STRATEGY for Left Main Coronary Bifurcation Lesion II

Study Overview
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Brief Summary
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In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion. In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

Official Title
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A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: One stent technique alone
* Device: One stent technique + Elective FKB
* Procedure: Provisional approach
* Device: Elective 2-stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥20 years Left main bifurcation lesion on coronary angiography Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis > 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation Exclusion Criteria: The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus Patients who have received DES implantation in the target lesion prior to enrollment

Ages Eligible for Study
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Minimum Age: 20 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: One stent technique alone<br>One stent technique alone for non-true LM bifurcation | Device: One stent technique alone<br>* One stent technique alone with drug-eluting stent<br>|
| Experimental: One stent technique + Elective FKB<br>One stent technique + Elective FKB for non-true LM bifurcation | Device: One stent technique + Elective FKB<br>* One stent technique + Elective FKB with drug-eluting stents + balloon<br>|
| Experimental: Provisional approach<br>Provisional approach for true LM bifurcation | Procedure: Provisional approach<br>* Provisional approach with drung-eluting stents<br>|
| Experimental: Elective 2-stent<br>Elective 2-stent for true LM bifurcation | Device: Elective 2-stent<br>* Elective 2-stent with drug-eluting stents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization | 12-month | 

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-month | 
| Angiographic in-segment restenosis rate | as measured by 9-month quantitative coronary analysis | 9 months | 
| Target vessel revascularization (TVR) | TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery. | 12-month | 
| Stent thrombosis | Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis. | 12-month | 
| 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-month | 
| 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-month | 
| Periprocedural CK-MB elevation | Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure. | the first 48 hours after PCI | 
| Procedure success rate |  | the first 48 hours after PCI | 
| Procedure time |  | immediate after PCI | 
| Amount of contrast dye |  | immediate after PCI | 

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