The DUAL-ACS trial, a randomized multicenter study, was designed to evaluate whether a strategy of P2Y12 inhibitor monotherapy after a short period of dual antiplatelet therapy (DAPT) could provide benefits in mortality and major clinical events compared with standard DAPT. The prespecified primary endpoint was all-cause mortality.
The study included 5,052 patients with acute coronary syndrome (ACS). The standard regimen consisted of 12 months of aspirin plus a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor, according to local practice). The short DAPT strategy involved 1 to 3 months of aspirin plus a P2Y12 inhibitor, followed by P2Y12 inhibitor monotherapy (SAPT) to complete one year.
Compared with prolonged DAPT, P2Y12 inhibitor monotherapy after a short DAPT period reduced bleeding events (3.2% vs 4.0%; HR 0.78; 95% CI 0.58–1.06; p=0.0977), without increasing ischemic events: all-cause mortality 2.7% vs 3.4% (HR 0.78; 95% CI 0.57–1.07; p=0.1232), and myocardial infarction in 8% overall.
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The authors concluded that, due to the early termination of the DUAL-ACS trial, the study hypothesis could not be tested reliably. However, the findings suggest that P2Y12 inhibitor monotherapy after a short DAPT course may reduce bleeding without increasing ischemic events.
Reference: Stefan James et al. Hot Line Session 6, ESC 2025, Madrid, España.
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