One-month dual antiplatelet therapy followed by prasugrel monotherapy at a reduced dose: the 4D-ACS randomised trial

The efficacy and safety of a 1-month prasugrel-based dual antiplatelet therapy (DAPT) strategy followed by reduced-dose prasugrel monotherapy in acute coronary syndrome (ACS) patients treated with drug-coated stents (DCS) have not been studied. We aimed to evaluate the safety and efficacy of a 1-mon...

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Published in:	EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology Vol. 21; no. 14; p. e796
Main Authors:	Jang, Youngwoo, Park, Sang-Don, Lee, Joon Pyo, Choi, Seong Huan, Kong, Min Gyu, Won, Yoon Sun, Kim, Minsu, Lee, Kyoung Hoon, Han, Seung Hwan, Kwon, Sung Woo, Suh, Jon, Kang, Woong Chol
Format:	Journal Article
Language:	English
Published:	France 21.07.2025
Subjects:	Acute Coronary Syndrome - drug therapy Acute Coronary Syndrome - therapy Aged Aspirin - administration & dosage Aspirin - adverse effects Aspirin - therapeutic use Drug Therapy, Combination Drug-Eluting Stents Dual Anti-Platelet Therapy - methods Female Hemorrhage - chemically induced Humans Male Middle Aged Percutaneous Coronary Intervention - methods Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - therapeutic use Prasugrel Hydrochloride - administration & dosage Prasugrel Hydrochloride - adverse effects Prasugrel Hydrochloride - therapeutic use Treatment Outcome
ISSN:	1969-6213, 1969-6213
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Summary:	The efficacy and safety of a 1-month prasugrel-based dual antiplatelet therapy (DAPT) strategy followed by reduced-dose prasugrel monotherapy in acute coronary syndrome (ACS) patients treated with drug-coated stents (DCS) have not been studied. We aimed to evaluate the safety and efficacy of a 1-month prasugrel-based DAPT regimen followed by reduced-dose monotherapy in ACS patients receiving a DCS. In the multicentre, randomised, open-label trial, 656 ACS patients (age: 60.9±9.7 years; 82.6% male) receiving DCS were randomised to either 1-month DAPT with aspirin 100 mg and prasugrel 10 mg (or 5 mg in patients aged ≥75 years or body weight <60 kg) followed by prasugrel 5 mg monotherapy (1M-DAPT) or 12-month DAPT with aspirin and prasugrel 5 mg (12M-DAPT). The primary endpoint was 12-month net adverse clinical events (NACE), a composite of death, non-fatal myocardial infarction, stroke, ischaemia-driven target vessel revascularisation, and Bleeding Academic Research Consortium Type 2-5 bleeding. NACE occurred in 4.9% of the 1M-DAPT group and 8.8% of the 12M-DAPT group, meeting the criteria for both non-inferiority (non-inferiority margin: 2.0%; absolute difference: -3.9%; 95% confidence interval [CI] for absolute difference: -6.7% to -0.2%; p=0.014) and superiority (hazard ratio [HR] 0.51; 95% CI: 0.27-0.95; p=0.034). Any bleeding occurred in 1.2% vs 5.2% (HR 0.23; p=0.009), and major bleeding occurred in 0.6% vs 4.6% (HR 0.13; p=0.007) in the 1M-DAPT versus 12M-DAPT group, respectively. Ischaemic outcomes were similar. In ACS patients treated with DCS, a 1-month prasugrel-based DAPT strategy followed by prasugrel 5 mg monotherapy reduced NACE by 49%, mainly driven by a 77% reduction of bleeding events without compromising ischaemic safety.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1969-6213 1969-6213
DOI:	10.4244/EIJ-D-25-00331