Key result
One-month DAPT followed by prasugrel 5 mg monotherapy was noninferior and superior to 12-month DAPT for NACE in ACS patients receiving drug-coated stents (HR 0.51; 95% CI 0.27-0.95; p=0.034).
Why the study?
The efficacy and safety of a 1-month prasugrel-based DAPT strategy followed by reduced-dose prasugrel monotherapy in ACS patients treated with drug-coated stents had not been studied.
Does 1-month DAPT followed by reduced-dose prasugrel monotherapy reduce net adverse clinical events in ACS patients receiving drug-coated stents compared to 12-month DAPT?
RCT (n=656)
Open-label
randomized
Yes
Does 1-month DAPT followed by reduced-dose prasugrel monotherapy reduce net adverse clinical events in ACS patients receiving drug-coated stents compared to 12-month DAPT?
Hazard Ratio: 0.51 (95% CI 0.27–0.95)
Absolute Event Rate: 4.9% vs 8.8%
Absolute Risk Reduction: 3.9%
p-value: p=0.014 for non-inferiority, p=0.034 for superiority
A 1-month DAPT strategy followed by reduced-dose prasugrel monotherapy significantly reduced net adverse clinical events compared to 12-month DAPT in ACS patients treated with drug-coated stents, driven by reduced bleeding.
Supports 1-month DAPT with reduced-dose prasugrel in ACS; extends evidence for abbreviated regimens post-drug-coated stents.
BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Park et al. (2025) conducted an RCT in Acute coronary syndrome (ACS) (n=656). 1-month prasugrel-based DAPT followed by reduced-dose prasugrel monotherapy vs. 12-month DAPT with aspirin and prasugrel 5 mg was evaluated on 12-month net adverse clinical events (NACE), a composite of death, non-fatal myocardial infarction, stroke, ischaemia-driven target vessel revascularisation, and BARC Type 2-5 bleeding (HR 0.51, 95% CI 0.27-0.95, p=p=0.014 for non-inferiority, p=0.034 for superiority). One-month DAPT followed by prasugrel 5 mg monotherapy was noninferior and superior to 12-month DAPT for NACE in ACS patients receiving drug-coated stents (HR 0.51; 95% CI 0.27-0.95; p=0.034).
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