Clinical question: Is short-term, dual antiplatelet therapy noninferior to long-term therapy in zotarolimus-eluting stents?
Background: Current guidelines recommend long-term (>12 months) dual antiplatelet therapy after the placement of drug-eluting stents. The optimal therapy duration in second-generation drug-eluting stents has not been studied; moreover, some studies with multiple drug-eluting stents have suggested no added benefit from long-term therapy.
Study design: Randomized controlled trial.
Setting: Brazil, multi-center.
Synopsis: Researchers randomized 3,211 patients with stable coronary artery disease (CAD) or low-risk acute coronary syndrome (ACS) undergoing intervention with zotarolimus-eluting stents to short-term (three months) or long-term (12 months) dual antiplatelet therapy. Exclusion criteria included ST-elevation myocardial infarction (STEMI), previous drug-eluting stent, scheduled elective surgery within 12 months, or contraindication to aspirin or clopidogrel. Primary endpoints were a composite of death from any cause, MI, stroke, or major bleeding. Secondary endpoints were stent thrombosis, target lesion revascularization, adverse cardiac event, and any bleed.
At one-year follow-up, the short-term group had similar primary (6.0% vs. 5.8%) and secondary (8.3% vs. 7.4%) outcomes compared to the long-term. The short-term group’s noninferiority also was seen in several key subgroups.
This study included patients with stable CAD or low-risk ACS and cannot be generalized to higher-risk patients. Results for zotarolimus-eluting stents cannot be generalized to other second-generation drug-eluting stents.
Bottom line: Zotarolimus-eluting stents, followed by three months of dual antiplatelet therapy, were noninferior to 12 months of therapy in patients with stable CAD or low-risk ACS.
Citation: Feres F, Costa RA, Abizaid A, et al. Three vs. twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. JAMA. 2013;310(23):2510-2522.