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

Study Overview
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Brief Summary
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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.

Detailed Description
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Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues. Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results Difference between SES and EES Impact of abnormal OCT findings on long-term clinical outcome (3yr)

Official Title
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Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Procedure: kissing balloon inflation
* Device: EES vs. SES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB). The lesion is appropriate for the provisional MV stenting. The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB. Exclusion Criteria: Left main coronary bifurcation Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus Left ventricular ejection fraction < 30% Shock state Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SES-KB<br>Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation. | Procedure: kissing balloon inflation<br>* Kissing balloon inflation following the MV stenting<br>Device: EES vs. SES<br>* Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.<br>|
| Active Comparator: SES-NK<br>SES is deployed in the MV without kissing balloon inflation. | Procedure: kissing balloon inflation<br>* Kissing balloon inflation following the MV stenting<br>Device: EES vs. SES<br>* Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.<br>|
| Active Comparator: EES-KB<br>Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation. | Procedure: kissing balloon inflation<br>* Kissing balloon inflation following the MV stenting<br>Device: EES vs. SES<br>* Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.<br>|
| Active Comparator: EES-NK<br>EES is deployed in the MV without kissing balloon inflation. | Procedure: kissing balloon inflation<br>* Kissing balloon inflation following the MV stenting<br>Device: EES vs. SES<br>* Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abnormal intimal coverage | Optical coherence tomography (OCT) is planned at the 9-month follow-up period. Unevenness of intimal growth, number of uncovered struts, and frequency of thrombus attachment are evaluated. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifurcation lesion, drug-eluting stent, symmetric expansion