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Cardiovascular Research Foundation: Transcatheter Cardiovascular Therapeutics (TCT)
Mixed results with two stents for bifurcations
SAN FRANCISCO – Two separate randomized studies of treating coronary bifurcation lesions with a two-stent strategy rather than provisional stenting produced varying results that were reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 450-patient BIF IV (Nordic-Baltic Bifurcation Study IV) found statistically comparable 6-month rates of major adverse cardiac events in the two-stent and provisional stenting groups for the treatment of bifurcation lesions involving a large side branch. The two-stent strategy failed to meet a noninferiority endpoint at 9 months, however, in the separate 704-patient TRYTON (Tryton Bifurcation) trial compared with provisional stenting, which is the conventional strategy of stenting the main vessel and only stenting the side branch if it is compromised.
In BIF IV, at the 6-month follow-up, 1.8% of 229 patients in the two-stent group and 4.6% of 221 patients in the provisional stenting group developed one of the major adverse cardiac events (MACEs) in the primary composite endpoint: cardiac death; non–index-procedure-related myocardial infarction (MI); target-lesion revascularization; or definite stent thrombosis. The difference was not statistically significant, Dr. Indulis Kumsars and his associates reported.
Rates for individual secondary outcomes also were similar between groups, including rates for the separate MACE components and for target-vessel revascularization or for angina.
The study randomized patients at 16 European centers who had angina or non-ST elevation MI with stenosis involving the main vessel (at least 3 mm) and a true bifurcation lesion (at least 2.75 mm) in a large side branch. Average side branch lesions were significantly longer in the two-stent group (8 mm) than in the provisional stenting group (7.4 mm). Compared with the provisional stenting procedures, the two-stent procedures were significantly longer (93 vs. 74 minutes), and required more contrast volume (238 vs. 187 mL) and fluoroscopy time (23 vs. 14 minutes).
Provisional stenting has been accepted for treating most bifurcation lesions, but it had not been known whether it would work equally well in true bifurcation lesions involving a large side branch, said Dr. Kumsars of Pauls Stradins Clinical University Hospital, Riga, Latvia. The investigators had expected the two-stent technique to produce superior results.
"Longer and more complex procedures in the two-stent group did not translate into more procedural MIs," he said. Perhaps longer follow-up will identify the optimal strategy for treating true bifurcation lesions, he added.
The TRYTON trial included patients at 58 international sites with symptoms or evidence of ischemia from true bifurcation lesions involving a main coronary artery (2.5-4.0 mm) and a side branch (2.5-3.5 mm). Patients were randomized to receive a drug-eluting stent in the main vessel and provisional stenting in the side branch or the Tryton bare-metal dedicated bifurcation stent in the side branch and a drug-eluting stent in the main vessel. The Tryton stent is approved in Europe but is investigational in the United States.
At 9 months of follow-up, 12.8% in the provisional stenting group and 17.4% in the two-stent group showed target vessel failure, defined as cardiac death, target vessel MI, or target vessel revascularization. The 4.6% difference in failure rates had an upper limit of a 10.3% difference in the confidence interval, and so did not fall within the prespecified 5.5% difference to show noninferiority of one technique over the other, Dr. Martin B. Leon and his associates reported at the meeting, which was cosponsored by the American College of Cardiology.
The failure to reach clinical noninferiority was due mainly to relatively higher frequencies of small periprocedural creatinine kinase MB (CK-MB) elevations in the Tryton group, said Dr. Leon, professor of medicine at Columbia University, N.Y., and director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. One of the components of the primary outcome of target vessel failure – target vessel MI – was defined as periprocedural CK-MB elevations greater than three times normal levels.
Definite or probable stent thrombosis rates were low at 9 months: 0.3% in the provisional stenting group and 0.6% in the Tryton group. Target vessel revascularization was needed in 3.6% of the provisional group and 4.7% of the Tryton group. The percent diameter stenosis in the side branch at 9 months was significantly lower in the Tryton group (31.6%) than in the control group (38.6%), a positive outcome in the main secondary outcome measure.
Eight percent of patients in the provisional stenting arm crossed over to treatment with a second stent, a relatively low proportion. "It means the site investigators adhered to rigorous crossover criteria," Dr. Leon said.
Post hoc subset analyses suggested that the 41% of patients with larger side branches (more than 2.25 mm) showed greater benefit from the two-stent approach than did other patients.
Bifurcation lesions account for 15%-20% of all coronary lesions treated by percutaneous coronary intervention, Dr. Kumsars said.
Dr. Kumsars reported having no financial disclosures. Dr. Leon reported financial associations with Abbott, Boston Scientific, and Medtronic. Tryton Medical sponsored the TRYTON study.
The Tryton device kind of facilitates a Culotte technique in the bifurcation lesion, although it is a bare metal stent as opposed to a drug-eluting stent. While going beyond a negative primary endpoint to a positive subgroup outcome is statistically frowned upon, nonetheless, the outcome in the larger-side-branch group certainly is interesting. I think we’ve learned that small side branches are rarely clinically expressed.
Both in the TRYTON study and in Nordic-Baltic Bifurcation IV, there are still relatively short side-branch lesions. We all know of many, many cases where you’ve got long disease in the side branch where of course you’re going to need two stents. It wouldn’t make sense to put a long stent in the midportion of a side branch and then try to provisionally dilate just the bifurcation.
The main question that the investigators have to grapple with, and the U.S. Food and Drug Administration will be grappling with, is when would you use the Tryton device as opposed to a provisional side-branch balloon strategy and as opposed to using two drug-eluting stents? That’s an interesting question.
Dr. Gregg W. Stone is professor of medicine at Columbia University, New York, and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. He gave these comments as part of a panel discussion of Dr. Leon’s study at the meeting. He reported financial associations with multiple companies but not with Tryton Medical.
The Tryton device kind of facilitates a Culotte technique in the bifurcation lesion, although it is a bare metal stent as opposed to a drug-eluting stent. While going beyond a negative primary endpoint to a positive subgroup outcome is statistically frowned upon, nonetheless, the outcome in the larger-side-branch group certainly is interesting. I think we’ve learned that small side branches are rarely clinically expressed.
Both in the TRYTON study and in Nordic-Baltic Bifurcation IV, there are still relatively short side-branch lesions. We all know of many, many cases where you’ve got long disease in the side branch where of course you’re going to need two stents. It wouldn’t make sense to put a long stent in the midportion of a side branch and then try to provisionally dilate just the bifurcation.
The main question that the investigators have to grapple with, and the U.S. Food and Drug Administration will be grappling with, is when would you use the Tryton device as opposed to a provisional side-branch balloon strategy and as opposed to using two drug-eluting stents? That’s an interesting question.
Dr. Gregg W. Stone is professor of medicine at Columbia University, New York, and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. He gave these comments as part of a panel discussion of Dr. Leon’s study at the meeting. He reported financial associations with multiple companies but not with Tryton Medical.
The Tryton device kind of facilitates a Culotte technique in the bifurcation lesion, although it is a bare metal stent as opposed to a drug-eluting stent. While going beyond a negative primary endpoint to a positive subgroup outcome is statistically frowned upon, nonetheless, the outcome in the larger-side-branch group certainly is interesting. I think we’ve learned that small side branches are rarely clinically expressed.
Both in the TRYTON study and in Nordic-Baltic Bifurcation IV, there are still relatively short side-branch lesions. We all know of many, many cases where you’ve got long disease in the side branch where of course you’re going to need two stents. It wouldn’t make sense to put a long stent in the midportion of a side branch and then try to provisionally dilate just the bifurcation.
The main question that the investigators have to grapple with, and the U.S. Food and Drug Administration will be grappling with, is when would you use the Tryton device as opposed to a provisional side-branch balloon strategy and as opposed to using two drug-eluting stents? That’s an interesting question.
Dr. Gregg W. Stone is professor of medicine at Columbia University, New York, and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. He gave these comments as part of a panel discussion of Dr. Leon’s study at the meeting. He reported financial associations with multiple companies but not with Tryton Medical.
SAN FRANCISCO – Two separate randomized studies of treating coronary bifurcation lesions with a two-stent strategy rather than provisional stenting produced varying results that were reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 450-patient BIF IV (Nordic-Baltic Bifurcation Study IV) found statistically comparable 6-month rates of major adverse cardiac events in the two-stent and provisional stenting groups for the treatment of bifurcation lesions involving a large side branch. The two-stent strategy failed to meet a noninferiority endpoint at 9 months, however, in the separate 704-patient TRYTON (Tryton Bifurcation) trial compared with provisional stenting, which is the conventional strategy of stenting the main vessel and only stenting the side branch if it is compromised.
In BIF IV, at the 6-month follow-up, 1.8% of 229 patients in the two-stent group and 4.6% of 221 patients in the provisional stenting group developed one of the major adverse cardiac events (MACEs) in the primary composite endpoint: cardiac death; non–index-procedure-related myocardial infarction (MI); target-lesion revascularization; or definite stent thrombosis. The difference was not statistically significant, Dr. Indulis Kumsars and his associates reported.
Rates for individual secondary outcomes also were similar between groups, including rates for the separate MACE components and for target-vessel revascularization or for angina.
The study randomized patients at 16 European centers who had angina or non-ST elevation MI with stenosis involving the main vessel (at least 3 mm) and a true bifurcation lesion (at least 2.75 mm) in a large side branch. Average side branch lesions were significantly longer in the two-stent group (8 mm) than in the provisional stenting group (7.4 mm). Compared with the provisional stenting procedures, the two-stent procedures were significantly longer (93 vs. 74 minutes), and required more contrast volume (238 vs. 187 mL) and fluoroscopy time (23 vs. 14 minutes).
Provisional stenting has been accepted for treating most bifurcation lesions, but it had not been known whether it would work equally well in true bifurcation lesions involving a large side branch, said Dr. Kumsars of Pauls Stradins Clinical University Hospital, Riga, Latvia. The investigators had expected the two-stent technique to produce superior results.
"Longer and more complex procedures in the two-stent group did not translate into more procedural MIs," he said. Perhaps longer follow-up will identify the optimal strategy for treating true bifurcation lesions, he added.
The TRYTON trial included patients at 58 international sites with symptoms or evidence of ischemia from true bifurcation lesions involving a main coronary artery (2.5-4.0 mm) and a side branch (2.5-3.5 mm). Patients were randomized to receive a drug-eluting stent in the main vessel and provisional stenting in the side branch or the Tryton bare-metal dedicated bifurcation stent in the side branch and a drug-eluting stent in the main vessel. The Tryton stent is approved in Europe but is investigational in the United States.
At 9 months of follow-up, 12.8% in the provisional stenting group and 17.4% in the two-stent group showed target vessel failure, defined as cardiac death, target vessel MI, or target vessel revascularization. The 4.6% difference in failure rates had an upper limit of a 10.3% difference in the confidence interval, and so did not fall within the prespecified 5.5% difference to show noninferiority of one technique over the other, Dr. Martin B. Leon and his associates reported at the meeting, which was cosponsored by the American College of Cardiology.
The failure to reach clinical noninferiority was due mainly to relatively higher frequencies of small periprocedural creatinine kinase MB (CK-MB) elevations in the Tryton group, said Dr. Leon, professor of medicine at Columbia University, N.Y., and director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. One of the components of the primary outcome of target vessel failure – target vessel MI – was defined as periprocedural CK-MB elevations greater than three times normal levels.
Definite or probable stent thrombosis rates were low at 9 months: 0.3% in the provisional stenting group and 0.6% in the Tryton group. Target vessel revascularization was needed in 3.6% of the provisional group and 4.7% of the Tryton group. The percent diameter stenosis in the side branch at 9 months was significantly lower in the Tryton group (31.6%) than in the control group (38.6%), a positive outcome in the main secondary outcome measure.
Eight percent of patients in the provisional stenting arm crossed over to treatment with a second stent, a relatively low proportion. "It means the site investigators adhered to rigorous crossover criteria," Dr. Leon said.
Post hoc subset analyses suggested that the 41% of patients with larger side branches (more than 2.25 mm) showed greater benefit from the two-stent approach than did other patients.
Bifurcation lesions account for 15%-20% of all coronary lesions treated by percutaneous coronary intervention, Dr. Kumsars said.
Dr. Kumsars reported having no financial disclosures. Dr. Leon reported financial associations with Abbott, Boston Scientific, and Medtronic. Tryton Medical sponsored the TRYTON study.
SAN FRANCISCO – Two separate randomized studies of treating coronary bifurcation lesions with a two-stent strategy rather than provisional stenting produced varying results that were reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 450-patient BIF IV (Nordic-Baltic Bifurcation Study IV) found statistically comparable 6-month rates of major adverse cardiac events in the two-stent and provisional stenting groups for the treatment of bifurcation lesions involving a large side branch. The two-stent strategy failed to meet a noninferiority endpoint at 9 months, however, in the separate 704-patient TRYTON (Tryton Bifurcation) trial compared with provisional stenting, which is the conventional strategy of stenting the main vessel and only stenting the side branch if it is compromised.
In BIF IV, at the 6-month follow-up, 1.8% of 229 patients in the two-stent group and 4.6% of 221 patients in the provisional stenting group developed one of the major adverse cardiac events (MACEs) in the primary composite endpoint: cardiac death; non–index-procedure-related myocardial infarction (MI); target-lesion revascularization; or definite stent thrombosis. The difference was not statistically significant, Dr. Indulis Kumsars and his associates reported.
Rates for individual secondary outcomes also were similar between groups, including rates for the separate MACE components and for target-vessel revascularization or for angina.
The study randomized patients at 16 European centers who had angina or non-ST elevation MI with stenosis involving the main vessel (at least 3 mm) and a true bifurcation lesion (at least 2.75 mm) in a large side branch. Average side branch lesions were significantly longer in the two-stent group (8 mm) than in the provisional stenting group (7.4 mm). Compared with the provisional stenting procedures, the two-stent procedures were significantly longer (93 vs. 74 minutes), and required more contrast volume (238 vs. 187 mL) and fluoroscopy time (23 vs. 14 minutes).
Provisional stenting has been accepted for treating most bifurcation lesions, but it had not been known whether it would work equally well in true bifurcation lesions involving a large side branch, said Dr. Kumsars of Pauls Stradins Clinical University Hospital, Riga, Latvia. The investigators had expected the two-stent technique to produce superior results.
"Longer and more complex procedures in the two-stent group did not translate into more procedural MIs," he said. Perhaps longer follow-up will identify the optimal strategy for treating true bifurcation lesions, he added.
The TRYTON trial included patients at 58 international sites with symptoms or evidence of ischemia from true bifurcation lesions involving a main coronary artery (2.5-4.0 mm) and a side branch (2.5-3.5 mm). Patients were randomized to receive a drug-eluting stent in the main vessel and provisional stenting in the side branch or the Tryton bare-metal dedicated bifurcation stent in the side branch and a drug-eluting stent in the main vessel. The Tryton stent is approved in Europe but is investigational in the United States.
At 9 months of follow-up, 12.8% in the provisional stenting group and 17.4% in the two-stent group showed target vessel failure, defined as cardiac death, target vessel MI, or target vessel revascularization. The 4.6% difference in failure rates had an upper limit of a 10.3% difference in the confidence interval, and so did not fall within the prespecified 5.5% difference to show noninferiority of one technique over the other, Dr. Martin B. Leon and his associates reported at the meeting, which was cosponsored by the American College of Cardiology.
The failure to reach clinical noninferiority was due mainly to relatively higher frequencies of small periprocedural creatinine kinase MB (CK-MB) elevations in the Tryton group, said Dr. Leon, professor of medicine at Columbia University, N.Y., and director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. One of the components of the primary outcome of target vessel failure – target vessel MI – was defined as periprocedural CK-MB elevations greater than three times normal levels.
Definite or probable stent thrombosis rates were low at 9 months: 0.3% in the provisional stenting group and 0.6% in the Tryton group. Target vessel revascularization was needed in 3.6% of the provisional group and 4.7% of the Tryton group. The percent diameter stenosis in the side branch at 9 months was significantly lower in the Tryton group (31.6%) than in the control group (38.6%), a positive outcome in the main secondary outcome measure.
Eight percent of patients in the provisional stenting arm crossed over to treatment with a second stent, a relatively low proportion. "It means the site investigators adhered to rigorous crossover criteria," Dr. Leon said.
Post hoc subset analyses suggested that the 41% of patients with larger side branches (more than 2.25 mm) showed greater benefit from the two-stent approach than did other patients.
Bifurcation lesions account for 15%-20% of all coronary lesions treated by percutaneous coronary intervention, Dr. Kumsars said.
Dr. Kumsars reported having no financial disclosures. Dr. Leon reported financial associations with Abbott, Boston Scientific, and Medtronic. Tryton Medical sponsored the TRYTON study.
AT TCT 2013
Major finding: In the Nordic-Baltic trial, MACE rates were 1.8% in the two-stent group and 4.6% with provisional stenting at 6 months. In the TRYTON trial, target-vessel failure occurred in 17.4% of the two-stent group and 12.8% of the provisional stenting group at 9 months.
Data source: Separate multinational trials randomizing 450 and 704 patients, respectively, to two-stent or provisional stenting for true coronary bifurcation lesions.
Disclosures: Dr. Kumsars reported having no financial disclosures. Dr. Leon reported financial associations with Abbott, Boston Scientific, and Medtronic. Tryton Medical sponsored the TRYTON study.
Higher PCI risk in diabetes not due to insulin
SAN FRANCISCO – Insulin use did not influence the higher risk for cardiovascular events after percutaneous coronary intervention compared with coronary artery bypass grafting in patients with diabetes and multivessel coronary disease, according to a secondary analysis of data from a 1,900-patient randomized trial.
The differences in clinical outcomes between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with a drug-eluting stent were maintained regardless of the presence or absence of insulin treatment, Dr. George D. Dangas and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
In the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial, rates for the primary outcomes (a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke) were significantly higher in patients treated with PCI than in those treated with CABG – 27% vs. 19% (N. Engl. J. Med. 2012;367:2375-84).
The current analysis of data for the 1,850 patients who underwent revascularization compared the 32% who were on insulin at baseline with the 68% who were not on insulin treatment. Five-year rates for the primary endpoint were 29% in the insulin-treated group and 19% in the non–insulin-treated group, said Dr. Dangas, professor of medicine and surgery at the Icahn School of Medicine at Mount Sinai, New York.
Within both the insulin and noninsulin treatment subgroups, outcomes were worse with PCI than with CABG. In the insulin-treated subgroup, 5-year rates for the primary outcome were 32% after PCI and 24% after CABG. In the non–insulin-treated subgroup, 5-year rates for the primary outcome were 25% after PCI and 16% after CABG.
As in the main study, stroke rates were higher after CABG than with PCI in both the insulin and noninsulin groups, but rates of death, myocardial infarction, or major adverse cardiac and cerebrovascular events were higher after PCI compared with CABG. The fact that these trends appeared in both insulin and noninsulin subgroups is "something we really haven’t seen before so clearly," coinvestigator Dr. Michael E. Farkouh said at a separate press briefing
Baseline variables were very different in the insulin-treated and non–insulin-treated subgroups. "They were a sicker group of patients," said Dr. Farkouh, a cardiologist at the Icahn School of Medicine at Mount Sinai.
Patients on insulin were significantly more likely to be female and to have a higher body mass index; a longer history of diabetes; a higher hemoglobin A1c level; higher glucose level on the day of the procedure; higher blood urea nitrogen level; and a history of hypertension, peripheral neuropathy, congestive heart failure, and acute coronary syndrome. Insulin-treated patients were less likely to be New York Heart Association class 1.
The secondary analysis was limited because the study did not randomize patients based on insulin treatment, Dr. Dangas said at the meeting, which was cosponsored by the American College of Cardiology. The differences in outcomes between the insulin and noninsulin subgroups could be due to residual confounding, insulin resistance, or side effects of insulin treatment.
Not all patients in the FREEDOM trial have reached 5 years of follow-up. "We believe that there is no interaction" between insulin and outcomes "based on our statistical analysis, but we believe longer-term follow-up will help us to define this better," Dr. Farkouh said.
Approximately 26% of U.S. diabetes patients are treated with insulin.
FREEDOM was sponsored by the National Heart, Lung, and Blood Institute. Dr. Dangas reported having no financial disclosures. Dr. Farkouh reported financial associations with Eli Lilly, Sanofi, and other companies.
On Twitter @sherryboschert
SAN FRANCISCO – Insulin use did not influence the higher risk for cardiovascular events after percutaneous coronary intervention compared with coronary artery bypass grafting in patients with diabetes and multivessel coronary disease, according to a secondary analysis of data from a 1,900-patient randomized trial.
The differences in clinical outcomes between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with a drug-eluting stent were maintained regardless of the presence or absence of insulin treatment, Dr. George D. Dangas and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
In the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial, rates for the primary outcomes (a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke) were significantly higher in patients treated with PCI than in those treated with CABG – 27% vs. 19% (N. Engl. J. Med. 2012;367:2375-84).
The current analysis of data for the 1,850 patients who underwent revascularization compared the 32% who were on insulin at baseline with the 68% who were not on insulin treatment. Five-year rates for the primary endpoint were 29% in the insulin-treated group and 19% in the non–insulin-treated group, said Dr. Dangas, professor of medicine and surgery at the Icahn School of Medicine at Mount Sinai, New York.
Within both the insulin and noninsulin treatment subgroups, outcomes were worse with PCI than with CABG. In the insulin-treated subgroup, 5-year rates for the primary outcome were 32% after PCI and 24% after CABG. In the non–insulin-treated subgroup, 5-year rates for the primary outcome were 25% after PCI and 16% after CABG.
As in the main study, stroke rates were higher after CABG than with PCI in both the insulin and noninsulin groups, but rates of death, myocardial infarction, or major adverse cardiac and cerebrovascular events were higher after PCI compared with CABG. The fact that these trends appeared in both insulin and noninsulin subgroups is "something we really haven’t seen before so clearly," coinvestigator Dr. Michael E. Farkouh said at a separate press briefing
Baseline variables were very different in the insulin-treated and non–insulin-treated subgroups. "They were a sicker group of patients," said Dr. Farkouh, a cardiologist at the Icahn School of Medicine at Mount Sinai.
Patients on insulin were significantly more likely to be female and to have a higher body mass index; a longer history of diabetes; a higher hemoglobin A1c level; higher glucose level on the day of the procedure; higher blood urea nitrogen level; and a history of hypertension, peripheral neuropathy, congestive heart failure, and acute coronary syndrome. Insulin-treated patients were less likely to be New York Heart Association class 1.
The secondary analysis was limited because the study did not randomize patients based on insulin treatment, Dr. Dangas said at the meeting, which was cosponsored by the American College of Cardiology. The differences in outcomes between the insulin and noninsulin subgroups could be due to residual confounding, insulin resistance, or side effects of insulin treatment.
Not all patients in the FREEDOM trial have reached 5 years of follow-up. "We believe that there is no interaction" between insulin and outcomes "based on our statistical analysis, but we believe longer-term follow-up will help us to define this better," Dr. Farkouh said.
Approximately 26% of U.S. diabetes patients are treated with insulin.
FREEDOM was sponsored by the National Heart, Lung, and Blood Institute. Dr. Dangas reported having no financial disclosures. Dr. Farkouh reported financial associations with Eli Lilly, Sanofi, and other companies.
On Twitter @sherryboschert
SAN FRANCISCO – Insulin use did not influence the higher risk for cardiovascular events after percutaneous coronary intervention compared with coronary artery bypass grafting in patients with diabetes and multivessel coronary disease, according to a secondary analysis of data from a 1,900-patient randomized trial.
The differences in clinical outcomes between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with a drug-eluting stent were maintained regardless of the presence or absence of insulin treatment, Dr. George D. Dangas and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
In the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial, rates for the primary outcomes (a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke) were significantly higher in patients treated with PCI than in those treated with CABG – 27% vs. 19% (N. Engl. J. Med. 2012;367:2375-84).
The current analysis of data for the 1,850 patients who underwent revascularization compared the 32% who were on insulin at baseline with the 68% who were not on insulin treatment. Five-year rates for the primary endpoint were 29% in the insulin-treated group and 19% in the non–insulin-treated group, said Dr. Dangas, professor of medicine and surgery at the Icahn School of Medicine at Mount Sinai, New York.
Within both the insulin and noninsulin treatment subgroups, outcomes were worse with PCI than with CABG. In the insulin-treated subgroup, 5-year rates for the primary outcome were 32% after PCI and 24% after CABG. In the non–insulin-treated subgroup, 5-year rates for the primary outcome were 25% after PCI and 16% after CABG.
As in the main study, stroke rates were higher after CABG than with PCI in both the insulin and noninsulin groups, but rates of death, myocardial infarction, or major adverse cardiac and cerebrovascular events were higher after PCI compared with CABG. The fact that these trends appeared in both insulin and noninsulin subgroups is "something we really haven’t seen before so clearly," coinvestigator Dr. Michael E. Farkouh said at a separate press briefing
Baseline variables were very different in the insulin-treated and non–insulin-treated subgroups. "They were a sicker group of patients," said Dr. Farkouh, a cardiologist at the Icahn School of Medicine at Mount Sinai.
Patients on insulin were significantly more likely to be female and to have a higher body mass index; a longer history of diabetes; a higher hemoglobin A1c level; higher glucose level on the day of the procedure; higher blood urea nitrogen level; and a history of hypertension, peripheral neuropathy, congestive heart failure, and acute coronary syndrome. Insulin-treated patients were less likely to be New York Heart Association class 1.
The secondary analysis was limited because the study did not randomize patients based on insulin treatment, Dr. Dangas said at the meeting, which was cosponsored by the American College of Cardiology. The differences in outcomes between the insulin and noninsulin subgroups could be due to residual confounding, insulin resistance, or side effects of insulin treatment.
Not all patients in the FREEDOM trial have reached 5 years of follow-up. "We believe that there is no interaction" between insulin and outcomes "based on our statistical analysis, but we believe longer-term follow-up will help us to define this better," Dr. Farkouh said.
Approximately 26% of U.S. diabetes patients are treated with insulin.
FREEDOM was sponsored by the National Heart, Lung, and Blood Institute. Dr. Dangas reported having no financial disclosures. Dr. Farkouh reported financial associations with Eli Lilly, Sanofi, and other companies.
On Twitter @sherryboschert
AT TCT 2013
Major finding: Five-year rates of death from any cause, nonfatal MI, or nonfatal stroke were 29% in the insulin-treated subgroup and 19% in the non–insulin-treated group.
Data source: Secondary analysis of data from the FREEDOM trial on patients with diabetes and multivessel coronary disease treated with PCI or CABG, comparing the 32% of patients on insulin with those not on insulin.
Disclosures: FREEDOM was sponsored by the National Heart, Lung, and Blood Institute. Dr. Dangas reported having no financial disclosures. Dr. Farkouh reported financial associations with Eli Lilly, Sanofi, and other companies.
Repositionable aortic valve meets performance goals
SAN FRANCISCO – A mean aortic valve pressure gradient of 11.5 mm Hg 30 days after transcatheter aortic valve replacement with the investigational repositionable Lotus valve in 120 patients was significantly better than the performance goal of 18 mm Hg, a study showed.
Approximately 4% of patients in the prospective registry study died within the 30 days and 2% had a disabling stroke, both of which could be considered low rates, Dr. Ian T. Meredith said at the Transcatheter Cardiovascular Therapeutics annual meeting. Another 4% of patients developed nondisabling strokes by the 30-day follow-up in an intent-to-treat analysis.
Aortic regurgitation rates were "negligible" after the procedure, said Dr. Meredith of Monash Medical Centre, Clayton, Australia, and professor of cardiology at Monash University, Melbourne.
Before valve replacement, 15% of patients had moderate or severe aortic regurgitation. Thirty days later, none had severe and 1% had moderate aortic regurgitation in the REPRISE II study (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System – Evaluation of Safety and Performance).
Mild aortic regurgitation rates went from 44% at baseline to 17% at 30 days. Trace regurgitation was seen in 21% at baseline and at 30 days of follow-up.
The primary endpoints in the study were mean aortic valve pressure gradient at 30 days and 30-day all-cause mortality. The mean aortic gradient decreased from 46 mm Hg at baseline to 12.1 mm Hg at discharge and 11.5 mm Hg at 30 days. The mean effective orifice area increased from 0.7 cm2 at baseline to 1.6 cm2 at discharge and 1.7 cm2 at 30 days. Clinical event rates were similar to those reported in other valve trials, he said.
The 14-center study enrolled patients between October 2012 and April 2013 who were aged at least 70 years and rated New York Heart Association class II or greater. They had an aortic valve area less than 1 cm2, an aortic annulus measuring 19-27 mm, and a mean pressure gradient greater than 40 mm Hg or a jet velocity greater than 4 m/sec. Patients also had a Society of Thoracic Surgeons score of at least 8% and/or high surgical risk due to frailty or comorbidities.
The Lotus valve can be assessed in position before release, shortened or expanded mechanically, and, if desired, repositioned or fully resheathed and retrieved. It includes patented adaptive seal technology on the outside surfaces of the valve to fill up irregular surfaces of the fractured native aortic valve and reduce paravalvular leakage, Dr. Meredith said. The study used two valve sizes, 23 mm and 27 mm.
All 120 Lotus valves were successfully placed. Repositionings of 31 valves were all successful, and attempted retrievals of 6 valves were all successful. "As a consequence of this, there was no valve migration, no embolization, no ectopic valve deployment, and absolutely no need to put a second valve inside a valve for incorrect positioning or aortic regurgitation," he said at the meeting, cosponsored by the American College of Cardiology.
New pacemakers were needed in 29% (34 patients), mainly for third-degree atrioventricular block in 30 patients. "Perhaps the most important determinant of new pacemaker insertion was oversizing of the left ventricular outflow tract or the annulus due to the fact that only two valve sizes were available for this study," Dr. Meredith said. He predicted that this high rate of pacemaker implantation could be halved when more Lotus valve sizes and a more flexible catheter are available for future trials.
"We use the Lotus valve. The beauty of the valve is it can be repositioned and retrieved," Dr. A. Pieter Kappetein said at a press briefing. "You can plant the valve with a lot of confidence for the operator. At every stage of the procedure, you can control. I think that is the beauty of this valve," said Dr. Kappetein, professor of thoracic surgery at Erasmus University, Rotterdam, the Netherlands.
The Lotus valve system is available at selected centers in Europe and is not yet approved in the United States or Japan. The investigators plan to conduct a 130-patient extension of REPRISE II and a 1,000-patient pivotal trial (REPRISE III) to seek Food and Drug Administration approval.
Boston Scientific, which makes the Lotus valve system, funded the study. Dr. Meredith reported financial associations with Boston Scientific and Medtronic.
On Twitter @sherryboschert
SAN FRANCISCO – A mean aortic valve pressure gradient of 11.5 mm Hg 30 days after transcatheter aortic valve replacement with the investigational repositionable Lotus valve in 120 patients was significantly better than the performance goal of 18 mm Hg, a study showed.
Approximately 4% of patients in the prospective registry study died within the 30 days and 2% had a disabling stroke, both of which could be considered low rates, Dr. Ian T. Meredith said at the Transcatheter Cardiovascular Therapeutics annual meeting. Another 4% of patients developed nondisabling strokes by the 30-day follow-up in an intent-to-treat analysis.
Aortic regurgitation rates were "negligible" after the procedure, said Dr. Meredith of Monash Medical Centre, Clayton, Australia, and professor of cardiology at Monash University, Melbourne.
Before valve replacement, 15% of patients had moderate or severe aortic regurgitation. Thirty days later, none had severe and 1% had moderate aortic regurgitation in the REPRISE II study (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System – Evaluation of Safety and Performance).
Mild aortic regurgitation rates went from 44% at baseline to 17% at 30 days. Trace regurgitation was seen in 21% at baseline and at 30 days of follow-up.
The primary endpoints in the study were mean aortic valve pressure gradient at 30 days and 30-day all-cause mortality. The mean aortic gradient decreased from 46 mm Hg at baseline to 12.1 mm Hg at discharge and 11.5 mm Hg at 30 days. The mean effective orifice area increased from 0.7 cm2 at baseline to 1.6 cm2 at discharge and 1.7 cm2 at 30 days. Clinical event rates were similar to those reported in other valve trials, he said.
The 14-center study enrolled patients between October 2012 and April 2013 who were aged at least 70 years and rated New York Heart Association class II or greater. They had an aortic valve area less than 1 cm2, an aortic annulus measuring 19-27 mm, and a mean pressure gradient greater than 40 mm Hg or a jet velocity greater than 4 m/sec. Patients also had a Society of Thoracic Surgeons score of at least 8% and/or high surgical risk due to frailty or comorbidities.
The Lotus valve can be assessed in position before release, shortened or expanded mechanically, and, if desired, repositioned or fully resheathed and retrieved. It includes patented adaptive seal technology on the outside surfaces of the valve to fill up irregular surfaces of the fractured native aortic valve and reduce paravalvular leakage, Dr. Meredith said. The study used two valve sizes, 23 mm and 27 mm.
All 120 Lotus valves were successfully placed. Repositionings of 31 valves were all successful, and attempted retrievals of 6 valves were all successful. "As a consequence of this, there was no valve migration, no embolization, no ectopic valve deployment, and absolutely no need to put a second valve inside a valve for incorrect positioning or aortic regurgitation," he said at the meeting, cosponsored by the American College of Cardiology.
New pacemakers were needed in 29% (34 patients), mainly for third-degree atrioventricular block in 30 patients. "Perhaps the most important determinant of new pacemaker insertion was oversizing of the left ventricular outflow tract or the annulus due to the fact that only two valve sizes were available for this study," Dr. Meredith said. He predicted that this high rate of pacemaker implantation could be halved when more Lotus valve sizes and a more flexible catheter are available for future trials.
"We use the Lotus valve. The beauty of the valve is it can be repositioned and retrieved," Dr. A. Pieter Kappetein said at a press briefing. "You can plant the valve with a lot of confidence for the operator. At every stage of the procedure, you can control. I think that is the beauty of this valve," said Dr. Kappetein, professor of thoracic surgery at Erasmus University, Rotterdam, the Netherlands.
The Lotus valve system is available at selected centers in Europe and is not yet approved in the United States or Japan. The investigators plan to conduct a 130-patient extension of REPRISE II and a 1,000-patient pivotal trial (REPRISE III) to seek Food and Drug Administration approval.
Boston Scientific, which makes the Lotus valve system, funded the study. Dr. Meredith reported financial associations with Boston Scientific and Medtronic.
On Twitter @sherryboschert
SAN FRANCISCO – A mean aortic valve pressure gradient of 11.5 mm Hg 30 days after transcatheter aortic valve replacement with the investigational repositionable Lotus valve in 120 patients was significantly better than the performance goal of 18 mm Hg, a study showed.
Approximately 4% of patients in the prospective registry study died within the 30 days and 2% had a disabling stroke, both of which could be considered low rates, Dr. Ian T. Meredith said at the Transcatheter Cardiovascular Therapeutics annual meeting. Another 4% of patients developed nondisabling strokes by the 30-day follow-up in an intent-to-treat analysis.
Aortic regurgitation rates were "negligible" after the procedure, said Dr. Meredith of Monash Medical Centre, Clayton, Australia, and professor of cardiology at Monash University, Melbourne.
Before valve replacement, 15% of patients had moderate or severe aortic regurgitation. Thirty days later, none had severe and 1% had moderate aortic regurgitation in the REPRISE II study (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System – Evaluation of Safety and Performance).
Mild aortic regurgitation rates went from 44% at baseline to 17% at 30 days. Trace regurgitation was seen in 21% at baseline and at 30 days of follow-up.
The primary endpoints in the study were mean aortic valve pressure gradient at 30 days and 30-day all-cause mortality. The mean aortic gradient decreased from 46 mm Hg at baseline to 12.1 mm Hg at discharge and 11.5 mm Hg at 30 days. The mean effective orifice area increased from 0.7 cm2 at baseline to 1.6 cm2 at discharge and 1.7 cm2 at 30 days. Clinical event rates were similar to those reported in other valve trials, he said.
The 14-center study enrolled patients between October 2012 and April 2013 who were aged at least 70 years and rated New York Heart Association class II or greater. They had an aortic valve area less than 1 cm2, an aortic annulus measuring 19-27 mm, and a mean pressure gradient greater than 40 mm Hg or a jet velocity greater than 4 m/sec. Patients also had a Society of Thoracic Surgeons score of at least 8% and/or high surgical risk due to frailty or comorbidities.
The Lotus valve can be assessed in position before release, shortened or expanded mechanically, and, if desired, repositioned or fully resheathed and retrieved. It includes patented adaptive seal technology on the outside surfaces of the valve to fill up irregular surfaces of the fractured native aortic valve and reduce paravalvular leakage, Dr. Meredith said. The study used two valve sizes, 23 mm and 27 mm.
All 120 Lotus valves were successfully placed. Repositionings of 31 valves were all successful, and attempted retrievals of 6 valves were all successful. "As a consequence of this, there was no valve migration, no embolization, no ectopic valve deployment, and absolutely no need to put a second valve inside a valve for incorrect positioning or aortic regurgitation," he said at the meeting, cosponsored by the American College of Cardiology.
New pacemakers were needed in 29% (34 patients), mainly for third-degree atrioventricular block in 30 patients. "Perhaps the most important determinant of new pacemaker insertion was oversizing of the left ventricular outflow tract or the annulus due to the fact that only two valve sizes were available for this study," Dr. Meredith said. He predicted that this high rate of pacemaker implantation could be halved when more Lotus valve sizes and a more flexible catheter are available for future trials.
"We use the Lotus valve. The beauty of the valve is it can be repositioned and retrieved," Dr. A. Pieter Kappetein said at a press briefing. "You can plant the valve with a lot of confidence for the operator. At every stage of the procedure, you can control. I think that is the beauty of this valve," said Dr. Kappetein, professor of thoracic surgery at Erasmus University, Rotterdam, the Netherlands.
The Lotus valve system is available at selected centers in Europe and is not yet approved in the United States or Japan. The investigators plan to conduct a 130-patient extension of REPRISE II and a 1,000-patient pivotal trial (REPRISE III) to seek Food and Drug Administration approval.
Boston Scientific, which makes the Lotus valve system, funded the study. Dr. Meredith reported financial associations with Boston Scientific and Medtronic.
On Twitter @sherryboschert
AT TCT 2013
Major finding: The 30-day mean aortic valve pressure gradient was 11.5 mm Hg, and 4% of patients died within 30 days.
Data source: A prospective registry study of 120 patients with aortic stenosis and high surgery risk who underwent transcatheter aortic valve replacement with the Lotus valve system.
Disclosures: Boston Scientific, which makes the Lotus valve system, funded the study. Dr. Meredith reported financial associations with Boston Scientific and Medtronic.
Outcomes at 1 year similar for Resolute Integrity and BioMatrix Flex stents
SAN FRANCISCO – Major adverse cardiac events were comparable at 5.3% of 1,502 patients who received a zotarolimus-eluting stent with a permanent polymer coating and 5.1% of 1,497 patients who received a biolimus-eluting stent with a biodegradable polymer coating in a population-based randomized trial.
The 1-year outcomes in the Scandinavian study, known as the SORT-OUT VI trial, showed that the Resolute Integrity zotarolimus-eluting stent is noninferior to the BioMatrix Flex Biolimus A9-eluting stent. The trial results represent the first large comparison study of the two systems that included all comers, Dr. Bent Raungaard said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The primary outcome measure was a composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget lesion), or target lesion revascularization within a year of stent implantation. The study enrolled adults with chronic stable coronary artery disease or acute coronary syndromes who had at least one coronary lesion with more than 50% diameter stenosis in a vessel with a reference diameter of 2.25-4 mm and who were undergoing percutaneous coronary intervention (PCI).
At the 1-year follow-up, cardiac death rates were 1.5% with the Resolute Integrity stent and 1.7% with the BioMatrix Flex stent, and the rates of MI were 1.3% and 0.9%, respectively, reported Dr. Raungaard of Aalborg (Denmark) University Hospital and his associates. Rates of target lesion revascularization were 3.5% with the Resolute Integrity stent and 3.1% with the BioMatrix Flex stent.
Rates were similar between groups at 1 year for target vessel revascularization (4.5% with Resolute Integrity and 4.7% with BioMatrix Flex), definite stent thrombosis (0.6% and 0.4%, respectively), and definite or probable stent thrombosis (0.8% and 0.5%, respectively).
"Both the zotarolimus-eluting stents and the biolimus-eluting stents were associated with low rates of major adverse cardiac events," Dr. Raungaard said.
Dr. Gregg W. Stone, moderator of the session for Dr. Raungaard’s presentation, noted that the major cardiac event rates were about what investigators had predicted for the zotarolimus-eluting stent and lower than predicted for the biolimus-eluting stent. "The take-home message here is that event rates were very low," said Dr. Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. "I guess this begs the fact that we may need to start looking at higher-risk populations to bring out the differences between the devices," he said.
Baseline characteristics of patients were similar between groups, except that a significantly higher proportion of patients in the BioMatrix Flex group had undergone prior PCI (22%) compared with the Resolute Integrity group (19%), he said at the meeting, cosponsored by the American College of Cardiology. A higher proportion of patients in the Resolute Integrity group had more than one coronary lesion (25%) compared with the BioMatrix Flex group (22%). Total stent length per patient was significantly longer in the Resolute Integrity group (21 mm) than in the BioMatrix Flex group (18 mm).
The trial excluded patients who were expected to die within a year, who could not provide written informed consent, or who were deemed to be at unacceptable risk if put on 12 months of dual antiplatelet treatment. It also excluded patients who were allergic to aspirin, clopidogrel, prasugrel, ticagrelor, zotarolimus, or biolimus.
The study was funded by Biosensors Interventional Technologies, which makes the biolimus-eluting biodegradable stent, and by Medtronic CardioVascular, which makes the zotarolimus-eluting permanent polymer stent. Dr. Raungaard reported having no financial disclosures.
[email protected]
On Twitter @sherryboschert
SAN FRANCISCO – Major adverse cardiac events were comparable at 5.3% of 1,502 patients who received a zotarolimus-eluting stent with a permanent polymer coating and 5.1% of 1,497 patients who received a biolimus-eluting stent with a biodegradable polymer coating in a population-based randomized trial.
The 1-year outcomes in the Scandinavian study, known as the SORT-OUT VI trial, showed that the Resolute Integrity zotarolimus-eluting stent is noninferior to the BioMatrix Flex Biolimus A9-eluting stent. The trial results represent the first large comparison study of the two systems that included all comers, Dr. Bent Raungaard said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The primary outcome measure was a composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget lesion), or target lesion revascularization within a year of stent implantation. The study enrolled adults with chronic stable coronary artery disease or acute coronary syndromes who had at least one coronary lesion with more than 50% diameter stenosis in a vessel with a reference diameter of 2.25-4 mm and who were undergoing percutaneous coronary intervention (PCI).
At the 1-year follow-up, cardiac death rates were 1.5% with the Resolute Integrity stent and 1.7% with the BioMatrix Flex stent, and the rates of MI were 1.3% and 0.9%, respectively, reported Dr. Raungaard of Aalborg (Denmark) University Hospital and his associates. Rates of target lesion revascularization were 3.5% with the Resolute Integrity stent and 3.1% with the BioMatrix Flex stent.
Rates were similar between groups at 1 year for target vessel revascularization (4.5% with Resolute Integrity and 4.7% with BioMatrix Flex), definite stent thrombosis (0.6% and 0.4%, respectively), and definite or probable stent thrombosis (0.8% and 0.5%, respectively).
"Both the zotarolimus-eluting stents and the biolimus-eluting stents were associated with low rates of major adverse cardiac events," Dr. Raungaard said.
Dr. Gregg W. Stone, moderator of the session for Dr. Raungaard’s presentation, noted that the major cardiac event rates were about what investigators had predicted for the zotarolimus-eluting stent and lower than predicted for the biolimus-eluting stent. "The take-home message here is that event rates were very low," said Dr. Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. "I guess this begs the fact that we may need to start looking at higher-risk populations to bring out the differences between the devices," he said.
Baseline characteristics of patients were similar between groups, except that a significantly higher proportion of patients in the BioMatrix Flex group had undergone prior PCI (22%) compared with the Resolute Integrity group (19%), he said at the meeting, cosponsored by the American College of Cardiology. A higher proportion of patients in the Resolute Integrity group had more than one coronary lesion (25%) compared with the BioMatrix Flex group (22%). Total stent length per patient was significantly longer in the Resolute Integrity group (21 mm) than in the BioMatrix Flex group (18 mm).
The trial excluded patients who were expected to die within a year, who could not provide written informed consent, or who were deemed to be at unacceptable risk if put on 12 months of dual antiplatelet treatment. It also excluded patients who were allergic to aspirin, clopidogrel, prasugrel, ticagrelor, zotarolimus, or biolimus.
The study was funded by Biosensors Interventional Technologies, which makes the biolimus-eluting biodegradable stent, and by Medtronic CardioVascular, which makes the zotarolimus-eluting permanent polymer stent. Dr. Raungaard reported having no financial disclosures.
[email protected]
On Twitter @sherryboschert
SAN FRANCISCO – Major adverse cardiac events were comparable at 5.3% of 1,502 patients who received a zotarolimus-eluting stent with a permanent polymer coating and 5.1% of 1,497 patients who received a biolimus-eluting stent with a biodegradable polymer coating in a population-based randomized trial.
The 1-year outcomes in the Scandinavian study, known as the SORT-OUT VI trial, showed that the Resolute Integrity zotarolimus-eluting stent is noninferior to the BioMatrix Flex Biolimus A9-eluting stent. The trial results represent the first large comparison study of the two systems that included all comers, Dr. Bent Raungaard said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The primary outcome measure was a composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget lesion), or target lesion revascularization within a year of stent implantation. The study enrolled adults with chronic stable coronary artery disease or acute coronary syndromes who had at least one coronary lesion with more than 50% diameter stenosis in a vessel with a reference diameter of 2.25-4 mm and who were undergoing percutaneous coronary intervention (PCI).
At the 1-year follow-up, cardiac death rates were 1.5% with the Resolute Integrity stent and 1.7% with the BioMatrix Flex stent, and the rates of MI were 1.3% and 0.9%, respectively, reported Dr. Raungaard of Aalborg (Denmark) University Hospital and his associates. Rates of target lesion revascularization were 3.5% with the Resolute Integrity stent and 3.1% with the BioMatrix Flex stent.
Rates were similar between groups at 1 year for target vessel revascularization (4.5% with Resolute Integrity and 4.7% with BioMatrix Flex), definite stent thrombosis (0.6% and 0.4%, respectively), and definite or probable stent thrombosis (0.8% and 0.5%, respectively).
"Both the zotarolimus-eluting stents and the biolimus-eluting stents were associated with low rates of major adverse cardiac events," Dr. Raungaard said.
Dr. Gregg W. Stone, moderator of the session for Dr. Raungaard’s presentation, noted that the major cardiac event rates were about what investigators had predicted for the zotarolimus-eluting stent and lower than predicted for the biolimus-eluting stent. "The take-home message here is that event rates were very low," said Dr. Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. "I guess this begs the fact that we may need to start looking at higher-risk populations to bring out the differences between the devices," he said.
Baseline characteristics of patients were similar between groups, except that a significantly higher proportion of patients in the BioMatrix Flex group had undergone prior PCI (22%) compared with the Resolute Integrity group (19%), he said at the meeting, cosponsored by the American College of Cardiology. A higher proportion of patients in the Resolute Integrity group had more than one coronary lesion (25%) compared with the BioMatrix Flex group (22%). Total stent length per patient was significantly longer in the Resolute Integrity group (21 mm) than in the BioMatrix Flex group (18 mm).
The trial excluded patients who were expected to die within a year, who could not provide written informed consent, or who were deemed to be at unacceptable risk if put on 12 months of dual antiplatelet treatment. It also excluded patients who were allergic to aspirin, clopidogrel, prasugrel, ticagrelor, zotarolimus, or biolimus.
The study was funded by Biosensors Interventional Technologies, which makes the biolimus-eluting biodegradable stent, and by Medtronic CardioVascular, which makes the zotarolimus-eluting permanent polymer stent. Dr. Raungaard reported having no financial disclosures.
[email protected]
On Twitter @sherryboschert
AT TCT 2013
Major finding: Rates of major adverse cardiac events at 1 year were 5.3% with the Resolute Integrity stent and 5.1% with the BioMatrix Flex stent.
Data source: A randomized, population-based, multicenter, noninferiority study of 2,999 patients with stable coronary artery disease or acute coronary syndrome undergoing PCI.
Disclosures: The study was funded by Biosensors Interventional Technologies, which makes the biolimus-eluting biodegradable stent, and by Medtronic CardioVascular, which makes the zotarolimus-eluting permanent polymer stent. Dr. Raungaard reported having no financial disclosures.
Drug-eluting stent edges drug-eluting balloon
SAN FRANCISCO – Treating bare metal stent in-stent restenosis using a drug-eluting stent yielded a significantly larger minimal lumen diameter 1 year later, compared with treatment using a drug-eluting balloon in a study of 189 patients.
A second-generation everolimus-eluting stent bested a paclitaxel-eluting balloon in the primary outcome of the prospective, randomized trial after adjusting for age, smoking history, stenosis, and the presence of diabetes.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The in-segment minimal lumen diameter was 2.36 mm for the 94 patients in the stent group and 2.01 mm for the 95 patients in the balloon group. The in-lesion minimal lumen diameter was 2.44 mm in the stent group and 2.03 mm in the balloon group. Both differences were statistically significant, Dr. Fernando Alfonso and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The rate of restenosis (greater than 50% lumen diameter narrowing) at the 1-year follow-up point was very low in both groups: 4.7% in the stent group and 9.5% in the balloon group. That difference was not statistically significant between groups.
Median in-segment late loss (the difference between minimal lumen diameter at completion of the procedure and at 1 year follow-up) was strikingly small and did not differ significantly between groups, reported Dr. Alfonso, an interventional cardiologist at Hospital Universitario Clinico San Carlos, Madrid.
Late loss in the stent group was 0.04 mm and in the balloon group was 0.14 mm, he added.
Rates of major adverse cardiac events were similar between groups: 94% in the stent group and 91% in the balloon group died of cardiac-related causes or had an MI or target vessel revascularization within a year of treatment. Rates of major adverse events also were statistically similar between groups in the RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent) trial.
A total of 6% of patients in the stent group and 12% in the balloon group developed a major adverse event; these rates were statistically similar. Four patients in the balloon group and none in the stent group died; three of the deaths were from noncardiac causes. Four patients in the stent group and three in the balloon group had an acute MI. Two patients in the stent group and six in the balloon group underwent target vessel revascularization. (Some patients had more than one adverse event.)
"In patients with bare metal stent in-stent restenosis, both drug-eluting balloons and everolimus-eluting stents provide excellent clinical outcomes" and excellent angiographic findings with very low late loss and low restenosis rates, Dr. Alfonso said at the meeting, cosponsored by the American College of Cardiology. "Further studies with larger numbers of patients and longer follow-up are required to elucidate if these superior late angiographic findings may eventually translate into a clinical benefit." In the meantime, drug-eluting balloons appear to offer "a very good alternative" for patients who may not be good candidates for drug-eluting stents, he said.
The study included patients aged 20-85 years at 25 Spanish centers who had more than 50% stenosis in a bare metal stent and angina or silent ischemia. In-segment quantitative coronary angiography measurements were similar between groups at baseline: the reference diameter was 2.63 mm in the stent group and 2.62 mm in the balloon group, and the lesion length was 13.8 mm in the stent group and 13.7 mm in the balloon group.
Patients who were randomized in 2010-2012 to receive Xience Prime everolimus-eluting stents (by Abbott Vascular) were significantly younger, compared with those who got SeQuent Please paclitaxel-eluting balloons (by B. Braun Surgical) – 64 vs. 67 years, respectively. Those in the stent group also were more likely to have ever smoked (75% vs. 59%, respectively). Eight patients in the balloon group eventually crossed over to stent implantation, and no patients in the stent group crossed over to balloons.
One-year follow-up was available for 170 patients (92%), and results were calculated in intent-to-treat analyses.
Dr. Alfonso reported having no financial disclosures.
On Twitter @sherryboschert
It seemed to me, as I was looking at the data, that drug-eluting balloons were pretty much going to be stuck in the peripheries. Yet these data, which are probably the best set of data that I’ve seen, tend to open the door. Maybe drug-eluting balloons have a role in the coronaries. There are lots of times that we don’t want to put in a drug-eluting stent, particularly in small vessels with long lesions. So I view this as a positive sign that there may be more choices for us that are meaningful.
Dr. Michael R. Mooney of the Minneapolis Heart Institute gave these comments during a panel discussion of the study at the meeting. He reported having no financial disclosures.
It seemed to me, as I was looking at the data, that drug-eluting balloons were pretty much going to be stuck in the peripheries. Yet these data, which are probably the best set of data that I’ve seen, tend to open the door. Maybe drug-eluting balloons have a role in the coronaries. There are lots of times that we don’t want to put in a drug-eluting stent, particularly in small vessels with long lesions. So I view this as a positive sign that there may be more choices for us that are meaningful.
Dr. Michael R. Mooney of the Minneapolis Heart Institute gave these comments during a panel discussion of the study at the meeting. He reported having no financial disclosures.
It seemed to me, as I was looking at the data, that drug-eluting balloons were pretty much going to be stuck in the peripheries. Yet these data, which are probably the best set of data that I’ve seen, tend to open the door. Maybe drug-eluting balloons have a role in the coronaries. There are lots of times that we don’t want to put in a drug-eluting stent, particularly in small vessels with long lesions. So I view this as a positive sign that there may be more choices for us that are meaningful.
Dr. Michael R. Mooney of the Minneapolis Heart Institute gave these comments during a panel discussion of the study at the meeting. He reported having no financial disclosures.
SAN FRANCISCO – Treating bare metal stent in-stent restenosis using a drug-eluting stent yielded a significantly larger minimal lumen diameter 1 year later, compared with treatment using a drug-eluting balloon in a study of 189 patients.
A second-generation everolimus-eluting stent bested a paclitaxel-eluting balloon in the primary outcome of the prospective, randomized trial after adjusting for age, smoking history, stenosis, and the presence of diabetes.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The in-segment minimal lumen diameter was 2.36 mm for the 94 patients in the stent group and 2.01 mm for the 95 patients in the balloon group. The in-lesion minimal lumen diameter was 2.44 mm in the stent group and 2.03 mm in the balloon group. Both differences were statistically significant, Dr. Fernando Alfonso and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The rate of restenosis (greater than 50% lumen diameter narrowing) at the 1-year follow-up point was very low in both groups: 4.7% in the stent group and 9.5% in the balloon group. That difference was not statistically significant between groups.
Median in-segment late loss (the difference between minimal lumen diameter at completion of the procedure and at 1 year follow-up) was strikingly small and did not differ significantly between groups, reported Dr. Alfonso, an interventional cardiologist at Hospital Universitario Clinico San Carlos, Madrid.
Late loss in the stent group was 0.04 mm and in the balloon group was 0.14 mm, he added.
Rates of major adverse cardiac events were similar between groups: 94% in the stent group and 91% in the balloon group died of cardiac-related causes or had an MI or target vessel revascularization within a year of treatment. Rates of major adverse events also were statistically similar between groups in the RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent) trial.
A total of 6% of patients in the stent group and 12% in the balloon group developed a major adverse event; these rates were statistically similar. Four patients in the balloon group and none in the stent group died; three of the deaths were from noncardiac causes. Four patients in the stent group and three in the balloon group had an acute MI. Two patients in the stent group and six in the balloon group underwent target vessel revascularization. (Some patients had more than one adverse event.)
"In patients with bare metal stent in-stent restenosis, both drug-eluting balloons and everolimus-eluting stents provide excellent clinical outcomes" and excellent angiographic findings with very low late loss and low restenosis rates, Dr. Alfonso said at the meeting, cosponsored by the American College of Cardiology. "Further studies with larger numbers of patients and longer follow-up are required to elucidate if these superior late angiographic findings may eventually translate into a clinical benefit." In the meantime, drug-eluting balloons appear to offer "a very good alternative" for patients who may not be good candidates for drug-eluting stents, he said.
The study included patients aged 20-85 years at 25 Spanish centers who had more than 50% stenosis in a bare metal stent and angina or silent ischemia. In-segment quantitative coronary angiography measurements were similar between groups at baseline: the reference diameter was 2.63 mm in the stent group and 2.62 mm in the balloon group, and the lesion length was 13.8 mm in the stent group and 13.7 mm in the balloon group.
Patients who were randomized in 2010-2012 to receive Xience Prime everolimus-eluting stents (by Abbott Vascular) were significantly younger, compared with those who got SeQuent Please paclitaxel-eluting balloons (by B. Braun Surgical) – 64 vs. 67 years, respectively. Those in the stent group also were more likely to have ever smoked (75% vs. 59%, respectively). Eight patients in the balloon group eventually crossed over to stent implantation, and no patients in the stent group crossed over to balloons.
One-year follow-up was available for 170 patients (92%), and results were calculated in intent-to-treat analyses.
Dr. Alfonso reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Treating bare metal stent in-stent restenosis using a drug-eluting stent yielded a significantly larger minimal lumen diameter 1 year later, compared with treatment using a drug-eluting balloon in a study of 189 patients.
A second-generation everolimus-eluting stent bested a paclitaxel-eluting balloon in the primary outcome of the prospective, randomized trial after adjusting for age, smoking history, stenosis, and the presence of diabetes.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The in-segment minimal lumen diameter was 2.36 mm for the 94 patients in the stent group and 2.01 mm for the 95 patients in the balloon group. The in-lesion minimal lumen diameter was 2.44 mm in the stent group and 2.03 mm in the balloon group. Both differences were statistically significant, Dr. Fernando Alfonso and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The rate of restenosis (greater than 50% lumen diameter narrowing) at the 1-year follow-up point was very low in both groups: 4.7% in the stent group and 9.5% in the balloon group. That difference was not statistically significant between groups.
Median in-segment late loss (the difference between minimal lumen diameter at completion of the procedure and at 1 year follow-up) was strikingly small and did not differ significantly between groups, reported Dr. Alfonso, an interventional cardiologist at Hospital Universitario Clinico San Carlos, Madrid.
Late loss in the stent group was 0.04 mm and in the balloon group was 0.14 mm, he added.
Rates of major adverse cardiac events were similar between groups: 94% in the stent group and 91% in the balloon group died of cardiac-related causes or had an MI or target vessel revascularization within a year of treatment. Rates of major adverse events also were statistically similar between groups in the RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent) trial.
A total of 6% of patients in the stent group and 12% in the balloon group developed a major adverse event; these rates were statistically similar. Four patients in the balloon group and none in the stent group died; three of the deaths were from noncardiac causes. Four patients in the stent group and three in the balloon group had an acute MI. Two patients in the stent group and six in the balloon group underwent target vessel revascularization. (Some patients had more than one adverse event.)
"In patients with bare metal stent in-stent restenosis, both drug-eluting balloons and everolimus-eluting stents provide excellent clinical outcomes" and excellent angiographic findings with very low late loss and low restenosis rates, Dr. Alfonso said at the meeting, cosponsored by the American College of Cardiology. "Further studies with larger numbers of patients and longer follow-up are required to elucidate if these superior late angiographic findings may eventually translate into a clinical benefit." In the meantime, drug-eluting balloons appear to offer "a very good alternative" for patients who may not be good candidates for drug-eluting stents, he said.
The study included patients aged 20-85 years at 25 Spanish centers who had more than 50% stenosis in a bare metal stent and angina or silent ischemia. In-segment quantitative coronary angiography measurements were similar between groups at baseline: the reference diameter was 2.63 mm in the stent group and 2.62 mm in the balloon group, and the lesion length was 13.8 mm in the stent group and 13.7 mm in the balloon group.
Patients who were randomized in 2010-2012 to receive Xience Prime everolimus-eluting stents (by Abbott Vascular) were significantly younger, compared with those who got SeQuent Please paclitaxel-eluting balloons (by B. Braun Surgical) – 64 vs. 67 years, respectively. Those in the stent group also were more likely to have ever smoked (75% vs. 59%, respectively). Eight patients in the balloon group eventually crossed over to stent implantation, and no patients in the stent group crossed over to balloons.
One-year follow-up was available for 170 patients (92%), and results were calculated in intent-to-treat analyses.
Dr. Alfonso reported having no financial disclosures.
On Twitter @sherryboschert
AT TCT 2013
Major finding: The in-segment minimal lumen diameter at 1 year was 2.36 mm with the second-generation everolimus-eluting stent and 2.01 mm with the paclitaxel-eluting balloon.
Data source: A prospective, multicenter, randomized trial in 189 patients treated for bare-metal stent in-stent restenosis.
Disclosures: Dr. Alfonso reported having no financial disclosures.
Noninvasive coronary test accurate for lesion-specific ischemia
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
[email protected] On Twitter @sherryboschert
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
[email protected] On Twitter @sherryboschert
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
[email protected] On Twitter @sherryboschert
AT TCT 2013
Major finding: The per-patient AUC was 0.82 with the FFRCT test, significantly better than 0.63 with CT angiography.
Data source: A prospective, international study of FFRCT in 254 patients who underwent CT and invasive angiography at 10 centers.
Disclosures: HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
Improved outcomes with CoreValve in extreme-risk patients
SAN FRANCISCO – Transcatheter aortic valve replacement with the self-expanding CoreValve in patients at extreme surgical risk significantly reduced the rate of death or major stroke at 1 year, from 43% to 26%, in a 487-patient pivotal trial.
The CoreValve Extreme Risk study gathered data from a registry of patients with symptomatic severe aortic stenosis who attempted an iliofemoral implantation procedure with the CoreValve at 40 U.S. sites. Results were compared with an "objective performance goal" derived from two sources: a meta-analysis of five contemporary balloon valvuloplasty series that found a 43% mortality and major stroke rate at 1 year, and the 1-year rate from the PARTNER B trial in inoperable patients (Placement of Aortic Transcatheter Valves, Cohort B), which was 50% but had a lower confidence bound of 43%.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The performance-goal comparison was necessary in the current study because randomizing these patients to medical therapy in a control group is no longer an acceptable option in the United States, Dr. Jeffrey J. Popma said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 1-year all-cause mortality rate was 24%, and the cardiovascular mortality was 18%, reported Dr. Popma, professor of medicine at Harvard Medical School, Boston.
Two percent of patients developed a major stroke within 1 month and 4% did so within 1 year.
Data from a continued access study involving another 830 extreme-risk patients who received the CoreValve through an iliofemoral approach are showing even better results, with a 16% rate of mortality or major stroke at 6 months, he added.
Among secondary endpoints at 1 year in the main study, 7% of patients developed any kind of stroke, 2% had an MI, 2% need reintervention, 41% had bleeding that met Valve Academic Research Consortium criteria, 8% had major vascular complications, and 27% required implantation of a permanent pacemaker, Dr. Popma reported at the meeting, cosponsored by the American College of Cardiology. Ninety percent of patients improved by at least one New York Heart Association functional class and 60% improved by at least two classes at 1 year of follow-up.
Paravalvular regurgitation of any severity was seen in 53% of patients 1 month after implantation and in 33% at 1 year. Moderate paravalvular leakage (PVL) affected 9% at 1 month and 4% at 1 year, and severe PVL affected 1.6% at 1 month and no patients at 1 year, Dr. Popma said. Among the 11% of patients with moderate PVL at 1 month, 80% of those who survived to 1 year had a reduction in leakage over time.
"We believe that’s why we did not find an association in the study between mild or moderate aortic regurgitation with respect to late-term mortality," though mortality risk was substantially higher with severe regurgitation, he said. One-year mortality rates were 86% with severe PVL and 24% with either moderate or mild PVL, compared with 18% in patients with no PVL.
The improvement in PVL rates over time may be due to use of CT angiography to select appropriate valve sizes for patients and continued expansion of the self-expanding frame over time. "That’s a remarkable finding, and it needs to be confirmed," Dr. Popma said.
The study focused on patients whose severe frailty, comorbidity, or disability put them at extreme risk of at least a 50% chance of death or irreversible morbidity within 30 days had they undergone surgical aortic valve replacement. A second U.S. pivotal trial of the CoreValve is focusing on patients at high (but not extreme) risk.
Most of the sites in the study had no experience with CoreValve before this study, Dr. Michael J. Mack noted at a press briefing. "The results are outstanding, but especially putting it in that light," said Dr. Mack, director of cardiovascular disease for the Baylor Scott & White Health System, Dallas, and a member of the steering committee for the PARTNER trial.
Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
On Twitter @sherryboschert
This is a brilliantly executed, rigorously performed study. After doing sham-control studies, as we did, in these extreme-risk patients, it’s difficult to do a randomized trial. I think these investigators did they best that they could. Using a performance goal standard was the right thing to do.
 |
|
I think that the results are good. It’s always difficult to compare study to study. They’re at different points in time, and we learn things over time. The CoreValve device is a lower-profile device, so there were fewer vascular complications, there was less major bleeding. Those things, in fact, can have an impact on 1-year mortality. The overall 1-year mortality was lower than in PARTNER. In PARTNER by intention to treat the mortality rate was 30.7%, and in the CoreValve study it was in the low 20% range. I think that that’s encouraging.
The stroke rates are encouraging. The pacemaker rates are predictable; it’s a by-product of the specific device. The importance of that is debatable, but it’s not really a concern. It was anticipated.
The paravalvular leakage (PVL) rate is interesting. Many studies with CoreValve suggest that either moderate or severe PVL is associated with an increase in late mortality, if not at 1 year later. It’s not a huge sample size; maybe over time with different definitions of PVL we’d begin to see that.
I am surprised by the 30-day to 1-year data that suggest a reduced PVL rate. I can understand how a self-expanding platform might change in the first 30 days; I can’t quite understand how it would change between 1 month and 12 months in a way that PVL would go down.
Martin B. Leon, M.D., is director of the Center for Interventional Vascular Therapy at Columbia University, New York, and served as principal investigator of the PARTNER trial of the competing Sapien valve.
This is a brilliantly executed, rigorously performed study. After doing sham-control studies, as we did, in these extreme-risk patients, it’s difficult to do a randomized trial. I think these investigators did they best that they could. Using a performance goal standard was the right thing to do.
|
|
I think that the results are good. It’s always difficult to compare study to study. They’re at different points in time, and we learn things over time. The CoreValve device is a lower-profile device, so there were fewer vascular complications, there was less major bleeding. Those things, in fact, can have an impact on 1-year mortality. The overall 1-year mortality was lower than in PARTNER. In PARTNER by intention to treat the mortality rate was 30.7%, and in the CoreValve study it was in the low 20% range. I think that that’s encouraging.
The stroke rates are encouraging. The pacemaker rates are predictable; it’s a by-product of the specific device. The importance of that is debatable, but it’s not really a concern. It was anticipated.
The paravalvular leakage (PVL) rate is interesting. Many studies with CoreValve suggest that either moderate or severe PVL is associated with an increase in late mortality, if not at 1 year later. It’s not a huge sample size; maybe over time with different definitions of PVL we’d begin to see that.
I am surprised by the 30-day to 1-year data that suggest a reduced PVL rate. I can understand how a self-expanding platform might change in the first 30 days; I can’t quite understand how it would change between 1 month and 12 months in a way that PVL would go down.
Martin B. Leon, M.D., is director of the Center for Interventional Vascular Therapy at Columbia University, New York, and served as principal investigator of the PARTNER trial of the competing Sapien valve.
This is a brilliantly executed, rigorously performed study. After doing sham-control studies, as we did, in these extreme-risk patients, it’s difficult to do a randomized trial. I think these investigators did they best that they could. Using a performance goal standard was the right thing to do.
|
|
I think that the results are good. It’s always difficult to compare study to study. They’re at different points in time, and we learn things over time. The CoreValve device is a lower-profile device, so there were fewer vascular complications, there was less major bleeding. Those things, in fact, can have an impact on 1-year mortality. The overall 1-year mortality was lower than in PARTNER. In PARTNER by intention to treat the mortality rate was 30.7%, and in the CoreValve study it was in the low 20% range. I think that that’s encouraging.
The stroke rates are encouraging. The pacemaker rates are predictable; it’s a by-product of the specific device. The importance of that is debatable, but it’s not really a concern. It was anticipated.
The paravalvular leakage (PVL) rate is interesting. Many studies with CoreValve suggest that either moderate or severe PVL is associated with an increase in late mortality, if not at 1 year later. It’s not a huge sample size; maybe over time with different definitions of PVL we’d begin to see that.
I am surprised by the 30-day to 1-year data that suggest a reduced PVL rate. I can understand how a self-expanding platform might change in the first 30 days; I can’t quite understand how it would change between 1 month and 12 months in a way that PVL would go down.
Martin B. Leon, M.D., is director of the Center for Interventional Vascular Therapy at Columbia University, New York, and served as principal investigator of the PARTNER trial of the competing Sapien valve.
SAN FRANCISCO – Transcatheter aortic valve replacement with the self-expanding CoreValve in patients at extreme surgical risk significantly reduced the rate of death or major stroke at 1 year, from 43% to 26%, in a 487-patient pivotal trial.
The CoreValve Extreme Risk study gathered data from a registry of patients with symptomatic severe aortic stenosis who attempted an iliofemoral implantation procedure with the CoreValve at 40 U.S. sites. Results were compared with an "objective performance goal" derived from two sources: a meta-analysis of five contemporary balloon valvuloplasty series that found a 43% mortality and major stroke rate at 1 year, and the 1-year rate from the PARTNER B trial in inoperable patients (Placement of Aortic Transcatheter Valves, Cohort B), which was 50% but had a lower confidence bound of 43%.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The performance-goal comparison was necessary in the current study because randomizing these patients to medical therapy in a control group is no longer an acceptable option in the United States, Dr. Jeffrey J. Popma said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 1-year all-cause mortality rate was 24%, and the cardiovascular mortality was 18%, reported Dr. Popma, professor of medicine at Harvard Medical School, Boston.
Two percent of patients developed a major stroke within 1 month and 4% did so within 1 year.
Data from a continued access study involving another 830 extreme-risk patients who received the CoreValve through an iliofemoral approach are showing even better results, with a 16% rate of mortality or major stroke at 6 months, he added.
Among secondary endpoints at 1 year in the main study, 7% of patients developed any kind of stroke, 2% had an MI, 2% need reintervention, 41% had bleeding that met Valve Academic Research Consortium criteria, 8% had major vascular complications, and 27% required implantation of a permanent pacemaker, Dr. Popma reported at the meeting, cosponsored by the American College of Cardiology. Ninety percent of patients improved by at least one New York Heart Association functional class and 60% improved by at least two classes at 1 year of follow-up.
Paravalvular regurgitation of any severity was seen in 53% of patients 1 month after implantation and in 33% at 1 year. Moderate paravalvular leakage (PVL) affected 9% at 1 month and 4% at 1 year, and severe PVL affected 1.6% at 1 month and no patients at 1 year, Dr. Popma said. Among the 11% of patients with moderate PVL at 1 month, 80% of those who survived to 1 year had a reduction in leakage over time.
"We believe that’s why we did not find an association in the study between mild or moderate aortic regurgitation with respect to late-term mortality," though mortality risk was substantially higher with severe regurgitation, he said. One-year mortality rates were 86% with severe PVL and 24% with either moderate or mild PVL, compared with 18% in patients with no PVL.
The improvement in PVL rates over time may be due to use of CT angiography to select appropriate valve sizes for patients and continued expansion of the self-expanding frame over time. "That’s a remarkable finding, and it needs to be confirmed," Dr. Popma said.
The study focused on patients whose severe frailty, comorbidity, or disability put them at extreme risk of at least a 50% chance of death or irreversible morbidity within 30 days had they undergone surgical aortic valve replacement. A second U.S. pivotal trial of the CoreValve is focusing on patients at high (but not extreme) risk.
Most of the sites in the study had no experience with CoreValve before this study, Dr. Michael J. Mack noted at a press briefing. "The results are outstanding, but especially putting it in that light," said Dr. Mack, director of cardiovascular disease for the Baylor Scott & White Health System, Dallas, and a member of the steering committee for the PARTNER trial.
Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
On Twitter @sherryboschert
SAN FRANCISCO – Transcatheter aortic valve replacement with the self-expanding CoreValve in patients at extreme surgical risk significantly reduced the rate of death or major stroke at 1 year, from 43% to 26%, in a 487-patient pivotal trial.
The CoreValve Extreme Risk study gathered data from a registry of patients with symptomatic severe aortic stenosis who attempted an iliofemoral implantation procedure with the CoreValve at 40 U.S. sites. Results were compared with an "objective performance goal" derived from two sources: a meta-analysis of five contemporary balloon valvuloplasty series that found a 43% mortality and major stroke rate at 1 year, and the 1-year rate from the PARTNER B trial in inoperable patients (Placement of Aortic Transcatheter Valves, Cohort B), which was 50% but had a lower confidence bound of 43%.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The performance-goal comparison was necessary in the current study because randomizing these patients to medical therapy in a control group is no longer an acceptable option in the United States, Dr. Jeffrey J. Popma said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 1-year all-cause mortality rate was 24%, and the cardiovascular mortality was 18%, reported Dr. Popma, professor of medicine at Harvard Medical School, Boston.
Two percent of patients developed a major stroke within 1 month and 4% did so within 1 year.
Data from a continued access study involving another 830 extreme-risk patients who received the CoreValve through an iliofemoral approach are showing even better results, with a 16% rate of mortality or major stroke at 6 months, he added.
Among secondary endpoints at 1 year in the main study, 7% of patients developed any kind of stroke, 2% had an MI, 2% need reintervention, 41% had bleeding that met Valve Academic Research Consortium criteria, 8% had major vascular complications, and 27% required implantation of a permanent pacemaker, Dr. Popma reported at the meeting, cosponsored by the American College of Cardiology. Ninety percent of patients improved by at least one New York Heart Association functional class and 60% improved by at least two classes at 1 year of follow-up.
Paravalvular regurgitation of any severity was seen in 53% of patients 1 month after implantation and in 33% at 1 year. Moderate paravalvular leakage (PVL) affected 9% at 1 month and 4% at 1 year, and severe PVL affected 1.6% at 1 month and no patients at 1 year, Dr. Popma said. Among the 11% of patients with moderate PVL at 1 month, 80% of those who survived to 1 year had a reduction in leakage over time.
"We believe that’s why we did not find an association in the study between mild or moderate aortic regurgitation with respect to late-term mortality," though mortality risk was substantially higher with severe regurgitation, he said. One-year mortality rates were 86% with severe PVL and 24% with either moderate or mild PVL, compared with 18% in patients with no PVL.
The improvement in PVL rates over time may be due to use of CT angiography to select appropriate valve sizes for patients and continued expansion of the self-expanding frame over time. "That’s a remarkable finding, and it needs to be confirmed," Dr. Popma said.
The study focused on patients whose severe frailty, comorbidity, or disability put them at extreme risk of at least a 50% chance of death or irreversible morbidity within 30 days had they undergone surgical aortic valve replacement. A second U.S. pivotal trial of the CoreValve is focusing on patients at high (but not extreme) risk.
Most of the sites in the study had no experience with CoreValve before this study, Dr. Michael J. Mack noted at a press briefing. "The results are outstanding, but especially putting it in that light," said Dr. Mack, director of cardiovascular disease for the Baylor Scott & White Health System, Dallas, and a member of the steering committee for the PARTNER trial.
Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
On Twitter @sherryboschert
AT TCT 2013
Major finding: The rate of all-cause mortality or stroke at 1 year was 26%, compared with an objective performance goal of 43%.
Data source: Study of registry data on 487 patients with symptomatic severe aortic stenosis and attempted CoreValve implantation via iliofemoral access.
Disclosures: Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
Medical conferences going digital
The medical conferences of the future made a preview appearance at this year’s Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco. Paperless, electronic, interactive, and definitely high tech it was.
Every paid attendee was offered a new Samsung tablet computer, preloaded with pertinent apps and information, to personalize and keep if they wanted or return at the end of the meeting. If attendees preferred to download the apps to their own devices, that was fine too, and many of them did. (I got a loaner through the press room, and found it easy to use.)
Rather than tack the cost of the tablets onto registration fees, the organizers shifted funds from the no-longer-needed bulky printed programs and other materials to pay for the tablets, according to the Cardiovascular Research Foundation, cosponsor of the TCT meeting with the American College of Cardiology. No funds from industry were solicited for the tablets, no advertising appeared on the home screens, and the tablets were not being used to mine for user data of any kind, but the preloaded apps did contain some advertisements.
Paperless medical conferences are not new – many conferences eschew pulp these days, providing materials on zip drives instead of printed programs that attendees can load onto their computers. And apps for the larger medical conferences now are commonplace, too, for those who have their own smartphones or tablets. But this is the first time I’ve seen a conference give out tablets and include interactive social media features, convenient continuing medical education mechanisms, and more.
Through the apps, attendees could navigate the convention center; view abstracts; download speaker slides and disclosures; watch live cases; take notes; contact some faculty; find shuttle buses, hotels, and restaurants; and access exhibition materials. After attending a session, they could log their hours, write a review, and apply for CME credits through the apps. If they were willing to enable certain settings, they could see who else at the meeting was in their vicinity, and communicate with them.
Each of the major sessions I covered included a "digital moderator" in addition to the regular moderator. Instead of standing in line at microphones to ask questions, members of the audience texted comments and questions that appeared on a screen to the side of the main screen showing the presenter’s slides, so everyone could see them in real time. This feature wasn’t as much used as one might fear – doctors were still paying attention to the speaker, not staring down at their devices, for the most part. From what I could see, the digital moderators provided most of the texted comments and questions, though at one session the live moderator noted that audience texts were asking the speaker to comment about stroke risk, so he raised the question.
Keep in mind, the TCT always has been one of the most high-tech conferences happening in a very high-tech specialty, interventional cardiology. The typical setup in their main forum was similar to that in past meetings, a multitasking-palooza featuring a long dais of speakers and multiple video screens, with individual headsets that let you tune into whichever "channel" interests you most at the moment. Screens with live cases flank either end, with the presenter and his or her slides in the middle and screens promoting upcoming sessions and showing the audience texts in between the other screens.
TCT comes to San Francisco regularly because the city has the infrastructure to support these technologic demands, a spokeswoman in their press room told me. Some other locations haven’t been able to handle their needs.
I wondered if the technology will be so appealing that attendees might prefer virtual attendance rather than having to be there. It’s possible, she said, but unlikely. Like most people, these doctors value their face time.
On Twitter @sherryboschert
The medical conferences of the future made a preview appearance at this year’s Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco. Paperless, electronic, interactive, and definitely high tech it was.
Every paid attendee was offered a new Samsung tablet computer, preloaded with pertinent apps and information, to personalize and keep if they wanted or return at the end of the meeting. If attendees preferred to download the apps to their own devices, that was fine too, and many of them did. (I got a loaner through the press room, and found it easy to use.)
Rather than tack the cost of the tablets onto registration fees, the organizers shifted funds from the no-longer-needed bulky printed programs and other materials to pay for the tablets, according to the Cardiovascular Research Foundation, cosponsor of the TCT meeting with the American College of Cardiology. No funds from industry were solicited for the tablets, no advertising appeared on the home screens, and the tablets were not being used to mine for user data of any kind, but the preloaded apps did contain some advertisements.
Paperless medical conferences are not new – many conferences eschew pulp these days, providing materials on zip drives instead of printed programs that attendees can load onto their computers. And apps for the larger medical conferences now are commonplace, too, for those who have their own smartphones or tablets. But this is the first time I’ve seen a conference give out tablets and include interactive social media features, convenient continuing medical education mechanisms, and more.
Through the apps, attendees could navigate the convention center; view abstracts; download speaker slides and disclosures; watch live cases; take notes; contact some faculty; find shuttle buses, hotels, and restaurants; and access exhibition materials. After attending a session, they could log their hours, write a review, and apply for CME credits through the apps. If they were willing to enable certain settings, they could see who else at the meeting was in their vicinity, and communicate with them.
Each of the major sessions I covered included a "digital moderator" in addition to the regular moderator. Instead of standing in line at microphones to ask questions, members of the audience texted comments and questions that appeared on a screen to the side of the main screen showing the presenter’s slides, so everyone could see them in real time. This feature wasn’t as much used as one might fear – doctors were still paying attention to the speaker, not staring down at their devices, for the most part. From what I could see, the digital moderators provided most of the texted comments and questions, though at one session the live moderator noted that audience texts were asking the speaker to comment about stroke risk, so he raised the question.
Keep in mind, the TCT always has been one of the most high-tech conferences happening in a very high-tech specialty, interventional cardiology. The typical setup in their main forum was similar to that in past meetings, a multitasking-palooza featuring a long dais of speakers and multiple video screens, with individual headsets that let you tune into whichever "channel" interests you most at the moment. Screens with live cases flank either end, with the presenter and his or her slides in the middle and screens promoting upcoming sessions and showing the audience texts in between the other screens.
TCT comes to San Francisco regularly because the city has the infrastructure to support these technologic demands, a spokeswoman in their press room told me. Some other locations haven’t been able to handle their needs.
I wondered if the technology will be so appealing that attendees might prefer virtual attendance rather than having to be there. It’s possible, she said, but unlikely. Like most people, these doctors value their face time.
On Twitter @sherryboschert
The medical conferences of the future made a preview appearance at this year’s Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco. Paperless, electronic, interactive, and definitely high tech it was.
Every paid attendee was offered a new Samsung tablet computer, preloaded with pertinent apps and information, to personalize and keep if they wanted or return at the end of the meeting. If attendees preferred to download the apps to their own devices, that was fine too, and many of them did. (I got a loaner through the press room, and found it easy to use.)
Rather than tack the cost of the tablets onto registration fees, the organizers shifted funds from the no-longer-needed bulky printed programs and other materials to pay for the tablets, according to the Cardiovascular Research Foundation, cosponsor of the TCT meeting with the American College of Cardiology. No funds from industry were solicited for the tablets, no advertising appeared on the home screens, and the tablets were not being used to mine for user data of any kind, but the preloaded apps did contain some advertisements.
Paperless medical conferences are not new – many conferences eschew pulp these days, providing materials on zip drives instead of printed programs that attendees can load onto their computers. And apps for the larger medical conferences now are commonplace, too, for those who have their own smartphones or tablets. But this is the first time I’ve seen a conference give out tablets and include interactive social media features, convenient continuing medical education mechanisms, and more.
Through the apps, attendees could navigate the convention center; view abstracts; download speaker slides and disclosures; watch live cases; take notes; contact some faculty; find shuttle buses, hotels, and restaurants; and access exhibition materials. After attending a session, they could log their hours, write a review, and apply for CME credits through the apps. If they were willing to enable certain settings, they could see who else at the meeting was in their vicinity, and communicate with them.
Each of the major sessions I covered included a "digital moderator" in addition to the regular moderator. Instead of standing in line at microphones to ask questions, members of the audience texted comments and questions that appeared on a screen to the side of the main screen showing the presenter’s slides, so everyone could see them in real time. This feature wasn’t as much used as one might fear – doctors were still paying attention to the speaker, not staring down at their devices, for the most part. From what I could see, the digital moderators provided most of the texted comments and questions, though at one session the live moderator noted that audience texts were asking the speaker to comment about stroke risk, so he raised the question.
Keep in mind, the TCT always has been one of the most high-tech conferences happening in a very high-tech specialty, interventional cardiology. The typical setup in their main forum was similar to that in past meetings, a multitasking-palooza featuring a long dais of speakers and multiple video screens, with individual headsets that let you tune into whichever "channel" interests you most at the moment. Screens with live cases flank either end, with the presenter and his or her slides in the middle and screens promoting upcoming sessions and showing the audience texts in between the other screens.
TCT comes to San Francisco regularly because the city has the infrastructure to support these technologic demands, a spokeswoman in their press room told me. Some other locations haven’t been able to handle their needs.
I wondered if the technology will be so appealing that attendees might prefer virtual attendance rather than having to be there. It’s possible, she said, but unlikely. Like most people, these doctors value their face time.
On Twitter @sherryboschert
Shorter antiplatelet therapy after stenting found noninferior
SAN FRANCISCO – Adverse event rates 1 year after implantation of a second-generation zotarolimus-eluting coronary stent were similar for 3,120 patients regardless of whether they took 3 months or 12 months of dual-antiplatelet therapy in a prospective trial that randomized 3,120 patients in real-world settings.
Six percent in the 3-month group and 5.8% in the 12-month group developed one or more adverse events that were included in a composite primary endpoint: death from any cause; myocardial infarction; stroke; or major bleeding, Dr. Fausto Feres and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The results were significant in a noninferiority analysis.
The results should comfort clinicians who think they have to stop dual-antiplatelet therapy (DAPT) earlier than recommended in some patients who are at higher risk for bleeding complications, such as the elderly and patients with a history of hemorrhagic events, said Dr. Feres, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, an institution known for pioneering stent procedures.
The study tapped 33 clinical sites to enroll Brazilian patients who were undergoing percutaneous coronary intervention (PCI) with the second-generation Endeavor zotarolimus-eluting stent. All patients had stable or unstable angina or a recent MI, at least one coronary lesion suitable for PCI with the Endeavor stent, and a native vessel diameter of at least 2.5 mm with stenosis greater than 50%. The cohort consisted mainly of patients with stable coronary artery disease and a low risk of acute coronary syndrome.
Equal numbers were randomized to 3 or 12 months of DAPT with aspirin and 75 mg/day of clopidogrel to reduce the risk of thrombotic events. Current guidelines call for 12 months of DAPT after stent implantation. One-year follow-up data were available for 98% in each group.
Known as the OPTIMIZE trial (Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice), the study found that more than 99% of patients in each group completed 3 months of DAPT. One year after stent implantation, 6% who had been randomized to the 3-month group were still on DAPT, as were 97% of those randomized to the 12-month group.
The individual components of the combined endpoint did not differ significantly at 1-year follow-up. All-cause mortality was seen in 1.9% and 1.7% of the 3- and 12-month therapy groups; MI rates were 0.8% and 0.6%, respectively; stroke rates were 0.3% and 0.1%; and major bleeding occurred in 0.2% and 0.4%. Landmark analyses also found no significant differences between groups for these endpoints at 3 months.
Rates of definite or probable stent thrombosis at 1 year were 0.3% in the 3-month therapy group and 0.1% in the 12-month group, which was not a significant difference. There was a trend toward higher risk of bleeding at 1 year in patients on 12 months of DAPT, seen in 1% compared with 0.4% of those on 3 months of therapy, Dr. Feres reported at the meeting, cosponsored by the American College of Cardiology.
Secondary outcomes at 1 year showed that rates of other adverse clinical events also did not differ significantly between the two groups. Eight percent in the 3-month group and 7% in the 12-month group developed one or more major adverse coronary events: death, MI, emergent coronary artery bypass grafting, or target lesion revascularization. Three percent in each group died, 3% in each developed an MI, 4% in each had either cardiac death or an MI, and 0.3% in each developed a stroke. Major bleeding occurred in 0.6% of the 3-month group and 0.9% of the 12-month group. Target lesion revascularization rates were 3.5% in the 3-month group and 3.2% in the 12-month group.
Results did not differ by subgroups.
Rates for the primary outcome were lower than expected in both arms of the trial. Investigators expected a 9% rate, not the roughly 6% rate seen in both arms. The rate of major adverse coronary events at 1 year, however, was 8.4% in the 3-month group and 7.5% in the 12-month group.
Two previous studies in Italy and Korea of shortened-duration DAPT for patients receiving drug-eluting stents compared 6 months of therapy with 12 months of therapy. One other previous trial compared 3 months with 12 months of DAPT but compared two different stents, he said. All suggested that 12 months of DAPT may not always be needed, he said in an interview.
The current study excluded patients with primary or rescue PCI for ST-segment elevation MI, lesions located in a saphenous vein graft, patients with a previous PCI with a drug-eluting stent, and other less common exclusion criteria.
The findings from OPTIMIZE were published online concurrently with Dr. Feres’ presentation (JAMA 2013 Oct. 31 [doi: 10.1001/jama.2013.282183]).
Dr. Feres reported having financial relationships with BioSensors, Eli Lilly, and Medtronic, which markets the Endeavor stent and funded the study.
[email protected]
On Twitter @sherryboschert
My concern with this study lies with a noninferiority comparison using a composite primary endpoint that combines both efficacy (ischemic event) and safety (bleeding event) measures. Although this type of endpoint is selected to enhance power, it is problematic because of a lack of actual or expected concordance among its components. When concordant differences are present, the individual components lack power to determine if clinically meaningful differences exist.
In OPTIMIZE, a 10%-14% relative increase in ischemic events with 3 months of DAPT is counterbalanced by a 12% relative decrease in major bleeding. A counterbalance in relationship is graphically depicted in the analysis of stent thrombosis and major bleeding, with a 90-day landmark. Beyond 90 days, the absolute increase in events is 0.2% for both, which represents a fourfold relative increase in stent thrombosis with 3 months of DAPT and a twofold relative increase in major bleeding with longer therapy.
Indeed, the upper boundaries of the confidence intervals allow for a 35-fold increase in stent thrombosis with short treatment and an eightfold increase in major bleeding with longer therapy. This observation must be viewed in the context that OPTIMIZE excluded biomarker-positive acute coronary syndrome (ACS) within 30 days – those patients at greatest risk for stent thrombosis – and included subjects with an average age of 61 years – patients with a lower risk of bleeding events.
The exclusion of biomarker-positive ACS represents a significant portion of contemporary clinical practice, particularly in the context of relative efficacy for PCI and ACS vs. stable ischemic heart disease. Although the choice of clopidogrel vs. novel agents may be justified by exclusion of biomarker-positive ACS, the loading dose was not standardized by protocol. Finally, the Endeavor stent platform is problematic and difficult to extrapolate to other drug-eluting stents. Endeavor has largely been replaced by Resolute, which has a different polymer and drug-release kinetics.
More definitive conclusions about optimal DAPT duration still await the results of adequately powered, more inclusive, and contemporary randomized controlled trials.
Dean J. Kereiakes, M.D., is an interventional cardiologist at the Ohio Heart and Vascular Center, Cincinnati. These are excerpts of his remarks as discussant of the study at the meeting. Dr. Kereiakes reported financial associations with Medpace, HCRI, and other companies.
My concern with this study lies with a noninferiority comparison using a composite primary endpoint that combines both efficacy (ischemic event) and safety (bleeding event) measures. Although this type of endpoint is selected to enhance power, it is problematic because of a lack of actual or expected concordance among its components. When concordant differences are present, the individual components lack power to determine if clinically meaningful differences exist.
In OPTIMIZE, a 10%-14% relative increase in ischemic events with 3 months of DAPT is counterbalanced by a 12% relative decrease in major bleeding. A counterbalance in relationship is graphically depicted in the analysis of stent thrombosis and major bleeding, with a 90-day landmark. Beyond 90 days, the absolute increase in events is 0.2% for both, which represents a fourfold relative increase in stent thrombosis with 3 months of DAPT and a twofold relative increase in major bleeding with longer therapy.
Indeed, the upper boundaries of the confidence intervals allow for a 35-fold increase in stent thrombosis with short treatment and an eightfold increase in major bleeding with longer therapy. This observation must be viewed in the context that OPTIMIZE excluded biomarker-positive acute coronary syndrome (ACS) within 30 days – those patients at greatest risk for stent thrombosis – and included subjects with an average age of 61 years – patients with a lower risk of bleeding events.
The exclusion of biomarker-positive ACS represents a significant portion of contemporary clinical practice, particularly in the context of relative efficacy for PCI and ACS vs. stable ischemic heart disease. Although the choice of clopidogrel vs. novel agents may be justified by exclusion of biomarker-positive ACS, the loading dose was not standardized by protocol. Finally, the Endeavor stent platform is problematic and difficult to extrapolate to other drug-eluting stents. Endeavor has largely been replaced by Resolute, which has a different polymer and drug-release kinetics.
More definitive conclusions about optimal DAPT duration still await the results of adequately powered, more inclusive, and contemporary randomized controlled trials.
Dean J. Kereiakes, M.D., is an interventional cardiologist at the Ohio Heart and Vascular Center, Cincinnati. These are excerpts of his remarks as discussant of the study at the meeting. Dr. Kereiakes reported financial associations with Medpace, HCRI, and other companies.
My concern with this study lies with a noninferiority comparison using a composite primary endpoint that combines both efficacy (ischemic event) and safety (bleeding event) measures. Although this type of endpoint is selected to enhance power, it is problematic because of a lack of actual or expected concordance among its components. When concordant differences are present, the individual components lack power to determine if clinically meaningful differences exist.
In OPTIMIZE, a 10%-14% relative increase in ischemic events with 3 months of DAPT is counterbalanced by a 12% relative decrease in major bleeding. A counterbalance in relationship is graphically depicted in the analysis of stent thrombosis and major bleeding, with a 90-day landmark. Beyond 90 days, the absolute increase in events is 0.2% for both, which represents a fourfold relative increase in stent thrombosis with 3 months of DAPT and a twofold relative increase in major bleeding with longer therapy.
Indeed, the upper boundaries of the confidence intervals allow for a 35-fold increase in stent thrombosis with short treatment and an eightfold increase in major bleeding with longer therapy. This observation must be viewed in the context that OPTIMIZE excluded biomarker-positive acute coronary syndrome (ACS) within 30 days – those patients at greatest risk for stent thrombosis – and included subjects with an average age of 61 years – patients with a lower risk of bleeding events.
The exclusion of biomarker-positive ACS represents a significant portion of contemporary clinical practice, particularly in the context of relative efficacy for PCI and ACS vs. stable ischemic heart disease. Although the choice of clopidogrel vs. novel agents may be justified by exclusion of biomarker-positive ACS, the loading dose was not standardized by protocol. Finally, the Endeavor stent platform is problematic and difficult to extrapolate to other drug-eluting stents. Endeavor has largely been replaced by Resolute, which has a different polymer and drug-release kinetics.
More definitive conclusions about optimal DAPT duration still await the results of adequately powered, more inclusive, and contemporary randomized controlled trials.
Dean J. Kereiakes, M.D., is an interventional cardiologist at the Ohio Heart and Vascular Center, Cincinnati. These are excerpts of his remarks as discussant of the study at the meeting. Dr. Kereiakes reported financial associations with Medpace, HCRI, and other companies.
SAN FRANCISCO – Adverse event rates 1 year after implantation of a second-generation zotarolimus-eluting coronary stent were similar for 3,120 patients regardless of whether they took 3 months or 12 months of dual-antiplatelet therapy in a prospective trial that randomized 3,120 patients in real-world settings.
Six percent in the 3-month group and 5.8% in the 12-month group developed one or more adverse events that were included in a composite primary endpoint: death from any cause; myocardial infarction; stroke; or major bleeding, Dr. Fausto Feres and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The results were significant in a noninferiority analysis.
The results should comfort clinicians who think they have to stop dual-antiplatelet therapy (DAPT) earlier than recommended in some patients who are at higher risk for bleeding complications, such as the elderly and patients with a history of hemorrhagic events, said Dr. Feres, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, an institution known for pioneering stent procedures.
The study tapped 33 clinical sites to enroll Brazilian patients who were undergoing percutaneous coronary intervention (PCI) with the second-generation Endeavor zotarolimus-eluting stent. All patients had stable or unstable angina or a recent MI, at least one coronary lesion suitable for PCI with the Endeavor stent, and a native vessel diameter of at least 2.5 mm with stenosis greater than 50%. The cohort consisted mainly of patients with stable coronary artery disease and a low risk of acute coronary syndrome.
Equal numbers were randomized to 3 or 12 months of DAPT with aspirin and 75 mg/day of clopidogrel to reduce the risk of thrombotic events. Current guidelines call for 12 months of DAPT after stent implantation. One-year follow-up data were available for 98% in each group.
Known as the OPTIMIZE trial (Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice), the study found that more than 99% of patients in each group completed 3 months of DAPT. One year after stent implantation, 6% who had been randomized to the 3-month group were still on DAPT, as were 97% of those randomized to the 12-month group.
The individual components of the combined endpoint did not differ significantly at 1-year follow-up. All-cause mortality was seen in 1.9% and 1.7% of the 3- and 12-month therapy groups; MI rates were 0.8% and 0.6%, respectively; stroke rates were 0.3% and 0.1%; and major bleeding occurred in 0.2% and 0.4%. Landmark analyses also found no significant differences between groups for these endpoints at 3 months.
Rates of definite or probable stent thrombosis at 1 year were 0.3% in the 3-month therapy group and 0.1% in the 12-month group, which was not a significant difference. There was a trend toward higher risk of bleeding at 1 year in patients on 12 months of DAPT, seen in 1% compared with 0.4% of those on 3 months of therapy, Dr. Feres reported at the meeting, cosponsored by the American College of Cardiology.
Secondary outcomes at 1 year showed that rates of other adverse clinical events also did not differ significantly between the two groups. Eight percent in the 3-month group and 7% in the 12-month group developed one or more major adverse coronary events: death, MI, emergent coronary artery bypass grafting, or target lesion revascularization. Three percent in each group died, 3% in each developed an MI, 4% in each had either cardiac death or an MI, and 0.3% in each developed a stroke. Major bleeding occurred in 0.6% of the 3-month group and 0.9% of the 12-month group. Target lesion revascularization rates were 3.5% in the 3-month group and 3.2% in the 12-month group.
Results did not differ by subgroups.
Rates for the primary outcome were lower than expected in both arms of the trial. Investigators expected a 9% rate, not the roughly 6% rate seen in both arms. The rate of major adverse coronary events at 1 year, however, was 8.4% in the 3-month group and 7.5% in the 12-month group.
Two previous studies in Italy and Korea of shortened-duration DAPT for patients receiving drug-eluting stents compared 6 months of therapy with 12 months of therapy. One other previous trial compared 3 months with 12 months of DAPT but compared two different stents, he said. All suggested that 12 months of DAPT may not always be needed, he said in an interview.
The current study excluded patients with primary or rescue PCI for ST-segment elevation MI, lesions located in a saphenous vein graft, patients with a previous PCI with a drug-eluting stent, and other less common exclusion criteria.
The findings from OPTIMIZE were published online concurrently with Dr. Feres’ presentation (JAMA 2013 Oct. 31 [doi: 10.1001/jama.2013.282183]).
Dr. Feres reported having financial relationships with BioSensors, Eli Lilly, and Medtronic, which markets the Endeavor stent and funded the study.
[email protected]
On Twitter @sherryboschert
SAN FRANCISCO – Adverse event rates 1 year after implantation of a second-generation zotarolimus-eluting coronary stent were similar for 3,120 patients regardless of whether they took 3 months or 12 months of dual-antiplatelet therapy in a prospective trial that randomized 3,120 patients in real-world settings.
Six percent in the 3-month group and 5.8% in the 12-month group developed one or more adverse events that were included in a composite primary endpoint: death from any cause; myocardial infarction; stroke; or major bleeding, Dr. Fausto Feres and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The results were significant in a noninferiority analysis.
The results should comfort clinicians who think they have to stop dual-antiplatelet therapy (DAPT) earlier than recommended in some patients who are at higher risk for bleeding complications, such as the elderly and patients with a history of hemorrhagic events, said Dr. Feres, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, an institution known for pioneering stent procedures.
The study tapped 33 clinical sites to enroll Brazilian patients who were undergoing percutaneous coronary intervention (PCI) with the second-generation Endeavor zotarolimus-eluting stent. All patients had stable or unstable angina or a recent MI, at least one coronary lesion suitable for PCI with the Endeavor stent, and a native vessel diameter of at least 2.5 mm with stenosis greater than 50%. The cohort consisted mainly of patients with stable coronary artery disease and a low risk of acute coronary syndrome.
Equal numbers were randomized to 3 or 12 months of DAPT with aspirin and 75 mg/day of clopidogrel to reduce the risk of thrombotic events. Current guidelines call for 12 months of DAPT after stent implantation. One-year follow-up data were available for 98% in each group.
Known as the OPTIMIZE trial (Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice), the study found that more than 99% of patients in each group completed 3 months of DAPT. One year after stent implantation, 6% who had been randomized to the 3-month group were still on DAPT, as were 97% of those randomized to the 12-month group.
The individual components of the combined endpoint did not differ significantly at 1-year follow-up. All-cause mortality was seen in 1.9% and 1.7% of the 3- and 12-month therapy groups; MI rates were 0.8% and 0.6%, respectively; stroke rates were 0.3% and 0.1%; and major bleeding occurred in 0.2% and 0.4%. Landmark analyses also found no significant differences between groups for these endpoints at 3 months.
Rates of definite or probable stent thrombosis at 1 year were 0.3% in the 3-month therapy group and 0.1% in the 12-month group, which was not a significant difference. There was a trend toward higher risk of bleeding at 1 year in patients on 12 months of DAPT, seen in 1% compared with 0.4% of those on 3 months of therapy, Dr. Feres reported at the meeting, cosponsored by the American College of Cardiology.
Secondary outcomes at 1 year showed that rates of other adverse clinical events also did not differ significantly between the two groups. Eight percent in the 3-month group and 7% in the 12-month group developed one or more major adverse coronary events: death, MI, emergent coronary artery bypass grafting, or target lesion revascularization. Three percent in each group died, 3% in each developed an MI, 4% in each had either cardiac death or an MI, and 0.3% in each developed a stroke. Major bleeding occurred in 0.6% of the 3-month group and 0.9% of the 12-month group. Target lesion revascularization rates were 3.5% in the 3-month group and 3.2% in the 12-month group.
Results did not differ by subgroups.
Rates for the primary outcome were lower than expected in both arms of the trial. Investigators expected a 9% rate, not the roughly 6% rate seen in both arms. The rate of major adverse coronary events at 1 year, however, was 8.4% in the 3-month group and 7.5% in the 12-month group.
Two previous studies in Italy and Korea of shortened-duration DAPT for patients receiving drug-eluting stents compared 6 months of therapy with 12 months of therapy. One other previous trial compared 3 months with 12 months of DAPT but compared two different stents, he said. All suggested that 12 months of DAPT may not always be needed, he said in an interview.
The current study excluded patients with primary or rescue PCI for ST-segment elevation MI, lesions located in a saphenous vein graft, patients with a previous PCI with a drug-eluting stent, and other less common exclusion criteria.
The findings from OPTIMIZE were published online concurrently with Dr. Feres’ presentation (JAMA 2013 Oct. 31 [doi: 10.1001/jama.2013.282183]).
Dr. Feres reported having financial relationships with BioSensors, Eli Lilly, and Medtronic, which markets the Endeavor stent and funded the study.
[email protected]
On Twitter @sherryboschert
AT TCT 2013
Major finding: The incidence at 12 months of a composite of adverse events was 6% in patients randomized to 3 months of DAPT and 5.8% in those randomized to 12 months of therapy.
Data source: A prospective, randomized trial in 3,120 adult Brazilians receiving the Endeavor zotarolimus-eluting stent.
Disclosures: Dr. Feres reported having financial relationships with Biosensors, Eli Lilly and Co., and Medtronic, which markets the Endeavor stent and funded the study.
Prehospital bivalirudin reduced bleeding with PCI
SAN FRANCISCO – Giving bivalirudin in the ambulance to patients with ST-segment elevation MI before primary percutaneous coronary intervention significantly improved 30-day bleeding outcomes in a randomized controlled trial in 2,218 patients, compared with giving unfractionated or low-molecular-weight heparin and optional glycoprotein IIb/IIIa inhibitors.
The bivalirudin group showed nearly a 40% decrease in the primary outcome, a composite of death or major bleeding not associated with coronary artery bypass grafting (CABG), compared with the control group. Rates for the primary outcome were 5.1% in the bivalirudin group and 8.4% in the control group at 30 days, Dr. Philippe Gabriel Steg and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 30-day rate of acute stent thrombosis, however, was approximately sixfold higher in the bivalirudin group (1.1%) than in the control group (0.2%) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. That did not translate into an increased risk of infarction, which was similar in the bivalirudin group (1.7%) and the control group (0.9%), Dr. Steg and his colleagues said.
The rates of the main secondary outcome – a composite of death, reinfarction, or non-CABG major bleeding at 30 days – also were significantly lower in the bivalirudin group (6.7%) than in the control group (9.1%), said Dr. Steg, professor of cardiology at Université Paris-Diderot and director of the coronary care unit at Hôpital Bichat, Paris.
The study was published online simultaneously with the presentation (N. Engl. J. Med. 2013 Oct. 30 [doi: 10.1056/NEJMoa1311096]).
The benefit from bivalirudin came mainly from reduced bleeding, not reduced mortality. The risk of major bleeding not associated with CABG was 2.7% in the bivalirudin group and 6.1% in the control group, a significant 57% reduction.
Rates of cardiac or noncardiac death at 30 days did not differ significantly between groups, with cardiac death in 2.4% with bivalirudin and 3% in the control group, and noncardiac death in 0.5% and 0.1%, respectively.
The study was underpowered to assess mortality, Dr. Steg said in an interview. He hopes to assess mortality risk at 1 year by analyzing combined data from EUROMAX and a previous major trial that showed bivalirudin’s utility before percutaneous coronary intervention, the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial (N. Engl. J. Med. 2008;358:2218-30).
Dr. Steg and his associates conducted the EUROMAX study to see if these benefits were still true in the modern era of prehospital treatment and evolving use of glycoprotein IIb/IIIa inhibitors, platelet P2Y12 receptor inhibitors, and radial access for PCI.
The EUROMAX findings were consistent across subgroups of patients, including subgroups defined by PCI access site or by the choice of P2Y12 inhibitor, Dr. Steg reported at the meeting, cosponsored by the American College of Cardiology.
He believes the findings will change practices and convince emergency crews to choose bivalirudin in Europe, where anticoagulation commonly is started in ambulances before arrival at the hospital, a practice that has not yet caught on in most of the United States.
Dr. Gregg W. Stone, primary investigator of the HORIZONS-AMI trial and a discussant of EUROMAX at the meeting, put together a preliminary meta-analysis of the two studies, he reported. Preliminary results suggest significant benefits from bivalirudin in 30-day rates of major bleeding, transfusion, thrombocytopenia, mortality, and subacute stent thrombosis, with a roughly fivefold increase in the risk of acute stent thrombosis. Studies are warranted to determine whether antiplatelet therapy with cangrelor might be a solution to the acute thrombosis risk, said Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University, New York.
Dr. Steg received fees from The Medicines Company, which sponsored the study and markets bivalirudin, and he reported financial associations with 16 other companies. Four of his colleagues in the study were employees of The Medicines Company, and 12 other colleagues reported financial associations with that company and/or multiple other companies. Dr. Stone reported financial associations with Boston Scientific, Eli Lilly, and other companies.
[email protected]
On Twitter @sherryboschert
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Sherry Boschert/IMNG Medical Media
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This is an important trial that will change clinical practice, Dr. Bernard J. Gersh said in a panel discussion at a press briefing.
Dr. James B. Hermiller Jr. cautioned that it remains to be seen how the large difference between groups in major bleeding events translates into mortality over time.
Dr. Philippe Généreux said the results especially are important for a vast country like Canada, where transport to PCI often takes 45-60 minutes.
Asked what changes could get the United States to adopt prehospital initiation of anticoagulation, as is common in Europe, none of the panelists had a solution.
 |
Sherry Boschert/IMNG Medical Media
|
"We have a different competitive system" in Canada, said Dr. Généreux of New York–Presbyterian Hospital and Hôpital Sacré Coeur, Montreal. "I’ve never seen anything that suggests that prehospital administration and diagnosis are not beneficial, but how we are going to achieve that in the United States, I don’t know."
"It’s difficult to just get ECGs in the field, let alone administer anticoagulants, but we need to get there because this is very important," said Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn., said that it’s possible to change systemic practices in a regional system such as his that spans rural areas, but it’s much more difficult in big cities with multiple competing medical systems.
 |
Sherry Boschert/IMNG Medical Media
|
"I think there are real benefits to a national health care system as opposed to pure and simple competition. With a national or even a regional health care system, you can develop protocols and mandate them. This is what’s happened in many countries in Europe," he said. "Our current system, where you may have a city of a million people and four hospitals competing and four different ambulance systems, is not conducive to this. Unless people are prepared to sit down and say, ‘We’ll share the burden,’ I don’t have any idea" how the U.S. system will change.
Dr. Généreux reported financial associations with Cardiovascular Systems Inc. and Abbott Vascular. Dr. Gersh reported financial associations with Pharmaceutical Product Development, InspireMD, and multiple other companies.
|
Sherry Boschert/IMNG Medical Media
|
This is an important trial that will change clinical practice, Dr. Bernard J. Gersh said in a panel discussion at a press briefing.
Dr. James B. Hermiller Jr. cautioned that it remains to be seen how the large difference between groups in major bleeding events translates into mortality over time.
Dr. Philippe Généreux said the results especially are important for a vast country like Canada, where transport to PCI often takes 45-60 minutes.
Asked what changes could get the United States to adopt prehospital initiation of anticoagulation, as is common in Europe, none of the panelists had a solution.
|
Sherry Boschert/IMNG Medical Media
|
"We have a different competitive system" in Canada, said Dr. Généreux of New York–Presbyterian Hospital and Hôpital Sacré Coeur, Montreal. "I’ve never seen anything that suggests that prehospital administration and diagnosis are not beneficial, but how we are going to achieve that in the United States, I don’t know."
"It’s difficult to just get ECGs in the field, let alone administer anticoagulants, but we need to get there because this is very important," said Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn., said that it’s possible to change systemic practices in a regional system such as his that spans rural areas, but it’s much more difficult in big cities with multiple competing medical systems.
|
Sherry Boschert/IMNG Medical Media
|
"I think there are real benefits to a national health care system as opposed to pure and simple competition. With a national or even a regional health care system, you can develop protocols and mandate them. This is what’s happened in many countries in Europe," he said. "Our current system, where you may have a city of a million people and four hospitals competing and four different ambulance systems, is not conducive to this. Unless people are prepared to sit down and say, ‘We’ll share the burden,’ I don’t have any idea" how the U.S. system will change.
Dr. Généreux reported financial associations with Cardiovascular Systems Inc. and Abbott Vascular. Dr. Gersh reported financial associations with Pharmaceutical Product Development, InspireMD, and multiple other companies.
|
Sherry Boschert/IMNG Medical Media
|
This is an important trial that will change clinical practice, Dr. Bernard J. Gersh said in a panel discussion at a press briefing.
Dr. James B. Hermiller Jr. cautioned that it remains to be seen how the large difference between groups in major bleeding events translates into mortality over time.
Dr. Philippe Généreux said the results especially are important for a vast country like Canada, where transport to PCI often takes 45-60 minutes.
Asked what changes could get the United States to adopt prehospital initiation of anticoagulation, as is common in Europe, none of the panelists had a solution.
|
Sherry Boschert/IMNG Medical Media
|
"We have a different competitive system" in Canada, said Dr. Généreux of New York–Presbyterian Hospital and Hôpital Sacré Coeur, Montreal. "I’ve never seen anything that suggests that prehospital administration and diagnosis are not beneficial, but how we are going to achieve that in the United States, I don’t know."
"It’s difficult to just get ECGs in the field, let alone administer anticoagulants, but we need to get there because this is very important," said Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn., said that it’s possible to change systemic practices in a regional system such as his that spans rural areas, but it’s much more difficult in big cities with multiple competing medical systems.
|
Sherry Boschert/IMNG Medical Media
|
"I think there are real benefits to a national health care system as opposed to pure and simple competition. With a national or even a regional health care system, you can develop protocols and mandate them. This is what’s happened in many countries in Europe," he said. "Our current system, where you may have a city of a million people and four hospitals competing and four different ambulance systems, is not conducive to this. Unless people are prepared to sit down and say, ‘We’ll share the burden,’ I don’t have any idea" how the U.S. system will change.
Dr. Généreux reported financial associations with Cardiovascular Systems Inc. and Abbott Vascular. Dr. Gersh reported financial associations with Pharmaceutical Product Development, InspireMD, and multiple other companies.
SAN FRANCISCO – Giving bivalirudin in the ambulance to patients with ST-segment elevation MI before primary percutaneous coronary intervention significantly improved 30-day bleeding outcomes in a randomized controlled trial in 2,218 patients, compared with giving unfractionated or low-molecular-weight heparin and optional glycoprotein IIb/IIIa inhibitors.
The bivalirudin group showed nearly a 40% decrease in the primary outcome, a composite of death or major bleeding not associated with coronary artery bypass grafting (CABG), compared with the control group. Rates for the primary outcome were 5.1% in the bivalirudin group and 8.4% in the control group at 30 days, Dr. Philippe Gabriel Steg and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 30-day rate of acute stent thrombosis, however, was approximately sixfold higher in the bivalirudin group (1.1%) than in the control group (0.2%) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. That did not translate into an increased risk of infarction, which was similar in the bivalirudin group (1.7%) and the control group (0.9%), Dr. Steg and his colleagues said.
The rates of the main secondary outcome – a composite of death, reinfarction, or non-CABG major bleeding at 30 days – also were significantly lower in the bivalirudin group (6.7%) than in the control group (9.1%), said Dr. Steg, professor of cardiology at Université Paris-Diderot and director of the coronary care unit at Hôpital Bichat, Paris.
The study was published online simultaneously with the presentation (N. Engl. J. Med. 2013 Oct. 30 [doi: 10.1056/NEJMoa1311096]).
The benefit from bivalirudin came mainly from reduced bleeding, not reduced mortality. The risk of major bleeding not associated with CABG was 2.7% in the bivalirudin group and 6.1% in the control group, a significant 57% reduction.
Rates of cardiac or noncardiac death at 30 days did not differ significantly between groups, with cardiac death in 2.4% with bivalirudin and 3% in the control group, and noncardiac death in 0.5% and 0.1%, respectively.
The study was underpowered to assess mortality, Dr. Steg said in an interview. He hopes to assess mortality risk at 1 year by analyzing combined data from EUROMAX and a previous major trial that showed bivalirudin’s utility before percutaneous coronary intervention, the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial (N. Engl. J. Med. 2008;358:2218-30).
Dr. Steg and his associates conducted the EUROMAX study to see if these benefits were still true in the modern era of prehospital treatment and evolving use of glycoprotein IIb/IIIa inhibitors, platelet P2Y12 receptor inhibitors, and radial access for PCI.
The EUROMAX findings were consistent across subgroups of patients, including subgroups defined by PCI access site or by the choice of P2Y12 inhibitor, Dr. Steg reported at the meeting, cosponsored by the American College of Cardiology.
He believes the findings will change practices and convince emergency crews to choose bivalirudin in Europe, where anticoagulation commonly is started in ambulances before arrival at the hospital, a practice that has not yet caught on in most of the United States.
Dr. Gregg W. Stone, primary investigator of the HORIZONS-AMI trial and a discussant of EUROMAX at the meeting, put together a preliminary meta-analysis of the two studies, he reported. Preliminary results suggest significant benefits from bivalirudin in 30-day rates of major bleeding, transfusion, thrombocytopenia, mortality, and subacute stent thrombosis, with a roughly fivefold increase in the risk of acute stent thrombosis. Studies are warranted to determine whether antiplatelet therapy with cangrelor might be a solution to the acute thrombosis risk, said Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University, New York.
Dr. Steg received fees from The Medicines Company, which sponsored the study and markets bivalirudin, and he reported financial associations with 16 other companies. Four of his colleagues in the study were employees of The Medicines Company, and 12 other colleagues reported financial associations with that company and/or multiple other companies. Dr. Stone reported financial associations with Boston Scientific, Eli Lilly, and other companies.
[email protected]
On Twitter @sherryboschert
SAN FRANCISCO – Giving bivalirudin in the ambulance to patients with ST-segment elevation MI before primary percutaneous coronary intervention significantly improved 30-day bleeding outcomes in a randomized controlled trial in 2,218 patients, compared with giving unfractionated or low-molecular-weight heparin and optional glycoprotein IIb/IIIa inhibitors.
The bivalirudin group showed nearly a 40% decrease in the primary outcome, a composite of death or major bleeding not associated with coronary artery bypass grafting (CABG), compared with the control group. Rates for the primary outcome were 5.1% in the bivalirudin group and 8.4% in the control group at 30 days, Dr. Philippe Gabriel Steg and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 30-day rate of acute stent thrombosis, however, was approximately sixfold higher in the bivalirudin group (1.1%) than in the control group (0.2%) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. That did not translate into an increased risk of infarction, which was similar in the bivalirudin group (1.7%) and the control group (0.9%), Dr. Steg and his colleagues said.
The rates of the main secondary outcome – a composite of death, reinfarction, or non-CABG major bleeding at 30 days – also were significantly lower in the bivalirudin group (6.7%) than in the control group (9.1%), said Dr. Steg, professor of cardiology at Université Paris-Diderot and director of the coronary care unit at Hôpital Bichat, Paris.
The study was published online simultaneously with the presentation (N. Engl. J. Med. 2013 Oct. 30 [doi: 10.1056/NEJMoa1311096]).
The benefit from bivalirudin came mainly from reduced bleeding, not reduced mortality. The risk of major bleeding not associated with CABG was 2.7% in the bivalirudin group and 6.1% in the control group, a significant 57% reduction.
Rates of cardiac or noncardiac death at 30 days did not differ significantly between groups, with cardiac death in 2.4% with bivalirudin and 3% in the control group, and noncardiac death in 0.5% and 0.1%, respectively.
The study was underpowered to assess mortality, Dr. Steg said in an interview. He hopes to assess mortality risk at 1 year by analyzing combined data from EUROMAX and a previous major trial that showed bivalirudin’s utility before percutaneous coronary intervention, the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial (N. Engl. J. Med. 2008;358:2218-30).
Dr. Steg and his associates conducted the EUROMAX study to see if these benefits were still true in the modern era of prehospital treatment and evolving use of glycoprotein IIb/IIIa inhibitors, platelet P2Y12 receptor inhibitors, and radial access for PCI.
The EUROMAX findings were consistent across subgroups of patients, including subgroups defined by PCI access site or by the choice of P2Y12 inhibitor, Dr. Steg reported at the meeting, cosponsored by the American College of Cardiology.
He believes the findings will change practices and convince emergency crews to choose bivalirudin in Europe, where anticoagulation commonly is started in ambulances before arrival at the hospital, a practice that has not yet caught on in most of the United States.
Dr. Gregg W. Stone, primary investigator of the HORIZONS-AMI trial and a discussant of EUROMAX at the meeting, put together a preliminary meta-analysis of the two studies, he reported. Preliminary results suggest significant benefits from bivalirudin in 30-day rates of major bleeding, transfusion, thrombocytopenia, mortality, and subacute stent thrombosis, with a roughly fivefold increase in the risk of acute stent thrombosis. Studies are warranted to determine whether antiplatelet therapy with cangrelor might be a solution to the acute thrombosis risk, said Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University, New York.
Dr. Steg received fees from The Medicines Company, which sponsored the study and markets bivalirudin, and he reported financial associations with 16 other companies. Four of his colleagues in the study were employees of The Medicines Company, and 12 other colleagues reported financial associations with that company and/or multiple other companies. Dr. Stone reported financial associations with Boston Scientific, Eli Lilly, and other companies.
[email protected]
On Twitter @sherryboschert
AT TCT 2013
Major finding: Rates of death or major bleeding not associated with CABG were 5.1% in the bivalirudin group at 30 days and 8.4% in the control group.
Data source: A prospective, randomized study of 2,218 adults with ST-segment elevation myocardial infarction who received either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors while being transported for primary PCI.
Disclosures: Dr. Steg received fees from The Medicines Company, which sponsored the study and markets bivalirudin, and he reported financial associations with 16 other companies. Four of his colleagues in the study were employees of The Medicines Company, and 12 other colleagues reported financial associations with that company and/or multiple other companies. Dr. Stone reported financial associations with Boston Scientific, Eli Lilly, and other companies.
