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

Study Questions:

What is the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a US population?

Methods:

The R-US trial recruited patients with de novo native coronary lesions suitable for one- or two-vessel treatment with stents from 2.25-4.0 mm in diameter. In the main analysis cohort (2.5-3.5 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 one-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 authors concluded that 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.

Perspective:

This prospective, observational study suggests that the R-ZES, as compared with the E-ZES, is efficacious even in challenging patients with diabetes mellitus and small-size stents, with a low incidence of stent thrombosis. The R-ZES utilizes a new hydrophilic biocompatible polymer that provides extended release of zotarolimus over approximately 180 days. Additional prospective randomized studies are indicated to compare the R-ZES with other drug-eluting stent platforms with regard to restenosis, death, MI, and stent thrombosis.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Polymers, Coronary Vessels, Diabetes Mellitus, Stents


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