J 2022

Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy

VALGIMIGLI, Marco, Enrico FRIGOLI, Pascal VRANCKX, Yukio OZAKI, Marie-Claude MORICE et. al.

Basic information

Original name

Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy

Authors

VALGIMIGLI, Marco (guarantor), Enrico FRIGOLI, Pascal VRANCKX, Yukio OZAKI, Marie-Claude MORICE, Bernard CHEVALIER, Yoshinobu ONUMA, Stephan WINDECKER, Laurent DELORME, Petr KALA (203 Czech Republic, belonging to the institution), Sasko KEDEV, Rajpal K ABHAICHAND, Vasil VELCHEV, Willem DEWILDE, Jakub PODOLEC, Gregor LEIBUNDGUT, Dragan TOPIC, Carl SCHULTZ, Goran STANKOVIC, Astin LEE, Thomas JOHNSON, Pim A L TONINO, Aneta KLOTZKA, Maciej LESIAK, Renato D LOPES, Pieter C SMITS and Dik HEG

Edition

Journal of the American College of Cardiology, New York, Elsevier Science INC, 2022, 0735-1097

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 24.000

RIV identification code

RIV/00216224:14110/22:00128437

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.jacc.2022.04.065

UT WoS

000863530300004

Keywords in English

drug-eluting stent; dual antiplatelet therapy; high bleeding risk; P2Y12 inhibitor; acetylsalicylic acid

Tags

14110211, rivok

Tags

International impact, Reviewed
Změněno: 31/1/2023 12:30, Mgr. Tereza Miškechová

Abstract

V originále

BACKGROUND Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. OBJECTIVES The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. METHODS At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for >= 2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-ofcensoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. RESULTS In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. CONCLUSIONS In the MASTER DAPT adherent population, 1-month compared with >= 3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]
Displayed: 16/11/2024 17:26