- Question
- In patients with atrial fibrillation who underwent percutaneous coronary intervention (PCI), does dual therapy with dabigatran plus a P2Y12 inhibitor reduce bleeding compared with warfarin-based triple therapy?
- Design
- Multicenter, randomized, open-label, blinded-endpoint (PROBE) phase 3 trial of 2725 patients with a mean follow-up of 14 months. Outside the United States, elderly patients could only be assigned to dabigatran 110 mg or triple therapy.
- Population
- Patients with nonvalvular atrial fibrillation who had undergone PCI with stenting.
- Intervention
- Dual therapy with dabigatran (110 mg or 150 mg twice daily) plus clopidogrel or ticagrelor, without aspirin.
- Control
- Triple therapy with warfarin (INR 2.0–3.0) plus clopidogrel or ticagrelor and aspirin for 1 to 3 months.
- Primary outcome
- Time to first major or clinically relevant nonmajor bleeding event (ISTH criteria) during follow-up.
- Results
- The primary end point occurred in 15.4% with dabigatran 110 mg vs 26.9% with triple therapy (HR 0.52; 95% CI 0.42–0.63; P<0.001 for noninferiority and superiority), and in 20.2% with dabigatran 150 mg vs 25.7% in its comparison group (HR 0.72; 95% CI 0.58–0.88; P<0.001 for noninferiority). The composite efficacy end point (thromboembolic events, death, or unplanned revascularization) occurred in 13.7% with combined dual therapy vs 13.4% with triple therapy (HR 1.04; 95% CI 0.84–1.29; P=0.005 for noninferiority).
- Safety
- The rate of serious adverse events did not differ significantly among the groups.
- Conclusion
- Dual therapy with dabigatran and a P2Y12 inhibitor caused less bleeding than warfarin-based triple therapy and was noninferior for thromboembolic events, death, or unplanned revascularization.
- Why it matters
- It showed that in patients with atrial fibrillation after PCI, aspirin can be omitted to reduce bleeding without losing efficacy, supporting dual antithrombotic strategies in this setting.
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