Clinical Evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries: The RESOLUTE US Clinical Trial

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• 作者：Alan C. Yeung MD ; Martin B. Leon MD^‡ ; ; Ash Jain MD^† ; ; Thaddeus R. Tolleson MD^§ ; ; Douglas J. Spriggs MD ; Brent T. Mc Laurin MD^¶ ; ; Jeffrey J. Popma MD^# ; Peter J. Fitzgerald MD ; Donald E. Cutlip MD ; Joseph M. Massaro PhD^† ; † ; ; Laura Mauri MD ; MSc^‡ ; ‡ ; ; ^{lmauri1@partners.org} ; RESOLUTE US Investigators
• 关键词：coronary artery disease ; drug-eluting stent ; revascularization ; zotarolimus
• 刊名：Journal of the American College of Cardiology
• 出版年：2011
• 出版时间：26 April 2011
• 年：2011
• 卷：57
• 期：17
• 页码：1778-1783
• 全文大小：729 K

文摘

Objectives

The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.

Background

The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety.

Methods

The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores.

Results

Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4 % . In the main analysis cohort, TLF was 3.7 % at 12 months compared with historical E-ZES results (TLF = 6.5 % ). The R-ZES met the 3.3 % margin of noninferiority (rate difference = −2.8 % , upper 1-sided 95 % confidence interval: −1.3 % , p < 0.001). The overall TLF rate was 4.7 % , and rates of cardiac death, MI, and TLR were 0.7 % , 1.4 % , and 2.8 % , respectively. The 12-month rate of stent thrombosis was 0.1 % .

Conclusions

The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453)