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 Schotborgh;Jan Hoorntje;Christian Eek;Stéphane Cook;Marco Togni;Martijn Meuwissen;Niels van Royen;Ria van Vliet;Hans Wedel;Ronak Delewi;Felix Zijlstra;
1 Isala Hartcentrum, Isala Klinieken, Zwolle, Netherlands2 Cardiovascular Department, University of Trieste, Trieste, Italy3 Maasstad Ziekenhuis, Rotterdam, Netherlands4 American Heart of Poland, Ustroń, Poland5 Medical University of Silesia, Katowice, Poland6 Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, Netherlands7 University of Twente, Enschede, Netherlands8 American Heart of Poland, Chrzanów, Poland9 Haga Hospital, The Hague, Netherlands10 Zuyderland Medical Centre, Heerlen, Netherlands11 Department of Cardiology, Oslo Academic University, Oslo, Norway12 Department of Cardiology, University & Hospital, Fribourg, Switzerland13 Department of Cardiology, Amphia Hospital, Breda, Netherlands14 Department of Cardiology, Radboud University Medical Centre, Nijmegen, Netherlands15 Sahlgrenska Academy, University of Gothenburg, and Nordic School of Public Health, Gothenburg, Sweden16 Heart Centre, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
Checking for direct PDF access through Ovid
ObjectiveTo 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.DesignProspective, randomised, multicentre, non-inferiority trial.SettingPatients with STEMI treated with primary percutaneous coronary intervention (PCI) and second generation zotarolimus-eluting stent.ParticipantsPatients 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.InterventionsPatients 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 measuresThe 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.ResultsA 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.ConclusionsDAPT 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 registrationClinicaltrials.gov NCT01459627.