Why the study?
Treating patients who have CAD and AF with combined antiplatelet and anticoagulant therapies carries the potential to increase bleeding risk, leaving the comparative efficacy and safety of P2Y12 inhibitors versus aspirin unclear.
Does the use of P2Y12 inhibitors compared to aspirin affect cardiovascular or bleeding events in patients with atrial fibrillation and stable coronary artery disease receiving rivaroxaban?
Does the use of P2Y12 inhibitors compared to aspirin affect cardiovascular or bleeding events in patients with atrial fibrillation and stable coronary artery disease receiving rivaroxaban?
In patients with atrial fibrillation and stable coronary artery disease receiving rivaroxaban, the choice of P2Y12 inhibitor versus aspirin as the concomitant antiplatelet agent did not significantly alter cardiovascular efficacy or major bleeding risk.
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 P2Y 12 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 P2Y 12 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 (P2Y 12 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 P2Y 12 inhibitors or aspirin in the chronic phase. Trial registration number UMIN000016612; NCT02642419 .
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Fukaya et al. (2021) studied this question.
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