Ten‐year clinical outcomes from a randomized trial comparing new‐generation everolimus‐eluting stent versus first‐generation Sirolimus‐eluting stent: Results from the RESET extended study

Abstract

AbstractBackgroundNew‐generation drug‐eluting stents (DES) achieved technological innovations and reported clinical advantages as compared with first‐generation DES in clinical trials with 3–5 years follow‐up. However, detailed clinical outcome data in very long‐term follow‐up is still scarce.ObjectivesTo evaluate 10‐year clinical outcomes after first‐ and new‐generation DES implantation.MethodsIn this extende follow‐up study of the RESET, which is a largest randomized trial comparing everolimus‐eluting stent (EES) with Sirolimus‐eluting stent (SES), the study population consisted of 2892 patients from 84 centers. The primary efficacy and safety endpoints were target lesion revascularization (TLR) and a composite of death or myocardial infarction (MI), respectively. Complete 10‐year follow‐up was achieved in 87.9% of patients.ResultsCumulative 10‐year incidences of TLR and non‐TLR were not significantly different between EES and SES (13.9% vs. 15.7%, Log‐rank p = 0.20, and 33.4% vs. 31.3%, Log‐rank p = 0.30). The cumulative 10‐year incidence of death/MI was also not significantly different between the groups (32.5% vs. 34.4%, Log‐rank p = 0.18). Cumulative 10‐year incidence of definite stent thrombosis was numerically lower in EES than in SES (1.0% vs. 1.7%, Log‐rank p = 0.16). The lower risk of EES relative to SES was significant for a composite endpoint of target lesion failure (TLF: 19.6% vs. 24.9%, Log‐rank p = 0.001) and target vessel failure (TVF: 26.7% vs. 31.4%, Log‐rank p = 0.006).ConclusionDuring 10‐year of follow‐up, the risks for primary efficacy and safety endpoints were not significantly different between new‐generation EES and first‐generation SES, although EES compared with SES was associated with a lower risk for composite endpoints such as TLF and TVF.