April 15, 2019
Seven-Year Outcomes of RESET Trial Compare Sirolimus and Everolimus DESs
April 15, 2019— Hiroki Shiomi, MD, et al published 7-year outcomes from the RESET trial of drug-eluting stents (DESs) in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2019;12:637–647).
RESET is a randomized evaluation of a new-generation everolimus-eluting stent (EES) versus a first-generation sirolimus-eluting stent (SES). The aim of the trial is to compare very long-term (beyond 5 years) outcomes between the two devices to address the scarcity of these data when investigating whether new-generation DESs have clear clinical advantages over first-generation DESs.
As summarized in JACC: Cardiovascular Interventions, the original RESET population was composed of 3,197 patients from 100 centers. The extended 7-year follow-up study included 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients.
The investigators found that the cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES groups (10.2% vs 11.7%; hazard ratio, 0.87; 95% confidence interval [CI], 0.68–1.10; P = .24).
The RESET investigators reported:
- The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs 23.6%; hazard ratio, 0.85; 95% CI, 0.72 –1.005; P = .06).
- The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs 1.0%; P = .82).
- The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs 18.1%; hazard ratio, 0.72; 95% CI, 0.59–0.88; P = .001).