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Authors
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Professor of Medicine at Columbia University and Interventional Cardiologist and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical CenterGregg Stone, MD, FACC, FSCAI
Professor of Medicine at Columbia University and Interventional Cardiologist and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical CenterProfessor of Medicine at Columbia University and Interventional Cardiologist and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center
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Medical Director at The Christ Hospital Heart and Vascular CenterDean Kereiakes, MD, FACC, FSCAI
Medical Director at The Christ Hospital Heart and Vascular CenterMedical Director at The Christ Hospital Heart and Vascular Center
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Director Of Interventional Cardiology, Senior Academic Officer at Cleveland Clinic Lerner College of MedicineStephen Ellis, MD
Director Of Interventional Cardiology, Senior Academic Officer at Cleveland Clinic Lerner College of MedicineDirector Of Interventional Cardiology, Senior Academic Officer at Cleveland Clinic Lerner College of Medicine
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Experts
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Associate Professor of Cardiology at University of CataniaDavide Capodanno, MD, PhD
Associate Professor of Cardiology at University of CataniaAssociate Professor of Cardiology at University of Catania
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President and Medical Director at CVPath InstituteRenu Virmani, MD
President and Medical Director at CVPath InstitutePresident and Medical Director at CVPath Institute
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Interventional Cardiologist at the University Hospital Clinic, Barcelona, SpainSalvatore Brugaletta, MD, PhD, FESC
Interventional Cardiologist at the University Hospital Clinic, Barcelona, SpainInterventional Cardiologist at the University Hospital Clinic, Barcelona, Spain
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Professor for Translational Vascular Medicine at University Medical Center MainzTommaso Gori, MD, PhD
Professor for Translational Vascular Medicine at University Medical Center MainzProfessor for Translational Vascular Medicine at University Medical Center Mainz
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Professor of Medicine at University California, IrvineMorton Kern, MD, MSCAI, FAHA, FACC
Professor of Medicine at University California, IrvineProfessor of Medicine at University California, Irvine
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CEO at CVPath InstituteMichael Joner, MD
CEO at CVPath InstituteCEO at CVPath Institute
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Interventional Cardiologist, Cardiovascular Research at Fatebenefratelli HospitalBernardo Cortese, MD
Interventional Cardiologist, Cardiovascular Research at Fatebenefratelli HospitalInterventional Cardiologist, Cardiovascular Research at Fatebenefratelli Hospital
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Medical Director and Chief of Cardiology, Kerckhoff Heart and Thorax Center at University of GiessenChristian Hamm, MD, FESC, FACC, FAHA
Medical Director and Chief of Cardiology, Kerckhoff Heart and Thorax Center at University of GiessenMedical Director and Chief of Cardiology, Kerckhoff Heart and Thorax Center at University of Giessen
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Professor of Department of Cardiovascular Medicine at Kyoto University Graduate School of MedicineTakeshi Kimura, MD
Professor of Department of Cardiovascular Medicine at Kyoto University Graduate School of MedicineProfessor of Department of Cardiovascular Medicine at Kyoto University Graduate School of Medicine
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Professor of Medicine at Columbia University Irving Medical CenterJeffrey Moses, MD
Professor of Medicine at Columbia University Irving Medical CenterProfessor of Medicine at Columbia University Irving Medical Center
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Former Abbott Vascular R&D Leader, Bioresorbable Vascular Scaffold ExpertJames Oberhauser, Ph.D.
Former Abbott Vascular R&D Leader, Bioresorbable Vascular Scaffold ExpertFormer Abbott Vascular R&D Leader, Bioresorbable Vascular Scaffold Expert
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CEO of AccelLAB; Assistant Professor Of Medicine, University Of MontrealGuy Leclerc, MD, FACC
CEO of AccelLAB; Assistant Professor Of Medicine, University Of MontrealCEO of AccelLAB; Assistant Professor Of Medicine, University Of Montreal
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Professor of Medicine, Dept of Cardiology at Mount Sinai HospitalSamin Sharma, MD
Professor of Medicine, Dept of Cardiology at Mount Sinai HospitalProfessor of Medicine, Dept of Cardiology at Mount Sinai Hospital
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Director of Research, Cardiac Catheterization Laboratory at New York UniversitySripal Bangalore, MD
Director of Research, Cardiac Catheterization Laboratory at New York UniversityDirector of Research, Cardiac Catheterization Laboratory at New York University
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Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of MedicineAmit Kakkar, MD
Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of MedicineInterventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of Medicine
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Executive Director and Chief Scientific Officer of the CRF Skirball Research CenterJuan Granada, MD
Executive Director and Chief Scientific Officer of the CRF Skirball Research CenterExecutive Director and Chief Scientific Officer of the CRF Skirball Research Center
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Lead Moderators
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Editor at MedgadgetDr. Alice Ferng
Editor at MedgadgetEditor at Medgadget
About the Discussion
@NEJM Ask the Authors & Experts: Everolimus-eluting Bioresorbable Scaffolds for Coronary Artery Disease & Bioresorbable Vascular Scaffolds--Will Promise Become Reality?
Original Article
Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease
Background
In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.
Methods
In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt–chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.
Results
Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, −0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).
Conclusions
In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt–chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.)
Editorial
Bioresorbable Vascular Scaffolds — Will Promise Become Reality?
Excerpt
All other things being equal, most of us would agree that a coronary-artery stent that disappears after its useful function has been served would be preferable to a permanently indwelling device. Late stent failure occurs at a low but steady rate with the passage of time,1 and an increasing body of evidence implicates an accelerated form of atherosclerosis inside the stent as a common underlying cause.2 Moreover, the presence of a rigid metal scaffold in the vessel wall permanently abolishes physiologic vasomotion in the stented area.
With this in mind, researchers have sought to develop self-degrading coronary stents with enough strength to produce a good short-term result and a degradation profile that results in gradual breakdown in a safe manner.3 Thus far, most success in the field has been with polylactic acid stent technology. Two such devices have received CE-mark approval, which is a prerequisite for clinical use in Europe: the everolimus-eluting Absorb bioresorbable vascular scaffold system (Abbott Vascular) in 2011 and the novolimus-eluting DESolve bioresorbable coronary scaffold system (Elixir Medical) in 2013.
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Authors
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Professor of Medicine at Columbia University and Interventional Cardiologist and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical CenterGregg Stone, MD, FACC, FSCAI
Professor of Medicine at Columbia University and Interventional Cardiologist and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center
Professor of Medicine at Columbia University and Interventional Cardiologist and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center
-
Medical Director at The Christ Hospital Heart and Vascular CenterDean Kereiakes, MD, FACC, FSCAI
Medical Director at The Christ Hospital Heart and Vascular Center
Medical Director at The Christ Hospital Heart and Vascular Center
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Director Of Interventional Cardiology, Senior Academic Officer at Cleveland Clinic Lerner College of MedicineStephen Ellis, MD
Director Of Interventional Cardiology, Senior Academic Officer at Cleveland Clinic Lerner College of Medicine
Director Of Interventional Cardiology, Senior Academic Officer at Cleveland Clinic Lerner College of Medicine
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Experts
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Associate Professor of Cardiology at University of CataniaDavide Capodanno, MD, PhD
Associate Professor of Cardiology at University of Catania
Associate Professor of Cardiology at University of Catania
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President and Medical Director at CVPath InstituteRenu Virmani, MD
President and Medical Director at CVPath Institute
President and Medical Director at CVPath Institute
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Interventional Cardiologist at the University Hospital Clinic, Barcelona, SpainSalvatore Brugaletta, MD, PhD, FESC
Interventional Cardiologist at the University Hospital Clinic, Barcelona, Spain
Interventional Cardiologist at the University Hospital Clinic, Barcelona, Spain
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Professor for Translational Vascular Medicine at University Medical Center MainzTommaso Gori, MD, PhD
Professor for Translational Vascular Medicine at University Medical Center Mainz
Professor for Translational Vascular Medicine at University Medical Center Mainz
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Professor of Medicine at University California, IrvineMorton Kern, MD, MSCAI, FAHA, FACC
Professor of Medicine at University California, Irvine
Professor of Medicine at University California, Irvine
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CEO at CVPath InstituteMichael Joner, MD
CEO at CVPath Institute
CEO at CVPath Institute
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Interventional Cardiologist, Cardiovascular Research at Fatebenefratelli HospitalBernardo Cortese, MD
Interventional Cardiologist, Cardiovascular Research at Fatebenefratelli Hospital
Interventional Cardiologist, Cardiovascular Research at Fatebenefratelli Hospital
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Medical Director and Chief of Cardiology, Kerckhoff Heart and Thorax Center at University of GiessenChristian Hamm, MD, FESC, FACC, FAHA
Medical Director and Chief of Cardiology, Kerckhoff Heart and Thorax Center at University of Giessen
Medical Director and Chief of Cardiology, Kerckhoff Heart and Thorax Center at University of Giessen
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Professor of Department of Cardiovascular Medicine at Kyoto University Graduate School of MedicineTakeshi Kimura, MD
Professor of Department of Cardiovascular Medicine at Kyoto University Graduate School of Medicine
Professor of Department of Cardiovascular Medicine at Kyoto University Graduate School of Medicine
-
Professor of Medicine at Columbia University Irving Medical CenterJeffrey Moses, MD
Professor of Medicine at Columbia University Irving Medical Center
Professor of Medicine at Columbia University Irving Medical Center
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Former Abbott Vascular R&D Leader, Bioresorbable Vascular Scaffold ExpertJames Oberhauser, Ph.D.
Former Abbott Vascular R&D Leader, Bioresorbable Vascular Scaffold Expert
Former Abbott Vascular R&D Leader, Bioresorbable Vascular Scaffold Expert
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CEO of AccelLAB; Assistant Professor Of Medicine, University Of MontrealGuy Leclerc, MD, FACC
CEO of AccelLAB; Assistant Professor Of Medicine, University Of Montreal
CEO of AccelLAB; Assistant Professor Of Medicine, University Of Montreal
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Professor of Medicine, Dept of Cardiology at Mount Sinai HospitalSamin Sharma, MD
Professor of Medicine, Dept of Cardiology at Mount Sinai Hospital
Professor of Medicine, Dept of Cardiology at Mount Sinai Hospital
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Director of Research, Cardiac Catheterization Laboratory at New York UniversitySripal Bangalore, MD
Director of Research, Cardiac Catheterization Laboratory at New York University
Director of Research, Cardiac Catheterization Laboratory at New York University
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Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of MedicineAmit Kakkar, MD
Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of Medicine
Interventional Cardiology and Endovascular Specialist, Asst. Prof of Medicine Albert Einstein College of Medicine
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Executive Director and Chief Scientific Officer of the CRF Skirball Research CenterJuan Granada, MD
Executive Director and Chief Scientific Officer of the CRF Skirball Research Center
Executive Director and Chief Scientific Officer of the CRF Skirball Research Center
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Lead Moderators
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Editor at MedgadgetDr. Alice Ferng
Editor at Medgadget
Editor at Medgadget
