Hiroki Shiomi1, Ken Kozuma1, Takeshi Morimoto1, Keiichi Igarashi1, Kazushige Kadota1, Kengo Tanabe1, Yoshihiro Morino1, Takashi Akasaka1, Mitsuru Abe1, Satoru Suwa1, Toshiya Muramatsu1, Masakazu Kobayashi1, Kazuoki Dai1, Koichi Nakao1, Masaaki Uematsu1, Yasuhiro Tarutani1, Kenshi Fujii1, Charles A Simonton1, Takeshi Kimura2. 1. From the Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (H.S., T.K.); Department of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma); Division of General Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan (T. Morimoto); Department of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan (K.I.); Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K. Kadota); Department of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K.T.); Department of Cardiology, Iwate University Hospital, Morioka, Japan (Y.M.); Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan (T.A.); Department of Cardiology, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan (M.A.); Department of Cardiology, Juntendo University Shizuoka Hospital, Nagaoka, Japan (S.S.); Department of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan (T. Muramatsu); Department of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan (M.K.); Department of Cardiology, Hiroshima City Hospital, Hiroshima, Japan (K.D.); Department of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan (K.N.); Department of Cardiology, Kansai Rosai Hospital, Cardiovascular Center, Hyogo, Japan (M.U.); Department of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan (Y.T.); Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan (K.F.); and Abbott Vascular, Abbott Park, IL (C.A.S.). 2. From the Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (H.S., T.K.); Department of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma); Division of General Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan (T. Morimoto); Department of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan (K.I.); Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K. Kadota); Department of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K.T.); Department of Cardiology, Iwate University Hospital, Morioka, Japan (Y.M.); Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan (T.A.); Department of Cardiology, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan (M.A.); Department of Cardiology, Juntendo University Shizuoka Hospital, Nagaoka, Japan (S.S.); Department of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan (T. Muramatsu); Department of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan (M.K.); Department of Cardiology, Hiroshima City Hospital, Hiroshima, Japan (K.D.); Department of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan (K.N.); Department of Cardiology, Kansai Rosai Hospital, Cardiovascular Center, Hyogo, Japan (M.U.); Department of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan (Y.T.); Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan (K.F.); and Abbott Vascular, Abbott Park, IL (C.A.S.). taketaka@kuhp.kyoto-ua.ac.jp.
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 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.
RCT Entities:
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.
Authors: Jun Aono; Ernesto Ruiz-Rodriguez; Hua Qing; Hannes M Findeisen; Karrie L Jones; Elizabeth B Heywood; Dennis Bruemmer Journal: JACC Basic Transl Sci Date: 2016 Jan-Feb