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A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease (FAME 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100722
Recruitment Status : Active, not recruiting
First Posted : April 1, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
VZW Cardiovascular Research Center Aalst
Catharina Ziekenhuis Eindhoven
Golden Jubilee National Hospital
University of California, Irvine
Medtronic
Abbott Medical Devices
Genae
King's College Hospital, London
Houston Methodist DeBakey Heart and Vascular Center, Houston
Information provided by (Responsible Party):
William Fearon, Stanford University

Tracking Information
First Submitted Date  ICMJE March 21, 2014
First Posted Date  ICMJE April 1, 2014
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
MACCE [ Time Frame: 1 year ]
Death, MI, stroke and any repeat revascularization (MACCE) will be evaluated at 1 year, where subjects contribute data from time of randomization until the occurrence of MACCE or one year follow-up, whichever occurs first. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Death, MI, and stroke [ Time Frame: 3 years ]
Death, MI, and stroke will be evaluated at 3 years, where subjects contribute data from time of enrollment until the occurrence of one of the above events or three year follow-up, whichever occurs first. Subjects who die or are lost to follow up before this time will be censored at their last recorded activity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 27, 2014)
  • MACCE [ Time Frame: 2 years, 3 years, 5 years ]
    Death, MI, stroke and any repeat revascularization (MACCE) rate at 2 years, 3 years and 5 years
  • Death [ Time Frame: 1 year, 2years, 3 years, 5 years ]
    Death will be evaluated at 1 year, 2 years, 3 years and 5 years, excluding patients lost to follow-up from each arm
  • Myocardial infarction [ Time Frame: 1 year, 2 years, 3 years and 5 years ]
    MI will be evaluated at 1 year, 2 years, 3 years and 5 years, excluding patients lost to follow-up from each arm
  • Stroke [ Time Frame: 1 year, 2 years, 3 years and 5 years ]
    Stroke will be evaluated at 1 year, 2 years, 3 years and 5 years, excluding patients lost to follow-up from each arm
  • Repeat revascularization [ Time Frame: 1 year, 2 years, 3 years and 5 years ]
    Any repeat revascularization will be evaluated at 1 year, 2 years, 3 years and 5 years, excluding patients lost to follow-up from each arm
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Official Title  ICMJE 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
Brief 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).
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Disease
  • Coronary Stenosis
Intervention  ICMJE
  • Procedure: FFR guided PCI
    Other Name: Fractional Flow Reserve-Guided PCI
  • Procedure: CABG
    Other Name: Coronary Artery Bypass Graft Surgery
Study Arms  ICMJE
  • 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 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.
    Intervention: Procedure: FFR guided PCI
  • 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.
    Intervention: Procedure: CABG
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2014)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization)
  • 2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
  • 3. Recent STEMI (<5 days prior to randomization)
  • 4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
  • 5. Known left ventricular ejection fraction <30%
  • 6. Life expectancy < 2 years
  • 7. Requiring renal replacement therapy
  • 8. Undergoing evaluation for organ transplantation
  • 9. Participation or planned participation in another clinical trial, except for observational registries
  • 10. Pregnancy
  • 11. Inability to take dual antiplatelet therapy for six months
  • 12. Previous CABG
  • 13. Left main disease requiring revascularization
  • 14. Extremely calcified or tortuous vessels precluding FFR measurement
  • 15. Any target lesion with in-stent drug-eluting stent restenosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Denmark,   France,   Hungary,   Korea, Republic of,   Lithuania,   Netherlands,   New Zealand,   Norway,   Serbia,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02100722
Other Study ID Numbers  ICMJE FAME 3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Fearon, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • VZW Cardiovascular Research Center Aalst
  • Catharina Ziekenhuis Eindhoven
  • Golden Jubilee National Hospital
  • University of California, Irvine
  • Medtronic
  • Abbott Medical Devices
  • Genae
  • King's College Hospital, London
  • Houston Methodist DeBakey Heart and Vascular Center, Houston
Investigators  ICMJE
Study Chair: William F Fearon, MD Stanford University
Principal Investigator: Nico HJ Pijls, MD, PhD Catharina Hospital Eindhoven, The Netherlands
Principal Investigator: Bernard De Bruyne, MD, PhD VZW Cardiovascular Research Center Aalst
PRS Account Stanford University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP