Abstract 13810: Randomized Comparison of Sirolimus-eluting With Everolimus-eluting Stents in Clinical and Angiographic Outcome After Percutaneous Coronary Interventions for Bifurcation Lesions
Background: All-comer, randomized trials have yet to show whether new generation of drug-eluting stents (DES) has an efficacy for angiographic and clinical outcome for bifurcation lesions. The aim of this study was to compare the sirolimus- (SES) and everolimus eluting stents (EES) for bifurcation coronary artery disease.
Methods and Results: Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open label trial comparing EES with SES in Japan. From February and July 2010, 3197 patients (3927 lesions) were randomly assigned to receive either EES or SES. Of these, 1278 patients (1319 lesions) who underwent PCI for bifurcation disease (left main trunk bifurcations were excluded) were enrolled in this substudy. Serial angiographies (baseline and 8 to 12-month follow up) for main vessel were available in 229 lesions and analyzed at the independent core laboratory. Clinical events were followed for 2 years. Composite of cardiac death and myocardial infarction rate was similar between EES and SES group (EES vs. SES: 6.1% vs. 7.7%, p=0.27). In follow-up, in-stent late loss (EES vs. SES: -0.15 ± 0.40 mm vs. -0.14 ± 0.44 mm, p=0.84) and binary restenosis rate (EES vs. SES: 0.9% vs. 3.4%, p=0.37) were equivalent. There was no significant difference in 2-year target vessel and lesion failure (TVF and TLF) between two groups. However, at 1-year landmark analysis, TVF was significantly lower in EES group (EES vs. SES: 1.8% vs. 3.9%, p=0.033; Kaplan-Meier curves are shown in Figure ).
Conclusions: Two-year clinical and 8 to 12-month angiographic outcome after EES implantation was not different from that after SES implantation in bifurcation PCI, except for TVF at 1-year landmark analysis. In comparison with first generation of DES, EES may ameliorate long-term clinical outcome after PCI for bifurcation lesions.
- © 2013 by American Heart Association, Inc.