Randomized Trial of Polymer-Free Sirolimus- and Probucol-Eluting Stents Versus Durable Polymer Zotarolimus-Eluting Stents 5-Year Results of the ISAR-TEST-5 Trial

Kufner, Sebastian; Sorges, Jonas; Mehilli, Julinda; Cassese, Salvatore; Repp, Janika; Wiebe, Jens; Lohaus, Raphaela; Lahmann, Annalena; Rheude, Tobias; Ibrahim, Tareq; Massberg, Steffen; Laugwitz, Karl L.; Kastrati, Adnan und Byrne, Robert A. (2016): Randomized Trial of Polymer-Free Sirolimus- and Probucol-Eluting Stents Versus Durable Polymer Zotarolimus-Eluting Stents 5-Year Results of the ISAR-TEST-5 Trial. In: Journal of the American College of Cardiology (Jacc): Cardiovascular interventions, Bd. 9, Nr. 8: S. 784-792

Abstract

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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1936-8798
• Sprache: Englisch