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Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk
PC. Smits, E. Frigoli, P. Vranckx, Y. Ozaki, MC. Morice, B. Chevalier, Y. Onuma, S. Windecker, PAL. Tonino, M. Roffi, M. Lesiak, F. Mahfoud, J. Bartunek, D. Hildick-Smith, A. Colombo, G. Stankovic, A. Iñiguez, C. Schultz, R. Kornowski, PJL. Ong,...
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Free Medical Journals
from 1983 to 1 year ago
Open Access Digital Library
from 1998-01-01
- MeSH
- Anticoagulants therapeutic use MeSH
- Dimaprit analogs & derivatives MeSH
- Myocardial Infarction * drug therapy MeSH
- Platelet Aggregation Inhibitors adverse effects MeSH
- Drug Therapy, Combination MeSH
- Percutaneous Coronary Intervention * methods MeSH
- Hemorrhage chemically induced epidemiology MeSH
- Humans MeSH
- Polymers MeSH
- Stents MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear. OBJECTIVES: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction. METHODS: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTS: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT. CONCLUSIONS: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).
1st Department of Cardiology University of Medical Sciences Poznan Poland
Brighton and Sussex University Hospitals NHS Trust Brighton United Kingdom
Cardiac Center King Fahad Armed Forces Hospital Jeddah Saudi Arabia
Cardiovascular Center OLV Hospital Aalst Belgium
Cardiovascular European Research Center Massy France
Clinical Trial Unit University of Bern Bern Switzerland
Department of Cardiology Angiology Intensive Care Medicine Saarland University Homburg Germany
Department of Cardiology Bern University Hospital Bern Switzerland
Department of Cardiology Catharina Hospital Eindhoven the Netherlands
Department of Cardiology Fujita Health University School of Medicine Toyoake Aichi Japan
Department of Cardiology Imelda Hospital Bonheiden Bonheiden Belgium
Department of Cardiology Maasstad Hospital Rotterdam the Netherlands
Department of Cardiology Zorgsaam Hospital Terneuzen the Netherlands
Division of Cardiology Geneva University Hospitals Geneva Switzerland
Faculty of Medicine and Life Sciences Hasselt University Hasselt Belgium
Hospital Alvaro Cunqueiro Vigo Spain
National University of Ireland Galway Ireland
Rabin Medical Center Sackler School of Medicine Tel Aviv University Tel Aviv Israel
Tan Tock Seng Hospital Singapore
University Clinic of Cardiology Ss Cyril and Methodius University Skopje Macedonia
References provided by Crossref.org
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- $a Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk / $c PC. Smits, E. Frigoli, P. Vranckx, Y. Ozaki, MC. Morice, B. Chevalier, Y. Onuma, S. Windecker, PAL. Tonino, M. Roffi, M. Lesiak, F. Mahfoud, J. Bartunek, D. Hildick-Smith, A. Colombo, G. Stankovic, A. Iñiguez, C. Schultz, R. Kornowski, PJL. Ong, M. Alasnag, AE. Rodriguez, V. Paradies, P. Kala, S. Kedev, A. Al Mafragi, W. Dewilde, D. Heg, M. Valgimigli, MASTER DAPT Investigators
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- $a BACKGROUND: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear. OBJECTIVES: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction. METHODS: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTS: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT. CONCLUSIONS: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).
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