Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Study Overview
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Brief Summary
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The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.

Detailed Description
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The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.

Official Title
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Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Conservative strategy
* Procedure: Aggressive strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent vessel diameter stenosis > 75% Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test The reference diameter of both branches more than 2.3 mm by visual estimation Exclusion Criteria: Cardiogenic shock ST-elevation myocardial infarction within 48 hours of symptom onset Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%) Graft vessels Patients who have to receive clopidogrel due to other conditions Patients who have to receive warfarin, cilostazol or other antiplatelet therapy Hypersensitivity to clopidogrel or aspirin Expectant survival less than 1 year Women who plan to become pregnant Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months) Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conservative strategy<br> | Procedure: Conservative strategy<br>* Main vessel stenting was performed. Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) >75% in LM subgroup. Side branch stenting was performed if TIMI flow <3 in the Side branch after ballooning in non-LM subgroup, and DS >50% or dissection in the Side branch after ballooning in LM subgroup.<br>|
| Experimental: Aggressive strategy<br> | Procedure: Aggressive strategy<br>* Main vessel was performed. Side branch ballooning and kissing ballooning were done if DS >75% in the side branch after main vessel stenting in non-LM subgroup, and DS >50% in LM subgroup. Side branch stenting was performed if DS >50% in the side branch after ballooning in non-LM subgroup, and DS >30% or dissection in the side branch after ballooning in LM subgroup.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF) | composite of cardiac death, myocardial infarction, target vessel revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | All deaths were considered cardiac unless a definite non-cardiac cause could be established. | 12 months | 
| Myocardial infarction (MI) | MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure. | 12 months | 
| Target vessel revascularization (TVR) | TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery. | 12 months | 
| Target lesion revascularization (TLR) | TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel. | 12 months | 
| Stent thrombosis | Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis. | 12 months | 
| Periprocedural enzyme elevation | Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure. | during the hospitalization | 
| the incidence of binary angiographic restenosis in the main branch and side branch | as measured by 9-month quantitative coronary analysis | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Transluminal, Percutaneous Coronary