- Question
- Does an aspirin-free strategy with low-dose prasugrel during the first month after PCI reduce major bleeding, without increasing cardiovascular events, compared with standard dual antiplatelet therapy (DAPT)?
- Design
- Randomized, open-label (unmasked) trial that assigned 6002 patients just before PCI; the main analysis included 5966 patients and assessed events at 1 month.
- Population
- Patients with acute coronary syndrome or high bleeding risk undergoing stent PCI; mean age 71.6 years, 76.6% men and 75.0% with acute coronary syndrome.
- Intervention
- Prasugrel monotherapy 3.75 mg/day without aspirin after a 20 mg prasugrel loading dose; per the registry, switched to clopidogrel at 1 month.
- Control
- DAPT with aspirin 81-100 mg/day plus prasugrel 3.75 mg/day after the same 20 mg prasugrel load; per the registry, followed by aspirin alone from 1 month.
- Primary outcome
- Two coprimary endpoints at 1 month: major bleeding (BARC 3 or 5) tested for superiority, and a cardiovascular composite (cardiovascular death, myocardial infarction, definite stent thrombosis or ischemic stroke) tested for noninferiority with a 50% relative margin.
- Results
- Major bleeding occurred in 4.47% with the aspirin-free strategy and 4.71% with DAPT (HR 0.95; 95% CI 0.75-1.20; P for superiority = 0.66), so superiority was not shown. The cardiovascular composite was 4.12% versus 3.69% (HR 1.12; 95% CI 0.87-1.45; P for noninferiority = 0.01), meeting noninferiority.
- Safety
- The aspirin-free strategy had more unplanned coronary revascularization (1.05% vs 0.57%; HR 1.83; 95% CI 1.01-3.30) and more subacute definite or probable stent thrombosis (0.58% vs 0.17%; HR 3.40; 95% CI 1.26-9.23). There was no difference in net adverse clinical outcomes.
- Conclusion
- Omitting aspirin with low-dose prasugrel did not reduce major bleeding at 1 month and was noninferior for cardiovascular events, but came with a signal of excess coronary events.
- Why it matters
- It tested very early aspirin withdrawal after PCI in high-risk patients in a randomized trial, showing that the strategy offered no clear bleeding advantage and was accompanied by a signal of stent-related ischemic events.
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