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Frequent cannabis use tied to coronary artery disease
In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.
In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.
Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.
“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference.
“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.
“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.
“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview.
“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “Other mechanistic work published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.
“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”
ASCVD risk
Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, published in 2020, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).
“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.
“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.
“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”
‘All of Us’ observational study
In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.
They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.
There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.
Of these, 3,506 individuals had CAD, based on medical records.
Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; P = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.
The median age for daily users was 41, whereas the median age for never-users was 59.
GWAS analyses
The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.
“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”
The GWAS data for cannabis use disorder came from a recent meta-analysis of three cohorts: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.
The GWAS statistics for CAD were obtained from the CARDIoGRAMplusC4D Consortium.
Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; P = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).
A version of this article first appeared on Medscape.com.
In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.
In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.
Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.
“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference.
“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.
“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.
“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview.
“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “Other mechanistic work published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.
“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”
ASCVD risk
Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, published in 2020, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).
“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.
“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.
“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”
‘All of Us’ observational study
In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.
They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.
There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.
Of these, 3,506 individuals had CAD, based on medical records.
Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; P = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.
The median age for daily users was 41, whereas the median age for never-users was 59.
GWAS analyses
The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.
“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”
The GWAS data for cannabis use disorder came from a recent meta-analysis of three cohorts: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.
The GWAS statistics for CAD were obtained from the CARDIoGRAMplusC4D Consortium.
Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; P = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).
A version of this article first appeared on Medscape.com.
In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.
In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.
Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.
“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference.
“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.
“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.
“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview.
“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “Other mechanistic work published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.
“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”
ASCVD risk
Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, published in 2020, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).
“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.
“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.
“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”
‘All of Us’ observational study
In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.
They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.
There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.
Of these, 3,506 individuals had CAD, based on medical records.
Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; P = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.
The median age for daily users was 41, whereas the median age for never-users was 59.
GWAS analyses
The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.
“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”
The GWAS data for cannabis use disorder came from a recent meta-analysis of three cohorts: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.
The GWAS statistics for CAD were obtained from the CARDIoGRAMplusC4D Consortium.
Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; P = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).
A version of this article first appeared on Medscape.com.
FROM ACC 2023
Old drug verapamil may have new use in type 1 diabetes
In children and adolescents with new-onset type 1 diabetes, the calcium channel blocker verapamil slowed the destruction of insulin-producing pancreatic beta cells for up to a year, new data show.
Use of daily verapamil within a month of diagnosis resulted in a 30% increase in C-peptide secretion (a measure of preserved beta-cell function), compared with placebo at 52 weeks, without serious adverse events.
To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.
“We think this is a really, really exciting finding that’s hopefully going to impact the care for children with type 1 diabetes in the new-onset period,” lead author Gregory P. Forlenza, MD, said during his presentation of the data on Feb. 24 at the annual Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Berlin.
“In view of the favorable safety profile, particularly compared with immune-suppressive agents, once-a-day oral administration, and low cost, initiation of verapamil should be a consideration for newly diagnosed patients with type 1 diabetes,” added Dr. Forlenza, a pediatric endocrinologist at the Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora.
The data were also simultaneously published in JAMA, as part of the CLVer (Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes) trial.
The randomized, double-blind, six-center trial involved 113 participants, aged 7-17 years, with newly diagnosed type 1 diabetes. They were randomized to the most advanced commercially available automated insulin delivery systems available or standard care to test the effects of intensive glucose control on C-peptide levels for 52 weeks during the COVID-19 pandemic (July 2020 to September 2022). Eighty-eight patients who weighed 30 kg (66 lb) or more were further randomized (1:1) to daily extended-release verapamil or placebo for the same duration.
The positive findings for verapamil, published in one paper, contrasted with the negative ones for the automated insulin delivery (AID) system. The latter did not prevent the expected decline in C-peptide, putting to rest a long-held hypothesis that reducing glucotoxicity might preserve beta-cell function in newly diagnosed individuals with type 1 diabetes, noted Dr. Forlenza.
Could combination therapy work?
In recent years, immune-modulating agents have increasingly been shown to preserve beta-cell function in both new-onset and preclinical type 1 diabetes. One such agent, teplizumab (Tzield, Provention Bio), was approved by the U.S. Food and Drug Administration in November 2022 to delay type 1 diabetes onset in those at high risk.
Calcium channel blockers such as verapamil – used for years to treat hypertension and cardiac arrhythmias – may accomplish the same goal as teplizumab but in a different way, by reducing the protein overexpression that induces beta-cell apoptosis and death.
Dr. Forlenza showed a slide comparing the preservation of C-peptide, which was much lower with verapamil, at 30%, than with teplizumab, at 75%.
Asked to comment, session moderator Torben Biester, MD, a pediatric diabetologist at Auf der Bult-Zentrum Diabetes-Center for Children and Adolescents, Hanover, Germany, said: “[Verapamil] is a very cheap [daily] pill. [Teplizumab] is a very high-priced ... immune therapy in the United States ... an infusion twice for 10 days, so it’s a lot more burden for the patients and a lot more risk of side effects.”
“The future might be combination therapy,” added Dr. Biester.
And in an editorial published in JAMA and accompanying the two CLVer papers, Jennifer Couper, MD, of the University of Adelaide, agrees: “A well-tolerated, inexpensive, oral treatment such as verapamil with modest benefits on C-peptide production is relevant to practice.”
The new work “supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” she noted.
Verapamil results ‘brilliant’ but more work needed
In the verapamil part of the CLVer trial, by 52 weeks, verapamil doses in the youth who received it ranged from 120-360 mg/day based on weight and tolerance.
The primary outcome, C-peptide area under the curve, stayed stable, from 0.66 pmol/mL at baseline to 0.65 pmol/mL at 52 weeks in the verapamil group, compared with a drop from 0.60 pmol/mL down to 0.44 pmol/mL with placebo, a significant difference of 0.14 pmol/mL (P = .04), representing a 30% higher C-peptide level in the verapamil group.
“For us, this is a phenomenally exciting result,” Dr. Forlenza commented during his presentation.
At 52 weeks, A1c was 6.6% in the verapamil group versus 6.9% with placebo, which was not significantly different. Daily insulin dose was 0.65 versus 0.74 units/kg per day, respectively, also not significantly different.
One severe hypoglycemic event occurred in each group, and one diabetic ketoacidosis event occurred in the placebo group. In the verapamil group, three participants experienced “nonserious” electrocardiogram abnormalities and one had hypertension.
Dr. Biester said he isn’t “that concerned” about the small number of mild ECG abnormalities seen in the study with verapamil, as this is a known side effect. But overall, he said, “I would think that for a recommendation for routine use it’s too early after one study, even though the results are brilliant.”
He noted that he is involved in a similar ongoing study of verapamil in adults with new-onset type 1 diabetes, called Ver-A-T1D.
No C-peptide effect of tight glycemic control: ‘A tough pill’
In the AID part of the study, the 113 participants were randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact (a median of 35 times) by study staff, or standard management using a continuous glucose monitor (CGM) with an insulin pump or multiple daily injections.
At 52 weeks, A1c was 6.5% for the intensive group versus 7.1% with standard care, a significant difference. Time in blood glucose range of 70-180 mg/dL was significantly longer with intensive management, at 78%, compared with standard care, at 64%.
Nonetheless, the change in C-peptide area under the curve did not differ between the two groups, decreasing from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks with the AID system, compared with a decrease from 0.60 pmol/L down to 0.50 pmol/L with standard care (P = .89).
Dr. Forlenza commented that the hypothesis that tight glycemic control would delay the decline in C-peptide secretion “is something I think a lot of endocrinologists assumed to be true and something I’ve heard lots of colleagues over the years talk about.”
Consequently, he said these findings are “a tough pill for us to swallow ... but it’s important for us in the field to understand.”
“Even with frequent contacts that are well above the level we’d be able to do in standard clinical care, and even with use of the most advanced AID systems we have ... we saw absolutely no difference in stimulated C-peptide levels at any of the timepoints throughout the first year or at 52 weeks.”
“So, in our opinion, this,” combined with a prior study from 2022, “should put this hypothesis to rest,” he said.
“Excellent glycemic control has a benefit in and of itself, but it was not a successful intervention for beta-cell preservation.”
Dr. Forlenza has reported serving as a consultant, speaker, or advisory board member for Medtronic, Dexcom, Abbott, Tandem Diabetes Care, Insulet, Lilly, and Beta Bionics, and his institution has also received funding on his behalf for research grants from these companies. Dr. Biester has reported receiving speaker’s fees from DexCom, Medtronic, Novo Nordisk, F. Hoffmann–La Roche, Sanofi, and Ypsomed Holding; serving on advisory boards for Ascensia Diabetes Care Holdings, AstraZeneca, DexCom, and Medtronic; and receiving personal fees from SYNLAB; and is a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes. Dr. Couper has reported no relevant financial relationships.
The rationale for the companion CLVer analysis of the effect of reducing glucose toxicity via tight glycemic control on C-peptide progression dates back to an inpatient study published in 1989 involving 26 adolescents using an early artificial pancreas prototype called a Biostator, in which beta-cell preservation was achieved. However, two more recent studies of this approach, including one published in late 2022, did not show a difference. The CLVer analysis involved 113 participants randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact by study staff, or standard management using a CGM with a pump or multiple daily injections.
A version of this article originally appeared on Medscape.com.
In children and adolescents with new-onset type 1 diabetes, the calcium channel blocker verapamil slowed the destruction of insulin-producing pancreatic beta cells for up to a year, new data show.
Use of daily verapamil within a month of diagnosis resulted in a 30% increase in C-peptide secretion (a measure of preserved beta-cell function), compared with placebo at 52 weeks, without serious adverse events.
To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.
“We think this is a really, really exciting finding that’s hopefully going to impact the care for children with type 1 diabetes in the new-onset period,” lead author Gregory P. Forlenza, MD, said during his presentation of the data on Feb. 24 at the annual Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Berlin.
“In view of the favorable safety profile, particularly compared with immune-suppressive agents, once-a-day oral administration, and low cost, initiation of verapamil should be a consideration for newly diagnosed patients with type 1 diabetes,” added Dr. Forlenza, a pediatric endocrinologist at the Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora.
The data were also simultaneously published in JAMA, as part of the CLVer (Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes) trial.
The randomized, double-blind, six-center trial involved 113 participants, aged 7-17 years, with newly diagnosed type 1 diabetes. They were randomized to the most advanced commercially available automated insulin delivery systems available or standard care to test the effects of intensive glucose control on C-peptide levels for 52 weeks during the COVID-19 pandemic (July 2020 to September 2022). Eighty-eight patients who weighed 30 kg (66 lb) or more were further randomized (1:1) to daily extended-release verapamil or placebo for the same duration.
The positive findings for verapamil, published in one paper, contrasted with the negative ones for the automated insulin delivery (AID) system. The latter did not prevent the expected decline in C-peptide, putting to rest a long-held hypothesis that reducing glucotoxicity might preserve beta-cell function in newly diagnosed individuals with type 1 diabetes, noted Dr. Forlenza.
Could combination therapy work?
In recent years, immune-modulating agents have increasingly been shown to preserve beta-cell function in both new-onset and preclinical type 1 diabetes. One such agent, teplizumab (Tzield, Provention Bio), was approved by the U.S. Food and Drug Administration in November 2022 to delay type 1 diabetes onset in those at high risk.
Calcium channel blockers such as verapamil – used for years to treat hypertension and cardiac arrhythmias – may accomplish the same goal as teplizumab but in a different way, by reducing the protein overexpression that induces beta-cell apoptosis and death.
Dr. Forlenza showed a slide comparing the preservation of C-peptide, which was much lower with verapamil, at 30%, than with teplizumab, at 75%.
Asked to comment, session moderator Torben Biester, MD, a pediatric diabetologist at Auf der Bult-Zentrum Diabetes-Center for Children and Adolescents, Hanover, Germany, said: “[Verapamil] is a very cheap [daily] pill. [Teplizumab] is a very high-priced ... immune therapy in the United States ... an infusion twice for 10 days, so it’s a lot more burden for the patients and a lot more risk of side effects.”
“The future might be combination therapy,” added Dr. Biester.
And in an editorial published in JAMA and accompanying the two CLVer papers, Jennifer Couper, MD, of the University of Adelaide, agrees: “A well-tolerated, inexpensive, oral treatment such as verapamil with modest benefits on C-peptide production is relevant to practice.”
The new work “supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” she noted.
Verapamil results ‘brilliant’ but more work needed
In the verapamil part of the CLVer trial, by 52 weeks, verapamil doses in the youth who received it ranged from 120-360 mg/day based on weight and tolerance.
The primary outcome, C-peptide area under the curve, stayed stable, from 0.66 pmol/mL at baseline to 0.65 pmol/mL at 52 weeks in the verapamil group, compared with a drop from 0.60 pmol/mL down to 0.44 pmol/mL with placebo, a significant difference of 0.14 pmol/mL (P = .04), representing a 30% higher C-peptide level in the verapamil group.
“For us, this is a phenomenally exciting result,” Dr. Forlenza commented during his presentation.
At 52 weeks, A1c was 6.6% in the verapamil group versus 6.9% with placebo, which was not significantly different. Daily insulin dose was 0.65 versus 0.74 units/kg per day, respectively, also not significantly different.
One severe hypoglycemic event occurred in each group, and one diabetic ketoacidosis event occurred in the placebo group. In the verapamil group, three participants experienced “nonserious” electrocardiogram abnormalities and one had hypertension.
Dr. Biester said he isn’t “that concerned” about the small number of mild ECG abnormalities seen in the study with verapamil, as this is a known side effect. But overall, he said, “I would think that for a recommendation for routine use it’s too early after one study, even though the results are brilliant.”
He noted that he is involved in a similar ongoing study of verapamil in adults with new-onset type 1 diabetes, called Ver-A-T1D.
No C-peptide effect of tight glycemic control: ‘A tough pill’
In the AID part of the study, the 113 participants were randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact (a median of 35 times) by study staff, or standard management using a continuous glucose monitor (CGM) with an insulin pump or multiple daily injections.
At 52 weeks, A1c was 6.5% for the intensive group versus 7.1% with standard care, a significant difference. Time in blood glucose range of 70-180 mg/dL was significantly longer with intensive management, at 78%, compared with standard care, at 64%.
Nonetheless, the change in C-peptide area under the curve did not differ between the two groups, decreasing from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks with the AID system, compared with a decrease from 0.60 pmol/L down to 0.50 pmol/L with standard care (P = .89).
Dr. Forlenza commented that the hypothesis that tight glycemic control would delay the decline in C-peptide secretion “is something I think a lot of endocrinologists assumed to be true and something I’ve heard lots of colleagues over the years talk about.”
Consequently, he said these findings are “a tough pill for us to swallow ... but it’s important for us in the field to understand.”
“Even with frequent contacts that are well above the level we’d be able to do in standard clinical care, and even with use of the most advanced AID systems we have ... we saw absolutely no difference in stimulated C-peptide levels at any of the timepoints throughout the first year or at 52 weeks.”
“So, in our opinion, this,” combined with a prior study from 2022, “should put this hypothesis to rest,” he said.
“Excellent glycemic control has a benefit in and of itself, but it was not a successful intervention for beta-cell preservation.”
Dr. Forlenza has reported serving as a consultant, speaker, or advisory board member for Medtronic, Dexcom, Abbott, Tandem Diabetes Care, Insulet, Lilly, and Beta Bionics, and his institution has also received funding on his behalf for research grants from these companies. Dr. Biester has reported receiving speaker’s fees from DexCom, Medtronic, Novo Nordisk, F. Hoffmann–La Roche, Sanofi, and Ypsomed Holding; serving on advisory boards for Ascensia Diabetes Care Holdings, AstraZeneca, DexCom, and Medtronic; and receiving personal fees from SYNLAB; and is a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes. Dr. Couper has reported no relevant financial relationships.
The rationale for the companion CLVer analysis of the effect of reducing glucose toxicity via tight glycemic control on C-peptide progression dates back to an inpatient study published in 1989 involving 26 adolescents using an early artificial pancreas prototype called a Biostator, in which beta-cell preservation was achieved. However, two more recent studies of this approach, including one published in late 2022, did not show a difference. The CLVer analysis involved 113 participants randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact by study staff, or standard management using a CGM with a pump or multiple daily injections.
A version of this article originally appeared on Medscape.com.
In children and adolescents with new-onset type 1 diabetes, the calcium channel blocker verapamil slowed the destruction of insulin-producing pancreatic beta cells for up to a year, new data show.
Use of daily verapamil within a month of diagnosis resulted in a 30% increase in C-peptide secretion (a measure of preserved beta-cell function), compared with placebo at 52 weeks, without serious adverse events.
To put it another way, verapamil delayed the expected decline in C-peptide production from 3 months after diagnosis of type 1 diabetes to 6 months after diagnosis.
“We think this is a really, really exciting finding that’s hopefully going to impact the care for children with type 1 diabetes in the new-onset period,” lead author Gregory P. Forlenza, MD, said during his presentation of the data on Feb. 24 at the annual Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Berlin.
“In view of the favorable safety profile, particularly compared with immune-suppressive agents, once-a-day oral administration, and low cost, initiation of verapamil should be a consideration for newly diagnosed patients with type 1 diabetes,” added Dr. Forlenza, a pediatric endocrinologist at the Barbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora.
The data were also simultaneously published in JAMA, as part of the CLVer (Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes) trial.
The randomized, double-blind, six-center trial involved 113 participants, aged 7-17 years, with newly diagnosed type 1 diabetes. They were randomized to the most advanced commercially available automated insulin delivery systems available or standard care to test the effects of intensive glucose control on C-peptide levels for 52 weeks during the COVID-19 pandemic (July 2020 to September 2022). Eighty-eight patients who weighed 30 kg (66 lb) or more were further randomized (1:1) to daily extended-release verapamil or placebo for the same duration.
The positive findings for verapamil, published in one paper, contrasted with the negative ones for the automated insulin delivery (AID) system. The latter did not prevent the expected decline in C-peptide, putting to rest a long-held hypothesis that reducing glucotoxicity might preserve beta-cell function in newly diagnosed individuals with type 1 diabetes, noted Dr. Forlenza.
Could combination therapy work?
In recent years, immune-modulating agents have increasingly been shown to preserve beta-cell function in both new-onset and preclinical type 1 diabetes. One such agent, teplizumab (Tzield, Provention Bio), was approved by the U.S. Food and Drug Administration in November 2022 to delay type 1 diabetes onset in those at high risk.
Calcium channel blockers such as verapamil – used for years to treat hypertension and cardiac arrhythmias – may accomplish the same goal as teplizumab but in a different way, by reducing the protein overexpression that induces beta-cell apoptosis and death.
Dr. Forlenza showed a slide comparing the preservation of C-peptide, which was much lower with verapamil, at 30%, than with teplizumab, at 75%.
Asked to comment, session moderator Torben Biester, MD, a pediatric diabetologist at Auf der Bult-Zentrum Diabetes-Center for Children and Adolescents, Hanover, Germany, said: “[Verapamil] is a very cheap [daily] pill. [Teplizumab] is a very high-priced ... immune therapy in the United States ... an infusion twice for 10 days, so it’s a lot more burden for the patients and a lot more risk of side effects.”
“The future might be combination therapy,” added Dr. Biester.
And in an editorial published in JAMA and accompanying the two CLVer papers, Jennifer Couper, MD, of the University of Adelaide, agrees: “A well-tolerated, inexpensive, oral treatment such as verapamil with modest benefits on C-peptide production is relevant to practice.”
The new work “supports investigation of verapamil in combination with other effective agents during the earlier stages of type 1 diabetes before insulin dependence develops,” she noted.
Verapamil results ‘brilliant’ but more work needed
In the verapamil part of the CLVer trial, by 52 weeks, verapamil doses in the youth who received it ranged from 120-360 mg/day based on weight and tolerance.
The primary outcome, C-peptide area under the curve, stayed stable, from 0.66 pmol/mL at baseline to 0.65 pmol/mL at 52 weeks in the verapamil group, compared with a drop from 0.60 pmol/mL down to 0.44 pmol/mL with placebo, a significant difference of 0.14 pmol/mL (P = .04), representing a 30% higher C-peptide level in the verapamil group.
“For us, this is a phenomenally exciting result,” Dr. Forlenza commented during his presentation.
At 52 weeks, A1c was 6.6% in the verapamil group versus 6.9% with placebo, which was not significantly different. Daily insulin dose was 0.65 versus 0.74 units/kg per day, respectively, also not significantly different.
One severe hypoglycemic event occurred in each group, and one diabetic ketoacidosis event occurred in the placebo group. In the verapamil group, three participants experienced “nonserious” electrocardiogram abnormalities and one had hypertension.
Dr. Biester said he isn’t “that concerned” about the small number of mild ECG abnormalities seen in the study with verapamil, as this is a known side effect. But overall, he said, “I would think that for a recommendation for routine use it’s too early after one study, even though the results are brilliant.”
He noted that he is involved in a similar ongoing study of verapamil in adults with new-onset type 1 diabetes, called Ver-A-T1D.
No C-peptide effect of tight glycemic control: ‘A tough pill’
In the AID part of the study, the 113 participants were randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact (a median of 35 times) by study staff, or standard management using a continuous glucose monitor (CGM) with an insulin pump or multiple daily injections.
At 52 weeks, A1c was 6.5% for the intensive group versus 7.1% with standard care, a significant difference. Time in blood glucose range of 70-180 mg/dL was significantly longer with intensive management, at 78%, compared with standard care, at 64%.
Nonetheless, the change in C-peptide area under the curve did not differ between the two groups, decreasing from 0.57 pmol/mL at baseline to 0.45 pmol/mL at 52 weeks with the AID system, compared with a decrease from 0.60 pmol/L down to 0.50 pmol/L with standard care (P = .89).
Dr. Forlenza commented that the hypothesis that tight glycemic control would delay the decline in C-peptide secretion “is something I think a lot of endocrinologists assumed to be true and something I’ve heard lots of colleagues over the years talk about.”
Consequently, he said these findings are “a tough pill for us to swallow ... but it’s important for us in the field to understand.”
“Even with frequent contacts that are well above the level we’d be able to do in standard clinical care, and even with use of the most advanced AID systems we have ... we saw absolutely no difference in stimulated C-peptide levels at any of the timepoints throughout the first year or at 52 weeks.”
“So, in our opinion, this,” combined with a prior study from 2022, “should put this hypothesis to rest,” he said.
“Excellent glycemic control has a benefit in and of itself, but it was not a successful intervention for beta-cell preservation.”
Dr. Forlenza has reported serving as a consultant, speaker, or advisory board member for Medtronic, Dexcom, Abbott, Tandem Diabetes Care, Insulet, Lilly, and Beta Bionics, and his institution has also received funding on his behalf for research grants from these companies. Dr. Biester has reported receiving speaker’s fees from DexCom, Medtronic, Novo Nordisk, F. Hoffmann–La Roche, Sanofi, and Ypsomed Holding; serving on advisory boards for Ascensia Diabetes Care Holdings, AstraZeneca, DexCom, and Medtronic; and receiving personal fees from SYNLAB; and is a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes. Dr. Couper has reported no relevant financial relationships.
The rationale for the companion CLVer analysis of the effect of reducing glucose toxicity via tight glycemic control on C-peptide progression dates back to an inpatient study published in 1989 involving 26 adolescents using an early artificial pancreas prototype called a Biostator, in which beta-cell preservation was achieved. However, two more recent studies of this approach, including one published in late 2022, did not show a difference. The CLVer analysis involved 113 participants randomized 2:1 to one of two commercially available AID systems (Tandem t:slim X2 with Control-IQ or Medtronic 670G or 780G) plus frequent contact by study staff, or standard management using a CGM with a pump or multiple daily injections.
A version of this article originally appeared on Medscape.com.
Insomnia, short sleep linked to greater risk for MI
Insomnia – difficulty falling or staying asleep – was associated with a 69% greater risk of having a myocardial infarction than among adults without insomnia, according to new research.
Those who slept 5 or fewer hours per night had the highest risk for MI, and those with both diabetes and insomnia had double the risk for MI, compared with patients without these comorbidities.
The findings are from a meta-analysis of studies in more than 1 million patients, almost all without prior MI who were, on average, in their early 50s and followed for 9 years.
Yomna E. Dean, a medical student at Alexandria (Egypt) University, reported these results in a press briefing, and the study was simultaneously published in Clinical Cardiology. It will be presented at the upcoming at the annual scientific sessions of the American College of Cardiology.
“Insomnia and ]at least] 5 hours of sleep are highly associated with increased incidence of MI, an association comparable to that of other MI risk factors and as such, it should be considered as a risk factor for MI and to be incorporated into MI prevention guidelines,” the researchers concluded.
“We believe that [insomnia] should be screened and patients should be educated about the importance of sleep because nowadays insomnia is no longer a disease – sleep deprivation could also be a life choice,” Ms, Dean told a press conference prior to the meeting.
“Clinicians must educate the patients about the importance of sleep in maintaining a healthy heart and encourage proper sleep hygiene,” Ms. Dean reiterated in an email. “And if a patient still has insomnia, other methods should be considered such as cognitive-behavior[al] therapy for insomnia [CBT-I].”
Adds to growing evidence
This study does not allow any conclusion about whether treating insomnia will reduce heart attack risk, Jennifer L. Martin, PhD, president of the American Academy of Sleep Medicine, noted in a comment. Nor does it report the diversity of study participants, since insomnia is also a health equity issue, she noted, and insomnia symptoms and comorbidities were self-reported.
However, this analysis “adds to the growing evidence that poor quality or insufficient sleep is associated with poor health,” said Dr. Martin, professor of medicine at the University of California, Los Angeles, who was not involved with this research.
The study reinforces the recommendation from the American Heart Association, which includes “Get Healthy Sleep” as one of “Life’s Essential 8” for heart health, Dr. Martin noted.
“Particularly in primary care where disease prevention and health promotion are important, clinicians should be asking all patients about their sleep – just like they ask about diet and exercise – as a key aspect of maintaining heart health,” she said.
Advice about basic sleep hygiene advice is a first step, she noted.
When improved sleep hygiene is not enough to address chronic insomnia, the AASM’s clinical practice guidelines and the guidelines of the Department of Veterans Affairs/Department of Defense, recommend first-line treatment with CBT-I, typically offered by a sleep specialist or mental health clinician.
Similarly, the American College of Physicians suggests that sleeping pills should be reserved for short-term use in patients who may not benefit sufficiently from CBT-I.
Sleeping too little, too much, equally harmful
“Studies have found that insomnia and subsequent sleep deprivation puts the body under stress,” Ms. Dean said. “This triggers cortisol release which could accelerate atherosclerosis,” and increase risk of MI.
For this analysis, the researchers identified nine observational studies, published from 1998 to 2019, with data on incident MI in adults who had insomnia.
The diagnosis of insomnia was based on ICD diagnostic codes or on the DSM‐5, which defines insomnia as the presence of any of the following three symptoms: difficulty initiating sleep, difficulty maintaining sleep, or early morning awakening with inability to return to sleep. Patients with sleep apnea were excluded.
The studies were in populations in China, Germany, Norway, Taiwan, United Kingdom, and United States, in 1.1 million adults aged 18 and older. The patients had a mean age of 52 years and 13% had insomnia.
During follow-up, 2,406 of 153,881 patients with insomnia, and 12,398 of 1,030,375 patients without insomnia had an MI.
In the pooled analysis, patients with insomnia had a significantly increased risk of MI (relative risk, 1.69; P < .00001), after adjusting for age, gender, diabetes, hypertension, high cholesterol, and smoking.
Sleeping 5 hours or less was associated with a greater risk for MI than sleeping 6 hours, or 7-8 hours, but sleeping 9 hours or more was just as harmful.
Patients who had difficulty initiating and maintaining sleep – two symptoms of insomnia – had a 13% increased risk for MI compared with other patients (RR, 1.13; P = .003).
However, patients who had nonrestorative sleep and daytime dysfunction despite adequate sleep – which is common – did not have an increased risk of MI, compared with other patients (RR, 1.06; P = .46).
Women with insomnia had a 2.24-fold greater risk for MI than other women, whereas men with insomnia had a 2.03-fold greater risk for MI than other men.
Patients with insomnia had a greater risk for MI than those without insomnia in subgroups based on patients’ age (< 65 and > 65), follow up duration (≤ 5 years and > 5 years), and comorbidities (diabetes, hypertension, and hyperlipidemia).
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Insomnia – difficulty falling or staying asleep – was associated with a 69% greater risk of having a myocardial infarction than among adults without insomnia, according to new research.
Those who slept 5 or fewer hours per night had the highest risk for MI, and those with both diabetes and insomnia had double the risk for MI, compared with patients without these comorbidities.
The findings are from a meta-analysis of studies in more than 1 million patients, almost all without prior MI who were, on average, in their early 50s and followed for 9 years.
Yomna E. Dean, a medical student at Alexandria (Egypt) University, reported these results in a press briefing, and the study was simultaneously published in Clinical Cardiology. It will be presented at the upcoming at the annual scientific sessions of the American College of Cardiology.
“Insomnia and ]at least] 5 hours of sleep are highly associated with increased incidence of MI, an association comparable to that of other MI risk factors and as such, it should be considered as a risk factor for MI and to be incorporated into MI prevention guidelines,” the researchers concluded.
“We believe that [insomnia] should be screened and patients should be educated about the importance of sleep because nowadays insomnia is no longer a disease – sleep deprivation could also be a life choice,” Ms, Dean told a press conference prior to the meeting.
“Clinicians must educate the patients about the importance of sleep in maintaining a healthy heart and encourage proper sleep hygiene,” Ms. Dean reiterated in an email. “And if a patient still has insomnia, other methods should be considered such as cognitive-behavior[al] therapy for insomnia [CBT-I].”
Adds to growing evidence
This study does not allow any conclusion about whether treating insomnia will reduce heart attack risk, Jennifer L. Martin, PhD, president of the American Academy of Sleep Medicine, noted in a comment. Nor does it report the diversity of study participants, since insomnia is also a health equity issue, she noted, and insomnia symptoms and comorbidities were self-reported.
However, this analysis “adds to the growing evidence that poor quality or insufficient sleep is associated with poor health,” said Dr. Martin, professor of medicine at the University of California, Los Angeles, who was not involved with this research.
The study reinforces the recommendation from the American Heart Association, which includes “Get Healthy Sleep” as one of “Life’s Essential 8” for heart health, Dr. Martin noted.
“Particularly in primary care where disease prevention and health promotion are important, clinicians should be asking all patients about their sleep – just like they ask about diet and exercise – as a key aspect of maintaining heart health,” she said.
Advice about basic sleep hygiene advice is a first step, she noted.
When improved sleep hygiene is not enough to address chronic insomnia, the AASM’s clinical practice guidelines and the guidelines of the Department of Veterans Affairs/Department of Defense, recommend first-line treatment with CBT-I, typically offered by a sleep specialist or mental health clinician.
Similarly, the American College of Physicians suggests that sleeping pills should be reserved for short-term use in patients who may not benefit sufficiently from CBT-I.
Sleeping too little, too much, equally harmful
“Studies have found that insomnia and subsequent sleep deprivation puts the body under stress,” Ms. Dean said. “This triggers cortisol release which could accelerate atherosclerosis,” and increase risk of MI.
For this analysis, the researchers identified nine observational studies, published from 1998 to 2019, with data on incident MI in adults who had insomnia.
The diagnosis of insomnia was based on ICD diagnostic codes or on the DSM‐5, which defines insomnia as the presence of any of the following three symptoms: difficulty initiating sleep, difficulty maintaining sleep, or early morning awakening with inability to return to sleep. Patients with sleep apnea were excluded.
The studies were in populations in China, Germany, Norway, Taiwan, United Kingdom, and United States, in 1.1 million adults aged 18 and older. The patients had a mean age of 52 years and 13% had insomnia.
During follow-up, 2,406 of 153,881 patients with insomnia, and 12,398 of 1,030,375 patients without insomnia had an MI.
In the pooled analysis, patients with insomnia had a significantly increased risk of MI (relative risk, 1.69; P < .00001), after adjusting for age, gender, diabetes, hypertension, high cholesterol, and smoking.
Sleeping 5 hours or less was associated with a greater risk for MI than sleeping 6 hours, or 7-8 hours, but sleeping 9 hours or more was just as harmful.
Patients who had difficulty initiating and maintaining sleep – two symptoms of insomnia – had a 13% increased risk for MI compared with other patients (RR, 1.13; P = .003).
However, patients who had nonrestorative sleep and daytime dysfunction despite adequate sleep – which is common – did not have an increased risk of MI, compared with other patients (RR, 1.06; P = .46).
Women with insomnia had a 2.24-fold greater risk for MI than other women, whereas men with insomnia had a 2.03-fold greater risk for MI than other men.
Patients with insomnia had a greater risk for MI than those without insomnia in subgroups based on patients’ age (< 65 and > 65), follow up duration (≤ 5 years and > 5 years), and comorbidities (diabetes, hypertension, and hyperlipidemia).
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Insomnia – difficulty falling or staying asleep – was associated with a 69% greater risk of having a myocardial infarction than among adults without insomnia, according to new research.
Those who slept 5 or fewer hours per night had the highest risk for MI, and those with both diabetes and insomnia had double the risk for MI, compared with patients without these comorbidities.
The findings are from a meta-analysis of studies in more than 1 million patients, almost all without prior MI who were, on average, in their early 50s and followed for 9 years.
Yomna E. Dean, a medical student at Alexandria (Egypt) University, reported these results in a press briefing, and the study was simultaneously published in Clinical Cardiology. It will be presented at the upcoming at the annual scientific sessions of the American College of Cardiology.
“Insomnia and ]at least] 5 hours of sleep are highly associated with increased incidence of MI, an association comparable to that of other MI risk factors and as such, it should be considered as a risk factor for MI and to be incorporated into MI prevention guidelines,” the researchers concluded.
“We believe that [insomnia] should be screened and patients should be educated about the importance of sleep because nowadays insomnia is no longer a disease – sleep deprivation could also be a life choice,” Ms, Dean told a press conference prior to the meeting.
“Clinicians must educate the patients about the importance of sleep in maintaining a healthy heart and encourage proper sleep hygiene,” Ms. Dean reiterated in an email. “And if a patient still has insomnia, other methods should be considered such as cognitive-behavior[al] therapy for insomnia [CBT-I].”
Adds to growing evidence
This study does not allow any conclusion about whether treating insomnia will reduce heart attack risk, Jennifer L. Martin, PhD, president of the American Academy of Sleep Medicine, noted in a comment. Nor does it report the diversity of study participants, since insomnia is also a health equity issue, she noted, and insomnia symptoms and comorbidities were self-reported.
However, this analysis “adds to the growing evidence that poor quality or insufficient sleep is associated with poor health,” said Dr. Martin, professor of medicine at the University of California, Los Angeles, who was not involved with this research.
The study reinforces the recommendation from the American Heart Association, which includes “Get Healthy Sleep” as one of “Life’s Essential 8” for heart health, Dr. Martin noted.
“Particularly in primary care where disease prevention and health promotion are important, clinicians should be asking all patients about their sleep – just like they ask about diet and exercise – as a key aspect of maintaining heart health,” she said.
Advice about basic sleep hygiene advice is a first step, she noted.
When improved sleep hygiene is not enough to address chronic insomnia, the AASM’s clinical practice guidelines and the guidelines of the Department of Veterans Affairs/Department of Defense, recommend first-line treatment with CBT-I, typically offered by a sleep specialist or mental health clinician.
Similarly, the American College of Physicians suggests that sleeping pills should be reserved for short-term use in patients who may not benefit sufficiently from CBT-I.
Sleeping too little, too much, equally harmful
“Studies have found that insomnia and subsequent sleep deprivation puts the body under stress,” Ms. Dean said. “This triggers cortisol release which could accelerate atherosclerosis,” and increase risk of MI.
For this analysis, the researchers identified nine observational studies, published from 1998 to 2019, with data on incident MI in adults who had insomnia.
The diagnosis of insomnia was based on ICD diagnostic codes or on the DSM‐5, which defines insomnia as the presence of any of the following three symptoms: difficulty initiating sleep, difficulty maintaining sleep, or early morning awakening with inability to return to sleep. Patients with sleep apnea were excluded.
The studies were in populations in China, Germany, Norway, Taiwan, United Kingdom, and United States, in 1.1 million adults aged 18 and older. The patients had a mean age of 52 years and 13% had insomnia.
During follow-up, 2,406 of 153,881 patients with insomnia, and 12,398 of 1,030,375 patients without insomnia had an MI.
In the pooled analysis, patients with insomnia had a significantly increased risk of MI (relative risk, 1.69; P < .00001), after adjusting for age, gender, diabetes, hypertension, high cholesterol, and smoking.
Sleeping 5 hours or less was associated with a greater risk for MI than sleeping 6 hours, or 7-8 hours, but sleeping 9 hours or more was just as harmful.
Patients who had difficulty initiating and maintaining sleep – two symptoms of insomnia – had a 13% increased risk for MI compared with other patients (RR, 1.13; P = .003).
However, patients who had nonrestorative sleep and daytime dysfunction despite adequate sleep – which is common – did not have an increased risk of MI, compared with other patients (RR, 1.06; P = .46).
Women with insomnia had a 2.24-fold greater risk for MI than other women, whereas men with insomnia had a 2.03-fold greater risk for MI than other men.
Patients with insomnia had a greater risk for MI than those without insomnia in subgroups based on patients’ age (< 65 and > 65), follow up duration (≤ 5 years and > 5 years), and comorbidities (diabetes, hypertension, and hyperlipidemia).
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACC 2023
Red wine’s potential benefits for cardiovascular health
In recent weeks, you may have noticed some familiar headlines about red wine and cardiovascular health. Why the sudden return of these stories? Because of an article recently published in the American Journal of Clinical Nutrition.
Funded in part by a grant from the São Paulo Research Foundation (FAPESP), the “Wine Flora Study” was carried out by prominent researchers from institutions in South America, Europe, and the United States: University of São Paulo; State University of Campinas, São Paulo; University of Brasília; University of Verona (Italy); Austrian Institute of Technology, Tulln; and Harvard Medical School, Boston. The team looked into the effects of red wine on gut flora and plasma levels of trimethylamine-N-oxide (TMAO). And what they found was quite interesting.
The study
Previous results have pointed to the beneficial effect that red wine has on the gut microbiome.
The Wine Flora Study involved 42 men (average age, 60 years) with documented coronary artery disease. The trial encompassed two 3-week interventions. In one, the participants consumed 250 mL of red wine per day; the red wine sample had an alcohol content (% v) of 12.75. The Brazilian Wine Institute produced and supplied the red wine: a 2014 Merlot bottled in August 2016 and customized for the study. The second intervention involved alcohol abstention.
Each intervention was preceded by a 2-week washout period. Because certain foods and drinks could interfere with the results, the participants were instructed not to consume alcoholic beverages, fermented foods (yogurt, kombucha, soy lecithin, kefir, sauerkraut, and other fermented vegetables), synthetic prebiotics (insulin, fructooligosaccharides), fiber, dairy, food polyphenols (grapes, grape juice, cranberries, strawberries), and probiotics.
At each intervention, the gut microbiota was analyzed via 16S ribosomal RNA highthroughput sequencing. This method makes it possible to identify bacterial species. The plasma metabolome of 20 randomly selected participants was evaluated by ultra–high-performance liquid chromatography with tandem mass spectrometry. In this method, liquid chromatography separates the compounds, and a mass spectrometer is used to analyze them.
One of the metabolites of interest was TMAO, which is produced from the trimethylamine released when gut bacteria process protein-rich foods. TMAO has been identified as playing a role in the development of atherosclerosis.
Results
with a difference in beta diversity and predominance of Parasutterella, Ruminococcaceae, several Bacteroides species, and Prevotella.
Plasma metabolomic analysis revealed significant changes in metabolites after red wine consumption, consistent with improved redox homeostasis, which is involved in the oxidative stress that promotes atherosclerosis.
Plasma TMAO, however, did not differ between red wine intervention and alcohol abstention.
Implications
The researchers concluded that modulation of the gut microbiota may contribute to the putative cardiovascular benefits of moderate red wine consumption. But, as they were careful to point out in the very title of the study, a red wine intervention does not modify plasma TMAO. They also mentioned that the 3-week period may have been too short for the findings to serve as the basis for promoting any meaningful modification. In addition, the team emphasized that these data remain hypothesisgenerating and pave the way for future research.
In an interview with FAPESP, the study’s corresponding author, Protásio Lemos da Luz, MD, PhD, warned about the risks associated with drinking too much alcohol (> 8.5 oz., or 250 mL, of wine daily).
It should be kept in mind that, in Brazil, people do not drink nearly as much wine as they do beer or liquor. Furthermore, the evidence that is available does not provide confirmation of the existence or the extent of the protective health effects associated with light or moderate alcohol intake.
This article was translated from the Medscape Portuguese edition. A version appeared on Medscape.com.
In recent weeks, you may have noticed some familiar headlines about red wine and cardiovascular health. Why the sudden return of these stories? Because of an article recently published in the American Journal of Clinical Nutrition.
Funded in part by a grant from the São Paulo Research Foundation (FAPESP), the “Wine Flora Study” was carried out by prominent researchers from institutions in South America, Europe, and the United States: University of São Paulo; State University of Campinas, São Paulo; University of Brasília; University of Verona (Italy); Austrian Institute of Technology, Tulln; and Harvard Medical School, Boston. The team looked into the effects of red wine on gut flora and plasma levels of trimethylamine-N-oxide (TMAO). And what they found was quite interesting.
The study
Previous results have pointed to the beneficial effect that red wine has on the gut microbiome.
The Wine Flora Study involved 42 men (average age, 60 years) with documented coronary artery disease. The trial encompassed two 3-week interventions. In one, the participants consumed 250 mL of red wine per day; the red wine sample had an alcohol content (% v) of 12.75. The Brazilian Wine Institute produced and supplied the red wine: a 2014 Merlot bottled in August 2016 and customized for the study. The second intervention involved alcohol abstention.
Each intervention was preceded by a 2-week washout period. Because certain foods and drinks could interfere with the results, the participants were instructed not to consume alcoholic beverages, fermented foods (yogurt, kombucha, soy lecithin, kefir, sauerkraut, and other fermented vegetables), synthetic prebiotics (insulin, fructooligosaccharides), fiber, dairy, food polyphenols (grapes, grape juice, cranberries, strawberries), and probiotics.
At each intervention, the gut microbiota was analyzed via 16S ribosomal RNA highthroughput sequencing. This method makes it possible to identify bacterial species. The plasma metabolome of 20 randomly selected participants was evaluated by ultra–high-performance liquid chromatography with tandem mass spectrometry. In this method, liquid chromatography separates the compounds, and a mass spectrometer is used to analyze them.
One of the metabolites of interest was TMAO, which is produced from the trimethylamine released when gut bacteria process protein-rich foods. TMAO has been identified as playing a role in the development of atherosclerosis.
Results
with a difference in beta diversity and predominance of Parasutterella, Ruminococcaceae, several Bacteroides species, and Prevotella.
Plasma metabolomic analysis revealed significant changes in metabolites after red wine consumption, consistent with improved redox homeostasis, which is involved in the oxidative stress that promotes atherosclerosis.
Plasma TMAO, however, did not differ between red wine intervention and alcohol abstention.
Implications
The researchers concluded that modulation of the gut microbiota may contribute to the putative cardiovascular benefits of moderate red wine consumption. But, as they were careful to point out in the very title of the study, a red wine intervention does not modify plasma TMAO. They also mentioned that the 3-week period may have been too short for the findings to serve as the basis for promoting any meaningful modification. In addition, the team emphasized that these data remain hypothesisgenerating and pave the way for future research.
In an interview with FAPESP, the study’s corresponding author, Protásio Lemos da Luz, MD, PhD, warned about the risks associated with drinking too much alcohol (> 8.5 oz., or 250 mL, of wine daily).
It should be kept in mind that, in Brazil, people do not drink nearly as much wine as they do beer or liquor. Furthermore, the evidence that is available does not provide confirmation of the existence or the extent of the protective health effects associated with light or moderate alcohol intake.
This article was translated from the Medscape Portuguese edition. A version appeared on Medscape.com.
In recent weeks, you may have noticed some familiar headlines about red wine and cardiovascular health. Why the sudden return of these stories? Because of an article recently published in the American Journal of Clinical Nutrition.
Funded in part by a grant from the São Paulo Research Foundation (FAPESP), the “Wine Flora Study” was carried out by prominent researchers from institutions in South America, Europe, and the United States: University of São Paulo; State University of Campinas, São Paulo; University of Brasília; University of Verona (Italy); Austrian Institute of Technology, Tulln; and Harvard Medical School, Boston. The team looked into the effects of red wine on gut flora and plasma levels of trimethylamine-N-oxide (TMAO). And what they found was quite interesting.
The study
Previous results have pointed to the beneficial effect that red wine has on the gut microbiome.
The Wine Flora Study involved 42 men (average age, 60 years) with documented coronary artery disease. The trial encompassed two 3-week interventions. In one, the participants consumed 250 mL of red wine per day; the red wine sample had an alcohol content (% v) of 12.75. The Brazilian Wine Institute produced and supplied the red wine: a 2014 Merlot bottled in August 2016 and customized for the study. The second intervention involved alcohol abstention.
Each intervention was preceded by a 2-week washout period. Because certain foods and drinks could interfere with the results, the participants were instructed not to consume alcoholic beverages, fermented foods (yogurt, kombucha, soy lecithin, kefir, sauerkraut, and other fermented vegetables), synthetic prebiotics (insulin, fructooligosaccharides), fiber, dairy, food polyphenols (grapes, grape juice, cranberries, strawberries), and probiotics.
At each intervention, the gut microbiota was analyzed via 16S ribosomal RNA highthroughput sequencing. This method makes it possible to identify bacterial species. The plasma metabolome of 20 randomly selected participants was evaluated by ultra–high-performance liquid chromatography with tandem mass spectrometry. In this method, liquid chromatography separates the compounds, and a mass spectrometer is used to analyze them.
One of the metabolites of interest was TMAO, which is produced from the trimethylamine released when gut bacteria process protein-rich foods. TMAO has been identified as playing a role in the development of atherosclerosis.
Results
with a difference in beta diversity and predominance of Parasutterella, Ruminococcaceae, several Bacteroides species, and Prevotella.
Plasma metabolomic analysis revealed significant changes in metabolites after red wine consumption, consistent with improved redox homeostasis, which is involved in the oxidative stress that promotes atherosclerosis.
Plasma TMAO, however, did not differ between red wine intervention and alcohol abstention.
Implications
The researchers concluded that modulation of the gut microbiota may contribute to the putative cardiovascular benefits of moderate red wine consumption. But, as they were careful to point out in the very title of the study, a red wine intervention does not modify plasma TMAO. They also mentioned that the 3-week period may have been too short for the findings to serve as the basis for promoting any meaningful modification. In addition, the team emphasized that these data remain hypothesisgenerating and pave the way for future research.
In an interview with FAPESP, the study’s corresponding author, Protásio Lemos da Luz, MD, PhD, warned about the risks associated with drinking too much alcohol (> 8.5 oz., or 250 mL, of wine daily).
It should be kept in mind that, in Brazil, people do not drink nearly as much wine as they do beer or liquor. Furthermore, the evidence that is available does not provide confirmation of the existence or the extent of the protective health effects associated with light or moderate alcohol intake.
This article was translated from the Medscape Portuguese edition. A version appeared on Medscape.com.
In weighing PCI vs. CABG for left main disease, diabetes matters
WASHINGTON – For patients with diabetes, there are trade-offs for selecting a percutaneous intervention (PCI) over coronary artery bypass grafting (CABG) for left main artery disease when either can be considered, according to a hypothesis-generating pooled analysis.
The pooled data from four trials indicate that either method of revascularization is “reasonable,” but risk of myocardial infarction and revascularization is higher and risk of stroke is lower in patients with diabetes following PCI relative to CABG, Prakriti Gaba, MD, said in presenting the analysis at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
Despite decades of advances in both PCI and CABG, the findings are remarkably similar to those of Emory Angioplasty Versus Surgery Trial (EAST), the first major study to compare PCI to CABG, which were published almost 30 years ago. In the new analysis, like in EAST, PCI and CABG were comparable for a primary composite endpoint overall, but patients with diabetes were the exception. In those, outcomes were modestly better after CABG, said Dr. Gaba, a cardiology fellow at Brigham and Women’s Hospital, Harvard Medical School, both in Boston.
“More and more I am hearing from practitioners that diabetes does not matter, but what I get from your data is that diabetes still matters,” said Spencer B. King, MD, a pioneer of PCI affiliated with Emory University, Atlanta.
Dr. King, the first author of the 1994 paper and a panelist in the late-breaking trial session where the new data were presented, pointed out that a relatively limited proportion of patients with diabetes are equally suitable for PCI and CABG because of other considerations. However, he said an updated look once again suggesting that PCI and CABG are not equivalent for left main lesions in patients with diabetes “is helpful to see.”
CABG traditionally preferred for left main revascularization
The issue was revisited because CABG has been preferred traditionally for left main disease, but there was increasing evidence that PCI is associated with similar survival, according to Dr. Gaba. These new data support that contention, even if it shows that outcomes are not the same in those with diabetes relative to those without.
In this pooled analysis, data were drawn from four trials. Each compared PCI with drug-eluting stents with CABG in patients that were considered suitable for either. From the four trials, the numbers in this analysis included 705 patients from SYNTAX, 600 patients from PRECOMBAT, 1,184 patients from NOBLE, and 1,905 patients from EXCEL.
The focus was on the 1,104 patients with diabetes relative to the 3,289 without. The primary endpoint was all-cause death at 5 years. The multiple secondary endpoints included cardiovascular (CV) death, MI, stroke, and revascularization.
Overall, the 5-year mortality, independent of revascularization procedure, was 14.8% for those with diabetes and 9.3% for those without (P < .001). For this endpoint, the rates were numerically lower but not statistically different for CABG whether patients had diabetes (14.1% vs. 15.3%) or no diabetes (8.9% vs. 9.7%).
However, the rate of spontaneous MI was twice as great with PCI than with CABG for those with diabetes (8.9% vs. 4.4%), which doubled the hazard ratio within significant confidence intervals (HR, 2.01; 95% CI, 1.21-3.35). The rates of revascularization were also about twice as great with PCI than with CABG (24.5% vs. 12.4%), again producing a twofold increase in risk (HR, 2.12; 95% CI, 1.56-2.87).
For stroke in patients with diabetes, there was no difference in events at 5 years for PCI relative to CABG (2.1% in both groups). However, in those without diabetes, a trend approaching significance favored CABG over PCI (1.2% vs. 2.1%; HR, 0.177; 95% CI, 0.99-1.77). This difference was concentrated in the first year, when stroke rates among those treated with CABG were more than double the rates among those treated with PCI. Over time, this difference dissipated so that the difference was reduced to a trend at the end of follow-up.
Data considered hypothesis generating
Although patients with diabetes were prespecified as a subgroup of interest in these studies, Dr. Gaba said that the data can only be considered hypothesis generating and pointed out several limitations, including the fact that these studies preceded some therapies, such as sodium-glucose cotransporter 2 inhibitors, that are known to affect CV outcomes.
However, Dr. King was not alone in suggesting that these data once again show that diabetes matters. Several panelists agreed, including the moderator of the session, Robert A Byrne, MBBcH, PhD, director of cardiology, Mater Private Hospital, Dublin.
“Of course, there has been a lot of discussion over the last 4 or 5 years about this issue since the long-term EXCEL data were presented,” Dr. Byrne said. He added that the team of investigators who put this together “have done a great service to the community” by providing a detailed combined analysis to explore the interaction between diabetes and outcomes relative to method of revascularization. Although PCI and CABG are not always equivalent choices for reasons other than diabetes, he echoed the sentiment that diabetes likely remains a variable to consider when considering revascularization of left main artery disease.
Dr. Gabi, Dr. Spencer, and Dr. Byrne report no potential conflicts of interest.
WASHINGTON – For patients with diabetes, there are trade-offs for selecting a percutaneous intervention (PCI) over coronary artery bypass grafting (CABG) for left main artery disease when either can be considered, according to a hypothesis-generating pooled analysis.
The pooled data from four trials indicate that either method of revascularization is “reasonable,” but risk of myocardial infarction and revascularization is higher and risk of stroke is lower in patients with diabetes following PCI relative to CABG, Prakriti Gaba, MD, said in presenting the analysis at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
Despite decades of advances in both PCI and CABG, the findings are remarkably similar to those of Emory Angioplasty Versus Surgery Trial (EAST), the first major study to compare PCI to CABG, which were published almost 30 years ago. In the new analysis, like in EAST, PCI and CABG were comparable for a primary composite endpoint overall, but patients with diabetes were the exception. In those, outcomes were modestly better after CABG, said Dr. Gaba, a cardiology fellow at Brigham and Women’s Hospital, Harvard Medical School, both in Boston.
“More and more I am hearing from practitioners that diabetes does not matter, but what I get from your data is that diabetes still matters,” said Spencer B. King, MD, a pioneer of PCI affiliated with Emory University, Atlanta.
Dr. King, the first author of the 1994 paper and a panelist in the late-breaking trial session where the new data were presented, pointed out that a relatively limited proportion of patients with diabetes are equally suitable for PCI and CABG because of other considerations. However, he said an updated look once again suggesting that PCI and CABG are not equivalent for left main lesions in patients with diabetes “is helpful to see.”
CABG traditionally preferred for left main revascularization
The issue was revisited because CABG has been preferred traditionally for left main disease, but there was increasing evidence that PCI is associated with similar survival, according to Dr. Gaba. These new data support that contention, even if it shows that outcomes are not the same in those with diabetes relative to those without.
In this pooled analysis, data were drawn from four trials. Each compared PCI with drug-eluting stents with CABG in patients that were considered suitable for either. From the four trials, the numbers in this analysis included 705 patients from SYNTAX, 600 patients from PRECOMBAT, 1,184 patients from NOBLE, and 1,905 patients from EXCEL.
The focus was on the 1,104 patients with diabetes relative to the 3,289 without. The primary endpoint was all-cause death at 5 years. The multiple secondary endpoints included cardiovascular (CV) death, MI, stroke, and revascularization.
Overall, the 5-year mortality, independent of revascularization procedure, was 14.8% for those with diabetes and 9.3% for those without (P < .001). For this endpoint, the rates were numerically lower but not statistically different for CABG whether patients had diabetes (14.1% vs. 15.3%) or no diabetes (8.9% vs. 9.7%).
However, the rate of spontaneous MI was twice as great with PCI than with CABG for those with diabetes (8.9% vs. 4.4%), which doubled the hazard ratio within significant confidence intervals (HR, 2.01; 95% CI, 1.21-3.35). The rates of revascularization were also about twice as great with PCI than with CABG (24.5% vs. 12.4%), again producing a twofold increase in risk (HR, 2.12; 95% CI, 1.56-2.87).
For stroke in patients with diabetes, there was no difference in events at 5 years for PCI relative to CABG (2.1% in both groups). However, in those without diabetes, a trend approaching significance favored CABG over PCI (1.2% vs. 2.1%; HR, 0.177; 95% CI, 0.99-1.77). This difference was concentrated in the first year, when stroke rates among those treated with CABG were more than double the rates among those treated with PCI. Over time, this difference dissipated so that the difference was reduced to a trend at the end of follow-up.
Data considered hypothesis generating
Although patients with diabetes were prespecified as a subgroup of interest in these studies, Dr. Gaba said that the data can only be considered hypothesis generating and pointed out several limitations, including the fact that these studies preceded some therapies, such as sodium-glucose cotransporter 2 inhibitors, that are known to affect CV outcomes.
However, Dr. King was not alone in suggesting that these data once again show that diabetes matters. Several panelists agreed, including the moderator of the session, Robert A Byrne, MBBcH, PhD, director of cardiology, Mater Private Hospital, Dublin.
“Of course, there has been a lot of discussion over the last 4 or 5 years about this issue since the long-term EXCEL data were presented,” Dr. Byrne said. He added that the team of investigators who put this together “have done a great service to the community” by providing a detailed combined analysis to explore the interaction between diabetes and outcomes relative to method of revascularization. Although PCI and CABG are not always equivalent choices for reasons other than diabetes, he echoed the sentiment that diabetes likely remains a variable to consider when considering revascularization of left main artery disease.
Dr. Gabi, Dr. Spencer, and Dr. Byrne report no potential conflicts of interest.
WASHINGTON – For patients with diabetes, there are trade-offs for selecting a percutaneous intervention (PCI) over coronary artery bypass grafting (CABG) for left main artery disease when either can be considered, according to a hypothesis-generating pooled analysis.
The pooled data from four trials indicate that either method of revascularization is “reasonable,” but risk of myocardial infarction and revascularization is higher and risk of stroke is lower in patients with diabetes following PCI relative to CABG, Prakriti Gaba, MD, said in presenting the analysis at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
Despite decades of advances in both PCI and CABG, the findings are remarkably similar to those of Emory Angioplasty Versus Surgery Trial (EAST), the first major study to compare PCI to CABG, which were published almost 30 years ago. In the new analysis, like in EAST, PCI and CABG were comparable for a primary composite endpoint overall, but patients with diabetes were the exception. In those, outcomes were modestly better after CABG, said Dr. Gaba, a cardiology fellow at Brigham and Women’s Hospital, Harvard Medical School, both in Boston.
“More and more I am hearing from practitioners that diabetes does not matter, but what I get from your data is that diabetes still matters,” said Spencer B. King, MD, a pioneer of PCI affiliated with Emory University, Atlanta.
Dr. King, the first author of the 1994 paper and a panelist in the late-breaking trial session where the new data were presented, pointed out that a relatively limited proportion of patients with diabetes are equally suitable for PCI and CABG because of other considerations. However, he said an updated look once again suggesting that PCI and CABG are not equivalent for left main lesions in patients with diabetes “is helpful to see.”
CABG traditionally preferred for left main revascularization
The issue was revisited because CABG has been preferred traditionally for left main disease, but there was increasing evidence that PCI is associated with similar survival, according to Dr. Gaba. These new data support that contention, even if it shows that outcomes are not the same in those with diabetes relative to those without.
In this pooled analysis, data were drawn from four trials. Each compared PCI with drug-eluting stents with CABG in patients that were considered suitable for either. From the four trials, the numbers in this analysis included 705 patients from SYNTAX, 600 patients from PRECOMBAT, 1,184 patients from NOBLE, and 1,905 patients from EXCEL.
The focus was on the 1,104 patients with diabetes relative to the 3,289 without. The primary endpoint was all-cause death at 5 years. The multiple secondary endpoints included cardiovascular (CV) death, MI, stroke, and revascularization.
Overall, the 5-year mortality, independent of revascularization procedure, was 14.8% for those with diabetes and 9.3% for those without (P < .001). For this endpoint, the rates were numerically lower but not statistically different for CABG whether patients had diabetes (14.1% vs. 15.3%) or no diabetes (8.9% vs. 9.7%).
However, the rate of spontaneous MI was twice as great with PCI than with CABG for those with diabetes (8.9% vs. 4.4%), which doubled the hazard ratio within significant confidence intervals (HR, 2.01; 95% CI, 1.21-3.35). The rates of revascularization were also about twice as great with PCI than with CABG (24.5% vs. 12.4%), again producing a twofold increase in risk (HR, 2.12; 95% CI, 1.56-2.87).
For stroke in patients with diabetes, there was no difference in events at 5 years for PCI relative to CABG (2.1% in both groups). However, in those without diabetes, a trend approaching significance favored CABG over PCI (1.2% vs. 2.1%; HR, 0.177; 95% CI, 0.99-1.77). This difference was concentrated in the first year, when stroke rates among those treated with CABG were more than double the rates among those treated with PCI. Over time, this difference dissipated so that the difference was reduced to a trend at the end of follow-up.
Data considered hypothesis generating
Although patients with diabetes were prespecified as a subgroup of interest in these studies, Dr. Gaba said that the data can only be considered hypothesis generating and pointed out several limitations, including the fact that these studies preceded some therapies, such as sodium-glucose cotransporter 2 inhibitors, that are known to affect CV outcomes.
However, Dr. King was not alone in suggesting that these data once again show that diabetes matters. Several panelists agreed, including the moderator of the session, Robert A Byrne, MBBcH, PhD, director of cardiology, Mater Private Hospital, Dublin.
“Of course, there has been a lot of discussion over the last 4 or 5 years about this issue since the long-term EXCEL data were presented,” Dr. Byrne said. He added that the team of investigators who put this together “have done a great service to the community” by providing a detailed combined analysis to explore the interaction between diabetes and outcomes relative to method of revascularization. Although PCI and CABG are not always equivalent choices for reasons other than diabetes, he echoed the sentiment that diabetes likely remains a variable to consider when considering revascularization of left main artery disease.
Dr. Gabi, Dr. Spencer, and Dr. Byrne report no potential conflicts of interest.
AT CRT 2023
Drinking beet juice tied to reduced post-PCI restenosis
WASHINGTON – Late lumen loss (LLL) after percutaneous interventions (PCI) can be reduced significantly by a daily glass of beet juice, according to a phase 2 randomized trial.
The protection against LLL, attributed to the nitrate contained in beet juice, was accompanied by a trend for a reduced risk of major adverse cardiovascular events (MACE), according to Krishnaraj Rathod, MBBS, BMedSci, PhD, who presented results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
The study grew out of relatively recent evidence that ingestion of nitrate-rich foods, such as beets, can trigger noncanonical pathways for nitric oxide generation, sometimes referred to as the nitrate-nitrite-nitric oxide sequence. Dr. Rathod cited experimental evidence associating this pathway with the traditional benefits of NO generation, such as anti-inflammatory and antithrombotic effects.
In this study, 300 patients scheduled for PCI to treat stable angina were randomized to the experimental arm of nitrate-rich beetroot juice or the control arm of nitrate-depleted beetroot juice. Each had a 70-mL glass of juice once daily. Dr. Rathod, a senior interventional cardiology registrar, Barts Heart Centre, London, described this as the equivalent of about four beets.
The primary endpoint of the study was in-stent LLL assessed by quantitative coronary angiography (QCA) at 6 months.
MACE, defined as death, MI, need for revascularization, and in-stent thrombosis, was assessed at 3, 9, 12, and 24 months. In addition, markers of NO activation, platelet reactivity, and inflammation were monitored.
Lumen loss reduced less than 50%
On OCA, the median stent LLL at 6 months was 0.244 mm in the nitrate-depleted beet juice group and 0.117 mm (P = .0165) in the group that received natural beet juice. The mean segment LLL similarly favored the natural beet juice (0.269 vs. 0.050 mm; P = .0011).
The same effect was reflected in the measurement of mean change in minimum lumen diameter at 6 months. From baseline, this in-stent measure was reduced at 6 months by 0.244 mm in the control group, but by only 0.117 mm in the group receiving the dietary nitrate (P = .0154 for two-way analysis of variance).
Over 24 months of follow-up, there were 18 MACE events in the control arm versus 9 in the arm randomized to dietary nitrate (P = .0718). There were no in-stent thromboses observed in either group, but death (two vs. five), MI (one vs. six), and target-vessel revascularization (six vs. seven) were all numerically lower in the group receiving dietary nitrate.
“Once-a-day oral dietary nitrate for 6 months was well tolerated and safe,” Dr. Rathod reported at the meeting.
Asked specifically about the taste of the daily glass of beet juice, Dr. Rathod acknowledged that some patients were not enamored, but many had no objections or even liked the taste.
The patients were reasonably representative of a PCI population. The mean age in both groups was 61 years. There were no significant differences in body mass index (approximately 29 kg/m2) or proportion with diabetes (22%), hypertension, or hypercholesterolemia (about 70% in both groups) and other comorbidities.
More PCI was performed in the left anterior descending artery (36.7% vs. 44.0%) in the control group, while less PCI was performed in the right coronary (27.3% vs. 30.7%). Neither difference was significant. The vast majority (~90%) of patients received drug-eluting stents with a mean of 1.4 implanted. Procedural success was 100% in both groups.
Discharge medications, including antiplatelet and antithrombotic therapies, were similar in the two groups.
Results characterized as highly positive
Based on the 53% reduction in LLL at 6 months and the trend for a MACE reduction, Dr. Rathod concluded that the results were highly positive.
“These results suggest that dietary nitrate may have a therapeutic role in reducing restenosis following PCI for stable angina,” he said.
In the discussion, several panelists pointed out that nearly one-third of patients were not available for evaluation at 6 months (41 of 150 in the experimental group and 51 of 150 in the control group) with further attrition at 1 and 2 years of follow-up. Of these about half were lost to follow-up and the other half withdrew.
The lack of follow-up on such a high proportion of participants is one weakness of this study,” acknowledged Hector M. Garcia-Garcia, MD, PhD, a cardiovascular researcher at MedStar Washington Hospital Center. However, he remains enthusiastic about the premise.
“It was encouraging to see every signal moving in the right direction,” said Dr. Garcia, who consulted with Dr. Rathod’s group on the design of the study. He called these data “promising,” and said they provide support for larger trial for a treatment with potential benefits at low cost.
George Dangas, MD, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York, was among panelists who seemed surprised by such positive findings from a simple but novel concept. However, he remains open to further evaluations.
“As with any surprising result, further confirmation in a large and multicenter trial should be anticipated,” he said in an interview. If, as this study suggests, dietary changes are capable of providing therapeutic NO at the vascular level, he suggested studies to demonstrate anti-inflammatory effects or other mechanistic benefits would be helpful.
“Other sources of oral nitrate would also be a worthwhile investigation,” he said.
Dr. Rathod reports no potential conflicts of interest. Dr. Garcia-Garcia reports ties to Abbott, Biotronik, Boston Scientific, CorFlow, Medtronic, Neovasc, Phillips, and Shockwave. Dr. Dangas reports financial relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, and Medtronic.
WASHINGTON – Late lumen loss (LLL) after percutaneous interventions (PCI) can be reduced significantly by a daily glass of beet juice, according to a phase 2 randomized trial.
The protection against LLL, attributed to the nitrate contained in beet juice, was accompanied by a trend for a reduced risk of major adverse cardiovascular events (MACE), according to Krishnaraj Rathod, MBBS, BMedSci, PhD, who presented results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
The study grew out of relatively recent evidence that ingestion of nitrate-rich foods, such as beets, can trigger noncanonical pathways for nitric oxide generation, sometimes referred to as the nitrate-nitrite-nitric oxide sequence. Dr. Rathod cited experimental evidence associating this pathway with the traditional benefits of NO generation, such as anti-inflammatory and antithrombotic effects.
In this study, 300 patients scheduled for PCI to treat stable angina were randomized to the experimental arm of nitrate-rich beetroot juice or the control arm of nitrate-depleted beetroot juice. Each had a 70-mL glass of juice once daily. Dr. Rathod, a senior interventional cardiology registrar, Barts Heart Centre, London, described this as the equivalent of about four beets.
The primary endpoint of the study was in-stent LLL assessed by quantitative coronary angiography (QCA) at 6 months.
MACE, defined as death, MI, need for revascularization, and in-stent thrombosis, was assessed at 3, 9, 12, and 24 months. In addition, markers of NO activation, platelet reactivity, and inflammation were monitored.
Lumen loss reduced less than 50%
On OCA, the median stent LLL at 6 months was 0.244 mm in the nitrate-depleted beet juice group and 0.117 mm (P = .0165) in the group that received natural beet juice. The mean segment LLL similarly favored the natural beet juice (0.269 vs. 0.050 mm; P = .0011).
The same effect was reflected in the measurement of mean change in minimum lumen diameter at 6 months. From baseline, this in-stent measure was reduced at 6 months by 0.244 mm in the control group, but by only 0.117 mm in the group receiving the dietary nitrate (P = .0154 for two-way analysis of variance).
Over 24 months of follow-up, there were 18 MACE events in the control arm versus 9 in the arm randomized to dietary nitrate (P = .0718). There were no in-stent thromboses observed in either group, but death (two vs. five), MI (one vs. six), and target-vessel revascularization (six vs. seven) were all numerically lower in the group receiving dietary nitrate.
“Once-a-day oral dietary nitrate for 6 months was well tolerated and safe,” Dr. Rathod reported at the meeting.
Asked specifically about the taste of the daily glass of beet juice, Dr. Rathod acknowledged that some patients were not enamored, but many had no objections or even liked the taste.
The patients were reasonably representative of a PCI population. The mean age in both groups was 61 years. There were no significant differences in body mass index (approximately 29 kg/m2) or proportion with diabetes (22%), hypertension, or hypercholesterolemia (about 70% in both groups) and other comorbidities.
More PCI was performed in the left anterior descending artery (36.7% vs. 44.0%) in the control group, while less PCI was performed in the right coronary (27.3% vs. 30.7%). Neither difference was significant. The vast majority (~90%) of patients received drug-eluting stents with a mean of 1.4 implanted. Procedural success was 100% in both groups.
Discharge medications, including antiplatelet and antithrombotic therapies, were similar in the two groups.
Results characterized as highly positive
Based on the 53% reduction in LLL at 6 months and the trend for a MACE reduction, Dr. Rathod concluded that the results were highly positive.
“These results suggest that dietary nitrate may have a therapeutic role in reducing restenosis following PCI for stable angina,” he said.
In the discussion, several panelists pointed out that nearly one-third of patients were not available for evaluation at 6 months (41 of 150 in the experimental group and 51 of 150 in the control group) with further attrition at 1 and 2 years of follow-up. Of these about half were lost to follow-up and the other half withdrew.
The lack of follow-up on such a high proportion of participants is one weakness of this study,” acknowledged Hector M. Garcia-Garcia, MD, PhD, a cardiovascular researcher at MedStar Washington Hospital Center. However, he remains enthusiastic about the premise.
“It was encouraging to see every signal moving in the right direction,” said Dr. Garcia, who consulted with Dr. Rathod’s group on the design of the study. He called these data “promising,” and said they provide support for larger trial for a treatment with potential benefits at low cost.
George Dangas, MD, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York, was among panelists who seemed surprised by such positive findings from a simple but novel concept. However, he remains open to further evaluations.
“As with any surprising result, further confirmation in a large and multicenter trial should be anticipated,” he said in an interview. If, as this study suggests, dietary changes are capable of providing therapeutic NO at the vascular level, he suggested studies to demonstrate anti-inflammatory effects or other mechanistic benefits would be helpful.
“Other sources of oral nitrate would also be a worthwhile investigation,” he said.
Dr. Rathod reports no potential conflicts of interest. Dr. Garcia-Garcia reports ties to Abbott, Biotronik, Boston Scientific, CorFlow, Medtronic, Neovasc, Phillips, and Shockwave. Dr. Dangas reports financial relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, and Medtronic.
WASHINGTON – Late lumen loss (LLL) after percutaneous interventions (PCI) can be reduced significantly by a daily glass of beet juice, according to a phase 2 randomized trial.
The protection against LLL, attributed to the nitrate contained in beet juice, was accompanied by a trend for a reduced risk of major adverse cardiovascular events (MACE), according to Krishnaraj Rathod, MBBS, BMedSci, PhD, who presented results at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
The study grew out of relatively recent evidence that ingestion of nitrate-rich foods, such as beets, can trigger noncanonical pathways for nitric oxide generation, sometimes referred to as the nitrate-nitrite-nitric oxide sequence. Dr. Rathod cited experimental evidence associating this pathway with the traditional benefits of NO generation, such as anti-inflammatory and antithrombotic effects.
In this study, 300 patients scheduled for PCI to treat stable angina were randomized to the experimental arm of nitrate-rich beetroot juice or the control arm of nitrate-depleted beetroot juice. Each had a 70-mL glass of juice once daily. Dr. Rathod, a senior interventional cardiology registrar, Barts Heart Centre, London, described this as the equivalent of about four beets.
The primary endpoint of the study was in-stent LLL assessed by quantitative coronary angiography (QCA) at 6 months.
MACE, defined as death, MI, need for revascularization, and in-stent thrombosis, was assessed at 3, 9, 12, and 24 months. In addition, markers of NO activation, platelet reactivity, and inflammation were monitored.
Lumen loss reduced less than 50%
On OCA, the median stent LLL at 6 months was 0.244 mm in the nitrate-depleted beet juice group and 0.117 mm (P = .0165) in the group that received natural beet juice. The mean segment LLL similarly favored the natural beet juice (0.269 vs. 0.050 mm; P = .0011).
The same effect was reflected in the measurement of mean change in minimum lumen diameter at 6 months. From baseline, this in-stent measure was reduced at 6 months by 0.244 mm in the control group, but by only 0.117 mm in the group receiving the dietary nitrate (P = .0154 for two-way analysis of variance).
Over 24 months of follow-up, there were 18 MACE events in the control arm versus 9 in the arm randomized to dietary nitrate (P = .0718). There were no in-stent thromboses observed in either group, but death (two vs. five), MI (one vs. six), and target-vessel revascularization (six vs. seven) were all numerically lower in the group receiving dietary nitrate.
“Once-a-day oral dietary nitrate for 6 months was well tolerated and safe,” Dr. Rathod reported at the meeting.
Asked specifically about the taste of the daily glass of beet juice, Dr. Rathod acknowledged that some patients were not enamored, but many had no objections or even liked the taste.
The patients were reasonably representative of a PCI population. The mean age in both groups was 61 years. There were no significant differences in body mass index (approximately 29 kg/m2) or proportion with diabetes (22%), hypertension, or hypercholesterolemia (about 70% in both groups) and other comorbidities.
More PCI was performed in the left anterior descending artery (36.7% vs. 44.0%) in the control group, while less PCI was performed in the right coronary (27.3% vs. 30.7%). Neither difference was significant. The vast majority (~90%) of patients received drug-eluting stents with a mean of 1.4 implanted. Procedural success was 100% in both groups.
Discharge medications, including antiplatelet and antithrombotic therapies, were similar in the two groups.
Results characterized as highly positive
Based on the 53% reduction in LLL at 6 months and the trend for a MACE reduction, Dr. Rathod concluded that the results were highly positive.
“These results suggest that dietary nitrate may have a therapeutic role in reducing restenosis following PCI for stable angina,” he said.
In the discussion, several panelists pointed out that nearly one-third of patients were not available for evaluation at 6 months (41 of 150 in the experimental group and 51 of 150 in the control group) with further attrition at 1 and 2 years of follow-up. Of these about half were lost to follow-up and the other half withdrew.
The lack of follow-up on such a high proportion of participants is one weakness of this study,” acknowledged Hector M. Garcia-Garcia, MD, PhD, a cardiovascular researcher at MedStar Washington Hospital Center. However, he remains enthusiastic about the premise.
“It was encouraging to see every signal moving in the right direction,” said Dr. Garcia, who consulted with Dr. Rathod’s group on the design of the study. He called these data “promising,” and said they provide support for larger trial for a treatment with potential benefits at low cost.
George Dangas, MD, PhD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York, was among panelists who seemed surprised by such positive findings from a simple but novel concept. However, he remains open to further evaluations.
“As with any surprising result, further confirmation in a large and multicenter trial should be anticipated,” he said in an interview. If, as this study suggests, dietary changes are capable of providing therapeutic NO at the vascular level, he suggested studies to demonstrate anti-inflammatory effects or other mechanistic benefits would be helpful.
“Other sources of oral nitrate would also be a worthwhile investigation,” he said.
Dr. Rathod reports no potential conflicts of interest. Dr. Garcia-Garcia reports ties to Abbott, Biotronik, Boston Scientific, CorFlow, Medtronic, Neovasc, Phillips, and Shockwave. Dr. Dangas reports financial relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, and Medtronic.
AT CRT 2023
Irregular sleep tied to markers of atherosclerosis
a new report suggests.
In particular, variation in sleep duration of more than 2 hours per night in the same week was tied to higher rates of atherosclerosis.
“Poor sleep is linked with several cardiovascular conditions, including heart disease, hypertension, and type 2 diabetes,” lead author Kelsie M. Full, PhD, MPH, assistant professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview.
“Overall, we found that participants who slept varying amounts of hours throughout the week (meaning that one night they slept less, one night they slept more) were more likely to have atherosclerosis than participants who slept about the same amount of time each night,” she said.
The study was published online in the Journal of the American Heart Association.
Analyzing associations
Dr. Full and colleagues examined data from 2032 participants in the Multi-Ethnic Study of Atherosclerosis Sleep Ancillary Study, which included adults aged between 45 and 84 years in six U.S. communities who completed 7-day wrist actigraphy assessment and kept a sleep diary between 2010 and 2013.
For subclinical markers of cardiovascular disease, participants underwent assessments of coronary artery calcium, carotid plaque presence, carotid intima-media thickness, and ankle-brachial index.
The research team assessed sleep duration, or the total number of minutes of sleep in a night, and sleep timing regularity, which was determined on the basis of the time someone initially fell asleep each night. They adjusted for cardiovascular disease risk factors and sleep characteristics, such as obstructive sleep apnea, sleep duration, and sleep fragmentation.
The average age of the participants was 68.6 years, and 53.6% were women. About 37.9% identified as White, 27.6% as Black or African American, 23.4% as Hispanic American, and 11.1% as Chinese American.
During the 7-day period, about 38% of participants experienced a change in sleep duration of more than 90 minutes, and 18% experienced a sleep duration change of more than 120 minutes. Those who had irregular sleep were more likely to be non-White, current smokers, have lower average annual incomes, have work shift schedules or did not work, and have a higher average body mass index.
For the study, sleep duration irregularity was defined as a standard deviation of more than 120 minutes. Those participants who had a greater degree of sleep irregularity were more likely to have high coronary artery calcium burden than those whose sleep duration was more more regular, defined as an SD of 60 minutes or less (> 300; prevalence ratio, 1.33; 95% confidence interval, 1.03-1.71), as well as abnormal ankle-brachial index (< 0.9, prevalence ratio, 1.75;95% CI, 1.03-2.95).
Further, those with irregular sleep timing (SD > 90 minutes) were more likely to have a high coronary artery calcium burden (prevalence ratio, 1.39; 95% CI, 1.07-1.82) in comparison with those with more regular sleep timing (SD < 30 minutes).
“The biggest surprise to me was that 30% of the participants in the study had total sleep times that varied by more than 90 minutes over the course of the week,” Dr. Full said. “This is consistent with prior studies that suggest that a large proportion of the general public have irregular sleep patterns, not just shift workers.”
Investigating next steps
In additional analyses, Dr. Full and colleagues found that sleep duration regularity continued to be associated with high coronary artery calcium burden and abnormal ankle-brachial index when accounting for severe obstructive sleep apnea, average nightly sleep duration, and average sleep fragmentation.
Notably, when sleep duration was added, all participants with more irregular sleep durations (SD > 60 minutes) were more likely to have a high coronary artery calcium burden, compared with those with regular sleep durations (SD < 60 minutes). The results remained when participants who reported shift work, including night shift work, were excluded.
Additional studies are needed to understand the mechanisms, the study authors wrote. Night-to-night variability in sleep duration and sleep timing can cause desynchronization in the sleep-wake timing and circadian disruption.
“A key issue highlighted in this study is that sleep irregularity itself, independent of how much sleep people were getting, was related to heart health. Sleep is a naturally recurring phenomenon, and maintaining regularity helps provide stability and predictability to the body,” Michael Grandner, PhD, associate professor of psychiatry and director of the sleep and health research program at the University of Arizona, Tucson, said in an interview.
Dr. Grandner, who wasn’t involved with this study, has researched sleep irregularity and associations with cardiovascular disease, diabetes, obesity, and many other adverse outcomes.
“When people have very irregular sleep schedules, it may make it harder for the body to optimally make good use of the sleep it is getting, since it such a moving target,” he said. “The unique angle here is the ability to focus on regularity of sleep.”
The study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health. One author received grants and consulting fees from pharmaceutical companies unrelated to the research. The other authors and Dr. Grandner disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
a new report suggests.
In particular, variation in sleep duration of more than 2 hours per night in the same week was tied to higher rates of atherosclerosis.
“Poor sleep is linked with several cardiovascular conditions, including heart disease, hypertension, and type 2 diabetes,” lead author Kelsie M. Full, PhD, MPH, assistant professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview.
“Overall, we found that participants who slept varying amounts of hours throughout the week (meaning that one night they slept less, one night they slept more) were more likely to have atherosclerosis than participants who slept about the same amount of time each night,” she said.
The study was published online in the Journal of the American Heart Association.
Analyzing associations
Dr. Full and colleagues examined data from 2032 participants in the Multi-Ethnic Study of Atherosclerosis Sleep Ancillary Study, which included adults aged between 45 and 84 years in six U.S. communities who completed 7-day wrist actigraphy assessment and kept a sleep diary between 2010 and 2013.
For subclinical markers of cardiovascular disease, participants underwent assessments of coronary artery calcium, carotid plaque presence, carotid intima-media thickness, and ankle-brachial index.
The research team assessed sleep duration, or the total number of minutes of sleep in a night, and sleep timing regularity, which was determined on the basis of the time someone initially fell asleep each night. They adjusted for cardiovascular disease risk factors and sleep characteristics, such as obstructive sleep apnea, sleep duration, and sleep fragmentation.
The average age of the participants was 68.6 years, and 53.6% were women. About 37.9% identified as White, 27.6% as Black or African American, 23.4% as Hispanic American, and 11.1% as Chinese American.
During the 7-day period, about 38% of participants experienced a change in sleep duration of more than 90 minutes, and 18% experienced a sleep duration change of more than 120 minutes. Those who had irregular sleep were more likely to be non-White, current smokers, have lower average annual incomes, have work shift schedules or did not work, and have a higher average body mass index.
For the study, sleep duration irregularity was defined as a standard deviation of more than 120 minutes. Those participants who had a greater degree of sleep irregularity were more likely to have high coronary artery calcium burden than those whose sleep duration was more more regular, defined as an SD of 60 minutes or less (> 300; prevalence ratio, 1.33; 95% confidence interval, 1.03-1.71), as well as abnormal ankle-brachial index (< 0.9, prevalence ratio, 1.75;95% CI, 1.03-2.95).
Further, those with irregular sleep timing (SD > 90 minutes) were more likely to have a high coronary artery calcium burden (prevalence ratio, 1.39; 95% CI, 1.07-1.82) in comparison with those with more regular sleep timing (SD < 30 minutes).
“The biggest surprise to me was that 30% of the participants in the study had total sleep times that varied by more than 90 minutes over the course of the week,” Dr. Full said. “This is consistent with prior studies that suggest that a large proportion of the general public have irregular sleep patterns, not just shift workers.”
Investigating next steps
In additional analyses, Dr. Full and colleagues found that sleep duration regularity continued to be associated with high coronary artery calcium burden and abnormal ankle-brachial index when accounting for severe obstructive sleep apnea, average nightly sleep duration, and average sleep fragmentation.
Notably, when sleep duration was added, all participants with more irregular sleep durations (SD > 60 minutes) were more likely to have a high coronary artery calcium burden, compared with those with regular sleep durations (SD < 60 minutes). The results remained when participants who reported shift work, including night shift work, were excluded.
Additional studies are needed to understand the mechanisms, the study authors wrote. Night-to-night variability in sleep duration and sleep timing can cause desynchronization in the sleep-wake timing and circadian disruption.
“A key issue highlighted in this study is that sleep irregularity itself, independent of how much sleep people were getting, was related to heart health. Sleep is a naturally recurring phenomenon, and maintaining regularity helps provide stability and predictability to the body,” Michael Grandner, PhD, associate professor of psychiatry and director of the sleep and health research program at the University of Arizona, Tucson, said in an interview.
Dr. Grandner, who wasn’t involved with this study, has researched sleep irregularity and associations with cardiovascular disease, diabetes, obesity, and many other adverse outcomes.
“When people have very irregular sleep schedules, it may make it harder for the body to optimally make good use of the sleep it is getting, since it such a moving target,” he said. “The unique angle here is the ability to focus on regularity of sleep.”
The study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health. One author received grants and consulting fees from pharmaceutical companies unrelated to the research. The other authors and Dr. Grandner disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
a new report suggests.
In particular, variation in sleep duration of more than 2 hours per night in the same week was tied to higher rates of atherosclerosis.
“Poor sleep is linked with several cardiovascular conditions, including heart disease, hypertension, and type 2 diabetes,” lead author Kelsie M. Full, PhD, MPH, assistant professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview.
“Overall, we found that participants who slept varying amounts of hours throughout the week (meaning that one night they slept less, one night they slept more) were more likely to have atherosclerosis than participants who slept about the same amount of time each night,” she said.
The study was published online in the Journal of the American Heart Association.
Analyzing associations
Dr. Full and colleagues examined data from 2032 participants in the Multi-Ethnic Study of Atherosclerosis Sleep Ancillary Study, which included adults aged between 45 and 84 years in six U.S. communities who completed 7-day wrist actigraphy assessment and kept a sleep diary between 2010 and 2013.
For subclinical markers of cardiovascular disease, participants underwent assessments of coronary artery calcium, carotid plaque presence, carotid intima-media thickness, and ankle-brachial index.
The research team assessed sleep duration, or the total number of minutes of sleep in a night, and sleep timing regularity, which was determined on the basis of the time someone initially fell asleep each night. They adjusted for cardiovascular disease risk factors and sleep characteristics, such as obstructive sleep apnea, sleep duration, and sleep fragmentation.
The average age of the participants was 68.6 years, and 53.6% were women. About 37.9% identified as White, 27.6% as Black or African American, 23.4% as Hispanic American, and 11.1% as Chinese American.
During the 7-day period, about 38% of participants experienced a change in sleep duration of more than 90 minutes, and 18% experienced a sleep duration change of more than 120 minutes. Those who had irregular sleep were more likely to be non-White, current smokers, have lower average annual incomes, have work shift schedules or did not work, and have a higher average body mass index.
For the study, sleep duration irregularity was defined as a standard deviation of more than 120 minutes. Those participants who had a greater degree of sleep irregularity were more likely to have high coronary artery calcium burden than those whose sleep duration was more more regular, defined as an SD of 60 minutes or less (> 300; prevalence ratio, 1.33; 95% confidence interval, 1.03-1.71), as well as abnormal ankle-brachial index (< 0.9, prevalence ratio, 1.75;95% CI, 1.03-2.95).
Further, those with irregular sleep timing (SD > 90 minutes) were more likely to have a high coronary artery calcium burden (prevalence ratio, 1.39; 95% CI, 1.07-1.82) in comparison with those with more regular sleep timing (SD < 30 minutes).
“The biggest surprise to me was that 30% of the participants in the study had total sleep times that varied by more than 90 minutes over the course of the week,” Dr. Full said. “This is consistent with prior studies that suggest that a large proportion of the general public have irregular sleep patterns, not just shift workers.”
Investigating next steps
In additional analyses, Dr. Full and colleagues found that sleep duration regularity continued to be associated with high coronary artery calcium burden and abnormal ankle-brachial index when accounting for severe obstructive sleep apnea, average nightly sleep duration, and average sleep fragmentation.
Notably, when sleep duration was added, all participants with more irregular sleep durations (SD > 60 minutes) were more likely to have a high coronary artery calcium burden, compared with those with regular sleep durations (SD < 60 minutes). The results remained when participants who reported shift work, including night shift work, were excluded.
Additional studies are needed to understand the mechanisms, the study authors wrote. Night-to-night variability in sleep duration and sleep timing can cause desynchronization in the sleep-wake timing and circadian disruption.
“A key issue highlighted in this study is that sleep irregularity itself, independent of how much sleep people were getting, was related to heart health. Sleep is a naturally recurring phenomenon, and maintaining regularity helps provide stability and predictability to the body,” Michael Grandner, PhD, associate professor of psychiatry and director of the sleep and health research program at the University of Arizona, Tucson, said in an interview.
Dr. Grandner, who wasn’t involved with this study, has researched sleep irregularity and associations with cardiovascular disease, diabetes, obesity, and many other adverse outcomes.
“When people have very irregular sleep schedules, it may make it harder for the body to optimally make good use of the sleep it is getting, since it such a moving target,” he said. “The unique angle here is the ability to focus on regularity of sleep.”
The study was supported by the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health. One author received grants and consulting fees from pharmaceutical companies unrelated to the research. The other authors and Dr. Grandner disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Concussion burden tied to later hypertension in football players
a new study suggests.
Among more than 4,000 participants, 37% had hypertension at a median of 24 years post career and reported a median concussion symptom score (CSS) of 23 on a scale of 0 to 130.
“We have long seen an incompletely explained link between football participation and later-life cardiovascular disease,” Aaron L. Baggish, MD, of Massachusetts Hospital and Harvard Medical School, Boston, told this news organization.
“This study tested [whether] concussion burden during years of active play would be a determinant of later-life hypertension, the most common cause of cardiovascular disease, and indeed found this relationship to be a strong one.”
The study was published online in Circulation.
Link to cognitive decline?
Dr. Baggish and colleagues recruited former professional American-style football (ASF) players to participate in a survey administered by the Football Players Health Study at Harvard University.
Concussion burden was quantified with respect to the occurrence and severity of common concussion symptoms – e.g., headaches, nausea, dizziness, confusion, loss of consciousness (LOC), disorientation, and feeling unsteady on one’s feet – over years of active participation.
Prevalent hypertension was determined either by the participants’ previously receiving from a clinician a recommendation for medication for “high blood pressure” or by the participants’ taking such medication at the time of survey completion. Diabetes status was determined by the participants’ receiving a prior recommendation for or prescription for “diabetes or high blood sugar” medication.
Of 15,070 invited to participate in the study, 4,168 did so. The mean age of the participants was 51.8 years; 39.4% were Black; the mean body mass index was 31.3; and 33.9% were linemen. Participants played for a mean of 6.9 seasons and were surveyed at a median 24.1 years post ASF career completion. The median CSS was 23.
A total of 1,542 participants (37.3%) had hypertension, and 8.8% had diabetes.
After adjustment for established hypertension risk factors, including smoking, race, diabetes, age, and BMI, there was a graded association between CSS category and odds of later-life hypertension and between high CSS exposure and prevalent hypertension.
Results persisted when LOC, a single highly specific severe concussion symptom, was used in isolation as a surrogate for CSS, the investigators noted.
“These results suggest that repetitive early-life brain injury may have later-life implications for cardiovascular health,” they wrote. They also noted that hypertension has been shown to independently increase the risk of cognitive decline.
While premature cognitive decline among ASF players is generally attributed to chronic traumatic encephalopathy, “data from the current study raise the possibility that some element of cognitive decline among former ASF players may be attributable to hypertension,” which is potentially treatable.
“Future studies clarifying associations and causal pathways between brain injury, hypertension, and brain health are warranted,” they concluded.
Dr. Baggish added, “We hope that clinicians will now understand that head injury is an independent risk factor for high blood pressure and will screen vulnerable populations accordingly, as this may lead to better recognition of previously underdiagnosed hypertension with subsequent opportunities for intervention.”
Close monitoring
Commenting on the study, Jonathan Kim, MD, chair-elect of the American College of Cardiology’s Sports–Cardiology Section and chief of sports cardiology at Emory University in Atlanta, said, “They clearly show an independent association, which is not causality but is a new finding that requires more research. To me, it really emphasizes that cardiovascular risk is the most important health consequence that we should be worried about in retired NFL [National Football League] players.
“There are multifactorial reasons – not just repetitive head trauma – why this athletic population is at risk for the development of high blood pressure, even among college players,” he said.
Dr. Kim’s team has shown in studies conducted in collaboration with Dr. Baggish and others that collegiate football players who gain weight and develop increased systolic blood pressure are at risk of developing a “pathologic” cardiovascular phenotype.
Other research from this group showed links between nonsteroidal anti-inflammatory drug use among high school and collegiate ASF players and increased cardiovascular risk, as well as ASF-associated hypertension and ventricular-arterial coupling.
The suggestion that late-life hypertension could play a role in premature cognitive decline among ASF players “warrants further study,” Dr. Kim said, “because we do know that hypertension in the general population can be associated with cognitive decline. So that’s an important future direction.”
He concluded: “It’s a matter of focusing on cardiac prevention.” After their careers, players should be counseled on the importance of losing weight and adopting heart-healthy habits. In addition to some of the traditional concerns that might lead to closer follow-up of these patients, “having a lot of concussions in the history could potentially be another risk factor that should warrant close monitoring of blood pressure and, of course, treatment if necessary.”
The study was supported by Harvard Catalyst/the Harvard Clinical and Translational Science Center and the NFL Players Association. Dr. Baggish and several coauthors have received funding from the NFL Players Association.
A version of this article originally appeared on Medscape.com.
a new study suggests.
Among more than 4,000 participants, 37% had hypertension at a median of 24 years post career and reported a median concussion symptom score (CSS) of 23 on a scale of 0 to 130.
“We have long seen an incompletely explained link between football participation and later-life cardiovascular disease,” Aaron L. Baggish, MD, of Massachusetts Hospital and Harvard Medical School, Boston, told this news organization.
“This study tested [whether] concussion burden during years of active play would be a determinant of later-life hypertension, the most common cause of cardiovascular disease, and indeed found this relationship to be a strong one.”
The study was published online in Circulation.
Link to cognitive decline?
Dr. Baggish and colleagues recruited former professional American-style football (ASF) players to participate in a survey administered by the Football Players Health Study at Harvard University.
Concussion burden was quantified with respect to the occurrence and severity of common concussion symptoms – e.g., headaches, nausea, dizziness, confusion, loss of consciousness (LOC), disorientation, and feeling unsteady on one’s feet – over years of active participation.
Prevalent hypertension was determined either by the participants’ previously receiving from a clinician a recommendation for medication for “high blood pressure” or by the participants’ taking such medication at the time of survey completion. Diabetes status was determined by the participants’ receiving a prior recommendation for or prescription for “diabetes or high blood sugar” medication.
Of 15,070 invited to participate in the study, 4,168 did so. The mean age of the participants was 51.8 years; 39.4% were Black; the mean body mass index was 31.3; and 33.9% were linemen. Participants played for a mean of 6.9 seasons and were surveyed at a median 24.1 years post ASF career completion. The median CSS was 23.
A total of 1,542 participants (37.3%) had hypertension, and 8.8% had diabetes.
After adjustment for established hypertension risk factors, including smoking, race, diabetes, age, and BMI, there was a graded association between CSS category and odds of later-life hypertension and between high CSS exposure and prevalent hypertension.
Results persisted when LOC, a single highly specific severe concussion symptom, was used in isolation as a surrogate for CSS, the investigators noted.
“These results suggest that repetitive early-life brain injury may have later-life implications for cardiovascular health,” they wrote. They also noted that hypertension has been shown to independently increase the risk of cognitive decline.
While premature cognitive decline among ASF players is generally attributed to chronic traumatic encephalopathy, “data from the current study raise the possibility that some element of cognitive decline among former ASF players may be attributable to hypertension,” which is potentially treatable.
“Future studies clarifying associations and causal pathways between brain injury, hypertension, and brain health are warranted,” they concluded.
Dr. Baggish added, “We hope that clinicians will now understand that head injury is an independent risk factor for high blood pressure and will screen vulnerable populations accordingly, as this may lead to better recognition of previously underdiagnosed hypertension with subsequent opportunities for intervention.”
Close monitoring
Commenting on the study, Jonathan Kim, MD, chair-elect of the American College of Cardiology’s Sports–Cardiology Section and chief of sports cardiology at Emory University in Atlanta, said, “They clearly show an independent association, which is not causality but is a new finding that requires more research. To me, it really emphasizes that cardiovascular risk is the most important health consequence that we should be worried about in retired NFL [National Football League] players.
“There are multifactorial reasons – not just repetitive head trauma – why this athletic population is at risk for the development of high blood pressure, even among college players,” he said.
Dr. Kim’s team has shown in studies conducted in collaboration with Dr. Baggish and others that collegiate football players who gain weight and develop increased systolic blood pressure are at risk of developing a “pathologic” cardiovascular phenotype.
Other research from this group showed links between nonsteroidal anti-inflammatory drug use among high school and collegiate ASF players and increased cardiovascular risk, as well as ASF-associated hypertension and ventricular-arterial coupling.
The suggestion that late-life hypertension could play a role in premature cognitive decline among ASF players “warrants further study,” Dr. Kim said, “because we do know that hypertension in the general population can be associated with cognitive decline. So that’s an important future direction.”
He concluded: “It’s a matter of focusing on cardiac prevention.” After their careers, players should be counseled on the importance of losing weight and adopting heart-healthy habits. In addition to some of the traditional concerns that might lead to closer follow-up of these patients, “having a lot of concussions in the history could potentially be another risk factor that should warrant close monitoring of blood pressure and, of course, treatment if necessary.”
The study was supported by Harvard Catalyst/the Harvard Clinical and Translational Science Center and the NFL Players Association. Dr. Baggish and several coauthors have received funding from the NFL Players Association.
A version of this article originally appeared on Medscape.com.
a new study suggests.
Among more than 4,000 participants, 37% had hypertension at a median of 24 years post career and reported a median concussion symptom score (CSS) of 23 on a scale of 0 to 130.
“We have long seen an incompletely explained link between football participation and later-life cardiovascular disease,” Aaron L. Baggish, MD, of Massachusetts Hospital and Harvard Medical School, Boston, told this news organization.
“This study tested [whether] concussion burden during years of active play would be a determinant of later-life hypertension, the most common cause of cardiovascular disease, and indeed found this relationship to be a strong one.”
The study was published online in Circulation.
Link to cognitive decline?
Dr. Baggish and colleagues recruited former professional American-style football (ASF) players to participate in a survey administered by the Football Players Health Study at Harvard University.
Concussion burden was quantified with respect to the occurrence and severity of common concussion symptoms – e.g., headaches, nausea, dizziness, confusion, loss of consciousness (LOC), disorientation, and feeling unsteady on one’s feet – over years of active participation.
Prevalent hypertension was determined either by the participants’ previously receiving from a clinician a recommendation for medication for “high blood pressure” or by the participants’ taking such medication at the time of survey completion. Diabetes status was determined by the participants’ receiving a prior recommendation for or prescription for “diabetes or high blood sugar” medication.
Of 15,070 invited to participate in the study, 4,168 did so. The mean age of the participants was 51.8 years; 39.4% were Black; the mean body mass index was 31.3; and 33.9% were linemen. Participants played for a mean of 6.9 seasons and were surveyed at a median 24.1 years post ASF career completion. The median CSS was 23.
A total of 1,542 participants (37.3%) had hypertension, and 8.8% had diabetes.
After adjustment for established hypertension risk factors, including smoking, race, diabetes, age, and BMI, there was a graded association between CSS category and odds of later-life hypertension and between high CSS exposure and prevalent hypertension.
Results persisted when LOC, a single highly specific severe concussion symptom, was used in isolation as a surrogate for CSS, the investigators noted.
“These results suggest that repetitive early-life brain injury may have later-life implications for cardiovascular health,” they wrote. They also noted that hypertension has been shown to independently increase the risk of cognitive decline.
While premature cognitive decline among ASF players is generally attributed to chronic traumatic encephalopathy, “data from the current study raise the possibility that some element of cognitive decline among former ASF players may be attributable to hypertension,” which is potentially treatable.
“Future studies clarifying associations and causal pathways between brain injury, hypertension, and brain health are warranted,” they concluded.
Dr. Baggish added, “We hope that clinicians will now understand that head injury is an independent risk factor for high blood pressure and will screen vulnerable populations accordingly, as this may lead to better recognition of previously underdiagnosed hypertension with subsequent opportunities for intervention.”
Close monitoring
Commenting on the study, Jonathan Kim, MD, chair-elect of the American College of Cardiology’s Sports–Cardiology Section and chief of sports cardiology at Emory University in Atlanta, said, “They clearly show an independent association, which is not causality but is a new finding that requires more research. To me, it really emphasizes that cardiovascular risk is the most important health consequence that we should be worried about in retired NFL [National Football League] players.
“There are multifactorial reasons – not just repetitive head trauma – why this athletic population is at risk for the development of high blood pressure, even among college players,” he said.
Dr. Kim’s team has shown in studies conducted in collaboration with Dr. Baggish and others that collegiate football players who gain weight and develop increased systolic blood pressure are at risk of developing a “pathologic” cardiovascular phenotype.
Other research from this group showed links between nonsteroidal anti-inflammatory drug use among high school and collegiate ASF players and increased cardiovascular risk, as well as ASF-associated hypertension and ventricular-arterial coupling.
The suggestion that late-life hypertension could play a role in premature cognitive decline among ASF players “warrants further study,” Dr. Kim said, “because we do know that hypertension in the general population can be associated with cognitive decline. So that’s an important future direction.”
He concluded: “It’s a matter of focusing on cardiac prevention.” After their careers, players should be counseled on the importance of losing weight and adopting heart-healthy habits. In addition to some of the traditional concerns that might lead to closer follow-up of these patients, “having a lot of concussions in the history could potentially be another risk factor that should warrant close monitoring of blood pressure and, of course, treatment if necessary.”
The study was supported by Harvard Catalyst/the Harvard Clinical and Translational Science Center and the NFL Players Association. Dr. Baggish and several coauthors have received funding from the NFL Players Association.
A version of this article originally appeared on Medscape.com.
FROM CIRCULATION
Two cups of coffee increase heart dangers with hypertension
according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.
What to know
People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.
Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.
An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.
Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.
Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.
This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.
A version of this article first appeared on Medscape.com.
according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.
What to know
People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.
Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.
An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.
Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.
Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.
This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.
A version of this article first appeared on Medscape.com.
according to researchers at Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo.
What to know
People with severely high blood pressure who drink two or more cups of caffeinated coffee each day could double their risk of dying from a heart attack, stroke, or any type of cardiovascular disease.
Too much coffee may raise blood pressure and lead to anxiety, heart palpitations, and difficulty sleeping.
An 8-ounce cup of coffee has 80-100 mg of caffeine, while an 8-ounce cup of green or black tea has 30-50 mg.
Drinking one cup of coffee a day or any amount of green tea was not associated with risk of death across any blood pressure categories, and drinking green tea was not associated with increased risk of death related to cardiovascular disease at any blood pressure level.
Frequent consumers of coffee were more likely to be younger, current smokers, current drinkers, to eat fewer vegetables, and to have higher total cholesterol levels and lower systolic blood pressure regardless of their blood pressure category.
This is a summary of the article “Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension,” published in the Journal of the American Heart Association.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF AMERICAN HEART ASSOCIATION
New ACC, AHA, SCAI interventional cardiology training guidance
The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.
It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.
“With this groundbreaking document, the writing committee provides a roadmap for both program directors and interventional cardiology trainees to help them progress through important training milestones,” Theodore A. Bass, MD, chair of the statement writing committee, says in a news release.
“The document defines the required competencies for the full scope of interventional cardiology, providing trainees for the first time with the information to support training across all these areas,” Dr. Bass adds.
Minimum of 250 procedures
To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:
- A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
- A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
- An option for additional post-fellowship training based on the trainee’s career goals.
The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.
Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.
To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.
Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.
In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.
Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.
Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.
The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.
The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
A version of this article first appeared on Medscape.com.
The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.
It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.
“With this groundbreaking document, the writing committee provides a roadmap for both program directors and interventional cardiology trainees to help them progress through important training milestones,” Theodore A. Bass, MD, chair of the statement writing committee, says in a news release.
“The document defines the required competencies for the full scope of interventional cardiology, providing trainees for the first time with the information to support training across all these areas,” Dr. Bass adds.
Minimum of 250 procedures
To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:
- A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
- A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
- An option for additional post-fellowship training based on the trainee’s career goals.
The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.
Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.
To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.
Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.
In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.
Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.
Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.
The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.
The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
A version of this article first appeared on Medscape.com.
The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.
It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.
“With this groundbreaking document, the writing committee provides a roadmap for both program directors and interventional cardiology trainees to help them progress through important training milestones,” Theodore A. Bass, MD, chair of the statement writing committee, says in a news release.
“The document defines the required competencies for the full scope of interventional cardiology, providing trainees for the first time with the information to support training across all these areas,” Dr. Bass adds.
Minimum of 250 procedures
To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:
- A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
- A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
- An option for additional post-fellowship training based on the trainee’s career goals.
The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.
Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.
To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.
Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.
In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.
Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.
Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.
The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.
The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
A version of this article first appeared on Medscape.com.