Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial [ST段抬高心肌梗死药物洗脱支架置入术后，6个月vs12个月双抗血小板治疗比较：多中心随机非劣效性试验]

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BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k3793 (Published 02 October 2018)
Cite this as: BMJ 2018;363:k3793

Authors
Elvin Kedhi, Enrico Fabris, Martin van der Ent, Pawel Buszman, Clemens von Birgelen, Vincent Roolvink, Alexander Zurakowski, Carl E Schotborgh, Jan C A Hoorntje, Christian Hasbø Eek, Stéphane Cook, Marco Togni, Martijn Meuwissen, Niels van Royen, Ria van Vliet, Hans Wedel, Ronak Delewi, Felix Zijlstra

Abstract
Objective To show that limiting dual antiplatelet therapy (DAPT) to six months in patients with event-free ST-elevation myocardial infarction (STEMI) results in a non-inferior clinical outcome versus DAPT for 12 months.

Design Prospective, randomised, multicentre, non-inferiority trial.

Setting Patients with STEMI treated with primary percutaneous coronary intervention (PCI) and second generation zotarolimus-eluting stent.

Participants Patients with STEMI aged 18 to 85 that underwent a primary PCI with the implantation of second generation drug-eluting stents were enrolled in the trial. Patients that were event-free at six months after primary PCI were randomised at this time point.

Interventions Patients that were taking DAPT and were event-free at six months were randomised 1:1 to single antiplatelet therapy (SAPT) (ie, aspirin only) or to DAPT for an additional six months. All patients that were randomised were then followed for another 18 months (ie, 24 months after the primary PCI).

Main outcome measures The primary endpoint was a composite of all cause mortality, any myocardial infarction, any revascularisation, stroke, and thrombolysis in myocardial infarction major bleeding at 18 months after randomisation.

Results A total of 1100 patients were enrolled in the trial between 19 December 2011 and 30 June 2015. 870 were randomised: 432 to SAPT versus 438 to DAPT. The primary endpoint occurred in 4.8% of patients receiving SAPT versus 6.6% of patients receiving DAPT (hazard ratio 0.73, 95% confidence interval 0.41 to 1.27, P=0.26). Non-inferiority was met (P=0.004 for non-inferiority), as the upper 95% confidence interval of 1.27 was smaller than the prespecified non-inferiority margin of 1.66.

Conclusions DAPT to six months was non-inferior to DAPT for 12 months in patients with event-free STEMI at six months after primary PCI with second generation drug-eluting stents.

Trial registration Clinicaltrials.gov NCT01459627.