Clinical trial NCT01560455: European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions
Official title: The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Disease
Keywords: stent
bifurcation
coronary
Lead sponsor: Royal Sussex County Hospital
Sponsor class: OTHER
Collaborators: name: Terumo Corporation
First posted: 2012-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Participation in another investigational drug or device study
* Patient unable to give informed consent

Primary outcomes:
measure: Composite primary endpoint (Death, MI, TVR)
timeFrame: 12 months
Secondary outcomes:
measure: Stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Sussex Cardiac Centre
state: East Sussex
Study officials:
References:
citation: Hildick-Smith D, Behan MW, Lassen JF, Chieffo A, Lefevre T, Stankovic G, Burzotta F, Pan M, Ferenc M, Bennett L, Hovasse T, Spence MJ, Oldroyd K, Brunel P, Carrie D, Baumbach A, Maeng M, Skipper N, Louvard Y. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations. Circ Cardiovasc Interv. 2016 Sep;9(9):e003643. doi: 10.1161/CIRCINTERVENTIONS.115.003643.