Clinical trial NCT02497014: The European Bifurcation Club Left Main Study
Official title: The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Transluminal Coronary Angioplasty
Coronary Artery Disease
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
Collaborators: name: Medtronic
First posted: 2015-07-14
Enrollment: 450
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: The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.


Eligibility criteria: Inclusion Criteria:

Patients must meet ALL of the inclusion criteria:

* Bifurcation distal left main stem stenosis \>50% and

  * Ischaemic symptoms, or
  * Positive non-invasive imaging for ischaemia, or
  * Positive FFR, or
  * LMS IVUS MLA \<6mm2
* Left main diameter ≤5.75mm
* 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:

* 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 10\^9/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
* Women of child-bearing potential or lactating

Primary outcomes:
measure: Composite of Death, Myocardial infarction and Target Lesion Revascularisation
timeFrame: 1 year
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Myocardial Infarction
timeFrame: 1 year
measure: Target Lesion Revascularization
timeFrame: 1 year
measure: Angina status
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 1 year
measure: Death
timeFrame: 3 years
measure: Myocardial Infarction
timeFrame: 3 years
measure: Target Lesion Revascularization
timeFrame: 3 years
Other outcomes:
measure: Procedure success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time.
timeFrame: up to 18 months
measure: Technical success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time.
timeFrame: up to 18 months
measure: Number of procedural and in-hospital Major adverse Cardiac Events (MACE)
timeFrame: up to 18 months
measure: Procedure duration
timeFrame: intraoperative
measure: Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time
timeFrame: up to 18 months
measure: X-ray dose
timeFrame: up to 18 months
measure: Economic evaluation by assessing all procedural costs for each stenting strategy
timeFrame: up to 18 months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen University Hospital
city: Fontaine-lès-Dijon
country: France
facility: Clinique de Fontaine
city: Lyon
country: France
facility: HCL CHU Luis Pradel
city: Massy
country: France
facility: Hopital Jacques Cartier
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: CHU Rangueil
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Catania
country: Italy
facility: University of Catania - Ferrarotto Hospital
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Universita Cattolica del Sacre Cuore
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Pau i Sant Creu
city: Cordoba
country: Spain
facility: Hospital de la Reina Sofia
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Brighton and Sussex University Hospitals NHS Trust
name: David Hildick-Smith, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.