Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

Conditions

Coronary Artery Disease

Keywords

Coronary stent

Brief summary

The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.

Detailed description

Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Shiomi H, Kozuma K, Morimoto T, Kadota K, Tanabe K, Morino Y, Akasaka T, Abe M, Takeji Y, Suwa S, Ito Y, Kobayashi M, Dai K, Nakao K, Tarutani Y, Taniguchi R, Nishikawa H, Yamamoto Y, Nakagawa Y, Ando K, Kobayashi K, Kawai K, Hibi K, Kimura T, RESET Investigators.

2019-04-0119 citations

10.1016/j.jcin.2019.01.234

Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies.

Watanabe H, Morimoto T, Shiomi H, Yoshikawa Y, Kato T, Saito N, Shizuta S, Ono K, Yamaji K, Ando K, Kaji S, Furukawa Y, Akao M, Ishikawa T, Tamura T, Yamamoto Y, Muramatsu T, Suwa S, Nakagawa Y, Kadota K, Takatsu Y, Nishikawa H, Hiasa Y, Hayashi Y, Miyazaki S, Kimura T.

2018-03-052 citations

10.1007/s12928-018-0517-x

Long-Term Clinical Outcomes After Everolimus- and Sirolimus-Eluting Coronary Stent Implantation

Hiroki Shiomi, Ken Kozuma, Takeshi Morimoto, Keiichi Igarashi, Kazushige Kadota et al. (19 authors)

Circulation Cardiovascular Interventions2014-05-0741 citations

10.1161/circinterventions.113.001322

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).

Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Takatsu Y, Nishikawa H, Yamamoto Y, Nakagawa Y, Hayashi Y, Iwabuchi M, Umeda H, Kawai K, Okada H, Kimura K, Simonton CA, Kozuma K, RESET Investigators.

2012-07-23100 citations

10.1161/circulationaha.112.104059

Interventions

DEVICEEverolimus-eluting stent

Everolimus-eluting stent

DEVICESirolimus-eluting stent

Sirolimus-eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
target-lesion revascularization	1-year
all-cause death or myocardial infarction	3-year

Secondary

Measure	Time frame
non-target-lesion revascularization	3-year
coronary artery bypass grafting	3-year
target-vessel revascularization	3-year
any repeat coronary revascularization	3-year
all-cause death	3-year
cardiac death	3-year
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization	3-year
stent thrombosis (Academic Research Consortium definition)	3-year
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes	3-year
bleeding complications (GUSTO and TIMI definition)	3-year
stent deployment success	at implantation
procedure time	at implantation
clinically-driven target-lesion revascularization	3-year
myocardial infarction	3-year
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization	3-year

Countries

Japan

Outcome results

None listed