The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coronary Disease
- Sponsor
- Royal Sussex County Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Composite primary endpoint (Death, MI, TVR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.
Detailed Description
Treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. Prior to the era of drug-eluting stents, the limited data which existed suggested that a strategy of stenting the main vessel, with balloon angioplasty alone of the side-branch if required was superior to stenting both vessels. Randomised trials of "all-comer" bifurcation lesions have now established that there is no advantage to systematic dual drug-eluting stent strategies. However, these trials included patients with no disease in the side branch, and small side branch vessels. Expert consensus suggests that "large" bifurcations with significant ostial side branch disease still merit a systematic total lesion coverage stent technique. This trial therefore is designed to assess the hypothesis that large true bifurcations with significant side branch ostial disease are more successfully treated with a systematic culotte technique than with the provisional T approach.
Investigators
David Hildick-Smith
Consultant Cardiologist
Royal Sussex County Hospital
Eligibility Criteria
Inclusion Criteria
- •"True" coronary bifurcation lesion (i.e. \>50% lesion in both main vessel and side branch) requiring revascularisation
- •Main vessel ≥ 2.5mm diameter (visual inspection)
- •Side branch ≥ 2.5mm diameter (visual inspection)
- •Side branch ostial lesion ≥5mm length
- •Patient ≥18 years old
- •Females of childbearing potential: -ve pregnancy test
Exclusion Criteria
- •Acute ST elevation myocardial infarction
- •Cardiogenic shock
- •Left main stem lesion of haemodynamic significance
- •Chronic total occlusion of either vessel
- •Additional Type C lesions requiring PCI
- •Either bifurcation vessel not suitable for stenting
- •Platelet count ≤50 x 109/mm3
- •Left ventricular ejection fraction ≤20%
- •Patient life expectancy less than 12 months
- •Known allergies to aspirin, clopidogrel, heparin, stainless steel, intravenous contrast (severe), or stent drug elutant
Outcomes
Primary Outcomes
Composite primary endpoint (Death, MI, TVR)
Time Frame: 12 months
Death Myocardial infarction Target Vessel Revascularisation
Secondary Outcomes
- Stent thrombosis(12 months)