Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial

Abstract

Objectives: The aim of this AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial subgroup analysis was to examine rivaroxaban monotherapy benefits and their relation to the time between stenting and enrollment among patients after coronary stenting.

Background: Of 2,215 patients with atrial fibrillation and stable coronary artery disease in the AFIRE trial, rivaroxaban monotherapy was noninferior to rivaroxaban plus antiplatelet therapy (combination therapy) in terms of efficacy and superior for safety endpoints. However, thrombotic risk after antiplatelet therapy cessation remained a concern among 1,444 patients who had undergone coronary stenting >1 year before enrollment.

Methods: The benefits of rivaroxaban monotherapy in coronary stenting subgroups were assessed for efficacy (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death of any cause), safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria), ischemic endpoints, net adverse clinical event, and time between stenting and enrollment.

Results: Efficacy and safety endpoints for monotherapy were superior to combination therapy, with HRs of 0.70 for efficacy (95% CI: 0.50-0.98; P = 0.036) and 0.55 for safety (95% CI: 0.33-0.92; P = 0.019). For ischemic endpoints, the HR was 0.82 (95% CI: 0.58-1.15; P = 0.240). The HR became smaller with longer time between stenting and enrollment (efficacy, P for interaction = 0.158; safety, P = 0.097).

Conclusions: In patients with atrial fibrillation after coronary stenting, the benefits of rivaroxaban monotherapy for efficacy and safety endpoints were consistent with those in the whole AFIRE trial population. The benefits became apparent with longer time between stenting and enrollment. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study [AFIRE]; UMIN000016612, NCT02642419).

Keywords: direct oral anticoagulant; percutaneous coronary intervention; stable coronary disease; stents.

Conflict of interest statement

Funding Support and Author Disclosures Funding was provided by the Japan Cardiovascular Research Foundation based on a contract with Bayer Yakuhin. Bayer Yakuhin had no role in the design of the trial, in the collection or analysis of the data, in the interpretation of the trial results, or in the writing of the manuscript. These funds were provided without restrictions or requirements. Mebix was financed by the Japan Cardiovascular Research Foundation on the basis of funds received from Bayer Yakuhin for their contribution in the selection of the participating centers, in the supervision or monitoring of the centers, in collecting trial data, in storing trial data, in data analysis of the trial results, and in the provision of editorial assistance with the preparation of the manuscript under the guidance of the authors. Dr Matoba has received grants from the Japan Cardiovascular Research Foundation; and personal fees from Nippon Boehringer Ingelheim, Daiichi-Sankyo, AstraZeneca, and Bayer Yakuhin. Dr Yasuda has received grants from Takeda Pharmaceutical, Abbott, and Boston Scientific; and personal fees from Daiichi-Sankyo and Bristol Myers Squibb. Dr Kaikita has received grants from Grants-in-Aid for Scientific Research (20K08451) from the Ministry of Education, Culture, Sports, Science, and Technology of Japan; and grants and personal fees from Bayer Yakuhin and Daiichi-Sankyo. Dr Akao has received grants from the Japan Agency for Medical Research and Development; personal fees from Bristol Myers Squibb and Nippon Boehringer Ingelheim; and grants and personal fees from Bayer Yakuhin and Daiichi-Sankyo. Dr Ako has received personal fees from Bayer Yakuhin and Sanofi; and grants and personal fees from Daiichi-Sankyo. Dr Nakamura has received grants and personal fees from Bayer Yakuhin, Daiichi-Sankyo, and Sanofi; and personal fees from Bristol Myers Squibb and Nippon Boehringer Ingelheim. Dr Miyauchi has received personal fees from Amgen Astellas BioPharma, Astellas Pharma, Merck Sharp & Dohme, Bayer Yakuhin, Sanofi, Takeda Pharmaceutical, Daiichi-Sankyo, Nippon Boehringer Ingelheim, and Bristol Myers Squibb. Dr Hagiwara has received grants and personal fees from Bayer Yakuhin; grants from Nippon Boehringer Ingelheim; and has received personal fees from Bristol Myers Squibb. Dr Kimura has received grants from the Japan Cardiovascular Research Foundation; grants and personal fees from Bayer Yakuhin, Daiichi-Sankyo, Sanofi, Merck Sharp & Dohme, and AstraZeneca; and personal fees from Bristol Myers Squibb and Nippon Boehringer Ingelheim. Dr Hirayama has received grants and personal fees from Boston Scientific Japan, Otsuka Pharmaceutical, Sanofi, Astellas Pharma, Bristol Myers Squibb, Daiichi-Sankyo, and Bayer Yakuhin; grants from Fukuda Denshi, Abbott Japan, Japan Lifeline, Takeda Pharmaceutical, and Sumitomo Dainippon Pharma; and personal fees from Toa Eiyo, Nippon Boehringer Ingelheim, Amgen Astellas BioPharma, and AstraZeneca. Dr Ogawa has received personal fees from Towa Pharmaceutical, Bristol Myers Squibb, Pfizer, Toa Eiyo, Bayer Yakuhin, and Novartis Pharma. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.