Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

Samsung Medical Center258 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Coronary Artery Disease

Interventions

Conservative strategyPROCEDURE

* 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.

Aggressive strategyPROCEDURE

* 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Target vessel failure (TVF)

composite of cardiac death, myocardial infarction, target vessel revascularization

Time frame: 12 months

Secondary Outcomes

Cardiac death

All deaths were considered cardiac unless a definite non-cardiac cause could be established.

Time frame: 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.

Time frame: 12 months

Target vessel revascularization (TVR)

TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.

Time frame: 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.

Time frame: 12 months

Stent thrombosis

Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.

Time frame: 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.

Time frame: during the hospitalization

Data from ClinicalTrials.gov

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