Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/36004
Title: | Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting An Open-Label, Randomized, Controlled Trial | Authors: | Smits, Pieter C. Frigoli, Enrico Tijssen, Jan Juni, Peter VRANCKX, Pascal Ozaki, Yukio Morice, Marie-Claude Chevalier, Bernard Onuma, Yoshinobu Windecker, Stephan Tonino, Pim A. L. Roffi, Marco Lesiak, Maciej Mahfoud, Felix Bartunek, Jozef Hildick-Smith, David Colombo, Antonio Stankovic, Goran Iniguez, Andres Schultz, Carl Kornowski, Ran Ong, Paul J. L. Alasnag, Mirvat Rodriguez, Alfredo E. Moschovitis, Aris Laanmets, Peep Heg, Dik Valgimigli, Marco |
Issue Date: | 2021 | Publisher: | LIPPINCOTT WILLIAMS & WILKINS | Source: | Circulation (New York, N.Y.), 144 (15) , p. 1196 -1211 | Abstract: | BACKGROUND: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. METHODS: In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued >= 2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued >= 5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTS: Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio [HR], 0.83 [95% CI, 0.60-1.15]; and HR, 0.88 [95% CI, 0.60-1.30], respectively) or without OAC indication (n=2913; HR, 1.01 [95% CI, 0.77-1.33]; or HR, 1.06 [95% CI, 0.79-1.44]; P-interaction=0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62-1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41-0.74]; P-interaction=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33-0.69]; P-interaction=0.021). CONCLUSIONS: Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. | Notes: | Smits, PC (corresponding author), Maasstad Hosp, Dept Cardiol, Maasstadweg 21, NL-3079 DZ Rotterdam, Netherlands. smitsp@maasstadziekenhuis.nl |
Keywords: | antiplatelet therapy;dual antiplatelet therapy;percutaneous coronary intervention | Document URI: | http://hdl.handle.net/1942/36004 | ISSN: | 0009-7322 | e-ISSN: | 1524-4539 | DOI: | 10.1161/CIRCULATIONAHA.121.056680 | ISI #: | WOS:000706426600007 | Rights: | 2021 The Authors. Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
CIRCULATIONAHA.121.056680.pdf | Published version | 510.04 kB | Adobe PDF | View/Open |
WEB OF SCIENCETM
Citations
52
checked on Sep 28, 2024
Page view(s)
22
checked on May 19, 2022
Download(s)
4
checked on May 19, 2022
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.