 2.4%; HR, 0.55).

However, this mortality benefit was found only in the subgroup of 2,524 patients who had uncontrolled diabetes when they were admitted to hospital (A1c >7.5%; mean A1c, 9.1%), and not in the propensity-matched subgroup of 2,672 patients who had controlled diabetes then (A1c up to 7.5%; mean A1c, 6.8%).

There was no significant difference in 1-year mortality in patients with versus without intensified treatment (15.8% vs. 17.8%).

There were also no significant between-group difference in rates of hospital readmission at 30 days (roughly 17%) or 1 year (roughly 51%).

The decreases in mean A1c from hospital discharge to 1 year later were also the same in both groups (going from 7.9% to 7.7%).

The study was funded by grants from the National Institute on Aging and the American College of Cardiology. Dr. Anderson has no relevant financial disclosures. Dr. McCoy reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases, AARP, and the Patient-Centered Outcomes Research Institute outside the submitted work. The disclosures of the other authors and the editorial coauthor are available with the article and commentary.

A new analysis has shown disparities in cardiovascular risk factors between Black and White adults in the United States, disparities that may be largely attributable to social determinants of health.

Investigators analyzed 20 years of data on over 50,500 U.S. adults drawn from the National Health and Nutrition Examination Surveys (NHANES) and found that, in the overall population, body mass index and hemoglobin A1c were significantly increased between 1999 and 2018, while serum total cholesterol and cigarette smoking were significantly decreased. Mean systolic blood pressure decreased between 1999 and 2010, but then increased after 2010.

The mean age- and sex-adjusted estimated 10-year risk for atherosclerotic cardiovascular disease (ASCVD) was consistently higher in Black participants vs. White participants, but the difference was attenuated after further adjusting for education, income, home ownership, employment, health insurance, and access to health care.

“These findings are helpful to guide the development of national public health policies for targeted interventions aimed at eliminating health disparities,” Jiang He, MD, PhD, Joseph S. Copes Chair and professor of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

“Interventions on social determinants of cardiovascular health should be tested in rigorous designed intervention trials,” said Dr. He, director of the Tulane University Translational Science Institute.

The study was published online Oct. 5 in JAMA.
 

‘Flattened’ CVD mortality?

Recent data show that the CVD mortality rate flattened, while the total number of cardiovascular deaths increased in the U.S. general population from 2010 to 2018, “but the reasons for this deceleration in the decline of CVD mortality are not entirely understood,” Dr. He said.

Moreover, “racial and ethnic differences in CVD mortality persist in the U.S. general population [but] the secular trends of cardiovascular risk factors among U.S. subpopulations with various racial and ethnic backgrounds and socioeconomic status are [also] not well understood,” he added. The effects of social determinants of health, such as education, income, home ownership, employment, health insurance, and access to health care on racial/ethnic differences in CVD risk, “are not well documented.”

To investigate these questions, the researchers drew on data from NHANES, a series of cross-sectional surveys in nationally representative samples of the U.S. population aged 20 years and older. The surveys are conducted in 2-year cycles and include data from 10 cycles conducted from 1999-2000 to 2017-2018 (n = 50,571, mean age 49.0-51.8 years; 48.2%-51.3% female).

Every 2 years, participants provided sociodemographic information, including age, race/ethnicity, sex, education, income, employment, housing, health insurance, and access to health care, as well as medical history and medication use. They underwent a physical examination that included weight and height, blood pressure, lipid levels, plasma glucose, and hemoglobin A1c.
 

Social determinants of health

Between 1999-2000 and 2017-2018, age- and sex-adjusted mean BMI and hemoglobin A1c increased, while mean serum total cholesterol and prevalence of smoking decreased (all P < .001).

Participants with at least a college education or high family income had “consistently lower levels” of cardiovascular risk factors. And although the mean age- and sex-adjusted 10-year risk for ASCVD was significantly higher in non-Hispanic Black vs. non-Hispanic White participants (difference, 1.4% [1.0%-1.7%] in 1999-2008 and 2.0% [1.7%-2.4%] in 2009-2018), the difference was attenuated (by –0.3% in 1999-2008 and 0.7% in 2009-2018) after the researchers further adjusted for education, income, home ownership, employment, health insurance, and access to health care.

The differences in cardiovascular risk factors between Black and White participants “may have been moderated by social determinants of health,” the authors noted.
 

Provide appropriate education

Commenting on the study in an interview, Mary Ann McLaughlin, MD, MPH, associate professor of medicine, cardiology, Icahn School of Medicine at Mount Sinai, New York, pointed out that two important cardiovascular risk factors associated with being overweight – hypertension and diabetes – remained higher in the Black population compared with the White population in this analysis.

“Physicians and health care systems should provide appropriate education and resources regarding risk factor modification regarding diet, exercise, and blood pressure control,” advised Dr. McLaughlin, who was not involved with the study.

“Importantly, smoking rates and cholesterol levels are lower in the Black population, compared to the White population, when adjusted for many important socioeconomic factors,” she pointed out.

Dr. McLaughlin added that other “important social determinants of health, such as neighborhood and access to healthy food, were not measured and should be addressed by physicians when optimizing cardiovascular risk.”

The research reported in this publication was supported by the National Heart, Lung, and Blood Institute and by the National Institute of General Medical Sciences. One of the researchers, Joshua D. Bundy, PhD, was supported by a grant from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. He and the other coauthors and Dr. McLaughlin reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A new analysis has shown disparities in cardiovascular risk factors between Black and White adults in the United States, disparities that may be largely attributable to social determinants of health.

Investigators analyzed 20 years of data on over 50,500 U.S. adults drawn from the National Health and Nutrition Examination Surveys (NHANES) and found that, in the overall population, body mass index and hemoglobin A1c were significantly increased between 1999 and 2018, while serum total cholesterol and cigarette smoking were significantly decreased. Mean systolic blood pressure decreased between 1999 and 2010, but then increased after 2010.

The mean age- and sex-adjusted estimated 10-year risk for atherosclerotic cardiovascular disease (ASCVD) was consistently higher in Black participants vs. White participants, but the difference was attenuated after further adjusting for education, income, home ownership, employment, health insurance, and access to health care.

“These findings are helpful to guide the development of national public health policies for targeted interventions aimed at eliminating health disparities,” Jiang He, MD, PhD, Joseph S. Copes Chair and professor of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

“Interventions on social determinants of cardiovascular health should be tested in rigorous designed intervention trials,” said Dr. He, director of the Tulane University Translational Science Institute.

The study was published online Oct. 5 in JAMA.
 

‘Flattened’ CVD mortality?

Recent data show that the CVD mortality rate flattened, while the total number of cardiovascular deaths increased in the U.S. general population from 2010 to 2018, “but the reasons for this deceleration in the decline of CVD mortality are not entirely understood,” Dr. He said.

Moreover, “racial and ethnic differences in CVD mortality persist in the U.S. general population [but] the secular trends of cardiovascular risk factors among U.S. subpopulations with various racial and ethnic backgrounds and socioeconomic status are [also] not well understood,” he added. The effects of social determinants of health, such as education, income, home ownership, employment, health insurance, and access to health care on racial/ethnic differences in CVD risk, “are not well documented.”

To investigate these questions, the researchers drew on data from NHANES, a series of cross-sectional surveys in nationally representative samples of the U.S. population aged 20 years and older. The surveys are conducted in 2-year cycles and include data from 10 cycles conducted from 1999-2000 to 2017-2018 (n = 50,571, mean age 49.0-51.8 years; 48.2%-51.3% female).

Every 2 years, participants provided sociodemographic information, including age, race/ethnicity, sex, education, income, employment, housing, health insurance, and access to health care, as well as medical history and medication use. They underwent a physical examination that included weight and height, blood pressure, lipid levels, plasma glucose, and hemoglobin A1c.
 

Social determinants of health

Between 1999-2000 and 2017-2018, age- and sex-adjusted mean BMI and hemoglobin A1c increased, while mean serum total cholesterol and prevalence of smoking decreased (all P < .001).

Participants with at least a college education or high family income had “consistently lower levels” of cardiovascular risk factors. And although the mean age- and sex-adjusted 10-year risk for ASCVD was significantly higher in non-Hispanic Black vs. non-Hispanic White participants (difference, 1.4% [1.0%-1.7%] in 1999-2008 and 2.0% [1.7%-2.4%] in 2009-2018), the difference was attenuated (by –0.3% in 1999-2008 and 0.7% in 2009-2018) after the researchers further adjusted for education, income, home ownership, employment, health insurance, and access to health care.

The differences in cardiovascular risk factors between Black and White participants “may have been moderated by social determinants of health,” the authors noted.
 

Provide appropriate education

Commenting on the study in an interview, Mary Ann McLaughlin, MD, MPH, associate professor of medicine, cardiology, Icahn School of Medicine at Mount Sinai, New York, pointed out that two important cardiovascular risk factors associated with being overweight – hypertension and diabetes – remained higher in the Black population compared with the White population in this analysis.

“Physicians and health care systems should provide appropriate education and resources regarding risk factor modification regarding diet, exercise, and blood pressure control,” advised Dr. McLaughlin, who was not involved with the study.

“Importantly, smoking rates and cholesterol levels are lower in the Black population, compared to the White population, when adjusted for many important socioeconomic factors,” she pointed out.

Dr. McLaughlin added that other “important social determinants of health, such as neighborhood and access to healthy food, were not measured and should be addressed by physicians when optimizing cardiovascular risk.”

The research reported in this publication was supported by the National Heart, Lung, and Blood Institute and by the National Institute of General Medical Sciences. One of the researchers, Joshua D. Bundy, PhD, was supported by a grant from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. He and the other coauthors and Dr. McLaughlin reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A new analysis has shown disparities in cardiovascular risk factors between Black and White adults in the United States, disparities that may be largely attributable to social determinants of health.

Investigators analyzed 20 years of data on over 50,500 U.S. adults drawn from the National Health and Nutrition Examination Surveys (NHANES) and found that, in the overall population, body mass index and hemoglobin A1c were significantly increased between 1999 and 2018, while serum total cholesterol and cigarette smoking were significantly decreased. Mean systolic blood pressure decreased between 1999 and 2010, but then increased after 2010.

The mean age- and sex-adjusted estimated 10-year risk for atherosclerotic cardiovascular disease (ASCVD) was consistently higher in Black participants vs. White participants, but the difference was attenuated after further adjusting for education, income, home ownership, employment, health insurance, and access to health care.

“These findings are helpful to guide the development of national public health policies for targeted interventions aimed at eliminating health disparities,” Jiang He, MD, PhD, Joseph S. Copes Chair and professor of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

“Interventions on social determinants of cardiovascular health should be tested in rigorous designed intervention trials,” said Dr. He, director of the Tulane University Translational Science Institute.

The study was published online Oct. 5 in JAMA.
 

‘Flattened’ CVD mortality?

Recent data show that the CVD mortality rate flattened, while the total number of cardiovascular deaths increased in the U.S. general population from 2010 to 2018, “but the reasons for this deceleration in the decline of CVD mortality are not entirely understood,” Dr. He said.

Moreover, “racial and ethnic differences in CVD mortality persist in the U.S. general population [but] the secular trends of cardiovascular risk factors among U.S. subpopulations with various racial and ethnic backgrounds and socioeconomic status are [also] not well understood,” he added. The effects of social determinants of health, such as education, income, home ownership, employment, health insurance, and access to health care on racial/ethnic differences in CVD risk, “are not well documented.”

To investigate these questions, the researchers drew on data from NHANES, a series of cross-sectional surveys in nationally representative samples of the U.S. population aged 20 years and older. The surveys are conducted in 2-year cycles and include data from 10 cycles conducted from 1999-2000 to 2017-2018 (n = 50,571, mean age 49.0-51.8 years; 48.2%-51.3% female).

Every 2 years, participants provided sociodemographic information, including age, race/ethnicity, sex, education, income, employment, housing, health insurance, and access to health care, as well as medical history and medication use. They underwent a physical examination that included weight and height, blood pressure, lipid levels, plasma glucose, and hemoglobin A1c.
 

Social determinants of health

Between 1999-2000 and 2017-2018, age- and sex-adjusted mean BMI and hemoglobin A1c increased, while mean serum total cholesterol and prevalence of smoking decreased (all P < .001).

Participants with at least a college education or high family income had “consistently lower levels” of cardiovascular risk factors. And although the mean age- and sex-adjusted 10-year risk for ASCVD was significantly higher in non-Hispanic Black vs. non-Hispanic White participants (difference, 1.4% [1.0%-1.7%] in 1999-2008 and 2.0% [1.7%-2.4%] in 2009-2018), the difference was attenuated (by –0.3% in 1999-2008 and 0.7% in 2009-2018) after the researchers further adjusted for education, income, home ownership, employment, health insurance, and access to health care.

The differences in cardiovascular risk factors between Black and White participants “may have been moderated by social determinants of health,” the authors noted.
 

Provide appropriate education

Commenting on the study in an interview, Mary Ann McLaughlin, MD, MPH, associate professor of medicine, cardiology, Icahn School of Medicine at Mount Sinai, New York, pointed out that two important cardiovascular risk factors associated with being overweight – hypertension and diabetes – remained higher in the Black population compared with the White population in this analysis.

“Physicians and health care systems should provide appropriate education and resources regarding risk factor modification regarding diet, exercise, and blood pressure control,” advised Dr. McLaughlin, who was not involved with the study.

“Importantly, smoking rates and cholesterol levels are lower in the Black population, compared to the White population, when adjusted for many important socioeconomic factors,” she pointed out.

Dr. McLaughlin added that other “important social determinants of health, such as neighborhood and access to healthy food, were not measured and should be addressed by physicians when optimizing cardiovascular risk.”

The research reported in this publication was supported by the National Heart, Lung, and Blood Institute and by the National Institute of General Medical Sciences. One of the researchers, Joshua D. Bundy, PhD, was supported by a grant from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. He and the other coauthors and Dr. McLaughlin reported no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.