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

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, 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.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work other than those listed above; no other financial relationships with organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Fig 1
Fig 1
Study flow diagram
Fig 2
Fig 2
Cumulative incidence of the primary composite endpoint. The number at risk was defined as the number of patients who had not had the event of interest and who were available for subsequent follow-up

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