Three vs twelve months of dual antiplatelet therapy after Zotarolimus-Eluting Stents the OPTIMIZE andomized trial

ABSTRACT

The current recommendation is for at least 12 months of dual antiplatelettherapy after implantation of a drug-eluting stent. However, the optimal duration of dualantiplatelet therapy with specific types of drug-eluting stents remains unknown.OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months(long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronaryintervention (PCI) with zotarolimus-eluting stents.DESIGN, SETTING, AND PATIENTS The OPTIMIZE trialwas an open-label, active-controlled, 11randomized noninferiority study including 3119 patients in 33 sites in Brazil between April2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligiblepatients were those with stable coronary artery disease or history of low-risk acute coronarysyndrome (ACS) undergoing PCI with zotarolimus-eluting stents.INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin(100-200mg daily) and clopidogrel (75mg daily) for 3 months (n = 1563) or 12 months(n = 1556), unless contraindicated because of occurrence of an end point.MAIN OUTCOMES AND MEASURES The primary end pointwas net adverse clinical and cerebralevents (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or majorbleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%.Secondary end points were major adverse cardiac events (MACE; a composite of all-causedeath, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization)and Academic Research Consortium definite or probable stent thrombosis.RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receivinglong-term therapy...