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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Sirolimus-eluting stent; Device: Everolimus-eluting stent

• Registration Number: NCT01035450
• Lead Sponsor: Takeshi Morimoto

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.

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Study Start: 2010-02
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3206

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus-eluting stent	Sirolimus-eluting stent	-
Everolimus-eluting stent	Everolimus-eluting stent	-

Primary Outcome Measures

Name	Time	Method
all-cause death or myocardial infarction	3-year
target-lesion revascularization	1-year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Cardiology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan