STRATEGY for Left Main Coronary Bifurcation Lesion II

Samsung Medical Center200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Coronary Artery Disease

Interventions

One stent technique aloneDEVICE

One stent technique alone with drug-eluting stent

One stent technique + Elective FKBDEVICE

One stent technique + Elective FKB with drug-eluting stents + balloon

Provisional approachPROCEDURE

Provisional approach with drung-eluting stents

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥20 years 2. Left main bifurcation lesion on coronary angiography 3. 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 4. 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: 1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus 2. Patients who have received DES implantation in the target lesion prior to enrollment

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Target lesion failure

defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization

Time frame: 12-month

Secondary Outcomes

Cardiac death

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

Time frame: 12-month

Angiographic in-segment restenosis rate

as measured by 9-month quantitative coronary analysis

Time frame: 9 months

Target vessel revascularization (TVR)

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

Time frame: 12-month

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-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.

Time frame: 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.

Time frame: 12-month

Data from ClinicalTrials.gov

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