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 : Active, not recruiting
First Posted : April 1, 2014
Results First Posted : January 20, 2022
Last Update Posted : January 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Coronary Stenosis||Procedure: FFR guided PCI Procedure: CABG Device: Resolute Integrity Stent Device: Resolute Onyx Stent||Not Applicable|
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)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 25, 2014|
|Actual Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 2024|
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.
Procedure: FFR guided PCI
Other Name: Fractional Flow Reserve-Guided PCI
Device: Resolute Integrity Stent
Durable polymer zotarolimus-eluting stent
Device: Resolute Onyx Stent
Durable polymer zotarolimus-eluting stent
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.
Coronary Artery Bypass Graft Surgery (CABG)
- 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.
- Number of Participants Experiencing Death, MI, or Stroke [ Time Frame: 1 year ]Subjects who died or are lost to follow up before this time were censored at their last recorded activity.
- Death [ Time Frame: 1 year ]Death evaluated excluding patients lost to follow-up from each arm
- Number of Participants Experiencing Myocardial Infarction [ Time Frame: 1 year ]MI evaluated excluding patients lost to follow-up from each arm
- Number of Participants Experiencing Stroke [ Time Frame: 1 year ]Stroke evaluated excluding patients lost to follow-up from each arm.
- Number of Participants Requiring Repeat Revascularization [ Time Frame: 1 year ]Any repeat revascularization evaluated excluding patients lost to follow-up from each arm
- Number of Participants Experiencing BARC Type 3-5 Bleeding [ Time Frame: 1 year ]Bleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding.
- Number of Participants Experiencing Acute Kidney Injury [ Time Frame: 1 year ]
- Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia [ Time Frame: 1 year ]
- Number of Participants Experiencing Definite Stent Thrombosis [ Time Frame: 1 year ]
- Number of Participants Experiencing Definite Symptomatic Graft Occlusion [ Time Frame: 1 year ]
- Number of Participants Requiring Rehospitalization Within 30 Days [ Time Frame: 30 days ]
- 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
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
|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|