Objective Patients with coronary artery disease (CAD) and atrial fibrillation (AF) can be treated with multiple antithrombotic therapies including antiplatelet and anticoagulant therapies; however, this has the potential to increase bleeding risk. Here, we aimed to evaluate the efficacy and safety of P2Y12 inhibitors and aspirin in patients also receiving anticoagulant therapy.
Methods We evaluated patients from the Atrial Fibrillation and Ischaemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial who received rivaroxaban plus an antiplatelet agent; the choice of antiplatelet agent was left to the physician’s discretion. The primary efficacy and safety end points, consistent with those of the AFIRE trial, were compared between P2Y12 inhibitors and aspirin groups. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation or death from any cause. The primary safety end point was major bleeding according to the International Society on Thrombosis and Haemostasis criteria.
Results A total of 1075 patients were included (P2Y12 inhibitor group, n=297; aspirin group, n=778). Approximately 60% of patients were administered proton pump inhibitors (PPIs) and there was no significant difference in PPI use in the groups. There were no significant differences in the primary end points between the groups (efficacy: HR 1.31; 95% CI 0.88 to 1.94; p=0.178; safety: HR 0.79; 95% CI 0.43 to 1.47; p=0.456).
Conclusions There were no significant differences in cardiovascular and bleeding events in patients with AF and stable CAD taking rivaroxaban with P2Y12 inhibitors or aspirin in the chronic phase.
Trial registration number UMIN000016612; NCT02642419.
- coronary artery disease
- atrial fibrillation
Data availability statement
Data are available on reasonable request.
Statistics from Altmetric.com
Contributors HF, JA, SY and HO contributed to the study conception and design, data acquisition and data analysis and interpretation. All authors contributed to the drafting and critical revision of the manuscript for important intellectual content and approved the final version of the manuscript for publication.
Funding The study was funded by Japan Cardiovascular Research Foundation and Bayer Yakuhin
Competing interests HF reports personal fees from Nippon Boehringer Ingelheim and Daiichi Sankyo. JA reports personal fees from Bayer Yakuhin and Sanofi, and grants and personal fees from Daiichi Sankyo. SY reports grants from Takeda Pharmaceutical, Abbott and Boston Scientific, and personal fees from Daiichi Sankyo and Bristol-Meyers. KKa reports 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. MA reports grants from the Japan Agency for Medical Research and Development (AMED), personal fees from Bristol-Myers Squibb and Nippon Boehringer Ingelheim, and grants and personal fees from Bayer Yakuhin and Daiichi Sankyo. TM reports grants from the Japan Cardiovascular Research Foundation and personal fees from Nippon Boehringer Ingelheim, Daiichi Sankyo, AstraZeneca and Bayer Yakuhin. MN reports grants and personal fees from Bayer Yakuhin, Daiichi Sankyo and Sanofi, and personal fees from Bristol-Myers Squibb and Nippon Boehringer Ingelheim. KMi reports personal fees from Amgen Astellas BioPharma, Astellas Pharma, MSD, Bayer Yakuhin, Sanofi, Takeda Pharmaceutical, Daiichi Sankyo, Nippon Boehringer Ingelheim and Bristol-Myers Squibb. NH reports grants and personal fees from Bayer Yakuhin, grants from Nippon Boehringer Ingelheim and personal fees from Bristol-Myers Squibb. KKi reports grants from the Japan Cardiovascular Research Foundation; grants and personal fees from Bayer Yakuhin, Daiichi Sankyo, Sanofi, MSD and AstraZeneca; and personal fees from Bristol-Myers Squibb and Nippon Boehringer Ingelheim. AH reports 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. HO reports personal fees from Towa Pharmaceutical, Bristol-Meyers Squibb, Pfizer, Toa Eiyo, Bayer Yakuhin and Novartis Pharma. All other authors declare no financial relationships relevant to the contents of this paper.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.