Real‐World Safety and Effectiveness Outcomes of a Zotarolimus‐Eluting Stent: Final 3‐Year Report of the RESOLUTE International Study

Objectives

We evaluated the safety and effectiveness of the Resolute? zotarolimus‐eluting stent (R‐ZES) in real‐world clinical practice through 3 years.

Background

A randomized comparison of the R‐ZES and the XIENCE V? everolimus‐eluting stent showed no difference in any outcomes through 3‐year follow‐up in high‐volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R‐ZES in real‐world clinical practice.

Methods

RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end‐point was the composite of cardiac death and target vessel myocardial infarction (TV‐MI) at 1 year. Secondary end‐points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST).

Results

At 3 years 97.2% of patients completed clinical follow‐up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV‐MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively.

Conclusions

The safety and effectiveness of the R‐ZES through 3 years in this real‐world all‐comer study was consistent with previously reported all‐comer trials. (J Interven Cardiol 2013;26:515‐523)