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).

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.