Download EBC MAIN: A European Bifurcation Club Trial

EBC MAIN:
A European Bifurcation Club Trial
David Hildick-Smith
Sussex Cardiac Centre, UK
TVT 2012
EBC MAIN
•  The European Bifurcation Club Left Main
Coronary Study - a randomised comparison of
Single versus Dual Stenting for True Bifurcation
Left Main Coronary Lesions
Hypothesis
•  “Left main coronary bifurcation lesions (type
1,1,1 or 0,1,1: both LAD and Cx >2.75mm
diameter) are best treated with a planned
provisional single stent strategy rather than a
planned dual stent strategy, with respect to
death, target lesion revascularisation and
myocardial infarction at 1 year.”
Inclusion criteria
•  Bifurcation distal left main stem stenosis >70% +
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Ischaemic symptoms
+ve non-invasive ischaemia testing
+ve FFR
LMS IVUS <6mm2
Left main diameter <6mm diameter
True bifurcation lesion type 1,1,1 or 0,1,1
LAD and Cx diameter both >=2.75mm
Unprotected left main
Patient ≥18 years old
Exclusion criteria
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STEMI <72 hours preceding
Cardiogenic shock
Chronic total occlusion of either vessel
>2 other coronary lesions planned for treatment
SYNTAX score for planned lesions to be treated >32
LMS trifurcation if all vessels are ≥2.75mm diameter
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
Participation in another investigational drug or device study
Patient unable to give informed consent
Study design
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Multicentre
Prospective
Randomised
450 patients
20 centres
Stent
Patient with left main stem true bifurcation lesion
(Medina class 1,1,1; 0,1,1:LAD and Cx both ≥2.75mm)
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Suitable for stent treatment
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Consent
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Randomisation to either:
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A: planned single stent strategy
B: planned dual stent strategy
Primary endpoint: Composite at 12 months of death, MI, TVR
Endpoints
•  Primary:
•  Death, Myocardial infarction and Target Lesion
Revascularisation at 12 months
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Death, MI, TLR, individually
Angina status
Stent thrombosis
Death, MI, TLR at 3 yrs, 5 yrs
Techniques
•  SINGLE STENT
•  provisional T according to EBC Consensus 2009
Techniques
•  DUAL STENT
•  Operator choice
•  Ancillary aspects – as per EBC Consensus 2009