Clinical evaluation of the Resolute XXXX -eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial.

@entity1 @entity17650 @entity6 @entity75 @entity177 @entity583 @entity204 @entity715
OBJECTIVES: The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute @entity17650 -eluting stent (R-ZES) in a U.S. population. BACKGROUND: The R-ZES releases @entity17650 over a 6-month period in order to achieve optimal clinical effectiveness and safety. METHODS: The R-US trial recruited @entity1 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 @entity177 ( @entity177 ) defined as the composite of @entity204 , @entity583 ( @entity583 ), and clinically-driven @entity75 revascularization (TLR), compared with data from Endeavor @entity17650 -eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores. RESULTS: Overall, 1,402 @entity1 were enrolled with a mean reference vessel diameter of 2.59    0.47 mm and @entity6 prevalence of 34.4%. In the main analysis cohort, @entity177 was 3.7% at 12 months compared with historical E-ZES results ( @entity177 = 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 @entity177 rate was 4.7%, and rates of @entity204 , @entity583 , and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent @entity715 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 @entity204 , @entity583 , and stent @entity715 at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).
