FFR-Guided PCI vs CABG for Coronary Artery Disease
(FAME 3 Trial)

Recruiting in Palo Alto (17 mi)

+45 other locations

Overseen byNico HJ Pijls, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults over 21 with multivessel coronary artery disease, which means they have significant blockages in all three major heart arteries but not the main left one. They must be experiencing chest pain or signs of poor blood flow to the heart and can undergo either stent placement or bypass surgery. Excluded are those with recent severe heart attacks, very weak hearts, short life expectancy, kidney failure requiring dialysis, planned organ transplants, pregnancy, or inability to take blood-thinning drugs for six months.

Inclusion Criteria

I have blockages in three major heart arteries but not the main one, treatable by surgery or stenting.

I am 21 or older with chest pain or signs of heart muscle issues.

Willing and able to provide informed, written consent

Exclusion Criteria

I need dialysis for my kidneys.

My stent in a blood vessel has narrowed again.

I cannot take dual antiplatelet therapy for six months.

+12 more

Participant Groups

The study compares two ways to improve blood flow in patients with blocked arteries: FFR-guided PCI (a procedure where a wire measures blood pressure differences across a blockage to guide stent placement) versus traditional bypass surgery (CABG). It aims to see if using FFR measurements before placing stents results in similar health outcomes as bypass surgery.

2Treatment groups

Active Control

Group I: FFR guided PCIActive Control3 Interventions

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.

Group II: CABGActive Control1 Intervention

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.