Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents 1-Year Outcomes from the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)

被引：112

作者：

Kimura, Takeshi ^{[1
]}

Morimoto, Takeshi ^{[2
]}

Natsuaki, Masahiro ^{[1
]}

Shiomi, Hiroki ^{[1
]}

Igarashi, Keiichi ^{[3
]}

Kadota, Kazushige ^{[4
]}

Tanabe, Kengo ^{[5
]}

Morino, Yoshihiro ^{[6
]}

Akasaka, Takashi ^{[7
]}

Takatsu, Yoshiki ^{[8
]}

Nishikawa, Hideo ^{[9
]}

Yamamoto, Yoshito ^{[10
]}

Nakagawa, Yoshihisa ^{[11
]}

Hayashi, Yasuhiko ^{[12
]}

Iwabuchi, Masashi ^{[13
]}

Umeda, Hisashi ^{[14
]}

Kawai, Kazuya ^{[15
]}

Okada, Hisayuki ^{[16
]}

Kimura, Kazuo ^{[17
]}

Simonton, Charles A. ^{[18
]}

Kozuma, Ken ^{[19
]}

机构：

[1] Kyoto Univ, Grad Sch Med, Dept Cardiovasc Med, Sakyo Ku, Kyoto 6068507, Japan

[2] Kinki Univ, Sch Med, Ctr Gen Internal Med Emergency Care, Osaka 589, Japan

[3] Hokkaido Social Insurance Hosp, Div Cardiol, Sapporo, Hokkaido, Japan

[4] Kurashiki Cent Hosp, Dept Cardiol, Kurashiki, Okayama, Japan

[5] Mitsui Mem Hosp, Div Cardiol, Tokyo 101, Japan

[6] Tokai Univ Hosp, Div Cardiol, Kanagawa, Japan

[7] Wakayama Med Univ Hosp, Dept Cardiovasc Med, Wakayama, Japan

[8] Hyogo Kenritsu Amagasaki Hosp, Div Cardiol, Kobe, Hyogo, Japan

[9] Mie Heart Ctr, Div Cardiol, Tsu, Mie, Japan

[10] Iwaki Kyoritsu Gen Hosp, Div Cardiol, Iwaki, Fukushima, Japan

[11] Tenri Hosp, Div Cardiol, Tenri, Nara 632, Japan

[12] Tsuchiya Gen Hosp, Div Cardiol, Hiroshima, Japan

[13] Kokura Mem Hosp, Div Cardiol, Kitakyushu, Fukuoka, Japan

[14] Toyota Mem Hosp, Div Cardiol, Toyota, Japan

[15] Chikamori Hosp, Div Cardiol, Kochi, Japan

[16] Seirei Hamamatsu Gen Hosp, Div Cardiol, Shizuoka, Japan

[17] Yokohama City Univ, Div Cardiol, Med Ctr, Yokohama, Kanagawa 232, Japan

[18] Abbott Vasc, Abbott Pk, IL USA

[19] Teikyo Univ Hosp, Div Cardiol, Tokyo, Japan

来源：

CIRCULATION | 2012年 / 126卷 / 10期

关键词：

restenosis; stent; thrombosis; ARTERY-DISEASE; DIABETES-MELLITUS; THROMBOSIS; INTERVENTION; IMPLANTATION; METAANALYSIS; REVASCULARIZATION; REGISTRY; LESIONS; COHORT;

D O I：

10.1161/CIRCULATIONAHA.112.104059

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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<0.0001, and 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<0.0001, and 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. (Circulation. 2012;126:1225-1236.)

引用

页码：1225 / +

页数：31

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