Coronary Artery Disease
Conditions
Keywords
Angioplasty, Transluminal, Percutaneous Coronary
Brief summary
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.
Interventions
DEVICEOne stent technique alone
One stent technique alone with drug-eluting stent
DEVICEOne stent technique + Elective FKB
One stent technique + Elective FKB with drug-eluting stents + balloon
PROCEDUREProvisional approach
Provisional approach with drung-eluting stents
DEVICEElective 2-stent
Elective 2-stent with drug-eluting stents
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 12-month | defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic in-segment restenosis rate | 9 months | as measured by 9-month quantitative coronary analysis |
| Target vessel revascularization (TVR) | 12-month | TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery. |
| Stent thrombosis | 12-month | Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis. |
| Myocardial infarction (MI) | 12-month | 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. |
| Cardiac death | 12-month | All deaths were considered cardiac unless a definite non-cardiac cause could be established. |
| Periprocedural CK-MB elevation | the first 48 hours after PCI | Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure. |
| Procedure success rate | the first 48 hours after PCI | — |
| Procedure time | immediate after PCI | — |
| Amount of contrast dye | immediate after PCI | — |
| Target lesion revascularization (TLR) | 12-month | TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel. |
Countries
South Korea
Outcome results
None listed