Long-term clinical outcomes after everolimus- and sirolimus-eluting coronary stent implantation: Final 3-year follow-up of the randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial

Hiroki Shiomi, Ken Kozuma, Takeshi Morimoto, Keiichi Igarashi, Kazushige Kadota, Kengo Tanabe, Yoshihiro Morino, Takashi Akasaka, Mitsuru Abe, Satoru Suwa, Toshiya Muramatsu, Masakazu Kobayashi, Kazuoki Dai, Koichi Nakao, Masaaki Uematsu, Yasuhiro Tarutani, Kenshi Fujii, Charles A. Simonton, Takeshi Kimura

Research output: Contribution to journalArticlepeer-review

33 Citations (Scopus)

Abstract

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 defnite stent thrombosis was low and was not signifcantly different between the 2 groups (0.5% versus 0.6%; P=0.81). There was no signifcant difference in the effcacy 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 signifcantly 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 signifcantly 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 effcacy 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 signifcantly lower cumulative incidences of target-lesion failure, which has been the most widely used primary end point in the stent-versus-stent trials.

Original languageEnglish
Pages (from-to)343-354
Number of pages12
JournalCirculation: Cardiovascular Interventions
Volume7
Issue number3
DOIs
Publication statusPublished - 06-2014
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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