Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

Authors:
  • TMTakeshi Morimoto
    Takeshi Morimoto
  • MNMasahiro Natsuaki
    Masahiro Natsuaki
  • HSHiroki Shiomi
    Hiroki Shiomi
  • KIKeiichi Igarashi
    Keiichi Igarashi
  • KKKazushige Kadota
    Kazushige Kadota
  • KTKengo Tanabe
    Kengo Tanabe
  • YMYoshihiro Morino
    Yoshihiro Morino
  • TATakashi Akasaka
    Takashi Akasaka
  • YTYoshiki Takatsu
    Yoshiki Takatsu
  • HNHideo Nishikawa
    Hideo Nishikawa
  • YYYoshito Yamamoto
    Yoshito Yamamoto
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Abstract
Background—: Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. 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. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES ( P noninferiority P superiority =0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P =0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P noninferiority P superiority =0.24) at 278±63 days after index stent implantation. Conclusions—: One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01035450.

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