Background-Long-term clinical outcomes of everolimus-eluting stent (EES) compared with sirolimus-eluting stent (SES) have not been evaluated fully yet, especially whether EES implantation could positively affect late adverse events reported after SES implantation occurring >1 year. Methods and Results-In this all-comer prospective multicenter randomized open-label trial, 3196 patients were assigned randomly to implant either EES (n=1596) or SES (n=1600). At 3 years, EES was noninferior to SES on the primary safety end point (all-cause death or myocardial infarction; 10.1% versus 11.5%; noninferiority P <0.001; and superiority P=0.19). Cumulative incidence of definite stent thrombosis was low and was not significantly different between the 2 groups (0.5% versus 0.6%; P=0.81). There was no significant difference in the efficacy end point of target-lesion revascularization between the EES and SES groups (6.6% versus 7.9%; P=0.16). However, the cumulative incidence of target-lesion failure (cardiac death/target-vessel myocardial infarction/ischemia-driven target-lesion revascularization) was significantly lower in the EES group than in the SES group (8.8% versus 11.4%; P=0.01). By a landmark analysis at 1 year, the cumulative incidence of very late stent thrombosis and late target-lesion revascularization was not significantly different between the 2 groups (0.2% versus 0.2%; P=0.99 and 2.2% versus 2.9%; P=0.21, respectively). Conclusions-The efficacy and safety outcomes for this trial after EES implantation remained comparable with those after SES implantation through 3-year follow-up. However, improvement of clinical outcome after EES implantation compared with SES implantation was suggested by the significantly lower cumulative incidences of target-lesion failure, which has been the most widely used primary end point in the stent-versus-stent trials. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450. stent implantation, which was considered to be one of the major concerns of the first-generation DES. [4][5][6][7] However, these reports were based on either observational studies using historical control or on meta-analyses that incorporate indirect comparison or include limited data >1 year. Head-to-head randomized trials comparing EES with SES reporting clinical outcomes >1 year after implantation were currently limited. 2,8,9 The Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET) is the largest prospective multicenter randomized trial comparing EES with SES.1,10 At 1 year, EES was demonstrated to be noninferior to SES for the primary efficacy end point of target-lesion revascularization (TLR) without any significant differences in the efficacy and safety outcomes. Longer term clinical follow-up, however, was clearly needed to evaluate whether EES could overcome the limitations of SES, such as late TLR and VLST >1 year after implantation. Therefore, we report 3-year clinical outcomes from the RESET study, focusing on late advers...
