The controversial extension of DAPT beyond the recommended 12 months after DES implantation appears to confer no added harm in patients at low risk of bleeding, according to the Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation (OPTIDUAL) trial presented in a Hot Line session yesterday. However, there was no statistically significant reduction in isachaemic outcomes as measured by a primary endpoint of death, MI, stroke and major bleeding.
Presenter Gerard Helft from the Institut de Cardiologie, Pitié-Salpétrière University Hospital, Paris, said the trial findings suggest that the duration of DAPT could be increased in this patient group ‘beyond 12 months’ based on a ‘case-by-case decision’ - so the optimal duration of DAPT after PCI remains a topic of debate.
The aim of the OPTIDUAL study was to investigate whether continuing clopidogrel for up to 48 months would be superior to stopping the drug at 12 months in reducing adverse clinical events following DES implantation.
The study was conducted at 58 sites in France between 2009 and 2013 in a cohort of 1385 patients. All were free of MACCE or bleeding, had been on DAPT for one year, and had undergone PCI with at least one DES for either ACS or stable CAD. They were randomised either to extended DAPT (n = 695) or to remain on aspirin alone (n = 690) for an additional 36 months with follow-up every six months between 12 and 48 months.
Results showed that the primary endpoint of death, MI, stroke and major bleeding was reached in 5.8% of the extended DAPT group and in 7.5% of the aspirin-only group, a non-significant result. However, there was a statistically borderline reduction in post-hoc analysis of ischaemic outcomes of 4.2% in the extended DAPT group and 6.4% in the aspirin group.
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