Journal
JACC-CARDIOVASCULAR INTERVENTIONS
Volume 10, Issue 3, Pages 255-264Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2016.11.007
Keywords
biolimus; drug-eluting; polymer; randomized clinical trial; stent; zotarolimus
Categories
Funding
- Biosensors Interventional Technologies Pte Ltd.
- Medtronic CardioVascular Inc.
- Biosensors
- Medtronic
- Boston Scientific
- Biosensors Interventional Technologies
- Volcano Corporation
- Terumo
- Biotronik
- St. Jude Medical
- Novo Nordisk Fonden [NNF14OC0008817] Funding Source: researchfish
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OBJECTIVES The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients. BACKGROUND Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking. METHODS The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months. RESULTS From March 2011 to August 2012, 2,999 patients were randomly assigned (1: 1) to receive either the zotarolimuseluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradablepolymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durablepolymer zotarolimus-elutingstent and in 10(0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33). CONCLUSIONS At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis. (C) 2017 by the American College of Cardiology Foundation.
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