Importance The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet 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 coronary intervention (PCI) with zotarolimus-eluting stents.
Design, Setting, and Patients The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents.
Interventions After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg 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 point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); 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-cause death, 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 receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]).
Conclusions and Relevance In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis.
Trial Registration clinicaltrials.gov Identifier: NCT01113372 Original recommendations for patients receiving first-generation drug-eluting stents (sirolimus- and paclitaxel-eluting stents) specified that these patients also receive 3 to 6 months of dual antiplatelet therapy with aspirin and a thienopyridine.1 However, limited trial data and retrospective analyses from real-world registries documented the occurrence of late and very late stent thrombosis and suggested that long-term (?12 months) dual antiplatelet therapy might be beneficial.2,3 Such outcomes, along with previous evidence obtained from studies of bare-metal stents, led to current guideline recommendations for prolonged dual antiplatelet therapy for all patients undergoing implantation of a drug-eluting stent.2- 6 Several observational studies showed a significant association between discontinuation of dual antiplatelet therapy and the occurrence of thrombotic events in the first 6 or 12 months after implantation of a drug-eluting stent, but not afterward.7- 10 Most recently, a few randomized trials of modest size tested different durations of dual antiplatelet therapy (3 or 6 months vs 12 or 24 months) with multiple drug-eluting stents, and results did not show benefits favoring prolonged therapy.11- 13 Moreover, many shortcomings have been identified with prolonged dual antiplatelet therapy, including bleeding and cost issues.14 At this point, even though recent trials comparing first- and second-generation drug-eluting stents have demonstrated superior safety profiles with newer devices (zotarolimus- and everolimus-eluting stents),15- 19 the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown.20 The zotarolimus-eluting stent with a phosphorylcholine durable polymer is a second-generation drug-eluting stent that has demonstrated safety and efficacy in previous reports, despite use of dual antiplatelet therapy of relatively short duration (3 to 6 months) in most trials.21 In the OPTIMIZE (Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice) trial, we sought to investigate the clinical implications of short-term (3 months) vs standard long-term (12 months) dual antiplatelet therapy in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) solely with a zotarolimus-eluting stent in daily clinical practice and to determine whether short-term dual antiplatelet therapy would be noninferior to long-term dual antiplatelet therapy.22
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