articleNew England Journal of MedicineAug 31, 2025Closed access

Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes

Hospital Israelita Albert Einstein · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · +29 more institutions

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Abstract

Background

Whether potent P2Y12 inhibitor monotherapy without aspirin initiated shortly after successful percutaneous coronary intervention (PCI) is effective and safe for patients with acute coronary syndromes is unclear.

Methods

We conducted a multicenter, open-label, randomized trial in Brazil involving patients with acute coronary syndromes who had undergone successful PCI. Patients were assigned in a 1:1 ratio within the first 4 days of hospitalization to stop treatment with aspirin and receive potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to receive dual antiplatelet therapy (aspirin and a potent P2Y12 inhibitor) for 12 months. The two ranked primary outcomes, assessed through 12 months, were a composite of death from any cause, myocardial infarction, stroke, or urgent target-vessel revascularization (tested for noninferiority, with a noninferiority margin of 2.5 percentage points) and major or clinically relevant nonmajor bleeding (tested for superiority).

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Funding