Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry

Abstract

Objectives: The purpose of this study was to investigate the medium-term (two year) outcome of the unrestricted utilization of sirolimus-eluting stents (SES) in an all-comer population.

Background: Despite the implantation of SES in over a million patients to date, limited data exist on long-term outcomes.

Methods: Sirolimus-eluting stents were used as the default strategy as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. A total of 508 consecutive patients with de novo lesions exclusively treated with SES were compared with 450 patients who received bare stents in the immediately preceding period (pre-SES group).

Results: Patients in the SES group more frequently had multivessel disease, more type C lesions, received more stents, and had more bifurcation stenting. At two years, the cumulative rate of major adverse cardiac events (death, myocardial infarction, or target vessel revascularization) was 15.4% in the SES group and 22.0% in the pre-SES group (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.50 to 0.91; p = 0.01). The two-year risk of target vessel revascularization in the SES group and in the pre-SES group was 8.2% and 14.8%, respectively (HR 0.53, 95% CI 0.36 to 0.79; p = 0.002).

Conclusions: In an unrestricted population, the beneficial effects of sirolimus-eluting stent implantation extend out to two years compared with bare-metal stents, driven by a reduction in re-intervention rates. These findings should be confirmed by the results of the large randomized trials.