Last updated on February 2018

A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

Brief description of study

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).

Detailed Study Description

The FAME 3 trial is a multicenter, international, randomized, controlled noninferiority trial. All patients with multivessel CAD (not involving the left main) will be screened by the site's Heart Team (including but not limited to an interventional cardiologist, cardiac surgeon and research coordinator). If all agree that the patient can be treated either with FFR-guided PCI or CABG, and all inclusion criteria are met and no exclusion criteria are met, then the patient will be randomized.

Baseline clinical, functional, laboratory and electrocardiographic data will be obtained. Patients will receive treatment within 4 weeks of randomization. Patients randomized to CABG will receive state of the art therapy at the discretion of the local surgeon with a strong emphasis on arterial revascularization. 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 drug-eluting stent (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred.

All patients will receive medical therapy as per published guidelines. Patients will follow-up at 1 and 6 months, and 1 and 3 years with an evaluation of clinical status, functional status, medications and events. Follow-up may be extended to 5 years, if funding allows.

Core lab analyses will include formal quantitative coronary angiography (QCA) of the baseline angiograms with calculation of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score and Functional SYNTAX Score.

Clinical Study Identifier: NCT02100722

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Kings College Hospital

London, United Kingdom
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Palo Alto VA

Palo Alto, CA United States
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Wythenshawe Hospital

Manchester, United Kingdom
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Atlanta VA Medical Center

Decatur, GA United States
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Centennial Heart

Nashville, TN United States
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Penn Presbyterian Medical Center

Philadelphia, PA United States
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Houston Methodist Hospital

Houston, TX United States
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Isala Klinieken

Zwolle, Netherlands
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Asan Medical Center

Seoul, Korea, Republic of
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Waikato Hospital

Hamilton, New Zealand
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University Hospitals Coventry and Warwickshire

Coventry and Warwickshire, United Kingdom
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Stanford University

Stanford, CA United States
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Lexinton VA

Lexington, KY United States
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Baystate Medical Center

Springfield, MA United States
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University of Virginia

Charlottesville, VA United States
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Peninsula Health

Frankston, Australia
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The Hague, Netherlands
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St. Thomas' Hospital

London, United Kingdom
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Recruitment Status: Open

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