Abstract
Original language | English |
---|---|
Pages (from-to) | 1196-1211 |
Number of pages | 16 |
Journal | Circulation |
Volume | 144 |
Issue number | 15 |
Early online date | 2021 |
DOIs | |
Publication status | Published - 2021 |
Keywords
- antiplatelet therapy
- dual antiplatelet therapy
- percutaneous coronary intervention
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In: Circulation, Vol. 144, No. 15, 2021, p. 1196-1211.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk with or without Oral Anticoagulant Therapy after Coronary Stenting
T2 - An Open-Label, Randomized, Controlled Trial
AU - Smits, Pieter C.
AU - Frigoli, Enrico
AU - Tijssen, Jan
AU - Jüni, Peter
AU - Vranckx, Pascal
AU - Ozaki, Yukio
AU - Morice, Marie-Claude
AU - Chevalier, Bernard
AU - Onuma, Yoshinobu
AU - Windecker, Stephan
AU - Tonino, Pim A. L.
AU - Roffi, Marco
AU - Lesiak, Maciej
AU - Mahfoud, Felix
AU - Bartunek, Jozef
AU - Hildick-Smith, David
AU - Colombo, Antonio
AU - Stankovic, Goran
AU - Iñiguez, Andrés
AU - Schultz, Carl
AU - Kornowski, Ran
AU - Ong, Paul J. L.
AU - Alasnag, Mirvat
AU - Rodriguez, Alfredo E.
AU - Moschovitis, Aris
AU - Laanmets, Peep
AU - Heg, Dik
AU - Valgimigli, Marco
N1 - Funding Information: Dr Roffi reports institutional research grants from Biotronik, Medtronic, Boston Scientific, GE Healthcare, and Terumo. Dr Mahfoud reports grants from Terumo, Deutsche Forschungsgemeinschaft (TRR 219), and Deutsche Gesellschaft für Kardiologie; grants and personal fees from Medtronic and Recor; and personal fees from Bayer and Boehringer Ingelheim. Dr Hildick-Smith reports personal fees from Terumo. Dr Schultz reports grants and personal fees from Abbott Vascular. Dr Valgimigli reports grants and personal fees from Terumo; and personal fees from Astra Zeneca, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFlow, Idorsia Pharmaceuticals LTD, Universität Basel, Dept Klinische Forschung, Vifor, Bristol Myers Squib SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio. The other authors report no conflicts. Funding Information: Dr Smits reports personal fees from Terumo and Opsense; grants and personal fees from Abbott Vascular, Microport, and Daichy Sankyo; and grants from SMT and Microport. Dr Heg reports that Clinical Trial Unit Bern, University of Bern, has a staff policy of not accepting honoraria or consultancy fees. However, Clinical Trial Unit Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. Dr Jüni reports honoraria (to the institution) from Amgen, Ava, and Fresenius; and grants from Appili Therapeutics. Dr Jüni serves as unpaid member of the steering group of trials funded by Appili Therapeutics, Abbott Vascular (EXCEL trial [Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]: https://clinicaltrials.gov/ct2/show/NCT01205776 ; comparing XIENCE Stent in subjects with unprotected left main coronary artery disease with coronary artery bypass graft surgery; no active involvement for over 3 years, no coauthored publication, but still listed as original member of statistical executive committee) and Terumo (MASTER DAPT trial: https://www.clinicaltrials.gov/ct2/show/NCT03023020 ; comparing abbreviated DAPT with prolonged DAPT in patients with a drug-eluting stent; ongoing active involvement as member of steering group), and has participated in advisory boards or consulting for Amgen, Ava, and Fresenius. Dr Vranckx reports personal fees from Daiichi Sankyo, Bayer AG, BLS Bering, and Astra Zeneca. Dr Ozaki reports grants from Takeda Pharmaceutical Company Ltd, Daiichi Sankyo Company Ltd, Otsuka Pharmaceutical Company Ltd, and Sanofi. Dr Morice is a shareholder and CEO of Cardiovascular European Research Center and a minor shareholder of Electroducer (a start-up not involved in the MASTER DAPT trial). Dr Chevalier reports personal fees from Terumo and the Cardiovascular European Research Center and holds stock options in Colibri. Dr Windecker reports grants from Abbott, Amgen, Astra Zeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CadioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson&Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron Pharmaceuticals, Sanofi-Aventis, Sinomed, Terumo, and V-Wave. Dr Windecker serves as unpaid advisory board member or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without effect on his personal remuneration. Dr Windecker is an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee. He is member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and of the Advisory Board of the Australian Victorian Heart Institute. He is chairperson of the ESC Congress Program Committee, former chairperson of the ESC Clinical Practice Guidelines Committee, and Deputy Editor of JACC CV Interventions. Funding Information: The study was sponsored by the European Cardiovascular Research Institute, a nonprofit organization, and received grant support from Terumo. Funding Information: Editorial support was provided by Sophie Rushton-Smith, PhD (MedLink Healthcare Communications, London, United Kingdom) and was funded by the European Cardiovascular Research Institute. The help and support provided by Dragica Paunovic, MD, for the funding of this trial is greatly appreciated. Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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]; Pinteraction=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]; Pinteraction=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]; Pinteraction=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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.
AB - 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]; Pinteraction=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]; Pinteraction=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]; Pinteraction=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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.
KW - antiplatelet therapy
KW - dual antiplatelet therapy
KW - percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85115153339&partnerID=8YFLogxK
U2 - https://doi.org/10.1161/CIRCULATIONAHA.121.056680
DO - https://doi.org/10.1161/CIRCULATIONAHA.121.056680
M3 - Article
C2 - 34455849
SN - 0009-7322
VL - 144
SP - 1196
EP - 1211
JO - Circulation
JF - Circulation
IS - 15
ER -