1. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease
- Author
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Bent Raungaard, Evald H. Christiansen, Hans Erik Bøtker, Henrik S. Hansen, Jan Ravkilde, Leif Thuesen, Jens Aarøe, Anton B. Villadsen, Christian J. Terkelsen, Lars R. Krusell, Michael Maeng, Steen D. Kristensen, Karsten T. Veien, Knud N. Hansen, Anders Junker, Morten Madsen, Søren L. Andersen, Svend E. Jensen, Lisette O. Jensen, Kristian Thygesen, Jacob Thorsted Sørensen, Bjarne Linde Nørgaard, Søren Lindholt Andersen, Svend Eggert Jensen, Evald Høj Christiansen, Henrik Steen Hansen, and Lisette Okkels Jensen
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Stent ,030204 cardiovascular system & hematology ,equipment and supplies ,medicine.disease ,Surgery ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Coronary thrombosis ,Internal medicine ,Cardiovascular agent ,medicine ,Cardiology ,Zotarolimus ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,Mace ,medicine.drug - Abstract
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 zotarolimus-eluting (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 biodegradable-polymer 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 durable-polymer zotarolimus-eluting stent 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.
- Published
- 2017
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