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An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial
Masahiro Natsuaki1, Hirotoshi Watanabe2, Takeshi Morimoto3
1Department of Cardiovascular Medicine, Saga University, Japan (M.N.).
An aspirin-free strategy using prasugrel monotherapy did not reduce bleeding rates compared to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). While noninferior for cardiovascular events, this approach showed a potential increase in coronary events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- High bleeding rates persist with dual antiplatelet therapy (DAPT) post-percutaneous coronary intervention (PCI), especially in acute coronary syndrome (ACS) or high bleeding risk patients.
- Aspirin-free strategies may lower early bleeding post-PCI without compromising cardiovascular outcomes, but require validation in randomized trials.
Purpose of the Study:
- To evaluate the efficacy and safety of an aspirin-free prasugrel monotherapy strategy compared to DAPT in patients undergoing PCI.
- To assess superiority for major bleeding and noninferiority for cardiovascular events within one month post-PCI.
Main Methods:
- A randomized trial involving 6002 patients with ACS or high bleeding risk undergoing PCI.
- Patients were assigned to either prasugrel monotherapy (no-aspirin group) or DAPT (aspirin plus prasugrel).
- Coprimary endpoints included major bleeding and a composite of cardiovascular events.
Main Results:
- The aspirin-free group was not superior in reducing major bleeding (4.47% vs. 4.71%) but was noninferior for cardiovascular events (4.12% vs. 3.69%) at 1 month.
- No significant differences were observed in net adverse clinical outcomes or individual cardiovascular event components.
- The no-aspirin group showed a higher incidence of unplanned coronary revascularization and subacute stent thrombosis.
Conclusions:
- An aspirin-free strategy with low-dose prasugrel did not achieve superiority for major bleeding post-PCI compared to DAPT.
- The aspirin-free strategy was noninferior for cardiovascular events but carried a signal of increased coronary events, including stent thrombosis.
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