Limiting DAPT to six months was non-inferior to 12 months of DAPT in event-free STEMI patients after primary PCI (HR 0.73; 95% CI 0.41-1.27; P=0.004 for non-inferiority).
RCT (n=870)
1:1
Yes
Does limiting dual antiplatelet therapy to 6 months followed by single antiplatelet therapy result in non-inferior clinical outcomes compared to 12 months of dual antiplatelet therapy in event-free STEMI patients after primary PCI?
In patients with STEMI who are event-free at 6 months after primary PCI with second-generation drug-eluting stents, 6 months of DAPT is non-inferior to 12 months of DAPT for preventing major adverse cardiovascular and bleeding events.
Effect estimate: HR 0.73 (95% CI 0.41-1.27)
Absolute Event Rate: 4.8% vs 6.6%
p-value: p=0.004 for non-inferiority
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 .
Kedhi et al. (2018) conducted an RCT in ST-elevation myocardial infarction (STEMI) (n=870). Single antiplatelet therapy (SAPT) / 6-month DAPT vs. Dual antiplatelet therapy (DAPT) for 12 months was evaluated on Composite of all cause mortality, any myocardial infarction, any revascularisation, stroke, and thrombolysis in myocardial infarction major bleeding at 18 months after randomisation (HR 0.73, 95% CI 0.41-1.27, p=0.004 for non-inferiority). Limiting DAPT to six months was non-inferior to 12 months of DAPT in event-free STEMI patients after primary PCI (HR 0.73; 95% CI 0.41-1.27; P=0.004 for non-inferiority).
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