- Question
- Is potent P2Y12 inhibitor monotherapy without aspirin, started shortly after successful PCI for acute coronary syndrome, noninferior for ischemic events and safer for bleeding than dual antiplatelet therapy (DAPT) over 12 months?
- Design
- Multicenter, open-label, 1:1 randomized trial conducted in Brazil with 3410 patients in the intention-to-treat population. Randomization occurred within the first 4 days of hospitalization and follow-up was 12 months.
- Population
- Patients with acute coronary syndrome who had undergone successful percutaneous coronary intervention.
- Intervention
- Aspirin discontinuation with potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) for 12 months.
- Control
- DAPT with aspirin plus a potent P2Y12 inhibitor (ticagrelor or prasugrel) for 12 months.
- Primary outcome
- Two ranked primary outcomes at 12 months: a composite of all-cause death, myocardial infarction, stroke or urgent target-vessel revascularization (noninferiority, margin 2.5 percentage points) and major or clinically relevant nonmajor bleeding (superiority).
- Results
- The ischemic composite occurred in 119 patients (7.0%) with monotherapy and 93 (5.5%) with DAPT (absolute risk difference 1.47 percentage points; 95% CI −0.16 to 3.10; P = 0.11 for noninferiority). Major or clinically relevant nonmajor bleeding was 2.0% vs 4.9% (difference −2.97 percentage points; 95% CI −4.20 to −1.73).
- Safety
- Bleeding was lower with monotherapy. Stent thrombosis occurred in 12 patients with monotherapy and 4 with DAPT.
- Conclusion
- Potent P2Y12 inhibitor monotherapy was not shown to be noninferior to DAPT for the composite of death or ischemic events at 12 months, although it reduced bleeding.
- Why it matters
- It challenges early aspirin withdrawal after PCI in acute coronary syndrome, as the lower bleeding came with a failure to demonstrate ischemic noninferiority.
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 18, 2026