European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions (EBC TWO)

The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations

This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: single stent; Device: two stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 1DE
      • Sussex Cardiac Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single stent	Device: single stent; single stent; Other Names: Terumo Nobori stent
Active Comparator: dual stent; dual stent (culotte)	Device: two stent; culotte; Other Names: Terumo Nobori stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite primary endpoint (Death, MI, TVR)	Death Myocardial infarction Target Vessel Revascularisation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent thrombosis	Stent thrombosis	12 months

Collaborators and Investigators

• Sponsor: Royal Sussex County Hospital
• Collaborators: Terumo Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 11, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: stent; coronary; bifurcation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: EBC TWO