Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Trial A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Who is this study for? Adult patients with coronary artery disease
What treatments are being studied? FFR guided PCI
Status: Active_not_recruiting
Location: See all (45) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
• 2. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis
• 3. Willing and able to provide informed, written consent
Locations
United States
California
Palo Alto VA
Palo Alto
Stanford University
Stanford
Georgia
Atlanta VA Medical Center
Decatur
Illinois
Jesse Brown VA Medical Center
Chicago
Kansas
University of Kansas Medical Center
Lawrence
Kentucky
Lexinton VA
Lexington
University of Kentucky Medical Center
Lexington
Massachusetts
Baystate Medical Center
Springfield
Minnesota
HealthEast St. Joseph's Hospital
Saint Paul
Pennsylvania
Penn Presbyterian Medical Center
Philadelphia
Tennessee
Centennial Heart
Nashville
Texas
Houston Methodist Hospital
Houston
Virginia
University of Virginia
Charlottesville
Other Locations
Australia
Peninsula Health
Frankston
St. Vincent's Hospital Melbourne
Melbourne
Concord Hospital
Sydney
Royal North Shore
Sydney
University of Sydney
Sydney
Belgium
Cardiovascular Center Aalst
Aalst
Canada
Le'Centre Hospitalier de l'Universite de Montreal
Montreal
York PCI Group INC
Ontario
University of Ottawa Heart Institute
Ottawa
Denmark
Rigshospitalet University Hospital
Copenhagen
France
Cardiovascular Hospital
Lyon
Hungary
Hungarian Institute of Cardiology
Budapest
Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius
Netherlands
Catharina Hospital Eindhoven
Eindhoven
HagaZiekenhuis
The Hague
Isala Klinieken
Zwolle
New Zealand
Waikato Hospital
Hamilton
Norway
Stavanger University Hospital
Stavanger
Republic of Korea
Asan Medical Center
Seoul
Serbia
University Clinical Center of Serbia
Belgrade
Clinical Center Kragujevac
Kragujevac
Sweden
Sahlgrenska University Hospital
Goteborg
Danderyds Sjukhus
Stockholm
Karolinska Institutet, Dep of clinical science and education, Södersjukhuset
Stockholm
United Kingdom
Wales Heart Research Institute
Cardiff
University Hospitals Coventry and Warwickshire
Coventry And Warwickshire
Golden Jubilee National Hospital
Glasgow
Kings College Hospital
London
St. Thomas' Hospital
London
Wythenshawe Hospital
Manchester
Oxford University Hospital NHS Trust
Oxford
Southampton University Hospitals NHS Trust
Southhampton
Time Frame
Start Date: 2014-08-25
Completion Date: 2025-04
Participants
Target number of participants: 1500
Treatments
Active_comparator: FFR guided PCI
Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent (DES) as per usual routine. If the FFR is \>0.80 then PCI will be deferred. Only those sites with prior experience measuring FFR will be included in the FAME 3 trial. These patients in whom FFR of a particular lesion was not possible will be included in all analyses based on the intention to treat principle.
Active_comparator: CABG
CABG will be performed as per clinical routine at each participating center. Both off-pump and on-pump surgery are acceptable, as long as the surgeon and the site are experienced in the particular technique. An internal mammary graft to the LAD should be attempted in all cases, if feasible. Complete arterial revascularization is strongly recommended, however, each center should use a conduit strategy with which they are most comfortable. All vessels ≥ 1,5 mm in diameter and with ≥ 50% stenosis should be bypassed, if technically feasible.
Authors
Nico HJ Pijls, John Giacomini, Barry Uretsky, Emmanouil Brilakis, William F Fearon, Augusto Pichard, Habib Samady, Paul Myers, Shuaib Abdullah, William H Matthai, Alpesh Shah, Mladen Vidovich, Gilles Rioufol, Jaydeep Sarma, Giedrius Davidavicius, Philip MacCarthy, Olaf Wendler, Luke Tapp, Kreton Mavromatis, Branko Beleslin, Nils Witt, Nikola Jagic, Samer Mansour, Zsolt Piroth, Oskar Angeras, Nick Curzen, Thomas Engstroem, Alf Inge Larsen, Keith G Oldroyd, Petr Kala, Bernard de Bruyne, Gerard Devlin, Aun-Yeong Chong, Frederik M Zimmermann, Simon Redwood, Seung-Jung Park
Related Therapeutic Areas
Sponsors
Collaborators: Houston Methodist DeBakey Heart & Vascular Center, King's College Hospital NHS Trust, Genae, Catharina Ziekenhuis Eindhoven, University of California, Irvine, Abbott Medical Devices, Medtronic, Golden Jubilee National Hospital, VZW Cardiovascular Research Center Aalst
Leads: Stanford University