Journal
JACC-CARDIOVASCULAR INTERVENTIONS
Volume 9, Issue 8, Pages 784-792Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2016.01.009
Keywords
drug-eluting stent(s); long-term follow-up; probucol; randomized controlled trial; sirolimus; zotarolimus
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Funding
- Bavarian Research Foundation (BFS-ISAR Aktenzeichen AZ) [504/02]
- Bavarian Research Foundation (BFS-DES Aktenzeichen AZ) [668/05]
- European Union FP7 [PRESTIGE 260309]
- B. Braun Melsungen AG
- Biotronik
- Boston Scientific
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OBJECTIVES The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent. BACKGROUND It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy. METHODS In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization. RESULTS At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size. CONCLUSIONS Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin-vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533) (C) 2016 by the American College of Cardiology Foundation.
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