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

Abstract

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.

Resolute zotarolimus‐eluting stent in ST‐elevation myocardial infarction (resolute‐STEMI): A prespecified prospective register from the DAPT‐STEMI trial

“…Moreover it has been shown that patients who discontinued DAPT between 1 and 12 months after implantation of the R‐ZES had low rates of ST and adverse cardiac outcomes and recently the DAPT STEMI trial provided an important answer regarding the noninferiority of 6 months of DAPT compared to 12 months DAPT after R‐ZES implantation in the setting of pPCI for STEMI . Indeed 6‐month DAPT was noninferior in a patient‐oriented composite clinical endpoint versus the regimen of 12 months DAPT showing that a shorter DAPT duration is also feasible and safely applicable if clinically required in STEMI patients who received a R‐ZES.…”

Dual Antiplatelet Therapy Duration in Acute Coronary Syndrome Patients: The State of the Art and Open Issues

“…However, the efforts in reducing the duration of DAPT have been, so far, prevented by the fear of late (>30 days) and very late (>1 year) stent thrombosis, events that have prevented the spread of DES for many years. e development of newer generations of DES, with thinner struts, more predictable drug release, and lower grade of inflammation, thanks to biodegradable polymer or polymer-free technology, have allowed a faster re-endothelization, therefore reducing the rate of thrombotic complications to neglectable levels (<1%) and offering promising outcomes even with a shorter 1 to 6 months DAPT [12][13][14][15][16]22].…”

“…Since 2012, after the publication of the PRODYGY trial [23], that randomized 2013 patients to 6 vs. 12 months of DAPT after PCI, further 14 trials have addressed the feasibility of reducing the period of DAPT [15,16,[24][25][26][27][28][29][30][31][32][33][34][35], documenting the noninferiority of a shorter strategy as compared with the traditional 12 months in terms of antiischemic protection.…”

“…In the multicenter DAPT STEMI trial [15], a total of 870 STEMI patients treated with primary angioplasty and RESOLUTE Onyx Stent who were taking DAPT and were event-free at six months were randomized 1 : 1 to single antiplatelet therapy or to DAPTfor an additional six months. New ADP antagonists were similarly used in both groups (58%).…”

“…e recent results of large-scale randomized trials [15,16] evaluating the prognostic impact of a shorter vs. traditional 12-month DAPT in ACS patients undergoing coronary stenting with newer DES allow to reconsider the current therapeutic strategies in terms of antiplatelet treatment.…”