Real-World Safety and Effectiveness Outcomes of a Zotarolimus-Eluting Stent: Final 3-Year Report of the RESOLUTE International Study
Abstract
We evaluated the safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in real-world clinical practice through 3 years. 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. 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).
At 3 years 97.2% of patients completed clinical follow-up. The mean age was 63.411.2 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 +/- 20.5mm. 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. 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.