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Resorbable scaffold appears safe, effective in diabetes patients
An everolimus-eluting resorbable scaffold appeared to be safe and effective for percutaneous coronary intervention (PCI) in patients with diabetes and noncomplex coronary lesions, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology: Cardiovascular Interventions.
Patients with diabetes constitute an important and increasingly prevalent subgroup of PCI patients, who are at high risk of adverse clinical and angiographic outcomes such as MI, stent thrombosis, restenosis, and death. This is thought to be due to diabetic patients’ greater level of vascular inflammation and tendency toward a prothrombotic state and more complex angiographic features, said Dean J. Kereiakes, MD, of the Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati.
The substudy participants all received at least one resorbable scaffold in at least one target lesion. A total of 27.3% were insulin dependent and nearly 60% had HbA1c levels exceeding 7.0%. Notably, 18% of all the treated lesions in this analysis were less than 2.25 mm in diameter as assessed by quantitative coronary angiography, and approximately 60% had moderately to severely complex morphology.
The primary endpoint – the rate of target-lesion failure at 1-year follow-up – was 8.3%, which was well below the prespecified performance goal of 12.7%. This rate ranged from 4.4% to 10.9% across the different trials. A sensitivity analysis confirmed that the 1-year rate of target-lesion failure was significantly lower than the prespecified performance goal.
The rates of target-lesion failure, target-vessel MI, ischemia-driven target-lesion revascularization, and scaffold thrombosis were significantly higher in diabetic patients who required insulin than in those who did not. Older patient age, insulin dependency, and small target-vessel diameter all were independent predictors of target-lesion failure at 1 year.
The overall 1-year rate of scaffold thrombosis in this study was 2.3%, which is not surprising given the study population’s risk factors. For diabetic patients with appropriately sized vessels of greater than 2.25 mm diameter, the scaffold thrombosis rate was lower (1.3%).
In addition to being underpowered to assess rare adverse events, this study was limited in that it reported outcomes at 1 year, before resorption of the device was complete. It also reflects the first-time clinical experience with a resorbable scaffold for most of the participating investigators, “and one would expect that as with all new medical procedures, results will improve over time with increased operator experience,” the coauthors wrote.
Dr. Kereiakes reported being a consultant to Abbott Vascular, and his associates also reported ties to the company and to other industry sources.
An everolimus-eluting resorbable scaffold appeared to be safe and effective for percutaneous coronary intervention (PCI) in patients with diabetes and noncomplex coronary lesions, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology: Cardiovascular Interventions.
Patients with diabetes constitute an important and increasingly prevalent subgroup of PCI patients, who are at high risk of adverse clinical and angiographic outcomes such as MI, stent thrombosis, restenosis, and death. This is thought to be due to diabetic patients’ greater level of vascular inflammation and tendency toward a prothrombotic state and more complex angiographic features, said Dean J. Kereiakes, MD, of the Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati.
The substudy participants all received at least one resorbable scaffold in at least one target lesion. A total of 27.3% were insulin dependent and nearly 60% had HbA1c levels exceeding 7.0%. Notably, 18% of all the treated lesions in this analysis were less than 2.25 mm in diameter as assessed by quantitative coronary angiography, and approximately 60% had moderately to severely complex morphology.
The primary endpoint – the rate of target-lesion failure at 1-year follow-up – was 8.3%, which was well below the prespecified performance goal of 12.7%. This rate ranged from 4.4% to 10.9% across the different trials. A sensitivity analysis confirmed that the 1-year rate of target-lesion failure was significantly lower than the prespecified performance goal.
The rates of target-lesion failure, target-vessel MI, ischemia-driven target-lesion revascularization, and scaffold thrombosis were significantly higher in diabetic patients who required insulin than in those who did not. Older patient age, insulin dependency, and small target-vessel diameter all were independent predictors of target-lesion failure at 1 year.
The overall 1-year rate of scaffold thrombosis in this study was 2.3%, which is not surprising given the study population’s risk factors. For diabetic patients with appropriately sized vessels of greater than 2.25 mm diameter, the scaffold thrombosis rate was lower (1.3%).
In addition to being underpowered to assess rare adverse events, this study was limited in that it reported outcomes at 1 year, before resorption of the device was complete. It also reflects the first-time clinical experience with a resorbable scaffold for most of the participating investigators, “and one would expect that as with all new medical procedures, results will improve over time with increased operator experience,” the coauthors wrote.
Dr. Kereiakes reported being a consultant to Abbott Vascular, and his associates also reported ties to the company and to other industry sources.
An everolimus-eluting resorbable scaffold appeared to be safe and effective for percutaneous coronary intervention (PCI) in patients with diabetes and noncomplex coronary lesions, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the Journal of the American College of Cardiology: Cardiovascular Interventions.
Patients with diabetes constitute an important and increasingly prevalent subgroup of PCI patients, who are at high risk of adverse clinical and angiographic outcomes such as MI, stent thrombosis, restenosis, and death. This is thought to be due to diabetic patients’ greater level of vascular inflammation and tendency toward a prothrombotic state and more complex angiographic features, said Dean J. Kereiakes, MD, of the Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati.
The substudy participants all received at least one resorbable scaffold in at least one target lesion. A total of 27.3% were insulin dependent and nearly 60% had HbA1c levels exceeding 7.0%. Notably, 18% of all the treated lesions in this analysis were less than 2.25 mm in diameter as assessed by quantitative coronary angiography, and approximately 60% had moderately to severely complex morphology.
The primary endpoint – the rate of target-lesion failure at 1-year follow-up – was 8.3%, which was well below the prespecified performance goal of 12.7%. This rate ranged from 4.4% to 10.9% across the different trials. A sensitivity analysis confirmed that the 1-year rate of target-lesion failure was significantly lower than the prespecified performance goal.
The rates of target-lesion failure, target-vessel MI, ischemia-driven target-lesion revascularization, and scaffold thrombosis were significantly higher in diabetic patients who required insulin than in those who did not. Older patient age, insulin dependency, and small target-vessel diameter all were independent predictors of target-lesion failure at 1 year.
The overall 1-year rate of scaffold thrombosis in this study was 2.3%, which is not surprising given the study population’s risk factors. For diabetic patients with appropriately sized vessels of greater than 2.25 mm diameter, the scaffold thrombosis rate was lower (1.3%).
In addition to being underpowered to assess rare adverse events, this study was limited in that it reported outcomes at 1 year, before resorption of the device was complete. It also reflects the first-time clinical experience with a resorbable scaffold for most of the participating investigators, “and one would expect that as with all new medical procedures, results will improve over time with increased operator experience,” the coauthors wrote.
Dr. Kereiakes reported being a consultant to Abbott Vascular, and his associates also reported ties to the company and to other industry sources.
Key clinical point:
Major finding: The primary endpoint – the rate of target-lesion failure at 1 year follow-up – was 8.3%, which was well below the prespecified performance goal of 12.7%.
Data source: A prespecified formal substudy of 754 patients with diabetes who participated in three clinical trials and one device registry, assessing 1-year outcomes after PCI.
Disclosures: This pooled analysis, plus all the contributing trials and the device registry, were funded by Abbott Vascular, maker of the resorbable scaffold. Dr. Kereiakes reported being a consultant to Abbott Vascular, and his associates also reported ties to the company and to other industry sources.
“Honoring Our Mentors” Fellowship Open for Submission
The AATS Graham Foundation is calling for submission for its Denton A. Cooley “Honoring Our Mentors” fellowship.
Denton A. Cooley Fellowship
New! Provides a deserving CT surgeon resident or young postgraduate surgeon the opportunity to enrich his/her education during four weeks of study at the Texas Heart Institute and Baylor St. Luke’s Medical Center.
Deadline: December 30, 2016
Share:
The AATS Graham Foundation is calling for submission for its Denton A. Cooley “Honoring Our Mentors” fellowship.
Denton A. Cooley Fellowship
New! Provides a deserving CT surgeon resident or young postgraduate surgeon the opportunity to enrich his/her education during four weeks of study at the Texas Heart Institute and Baylor St. Luke’s Medical Center.
Deadline: December 30, 2016
Share:
The AATS Graham Foundation is calling for submission for its Denton A. Cooley “Honoring Our Mentors” fellowship.
Denton A. Cooley Fellowship
New! Provides a deserving CT surgeon resident or young postgraduate surgeon the opportunity to enrich his/her education during four weeks of study at the Texas Heart Institute and Baylor St. Luke’s Medical Center.
Deadline: December 30, 2016
Share:
AATS Submission Opportunities
Don’t miss the opportunity to submit to one of these AATS scholarship programs.
Deadline: January 20, 2017
AATS Member for a Day
North American medical students, and general and up to third year integrated CT Surgery
(I-6) surgery residents can accompany an AATS Member during portions of the AATS Centennial as an AATS Member for a Day.
The meeting takes place April 29-May 3, 2017 in Boston, MA.
Those selected will receive free hotel accommodations for three to four night in an AATS Centennial hotel. They will also be given a $250 meal and $500 travel stipend at the end of the meeting.
Eligibility/More information
Summer Internship Opportunity for First/Second Year Medical Students
First and second year medical students can spend the summer being exposed to
cardiothoracic surgery thanks to the AATS Summer Intern Scholarship. For eight weeks
(June – September), students will work in the CT department of an AATS member.
Those chosen receive $2,500 for living expenses. They also will be able to attend the AATS Centennial gratis.
The meeting takes place April 29 – May 3, 2017
Boston, MA.
AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at The AATS Centennial.
The meeting will take place April 29 - May 3, 2017
Boston, MA.
Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).
Non-MD CT Surgical Team Scientific Poster Competition
Non-MD cardiothoracic team professionals can submit a scientific poster for
the Perioperative/Team-Based Care Poster Competition.
Winning posters will be displayed at the AATS Centennial, April 29 – May 3, 2017
Boston, MA.
The competition winner will receive a $1,000 stipend to offset travel and accommodation costs.
Share:
Don’t miss the opportunity to submit to one of these AATS scholarship programs.
Deadline: January 20, 2017
AATS Member for a Day
North American medical students, and general and up to third year integrated CT Surgery
(I-6) surgery residents can accompany an AATS Member during portions of the AATS Centennial as an AATS Member for a Day.
The meeting takes place April 29-May 3, 2017 in Boston, MA.
Those selected will receive free hotel accommodations for three to four night in an AATS Centennial hotel. They will also be given a $250 meal and $500 travel stipend at the end of the meeting.
Eligibility/More information
Summer Internship Opportunity for First/Second Year Medical Students
First and second year medical students can spend the summer being exposed to
cardiothoracic surgery thanks to the AATS Summer Intern Scholarship. For eight weeks
(June – September), students will work in the CT department of an AATS member.
Those chosen receive $2,500 for living expenses. They also will be able to attend the AATS Centennial gratis.
The meeting takes place April 29 – May 3, 2017
Boston, MA.
AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at The AATS Centennial.
The meeting will take place April 29 - May 3, 2017
Boston, MA.
Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).
Non-MD CT Surgical Team Scientific Poster Competition
Non-MD cardiothoracic team professionals can submit a scientific poster for
the Perioperative/Team-Based Care Poster Competition.
Winning posters will be displayed at the AATS Centennial, April 29 – May 3, 2017
Boston, MA.
The competition winner will receive a $1,000 stipend to offset travel and accommodation costs.
Share:
Don’t miss the opportunity to submit to one of these AATS scholarship programs.
Deadline: January 20, 2017
AATS Member for a Day
North American medical students, and general and up to third year integrated CT Surgery
(I-6) surgery residents can accompany an AATS Member during portions of the AATS Centennial as an AATS Member for a Day.
The meeting takes place April 29-May 3, 2017 in Boston, MA.
Those selected will receive free hotel accommodations for three to four night in an AATS Centennial hotel. They will also be given a $250 meal and $500 travel stipend at the end of the meeting.
Eligibility/More information
Summer Internship Opportunity for First/Second Year Medical Students
First and second year medical students can spend the summer being exposed to
cardiothoracic surgery thanks to the AATS Summer Intern Scholarship. For eight weeks
(June – September), students will work in the CT department of an AATS member.
Those chosen receive $2,500 for living expenses. They also will be able to attend the AATS Centennial gratis.
The meeting takes place April 29 – May 3, 2017
Boston, MA.
AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at The AATS Centennial.
The meeting will take place April 29 - May 3, 2017
Boston, MA.
Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).
Non-MD CT Surgical Team Scientific Poster Competition
Non-MD cardiothoracic team professionals can submit a scientific poster for
the Perioperative/Team-Based Care Poster Competition.
Winning posters will be displayed at the AATS Centennial, April 29 – May 3, 2017
Boston, MA.
The competition winner will receive a $1,000 stipend to offset travel and accommodation costs.
Share:
AATS Mitral Conclave Call for Abstracts & Videos
AATS invites you to submit your abstracts and videos to the 2017 Mitral Conclave.
AATS Mitral Conclave
April 27-28, 2017
New York, NY
Submission Deadline:
Sunday, January 8, 2017 @ 11.59 pm EST
Share:
AATS invites you to submit your abstracts and videos to the 2017 Mitral Conclave.
AATS Mitral Conclave
April 27-28, 2017
New York, NY
Submission Deadline:
Sunday, January 8, 2017 @ 11.59 pm EST
Share:
AATS invites you to submit your abstracts and videos to the 2017 Mitral Conclave.
AATS Mitral Conclave
April 27-28, 2017
New York, NY
Submission Deadline:
Sunday, January 8, 2017 @ 11.59 pm EST
Share:
PCI noninferior to CABG for certain left main CAD
Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.
The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).
Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.
This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.
Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).
They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.
The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.
At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.
The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.
During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).
Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.
The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.
Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.
Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.
Dr. Stone and his associates reported ties to numerous industry sources.
The well-designed and rigorously conducted EXCEL trial’s take-home message is that most patients with left main CAD can now be managed equally well using either PCI or CABG, provided that their treatment team is as experienced as those participating in the study.
PCI may be favored in some patients because of its greater periprocedural safety, shorter hospital stay, and more rapid recovery. However, the composite rate of death, stroke, or MI after 30 days was higher with PCI (11.5% vs 7.9%). It is reassuring that these study participants will be followed for another 2 years so that longer-term events can be assessed.
Eugene Braunwald, MD, is in the Thrombolysis in Myocardial Infarction Study Group, in the cardiovascular division at Brigham and Women’s Hospital, and in the department of medicine at Harvard Medical School. He reported having no relevant financial disclosures. Dr. Braunwald made these remarks in an editorial accompanying Dr. Stone’s report (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMe1612570).
The well-designed and rigorously conducted EXCEL trial’s take-home message is that most patients with left main CAD can now be managed equally well using either PCI or CABG, provided that their treatment team is as experienced as those participating in the study.
PCI may be favored in some patients because of its greater periprocedural safety, shorter hospital stay, and more rapid recovery. However, the composite rate of death, stroke, or MI after 30 days was higher with PCI (11.5% vs 7.9%). It is reassuring that these study participants will be followed for another 2 years so that longer-term events can be assessed.
Eugene Braunwald, MD, is in the Thrombolysis in Myocardial Infarction Study Group, in the cardiovascular division at Brigham and Women’s Hospital, and in the department of medicine at Harvard Medical School. He reported having no relevant financial disclosures. Dr. Braunwald made these remarks in an editorial accompanying Dr. Stone’s report (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMe1612570).
The well-designed and rigorously conducted EXCEL trial’s take-home message is that most patients with left main CAD can now be managed equally well using either PCI or CABG, provided that their treatment team is as experienced as those participating in the study.
PCI may be favored in some patients because of its greater periprocedural safety, shorter hospital stay, and more rapid recovery. However, the composite rate of death, stroke, or MI after 30 days was higher with PCI (11.5% vs 7.9%). It is reassuring that these study participants will be followed for another 2 years so that longer-term events can be assessed.
Eugene Braunwald, MD, is in the Thrombolysis in Myocardial Infarction Study Group, in the cardiovascular division at Brigham and Women’s Hospital, and in the department of medicine at Harvard Medical School. He reported having no relevant financial disclosures. Dr. Braunwald made these remarks in an editorial accompanying Dr. Stone’s report (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMe1612570).
Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.
The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).
Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.
This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.
Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).
They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.
The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.
At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.
The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.
During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).
Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.
The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.
Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.
Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.
Dr. Stone and his associates reported ties to numerous industry sources.
Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.
The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).
Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.
This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.
Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).
They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.
The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.
At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.
The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.
During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).
Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.
The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.
Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.
Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.
Dr. Stone and his associates reported ties to numerous industry sources.
Key clinical point: PCI was found noninferior to CABG regarding the composite end point of death, stroke, or myocardial infarction in certain patients with left main CAD.
Major finding: The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (HR, 1.00) that demonstrates the noninferiority of PCI.
Data source: An international open-label randomized trial involving 1,905 patients followed for 3 years.
Disclosures: The EXCEL trial was funded by Abbott Vascular, maker of the everolimus-eluting stent used in this study. The company participated in the design of the trial and in selection and management of the treatment sites, but was not involved in managing or analyzing the data or writing the manuscript. Dr. Stone and his associates reported ties to numerous industry sources.
Don’t Miss the Celebration: AATS Centennial
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Saturday Courses
Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr
Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski
General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku
Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak
Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade
Sunday Symposia
AATS/STS Adult Cardiac Surgery Symposium Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani
AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin
AATS/STS General Thoracic Surgery Symposium Chairs
Seth Force, Moishe Liberman
Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman
Saturday Course/Sunday Symposia Program
Share:
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Saturday Courses
Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr
Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski
General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku
Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak
Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade
Sunday Symposia
AATS/STS Adult Cardiac Surgery Symposium Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani
AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin
AATS/STS General Thoracic Surgery Symposium Chairs
Seth Force, Moishe Liberman
Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman
Saturday Course/Sunday Symposia Program
Share:
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Saturday Courses
Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr
Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski
General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku
Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak
Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade
Sunday Symposia
AATS/STS Adult Cardiac Surgery Symposium Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani
AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin
AATS/STS General Thoracic Surgery Symposium Chairs
Seth Force, Moishe Liberman
Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman
Saturday Course/Sunday Symposia Program
Share:
Adaptive servo ventilation cuts atrial fib burden
ORLANDO – Adaptive servo ventilation produced a significant and clinically meaningful reduction in atrial fibrillation burden in patients with heart failure and sleep apnea in results from an exploratory, prospective, randomized study with 35 patients.
Adaptive servo ventilation (ASV) “may be an effective antiarrhythmic treatment producing a significant reduction in atrial fibrillation without clear evidence of being proarrhythmogenic,” Jonathan P. Piccini, MD, said at the annual scientific meeting of the Heart Failure Society of America. “Given the potential importance of this finding further studies should validate and quantify the efficacy of ASV for reducing atrial fibrillation in patients with or without heart failure.”
“A mound of data has shown that treating sleep apnea reduced arrhythmias, but until now it’s all been observational and retrospective,” Dr. Piccini, an electrophysiologist at Duke University in Durham, N.C., said in an interview. The study he reported is “the first time” the arrhythmia effects of a sleep apnea intervention, in this case ASV, was studied in a prospective, randomized way while using implanted devices to measure the antiarrhythmic effect of the treatment.
The new finding means that additional, larger studies are now needed, he said. “If patients have sleep apnea, treating the apnea may be an incredibly important way to prevent AF or reduce its burden”
The CAT-HF (Cardiovascular Improvements With Minute Ventilation-Targeted ASV Therapy in Heart Failure) trial was originally designed to randomize 215 heart failure patients with sleep disordered breathing – and who were hospitalized for heart failure – to optimal medical therapy with or without ASV at any of 15 centers in the United States and Germany. But in August 2015, results from the SERVE-HF (Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure) trial, which generally had a similar design to CAT-HF, showed an unexpected danger from ASV in patients with central sleep apnea and heart failure with reduced ejection fraction (N Engl J Med. 2015 Sept 17;373[12]:1095-105). In SERVE-HF, ASV was associated with significant increases in all-cause and cardiovascular mortality. As a result, enrollment into CAT-HF stopped prematurely with just 126 patients entered, and ASV treatment of patients already enrolled came to a halt.
The primary endpoint in the underpowered and shortened CAT-HF study, survival without cardiovascular hospitalization and with improved functional capacity measured on a 6-minute walk test, showed similar outcomes in both the ASV and control arms. But in a prespecified subgroup analysis by baseline ejection fraction, the 24 patients with heart failure with preserved ejection fraction (19% of the CAT-HF enrollment) showed a statistically significant, 62% relative improvement in the primary endpoint linked with ASV treatment compared with similar patients who did not receive ASV, Christopher M. O’Connor, MD, professor of medicine at Duke University, reported in May 2016 at the European Heart Failure meeting in Florence.
Dr. Piccini’s report focused on a prespecified subgroup analysis of CAT-HF designed to examine the impact of ASV on arrhythmias. Assessment of the impact of ASV on atrial fibrillation was possible in 35 of the 126 patients in CAT-HF who had an implanted cardiac device (pacemaker, defibrillator, or cardiac resynchronization device) with an atrial lead, and assessment of ventricular arrhythmias occurred in 46 of the CAT-HF patients with an implanted high-voltage device (a defibrillator or resynchronization device) that allowed monitoring of ventricular arrhythmias.
For the atrial fibrillation analysis, the 35 patients averaged 60 years of age, and about 90% had a reduced ejection fraction. About two-thirds had an apnea-hypopnea index greater than 30.
The results showed that the 19 patients randomized to receive ASV had an average atrial fibrillation burden of 30% at baseline that dropped to 14% after 6 months of treatment. In contrast, the 16 patients in the control arm had a AF burden of 6% at baseline and 8% after 6 months. The between-group difference for change in AF burden was statistically significant, Dr. Piccini reported, with a burden that decreased by a relative 21% with ASV treatment and increased by a relative 31% in the control arm.
Analysis of the ventricular arrhythmia subgroup showed that ASV had no statistically significant impact for either lowering or raising ventricular tachyarrhythmias or fibrillations.
Trying to reconcile this AF benefit and lack of ventricular arrhythmia harm from ASV in CAT-HF with the excess in cardiovascular deaths seen with ASV in SERVE-HF, Dr. Piccini speculated that some of the SERVE-HF deaths may not have been related to arrhythmia.
“Sudden cardiac death adjudication is profoundly difficult, and does not always equal ventricular arrhythmia,” he said. “We need to consider that some of the adverse events in patients with severe central sleep apnea and low left ventricular ejection fraction [enrolled in SERVE-HF] may have been due to causes other than arrhythmias. The CAT-HF results should motivate investigations of alternative mechanisms of death in SERVE-HF.”
The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support from ResMed and from Janssen, Gilead, St. Jude, Spectranetics, and he has been a consultant to Janssen, Spectranetics, Medtronic, GSK and BMS-Pfizer. Dr. O’Connor has been a consultant to ResMed and to several other drug and device companies.
[email protected]
On Twitter @mitchelzoler
A small prespecified sub-group of patients in the CAT-HF (Cardiovascuar improvements with minute ventilation-targeted ASV therapy in heart failure) trial randomized to adaptive servo ventilation (ASV) showed a 21% relative reduction in atrial fibrillation burden as compared to the control arm which had only 31% relative reduction. While the CAT-HF study was discontinued following results of SERVE-HF trial, this subgroup analysis included 35 patients (19 ASV arm; 16 control arm), the majority of whom had a reduced ejection fraction. This report poses interesting questions about effects of ASV on atrial fibrillation burden in those with reduced EF given the finding that central sleep apnea and Cheyne-Stokes respiration are shown to be associated with incident atrial fibrillation in older men (May et al. Am J Respir Crit Care Med 2016).
A small prespecified sub-group of patients in the CAT-HF (Cardiovascuar improvements with minute ventilation-targeted ASV therapy in heart failure) trial randomized to adaptive servo ventilation (ASV) showed a 21% relative reduction in atrial fibrillation burden as compared to the control arm which had only 31% relative reduction. While the CAT-HF study was discontinued following results of SERVE-HF trial, this subgroup analysis included 35 patients (19 ASV arm; 16 control arm), the majority of whom had a reduced ejection fraction. This report poses interesting questions about effects of ASV on atrial fibrillation burden in those with reduced EF given the finding that central sleep apnea and Cheyne-Stokes respiration are shown to be associated with incident atrial fibrillation in older men (May et al. Am J Respir Crit Care Med 2016).
A small prespecified sub-group of patients in the CAT-HF (Cardiovascuar improvements with minute ventilation-targeted ASV therapy in heart failure) trial randomized to adaptive servo ventilation (ASV) showed a 21% relative reduction in atrial fibrillation burden as compared to the control arm which had only 31% relative reduction. While the CAT-HF study was discontinued following results of SERVE-HF trial, this subgroup analysis included 35 patients (19 ASV arm; 16 control arm), the majority of whom had a reduced ejection fraction. This report poses interesting questions about effects of ASV on atrial fibrillation burden in those with reduced EF given the finding that central sleep apnea and Cheyne-Stokes respiration are shown to be associated with incident atrial fibrillation in older men (May et al. Am J Respir Crit Care Med 2016).
ORLANDO – Adaptive servo ventilation produced a significant and clinically meaningful reduction in atrial fibrillation burden in patients with heart failure and sleep apnea in results from an exploratory, prospective, randomized study with 35 patients.
Adaptive servo ventilation (ASV) “may be an effective antiarrhythmic treatment producing a significant reduction in atrial fibrillation without clear evidence of being proarrhythmogenic,” Jonathan P. Piccini, MD, said at the annual scientific meeting of the Heart Failure Society of America. “Given the potential importance of this finding further studies should validate and quantify the efficacy of ASV for reducing atrial fibrillation in patients with or without heart failure.”
“A mound of data has shown that treating sleep apnea reduced arrhythmias, but until now it’s all been observational and retrospective,” Dr. Piccini, an electrophysiologist at Duke University in Durham, N.C., said in an interview. The study he reported is “the first time” the arrhythmia effects of a sleep apnea intervention, in this case ASV, was studied in a prospective, randomized way while using implanted devices to measure the antiarrhythmic effect of the treatment.
The new finding means that additional, larger studies are now needed, he said. “If patients have sleep apnea, treating the apnea may be an incredibly important way to prevent AF or reduce its burden”
The CAT-HF (Cardiovascular Improvements With Minute Ventilation-Targeted ASV Therapy in Heart Failure) trial was originally designed to randomize 215 heart failure patients with sleep disordered breathing – and who were hospitalized for heart failure – to optimal medical therapy with or without ASV at any of 15 centers in the United States and Germany. But in August 2015, results from the SERVE-HF (Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure) trial, which generally had a similar design to CAT-HF, showed an unexpected danger from ASV in patients with central sleep apnea and heart failure with reduced ejection fraction (N Engl J Med. 2015 Sept 17;373[12]:1095-105). In SERVE-HF, ASV was associated with significant increases in all-cause and cardiovascular mortality. As a result, enrollment into CAT-HF stopped prematurely with just 126 patients entered, and ASV treatment of patients already enrolled came to a halt.
The primary endpoint in the underpowered and shortened CAT-HF study, survival without cardiovascular hospitalization and with improved functional capacity measured on a 6-minute walk test, showed similar outcomes in both the ASV and control arms. But in a prespecified subgroup analysis by baseline ejection fraction, the 24 patients with heart failure with preserved ejection fraction (19% of the CAT-HF enrollment) showed a statistically significant, 62% relative improvement in the primary endpoint linked with ASV treatment compared with similar patients who did not receive ASV, Christopher M. O’Connor, MD, professor of medicine at Duke University, reported in May 2016 at the European Heart Failure meeting in Florence.
Dr. Piccini’s report focused on a prespecified subgroup analysis of CAT-HF designed to examine the impact of ASV on arrhythmias. Assessment of the impact of ASV on atrial fibrillation was possible in 35 of the 126 patients in CAT-HF who had an implanted cardiac device (pacemaker, defibrillator, or cardiac resynchronization device) with an atrial lead, and assessment of ventricular arrhythmias occurred in 46 of the CAT-HF patients with an implanted high-voltage device (a defibrillator or resynchronization device) that allowed monitoring of ventricular arrhythmias.
For the atrial fibrillation analysis, the 35 patients averaged 60 years of age, and about 90% had a reduced ejection fraction. About two-thirds had an apnea-hypopnea index greater than 30.
The results showed that the 19 patients randomized to receive ASV had an average atrial fibrillation burden of 30% at baseline that dropped to 14% after 6 months of treatment. In contrast, the 16 patients in the control arm had a AF burden of 6% at baseline and 8% after 6 months. The between-group difference for change in AF burden was statistically significant, Dr. Piccini reported, with a burden that decreased by a relative 21% with ASV treatment and increased by a relative 31% in the control arm.
Analysis of the ventricular arrhythmia subgroup showed that ASV had no statistically significant impact for either lowering or raising ventricular tachyarrhythmias or fibrillations.
Trying to reconcile this AF benefit and lack of ventricular arrhythmia harm from ASV in CAT-HF with the excess in cardiovascular deaths seen with ASV in SERVE-HF, Dr. Piccini speculated that some of the SERVE-HF deaths may not have been related to arrhythmia.
“Sudden cardiac death adjudication is profoundly difficult, and does not always equal ventricular arrhythmia,” he said. “We need to consider that some of the adverse events in patients with severe central sleep apnea and low left ventricular ejection fraction [enrolled in SERVE-HF] may have been due to causes other than arrhythmias. The CAT-HF results should motivate investigations of alternative mechanisms of death in SERVE-HF.”
The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support from ResMed and from Janssen, Gilead, St. Jude, Spectranetics, and he has been a consultant to Janssen, Spectranetics, Medtronic, GSK and BMS-Pfizer. Dr. O’Connor has been a consultant to ResMed and to several other drug and device companies.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Adaptive servo ventilation produced a significant and clinically meaningful reduction in atrial fibrillation burden in patients with heart failure and sleep apnea in results from an exploratory, prospective, randomized study with 35 patients.
Adaptive servo ventilation (ASV) “may be an effective antiarrhythmic treatment producing a significant reduction in atrial fibrillation without clear evidence of being proarrhythmogenic,” Jonathan P. Piccini, MD, said at the annual scientific meeting of the Heart Failure Society of America. “Given the potential importance of this finding further studies should validate and quantify the efficacy of ASV for reducing atrial fibrillation in patients with or without heart failure.”
“A mound of data has shown that treating sleep apnea reduced arrhythmias, but until now it’s all been observational and retrospective,” Dr. Piccini, an electrophysiologist at Duke University in Durham, N.C., said in an interview. The study he reported is “the first time” the arrhythmia effects of a sleep apnea intervention, in this case ASV, was studied in a prospective, randomized way while using implanted devices to measure the antiarrhythmic effect of the treatment.
The new finding means that additional, larger studies are now needed, he said. “If patients have sleep apnea, treating the apnea may be an incredibly important way to prevent AF or reduce its burden”
The CAT-HF (Cardiovascular Improvements With Minute Ventilation-Targeted ASV Therapy in Heart Failure) trial was originally designed to randomize 215 heart failure patients with sleep disordered breathing – and who were hospitalized for heart failure – to optimal medical therapy with or without ASV at any of 15 centers in the United States and Germany. But in August 2015, results from the SERVE-HF (Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure) trial, which generally had a similar design to CAT-HF, showed an unexpected danger from ASV in patients with central sleep apnea and heart failure with reduced ejection fraction (N Engl J Med. 2015 Sept 17;373[12]:1095-105). In SERVE-HF, ASV was associated with significant increases in all-cause and cardiovascular mortality. As a result, enrollment into CAT-HF stopped prematurely with just 126 patients entered, and ASV treatment of patients already enrolled came to a halt.
The primary endpoint in the underpowered and shortened CAT-HF study, survival without cardiovascular hospitalization and with improved functional capacity measured on a 6-minute walk test, showed similar outcomes in both the ASV and control arms. But in a prespecified subgroup analysis by baseline ejection fraction, the 24 patients with heart failure with preserved ejection fraction (19% of the CAT-HF enrollment) showed a statistically significant, 62% relative improvement in the primary endpoint linked with ASV treatment compared with similar patients who did not receive ASV, Christopher M. O’Connor, MD, professor of medicine at Duke University, reported in May 2016 at the European Heart Failure meeting in Florence.
Dr. Piccini’s report focused on a prespecified subgroup analysis of CAT-HF designed to examine the impact of ASV on arrhythmias. Assessment of the impact of ASV on atrial fibrillation was possible in 35 of the 126 patients in CAT-HF who had an implanted cardiac device (pacemaker, defibrillator, or cardiac resynchronization device) with an atrial lead, and assessment of ventricular arrhythmias occurred in 46 of the CAT-HF patients with an implanted high-voltage device (a defibrillator or resynchronization device) that allowed monitoring of ventricular arrhythmias.
For the atrial fibrillation analysis, the 35 patients averaged 60 years of age, and about 90% had a reduced ejection fraction. About two-thirds had an apnea-hypopnea index greater than 30.
The results showed that the 19 patients randomized to receive ASV had an average atrial fibrillation burden of 30% at baseline that dropped to 14% after 6 months of treatment. In contrast, the 16 patients in the control arm had a AF burden of 6% at baseline and 8% after 6 months. The between-group difference for change in AF burden was statistically significant, Dr. Piccini reported, with a burden that decreased by a relative 21% with ASV treatment and increased by a relative 31% in the control arm.
Analysis of the ventricular arrhythmia subgroup showed that ASV had no statistically significant impact for either lowering or raising ventricular tachyarrhythmias or fibrillations.
Trying to reconcile this AF benefit and lack of ventricular arrhythmia harm from ASV in CAT-HF with the excess in cardiovascular deaths seen with ASV in SERVE-HF, Dr. Piccini speculated that some of the SERVE-HF deaths may not have been related to arrhythmia.
“Sudden cardiac death adjudication is profoundly difficult, and does not always equal ventricular arrhythmia,” he said. “We need to consider that some of the adverse events in patients with severe central sleep apnea and low left ventricular ejection fraction [enrolled in SERVE-HF] may have been due to causes other than arrhythmias. The CAT-HF results should motivate investigations of alternative mechanisms of death in SERVE-HF.”
The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support from ResMed and from Janssen, Gilead, St. Jude, Spectranetics, and he has been a consultant to Janssen, Spectranetics, Medtronic, GSK and BMS-Pfizer. Dr. O’Connor has been a consultant to ResMed and to several other drug and device companies.
[email protected]
On Twitter @mitchelzoler
Key clinical point:
Major finding: After 6 months, ASV produced a relative 21% drop in atrial fibrillation burden, compared with increased burden in control patients.
Data source: CAT-HF, a multicenter randomized trial that enrolled 126 heart failure patients with sleep apnea.
Disclosures: The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support and/or consultant fees from ResMed, Janssen, Gilead, St. Jude, Spectranetics, Medtronic, GSK and BMS-Pfizer.
Surgical treatment tops medical management of prosthetic valve endocarditis
NEW ORLEANS – Over the years patients with prosthetic valve endocarditis treated at Cleveland Clinic tended to fare better with surgery compared to medical management, some clinicians noted. However, there was no data to confirm their observations.
“It was not recognized widely. A lot of our colleagues continued to believe it could be adequately treated with the right antibiotic,” Nabin K. Shrestha, MD, said at the IDWeek 2016 annual meeting on infectious diseases.
So Dr Shrestha and his colleagues conducted a retrospective cohort study to compare outcomes between 253 surgically treated adults and 77 others treated medically between April 2008 and December 2012. Survival from the time of treatment decision was the primary outcome.
The groups differed on some demographic and clinical factors. For example, the medically treated group was older, had fewer men, and more patients with mitral valves. “We might think the medical patients might be too sick for surgery, and that could certainly be true, but … they could have been too well for surgery too,” Dr. Shrestha said. To control for these differences between groups, the investigators performed a number of statistical analyses, including a propensity score adjusted model and reduced Cox proportion hazards model.
“Patients with PVE have a high hazard of death if treated medically,” Dr. Shrestha said, based on a 6.68 hazard ratio. The higher risk of death associated with medical treatment remained significant when adjusted for age, sex, and other factors. “Compared to surgical treatment, medical treatment was associated with a seven-fold higher hazard of death overall,” Dr. Shrestha said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The medical treatment group also fared worse on a number of secondary outcomes. For example, this group had a five-fold higher risk of death during hospitalization compared to the surgery group (odds ratio, 4.65); a 12-fold higher risk of death within one year (OR, 11.70); a seven-fold higher risk of subsequent surgery for infective endocarditis (OR, 6.57); and an eight-fold higher odds of surgery for the same episode of infective endocarditis at a subsequent hospitalization (OR, 8.02).
A large sample size and setting the date of management decision as time zero to avoid survival selection bias “give us confidence in our findings.” Limitations include an inability to look at some important variables because of the retrospective design.
A meeting attendee commented that surgeons often request a patient be optimized medically prior to surgery, and asked if investigators looked at time from hospitalization to the operation.
“The median date from admission to surgery was six days in our database,” said Dr. Shrestha, who is a staff physician at the Cleveland Clinic in Ohio.
“Medical treatment overall is associated with significantly poorer outcomes in patients with PVE compared with surgical treatment,” Dr. Shrestha said. “Although some patients are not candidates for surgery, a definite diagnosis of PVE should prompt a surgical evaluation in the majority of patients.”
Dr. Shrestha reported having no disclosures.
NEW ORLEANS – Over the years patients with prosthetic valve endocarditis treated at Cleveland Clinic tended to fare better with surgery compared to medical management, some clinicians noted. However, there was no data to confirm their observations.
“It was not recognized widely. A lot of our colleagues continued to believe it could be adequately treated with the right antibiotic,” Nabin K. Shrestha, MD, said at the IDWeek 2016 annual meeting on infectious diseases.
So Dr Shrestha and his colleagues conducted a retrospective cohort study to compare outcomes between 253 surgically treated adults and 77 others treated medically between April 2008 and December 2012. Survival from the time of treatment decision was the primary outcome.
The groups differed on some demographic and clinical factors. For example, the medically treated group was older, had fewer men, and more patients with mitral valves. “We might think the medical patients might be too sick for surgery, and that could certainly be true, but … they could have been too well for surgery too,” Dr. Shrestha said. To control for these differences between groups, the investigators performed a number of statistical analyses, including a propensity score adjusted model and reduced Cox proportion hazards model.
“Patients with PVE have a high hazard of death if treated medically,” Dr. Shrestha said, based on a 6.68 hazard ratio. The higher risk of death associated with medical treatment remained significant when adjusted for age, sex, and other factors. “Compared to surgical treatment, medical treatment was associated with a seven-fold higher hazard of death overall,” Dr. Shrestha said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The medical treatment group also fared worse on a number of secondary outcomes. For example, this group had a five-fold higher risk of death during hospitalization compared to the surgery group (odds ratio, 4.65); a 12-fold higher risk of death within one year (OR, 11.70); a seven-fold higher risk of subsequent surgery for infective endocarditis (OR, 6.57); and an eight-fold higher odds of surgery for the same episode of infective endocarditis at a subsequent hospitalization (OR, 8.02).
A large sample size and setting the date of management decision as time zero to avoid survival selection bias “give us confidence in our findings.” Limitations include an inability to look at some important variables because of the retrospective design.
A meeting attendee commented that surgeons often request a patient be optimized medically prior to surgery, and asked if investigators looked at time from hospitalization to the operation.
“The median date from admission to surgery was six days in our database,” said Dr. Shrestha, who is a staff physician at the Cleveland Clinic in Ohio.
“Medical treatment overall is associated with significantly poorer outcomes in patients with PVE compared with surgical treatment,” Dr. Shrestha said. “Although some patients are not candidates for surgery, a definite diagnosis of PVE should prompt a surgical evaluation in the majority of patients.”
Dr. Shrestha reported having no disclosures.
NEW ORLEANS – Over the years patients with prosthetic valve endocarditis treated at Cleveland Clinic tended to fare better with surgery compared to medical management, some clinicians noted. However, there was no data to confirm their observations.
“It was not recognized widely. A lot of our colleagues continued to believe it could be adequately treated with the right antibiotic,” Nabin K. Shrestha, MD, said at the IDWeek 2016 annual meeting on infectious diseases.
So Dr Shrestha and his colleagues conducted a retrospective cohort study to compare outcomes between 253 surgically treated adults and 77 others treated medically between April 2008 and December 2012. Survival from the time of treatment decision was the primary outcome.
The groups differed on some demographic and clinical factors. For example, the medically treated group was older, had fewer men, and more patients with mitral valves. “We might think the medical patients might be too sick for surgery, and that could certainly be true, but … they could have been too well for surgery too,” Dr. Shrestha said. To control for these differences between groups, the investigators performed a number of statistical analyses, including a propensity score adjusted model and reduced Cox proportion hazards model.
“Patients with PVE have a high hazard of death if treated medically,” Dr. Shrestha said, based on a 6.68 hazard ratio. The higher risk of death associated with medical treatment remained significant when adjusted for age, sex, and other factors. “Compared to surgical treatment, medical treatment was associated with a seven-fold higher hazard of death overall,” Dr. Shrestha said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The medical treatment group also fared worse on a number of secondary outcomes. For example, this group had a five-fold higher risk of death during hospitalization compared to the surgery group (odds ratio, 4.65); a 12-fold higher risk of death within one year (OR, 11.70); a seven-fold higher risk of subsequent surgery for infective endocarditis (OR, 6.57); and an eight-fold higher odds of surgery for the same episode of infective endocarditis at a subsequent hospitalization (OR, 8.02).
A large sample size and setting the date of management decision as time zero to avoid survival selection bias “give us confidence in our findings.” Limitations include an inability to look at some important variables because of the retrospective design.
A meeting attendee commented that surgeons often request a patient be optimized medically prior to surgery, and asked if investigators looked at time from hospitalization to the operation.
“The median date from admission to surgery was six days in our database,” said Dr. Shrestha, who is a staff physician at the Cleveland Clinic in Ohio.
“Medical treatment overall is associated with significantly poorer outcomes in patients with PVE compared with surgical treatment,” Dr. Shrestha said. “Although some patients are not candidates for surgery, a definite diagnosis of PVE should prompt a surgical evaluation in the majority of patients.”
Dr. Shrestha reported having no disclosures.
Key clinical point:
Major finding: Compared to surgery, odds of death within one year higher were almost 7 times greater with medical treatment (hazard ratio, 6.68).
Data source: Presentation at IDWeek 2016
Disclosures: Dr. Nabin K. Shrestha had no relevant disclosures.
Mediterranean diet for secondary prevention cuts all-cause mortality
ROME – Adherence to the traditional Mediterranean diet by patients with known heart or cerebrovascular disease was independently linked with a marked reduction in their risk of all-cause mortality in the Italian Moli-Sani Study, Giovanni de Gaetano, MD, reported at the annual congress of the European Society of Cardiology.
Subjects in the top tertile in terms of food intake consistent with the Mediterranean diet were 37% less likely to die during more than 7 years of follow-up than were those in the bottom tertile, according to Dr. de Gaetano, head of the department of epidemiology and prevention at the IRCCS Mediterranean Neurologic Institute in Pozzilli, Italy.
The Moli-Sani Study is an ongoing population-based epidemiologic study of 25,000 adults in the mountainous, heavily agricultural Molise region of southern Italy. Dr. de Gaetano, who directs the study, presented a substudy involving 1,197 participants with established coronary heart disease or cerebrovascular disease at entry. Their average age at enrollment was 66 years. Subjects with coronary heart disease outnumbered those with cerebrovascular disease by roughly 2:1.
Food intake was recorded using the European Prospective Investigation into Cancer (EPIC) food-frequency questionnaire. Dr. de Gaetano and his coinvestigators assessed adherence to the traditional Mediterranean diet using the Mediterranean Diet Score (MDS), a validated 0-9 scoring system developed as part of the famous Seven Countries Study pioneered by the late Ancel Keys.
During a median 7.3 years of prospective follow-up, 208 deaths occurred in the study population. A 2-point increase in the MDS was independently associated with a 21% reduction in the risk of mortality in a multivariate Cox proportional hazards analysis adjusted for “everything we could think of,” according to Dr. de Gaetano, including baseline demographics, socioeconomic status, energy intake, body mass index, leisure time physical activity, waist-to-hip ratio, smoking status, diabetes, standard cardiovascular risk factors, and use of cardiovascular medications.
Subjects in the top tertile for adherence to the Mediterranean diet, with an MDS of 6-9, had an adjusted 37% relative risk reduction in all-cause mortality, compared with those having an MDS of 0-3.
The number of deaths is too small at this point in the prospective study to permit analysis of specific causes of death in a statistically valid manner. With another 3 years or so of follow-up, that analysis can and will be done, Dr. de Gaetano said.
The traditional Mediterranean diet is an eating pattern characteristic of the Mediterranean basin, he explained. It encourages large intake of vegetables, legumes, fruits, nuts, and cereals, along with moderately high consumption of fish, olive oil as the primary fat source, and moderate alcohol intake during meals, but low-to-moderate intake of dairy products and low consumption of meat and poultry.
As a sobering aside, he said that in the Molise region, far and away the biggest obstacle to adherence to the Mediterranean diet is economic.
“There was no difference in adherence to the Mediterranean diet between different socioeconomic classes in the Moli-Sani Study until 2007-2008, when the Italian economic crisis began. Since then there are significant differences according to socioeconomic condition. Poor people are obliged to follow the Mediterranean diet less,” Dr. de Gaetano said.
Telling a patient with cardiovascular disease who is in a low-income family of four to eat fish at least twice per week is impractical advice, he explained.
The ongoing Moli-Sani Study is funded by the Italian government. Dr. de Gaetano reported having no financial conflicts of interest.
ROME – Adherence to the traditional Mediterranean diet by patients with known heart or cerebrovascular disease was independently linked with a marked reduction in their risk of all-cause mortality in the Italian Moli-Sani Study, Giovanni de Gaetano, MD, reported at the annual congress of the European Society of Cardiology.
Subjects in the top tertile in terms of food intake consistent with the Mediterranean diet were 37% less likely to die during more than 7 years of follow-up than were those in the bottom tertile, according to Dr. de Gaetano, head of the department of epidemiology and prevention at the IRCCS Mediterranean Neurologic Institute in Pozzilli, Italy.
The Moli-Sani Study is an ongoing population-based epidemiologic study of 25,000 adults in the mountainous, heavily agricultural Molise region of southern Italy. Dr. de Gaetano, who directs the study, presented a substudy involving 1,197 participants with established coronary heart disease or cerebrovascular disease at entry. Their average age at enrollment was 66 years. Subjects with coronary heart disease outnumbered those with cerebrovascular disease by roughly 2:1.
Food intake was recorded using the European Prospective Investigation into Cancer (EPIC) food-frequency questionnaire. Dr. de Gaetano and his coinvestigators assessed adherence to the traditional Mediterranean diet using the Mediterranean Diet Score (MDS), a validated 0-9 scoring system developed as part of the famous Seven Countries Study pioneered by the late Ancel Keys.
During a median 7.3 years of prospective follow-up, 208 deaths occurred in the study population. A 2-point increase in the MDS was independently associated with a 21% reduction in the risk of mortality in a multivariate Cox proportional hazards analysis adjusted for “everything we could think of,” according to Dr. de Gaetano, including baseline demographics, socioeconomic status, energy intake, body mass index, leisure time physical activity, waist-to-hip ratio, smoking status, diabetes, standard cardiovascular risk factors, and use of cardiovascular medications.
Subjects in the top tertile for adherence to the Mediterranean diet, with an MDS of 6-9, had an adjusted 37% relative risk reduction in all-cause mortality, compared with those having an MDS of 0-3.
The number of deaths is too small at this point in the prospective study to permit analysis of specific causes of death in a statistically valid manner. With another 3 years or so of follow-up, that analysis can and will be done, Dr. de Gaetano said.
The traditional Mediterranean diet is an eating pattern characteristic of the Mediterranean basin, he explained. It encourages large intake of vegetables, legumes, fruits, nuts, and cereals, along with moderately high consumption of fish, olive oil as the primary fat source, and moderate alcohol intake during meals, but low-to-moderate intake of dairy products and low consumption of meat and poultry.
As a sobering aside, he said that in the Molise region, far and away the biggest obstacle to adherence to the Mediterranean diet is economic.
“There was no difference in adherence to the Mediterranean diet between different socioeconomic classes in the Moli-Sani Study until 2007-2008, when the Italian economic crisis began. Since then there are significant differences according to socioeconomic condition. Poor people are obliged to follow the Mediterranean diet less,” Dr. de Gaetano said.
Telling a patient with cardiovascular disease who is in a low-income family of four to eat fish at least twice per week is impractical advice, he explained.
The ongoing Moli-Sani Study is funded by the Italian government. Dr. de Gaetano reported having no financial conflicts of interest.
ROME – Adherence to the traditional Mediterranean diet by patients with known heart or cerebrovascular disease was independently linked with a marked reduction in their risk of all-cause mortality in the Italian Moli-Sani Study, Giovanni de Gaetano, MD, reported at the annual congress of the European Society of Cardiology.
Subjects in the top tertile in terms of food intake consistent with the Mediterranean diet were 37% less likely to die during more than 7 years of follow-up than were those in the bottom tertile, according to Dr. de Gaetano, head of the department of epidemiology and prevention at the IRCCS Mediterranean Neurologic Institute in Pozzilli, Italy.
The Moli-Sani Study is an ongoing population-based epidemiologic study of 25,000 adults in the mountainous, heavily agricultural Molise region of southern Italy. Dr. de Gaetano, who directs the study, presented a substudy involving 1,197 participants with established coronary heart disease or cerebrovascular disease at entry. Their average age at enrollment was 66 years. Subjects with coronary heart disease outnumbered those with cerebrovascular disease by roughly 2:1.
Food intake was recorded using the European Prospective Investigation into Cancer (EPIC) food-frequency questionnaire. Dr. de Gaetano and his coinvestigators assessed adherence to the traditional Mediterranean diet using the Mediterranean Diet Score (MDS), a validated 0-9 scoring system developed as part of the famous Seven Countries Study pioneered by the late Ancel Keys.
During a median 7.3 years of prospective follow-up, 208 deaths occurred in the study population. A 2-point increase in the MDS was independently associated with a 21% reduction in the risk of mortality in a multivariate Cox proportional hazards analysis adjusted for “everything we could think of,” according to Dr. de Gaetano, including baseline demographics, socioeconomic status, energy intake, body mass index, leisure time physical activity, waist-to-hip ratio, smoking status, diabetes, standard cardiovascular risk factors, and use of cardiovascular medications.
Subjects in the top tertile for adherence to the Mediterranean diet, with an MDS of 6-9, had an adjusted 37% relative risk reduction in all-cause mortality, compared with those having an MDS of 0-3.
The number of deaths is too small at this point in the prospective study to permit analysis of specific causes of death in a statistically valid manner. With another 3 years or so of follow-up, that analysis can and will be done, Dr. de Gaetano said.
The traditional Mediterranean diet is an eating pattern characteristic of the Mediterranean basin, he explained. It encourages large intake of vegetables, legumes, fruits, nuts, and cereals, along with moderately high consumption of fish, olive oil as the primary fat source, and moderate alcohol intake during meals, but low-to-moderate intake of dairy products and low consumption of meat and poultry.
As a sobering aside, he said that in the Molise region, far and away the biggest obstacle to adherence to the Mediterranean diet is economic.
“There was no difference in adherence to the Mediterranean diet between different socioeconomic classes in the Moli-Sani Study until 2007-2008, when the Italian economic crisis began. Since then there are significant differences according to socioeconomic condition. Poor people are obliged to follow the Mediterranean diet less,” Dr. de Gaetano said.
Telling a patient with cardiovascular disease who is in a low-income family of four to eat fish at least twice per week is impractical advice, he explained.
The ongoing Moli-Sani Study is funded by the Italian government. Dr. de Gaetano reported having no financial conflicts of interest.
Key clinical point:
Major finding: Italian patients with known cardiovascular disease who were in the top third in terms of adherence to the traditional Mediterranean diet were a fully adjusted 37% less likely to die of any cause during follow-up than those in the bottom tertile.
Data source: This substudy of the prospective, observational Italian Moli-Sani Study included 1,197 participants with coronary heart disease or cerebrovascular disease at baseline who were followed for a median of 7.3 years.
Disclosures: The ongoing Moli-Sani Study is funded by the Italian government. The presenter reported having no financial conflicts of interest.
MIs in pregnancy have worse prognosis
ROME – It’s fortunate that pregnancy-associated acute MIs are infrequent, because the associated in-hospital mortality is markedly higher than in similar-age nonchildbearing women, Reza Masoomi, MD, said at the annual congress of the European Society of Cardiology.
One likely contributor to the disparity in outcome is that current management appears to feature underutilization of percutaneous intervention in women who experience pregnancy-associated MI, according to Dr. Masoomi of the University of Kansas in Kansas City.
He presented an analysis of the U.S. National Inpatient Sample database for the years 2008-2012. The NIS is a nationally representative sample of hospitalizations drawn from all of the country’s nonfederal acute-care hospitals.
A total of 55,315 hospitalizations with a discharge diagnosis of acute MI were recorded in women aged 15-54 years during the study years, of which 453 involved an ante- or postpartum MI. Extrapolating from those figures, nearly 262,000 women aged 15-54 years across the U.S. had an acute MI during the study years, of whom an estimated 2,153 experienced a pregnancy-associated MI.
In-hospital mortality among women with peripregnancy MI was 7.2%, significantly higher than the 5.2% rate in women who weren’t pregnant.
Women with peripregnancy MI had a significantly higher rate of ST-elevation MI (STEMI) than did nonpregnant women with MI in their reproductive years, by a margin of 35.3% to 32.8%. They were younger, too: an average age of 34.9 years, compared with 47.3 years in nonpregnant patients with an MI. Nearly two-thirds of women with peripregnancy MI were nonwhite, compared with 47.3% of the comparison group.
Regardless of whether women with peripregnancy MI had a STEMI or non-STEMI, they had significantly lower rates of diagnostic coronary angiography and percutaneous intervention. They were also far less likely to receive drug-eluting stents.
Diagnostic coronary angiography was performed in 59% of women with pregnancy-associated STEMI, compared with 73% of nonpregnant women with a STEMI. Only 34% of patients with peripregnancy STEMI underwent PCI, compared with 61% of nonpregnant women with a STEMI. Drug-eluting stents were implanted in 12% of peripregnancy STEMI patients and in 35% of nonpregnant patients. In contrast, 10% of patients with a pregnancy-related STEMI underwent coronary artery bypass surgery, compared with 5% of nonpregnant women with a STEMI.
The PCI rate among women with a peripregnancy non-STEMI was 7.8%, compared with 28.7% in nonpregnant women with a non-STEMI. However, CABG was utilized less frequently in the peripregnancy non-STEMI group, by a margin of 4.4% to 5.9%.
Dr. Masoomi reported having no financial conflicts regarding his study.
ROME – It’s fortunate that pregnancy-associated acute MIs are infrequent, because the associated in-hospital mortality is markedly higher than in similar-age nonchildbearing women, Reza Masoomi, MD, said at the annual congress of the European Society of Cardiology.
One likely contributor to the disparity in outcome is that current management appears to feature underutilization of percutaneous intervention in women who experience pregnancy-associated MI, according to Dr. Masoomi of the University of Kansas in Kansas City.
He presented an analysis of the U.S. National Inpatient Sample database for the years 2008-2012. The NIS is a nationally representative sample of hospitalizations drawn from all of the country’s nonfederal acute-care hospitals.
A total of 55,315 hospitalizations with a discharge diagnosis of acute MI were recorded in women aged 15-54 years during the study years, of which 453 involved an ante- or postpartum MI. Extrapolating from those figures, nearly 262,000 women aged 15-54 years across the U.S. had an acute MI during the study years, of whom an estimated 2,153 experienced a pregnancy-associated MI.
In-hospital mortality among women with peripregnancy MI was 7.2%, significantly higher than the 5.2% rate in women who weren’t pregnant.
Women with peripregnancy MI had a significantly higher rate of ST-elevation MI (STEMI) than did nonpregnant women with MI in their reproductive years, by a margin of 35.3% to 32.8%. They were younger, too: an average age of 34.9 years, compared with 47.3 years in nonpregnant patients with an MI. Nearly two-thirds of women with peripregnancy MI were nonwhite, compared with 47.3% of the comparison group.
Regardless of whether women with peripregnancy MI had a STEMI or non-STEMI, they had significantly lower rates of diagnostic coronary angiography and percutaneous intervention. They were also far less likely to receive drug-eluting stents.
Diagnostic coronary angiography was performed in 59% of women with pregnancy-associated STEMI, compared with 73% of nonpregnant women with a STEMI. Only 34% of patients with peripregnancy STEMI underwent PCI, compared with 61% of nonpregnant women with a STEMI. Drug-eluting stents were implanted in 12% of peripregnancy STEMI patients and in 35% of nonpregnant patients. In contrast, 10% of patients with a pregnancy-related STEMI underwent coronary artery bypass surgery, compared with 5% of nonpregnant women with a STEMI.
The PCI rate among women with a peripregnancy non-STEMI was 7.8%, compared with 28.7% in nonpregnant women with a non-STEMI. However, CABG was utilized less frequently in the peripregnancy non-STEMI group, by a margin of 4.4% to 5.9%.
Dr. Masoomi reported having no financial conflicts regarding his study.
ROME – It’s fortunate that pregnancy-associated acute MIs are infrequent, because the associated in-hospital mortality is markedly higher than in similar-age nonchildbearing women, Reza Masoomi, MD, said at the annual congress of the European Society of Cardiology.
One likely contributor to the disparity in outcome is that current management appears to feature underutilization of percutaneous intervention in women who experience pregnancy-associated MI, according to Dr. Masoomi of the University of Kansas in Kansas City.
He presented an analysis of the U.S. National Inpatient Sample database for the years 2008-2012. The NIS is a nationally representative sample of hospitalizations drawn from all of the country’s nonfederal acute-care hospitals.
A total of 55,315 hospitalizations with a discharge diagnosis of acute MI were recorded in women aged 15-54 years during the study years, of which 453 involved an ante- or postpartum MI. Extrapolating from those figures, nearly 262,000 women aged 15-54 years across the U.S. had an acute MI during the study years, of whom an estimated 2,153 experienced a pregnancy-associated MI.
In-hospital mortality among women with peripregnancy MI was 7.2%, significantly higher than the 5.2% rate in women who weren’t pregnant.
Women with peripregnancy MI had a significantly higher rate of ST-elevation MI (STEMI) than did nonpregnant women with MI in their reproductive years, by a margin of 35.3% to 32.8%. They were younger, too: an average age of 34.9 years, compared with 47.3 years in nonpregnant patients with an MI. Nearly two-thirds of women with peripregnancy MI were nonwhite, compared with 47.3% of the comparison group.
Regardless of whether women with peripregnancy MI had a STEMI or non-STEMI, they had significantly lower rates of diagnostic coronary angiography and percutaneous intervention. They were also far less likely to receive drug-eluting stents.
Diagnostic coronary angiography was performed in 59% of women with pregnancy-associated STEMI, compared with 73% of nonpregnant women with a STEMI. Only 34% of patients with peripregnancy STEMI underwent PCI, compared with 61% of nonpregnant women with a STEMI. Drug-eluting stents were implanted in 12% of peripregnancy STEMI patients and in 35% of nonpregnant patients. In contrast, 10% of patients with a pregnancy-related STEMI underwent coronary artery bypass surgery, compared with 5% of nonpregnant women with a STEMI.
The PCI rate among women with a peripregnancy non-STEMI was 7.8%, compared with 28.7% in nonpregnant women with a non-STEMI. However, CABG was utilized less frequently in the peripregnancy non-STEMI group, by a margin of 4.4% to 5.9%.
Dr. Masoomi reported having no financial conflicts regarding his study.
Key clinical point:
Major finding: In-hospital mortality among U.S. women with peripregnancy MI was 7.2% during 2008-2012, significantly higher than the 5.2% rate in women of reproductive age who weren’t pregnant.
Data source: This analysis of data from the U.S. National Inpatient Sample concluded that of an estimated 261,806 U.S. women aged 15-54 years who had an acute MI during 2008-2012, a total of 2,153 of them had an ante- or postpartum-associated MI.
Disclosures: The study presenter reported having no financial conflicts of interest.