While dual antiplatelet therapy (DAPT) has long been the standard treatment for managing patients with acute coronary syndrome (ACS) undergoing coronary angioplasty, there is growing awareness of the need for a more patient-centered approach that will balance the ischemic protection offered by DAPT with the risk of bleeding complications.
4D-ACS, a randomized clinical trial conducted in Korea, included 656 East Asian patients with ACS, randomized 1:1 to receiving either one month DAPT with 100 mg aspirin and 10 mg prasugrel (with 5 mg reduced dose of prasugrel for ≥75 year-old or <60 kg patients), followed by prasugrel 5 mg monotherapy (DAPT-1M group); or the conventional 12-month DAPT regimen with aspirin and 5 mg prasugrel (DAPT-12M group). This study is one of the first to evaluate strategies for shortening or de-escalating DAPT.
Primary endpoint was net adverse clinical events (NACE) at 12 months, defined as a composite of death, non-fatal myocardial infarction, stroke, ischemia-driven target vessel revascularization, and Bleeding Academic Research Consortium (BARC) type 2–5 bleeding.
At 12 months, NACE rate resulted 4.9% among DAPT-1M patients and 8.8% in the DAPT-12M group, meeting the criteria for both non-inferiority and superiority. The incidence of major bleeding was 0.6% vs. 4.6% (HR 0.13; p = 0.007) for DAPT-1M and DAPT-12M groups, respectively. Ischemic events remained comparable between the two.
Conclusion
The 4D-ACS showed a de-escalation protocol of one-month DAPT followed by low-dose prasugrel monotherapy is safe and feasible in ACS patients treated with drug-eluting stents (DES). This strategy improved safety by significantly reducing bleeding risk with no compromise of ischemic protection. Short DAPT followed by monotherapy represents a viable therapeutic alternative, which sets apart from the rigid paradigm of prolonged DAPT toward a patient-centered, risk-adapted model.
Reference: Jang Y, Park S-D, Lee JP, et al EuroPCR 2025.
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