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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)

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ClinicalTrials.gov Identifier: NCT02100722
Recruitment Status : Recruiting
First Posted : April 1, 2014
Last Update Posted : October 10, 2017
Sponsor:
Collaborators:
VZW Cardiovascular Research Center Aalst
Catharina Ziekenhuis Eindhoven
Golden Jubilee National Hospital
University of California, Irvine
Medtronic
St. Jude Medical
Genae
King's College Hospital, London
Houston Methodist DeBakey Heart and Vascular Center, Houston
Information provided by (Responsible Party):
William Fearon, Stanford University

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).

Condition or disease Intervention/treatment Phase
Coronary Disease Coronary Stenosis Procedure: FFR guided PCI Procedure: CABG Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: FFR guided PCI
Other Name: Fractional Flow Reserve-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.
Procedure: CABG
Other Name: Coronary Artery Bypass Graft Surgery




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100722


Contacts
Contact: William F Fearon, MD 650-725-2621 wfearon@stanford.edu
Contact: Frederik M Zimmermann, MD 0031402398360 frederik.zimmermann@cze.nl

  Show 46 Study Locations
Sponsors and Collaborators
Stanford University
VZW Cardiovascular Research Center Aalst
Catharina Ziekenhuis Eindhoven
Golden Jubilee National Hospital
University of California, Irvine
Medtronic
St. Jude Medical
Genae
King's College Hospital, London
Houston Methodist DeBakey Heart and Vascular Center, Houston
Investigators
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

Additional Information:
Publications:
Responsible Party: William Fearon, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02100722     History of Changes
Other Study ID Numbers: FAME 3
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases