2-Year Clinical and Angiographic Outcomes From a Randomized Trial of Polymer-Free Dual Drug-Eluting Stents Versus Polymer-Based Cypher and Endeavor, Drug-Eluting Stents

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• 作者：Robert A. Byrne ; Adnan Kastrati ; Klaus Tiroch ; Stefanie Schulz ; Jü ; rgen Pache ; Susanne Pinieck ; Steffen Massberg ; Melchior Seyfarth ; Karl-Ludwig Laugwitz ; Katrin A. Birkmeier ; Albert Sch&#xf6 ; mig
• 关键词：polymer ; restenosis ; sirolimus ; zotarolimus
• 刊名：Journal of the American College of Cardiology
• 出版年：2010
• 出版时间：8 June 2010
• 年：2010
• 卷：55
• 期：23
• 页码：2536-2543
• 全文大小：253 K

文摘

Objectives

In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent (Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years.

Background

Long-term polymer residue is implicated in adverse events associated with delayed vessel healing after drug-eluting stent therapy. The second-generation ZES utilizes an enhanced biocompatibility polymer system whereas a new-generation Dual-DES employs a polymer-free drug-release system.

Methods

A total of 1,007 patients undergoing coronary stenting of de novo lesions in native vessels were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). Clinical follow-up was performed to 2 years. Angiographic follow-up was scheduled at 6 to 8 months and 2 years.

Results

There were no significant differences between groups regarding death/myocardial infarction (SES: 10.2 % vs. Dual-DES: 7.8 % vs. ZES: 9.2 % ; p = 0.61) or definite stent thrombosis (SES: 0.9 % vs. Dual-DES: 0.9 % vs. ZES: 0.6 % ; p = 0.87). Two-year target lesion revascularization (TLR) was 10.7 % , 7.7 % , and 14.3 % lesions in the SES, Dual-DES, and ZES groups, respectively (p = 0.009). Incident TLR between 1 and 2 years in the Dual-DES group (0.9 % ) was significantly lower than in the Cypher SES group (3.6 % ) (p = 0.009), but comparable to the Endeavor ZES group (0.7 % ) (p = 0.72). These findings mirrored those observed for binary restenosis.

Conclusions

At 2 years, there was no signal of a differential safety profile between the 3 stent platforms. Furthermore, the antirestenotic efficacy of both Dual-DES and ZES remained durable between 1 and 2 years, with Dual-DES maintaining an advantage over the entire 2-year period. (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents [ISAR-TEST-2]; NCT00332397)