Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Experimental: Aggressive strategy
Procedure: Aggressive strategy
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.
Target vessel failure (TVF) [ Time Frame: 12 months ]
composite of cardiac death, myocardial infarction, target vessel revascularization
Secondary Outcome Measures :
Cardiac death [ Time Frame: 12 months ]
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Myocardial infarction (MI) [ Time Frame: 12 months ]
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.
Target vessel revascularization (TVR) [ Time Frame: 12 months ]
TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.
Target lesion revascularization (TLR) [ Time Frame: 12 months ]
TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
Stent thrombosis [ Time Frame: 12 months ]
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Periprocedural enzyme elevation [ Time Frame: during the hospitalization ]
Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.
the incidence of binary angiographic restenosis in the main branch and side branch [ Time Frame: 9 months ]
as measured by 9-month quantitative coronary analysis
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
ST-elevation myocardial infarction within 48 hours of symptom onset
Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
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.