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
Alan C Yeung, Martin B Leon, Ash Jain, Thaddeus R Tolleson, Douglas J Spriggs, Brent T Mc Laurin, Jeffrey J Popma, Peter J Fitzgerald, Donald E Cutlip, Joseph M Massaro, Laura Mauri, RESOLUTE US Investigators, Alan C Yeung, Martin B Leon, Ash Jain, Thaddeus R Tolleson, Douglas J Spriggs, Brent T Mc Laurin, Jeffrey J Popma, Peter J Fitzgerald, Donald E Cutlip, Joseph M Massaro, Laura Mauri, RESOLUTE US Investigators
Abstract
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).
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed