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

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• 作者：Sebastian Kufner ; MD^a ; Jonas Sorges^a ; Julinda Mehilli ; MD^b ; ^c ; Salvatore Cassese ; MD ; PhD^a ; Janika Repp ; MD^a ; Jens Wiebe ; MD^a ; Raphaela Lohaus ; MD^a ; Annalena Lahmann ; MD^a ; Tobias Rheude ; MD^a ; Tareq Ibrahim ; MD^d ; Steffen Massberg ; MD^b ; ^c ; Karl L. Laugwitz ; MD^c ; ^d ; Adnan Kastrati ; MD^a ; ^c ; Robert A. Byrne ; MB ; BCh ; PhD^a ; ^{byrne@dhm.mhn.de" class="auth_mail" title="E-mail the corresponding author} ; for the ISAR-TEST-5 Investigators
• 关键词：drug-eluting stent(s) ; long-term follow-up ; probucol ; randomized controlled trial ; sirolimus ; zotarolimus
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：25 April 2016
• 年：2016
• 卷：9
• 期：8
• 页码：784-792
• 全文大小：1049 K

文摘

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)