Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion (J-REVERSE)

Shin Yukuhashi Hospital

Status: Unknown

Conditions: Ischemic Heart Disease

Treatments: Device: EES vs. SES; Procedure: kissing balloon inflation

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01266239

J-REVERSE

Details and patient eligibility

About

In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."

Full description

Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues.

1. Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results
2. Difference between SES and EES
3. Impact of abnormal OCT findings on long-term clinical outcome (3yr)

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
2. The lesion is appropriate for the provisional MV stenting.
3. The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.

Exclusion criteria

1. Left main coronary bifurcation
2. Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
3. Left ventricular ejection fraction < 30%
4. Shock state
5. Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

SES-KB

Active Comparator group

Description:

Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.

Treatment:

Device: EES vs. SES

Procedure: kissing balloon inflation

SES-NK

Active Comparator group

Description:

SES is deployed in the MV without kissing balloon inflation.

Treatment:

Device: EES vs. SES

Procedure: kissing balloon inflation

EES-KB

Active Comparator group

Description:

Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.

Treatment:

Device: EES vs. SES

Procedure: kissing balloon inflation

EES-NK

Active Comparator group

Description:

EES is deployed in the MV without kissing balloon inflation.

Treatment:

Device: EES vs. SES

Procedure: kissing balloon inflation