- Question
- In patients with nonvalvular atrial fibrillation undergoing PCI with stenting, does a rivaroxaban-based strategy plus one or two antiplatelet agents reduce clinically significant bleeding compared with a vitamin K antagonist plus dual antiplatelet therapy?
- Design
- Phase 3, multicenter, open-label (no masking) trial with 1:1:1 randomization of 2124 participants and 12 months of follow-up.
- Population
- Patients with nonvalvular atrial fibrillation who had undergone percutaneous coronary intervention with stent placement.
- Intervention
- Group 1: rivaroxaban 15 mg once daily plus a P2Y12 inhibitor for 12 months. Group 2: rivaroxaban 2.5 mg twice daily plus dual antiplatelet therapy (DAPT) for 1, 6, or 12 months.
- Control
- Dose-adjusted vitamin K antagonist (target INR 2.0 to 3.0) plus DAPT for 1, 6, or 12 months.
- Primary outcome
- Primary safety endpoint: clinically significant bleeding, a composite of TIMI major bleeding, TIMI minor bleeding, or bleeding requiring medical attention.
- Results
- Clinically significant bleeding occurred in 16.8% in group 1, 18.0% in group 2, and 26.7% in group 3 (HR group 1 vs. 3, 0.59; 95% CI, 0.47 to 0.76; P<0.001; HR group 2 vs. 3, 0.63; 95% CI, 0.50 to 0.80; P<0.001). Cardiovascular death, myocardial infarction, or stroke were similar across groups (6.5%, 5.6%, and 6.0%; no significant differences).
- Conclusion
- Both rivaroxaban-based strategies were associated with less clinically significant bleeding than standard therapy, with similar efficacy, although wide confidence intervals limit conclusions about efficacy.
- Why it matters
- It provided evidence that, in patients with atrial fibrillation undergoing PCI, rivaroxaban-based regimens can reduce bleeding compared with the traditional combination of a vitamin K antagonist and dual antiplatelet therapy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026