Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised clinical trial

1. 3 months of dual antiplatelet therapy (DAPT) in patients treated with Firehawk stents was non-inferior to 12 months of DAPT for the primary composite event of all-cause death, myocardial infarction, cerebrovascular accident and major bleeding at 18 months. 

Evidence Rating Level: 1 (Excellent)

With advancements in drug-eluting stents (DES), the incidence of stent thrombosis has dramatically declined. Current guidelines recommend DAPT for 12 months following stent placement for acute coronary syndrome (ACS). While newer studies have investigated shorter durations of DAPT among caucasian populations, such investigations have not been made in Asian populations. This study therefore sought to investigate the safety and efficacy of 3 months of DAPT versus 12 months of DAPT among a broad population of patients undergoing percutaneous coronary intervention (PCI) with Firehawk stents. Patients from 36 centres in China were randomized in a 1:1 ratio to either 3 months of DAPT or 12 months of DAPT following Firehawk stent placement for ACS. Notably, patients with ST-segment elevation myocardial infarction (STEMI) were excluded due to a higher risk of recurrent ischemia. The primary endpoint was net adverse clinical and cerebral events (NACCE) which was defined as a composite event of all-cause death, myocardial infarction, cerebrovascular accident and major bleeding events. 1222 patients were randomized to 3 months of DAPT (mean[SD] age, 63.4[9.6] years; 66.9% male) and 1223 patients were randomized to 12 months of DAPT (mean[SD] age, 63.4[10.1] years; 67.4% male). At 18 months, the incidence of NACCE was 10.1% (121 patients) in the 3-month DAPT group and 10.9% (131 patients) in the 12-month DAPT group, meeting non-inferiority for the 3-month DAPT group (absolute rate difference, − 0.76%; upper limit of 1-sided 97.5% CI, 1.70%; pnon-inferiority = 0.0003). Overall, this study found that among patients treated with Firehawk stents for ACS, 3 months of DAPT was non-inferior to 12 months of DAPT for NACCE. 

Click here to read this study in BMC Medicine

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