FFR-Guided PCI vs CABG for Coronary Artery Disease

(FAME 3 Trial)

Recruiting at 45 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Recent STEMI, Low ejection fraction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

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).

Research Team

Nico HJ Pijls, MD, PhD

Principal Investigator

Catharina Hospital Eindhoven, The Netherlands

Bernard De Bruyne, MD, PhD

Principal Investigator

VZW Cardiovascular Research Center Aalst

William F Fearon, MD

Principal Investigator

Stanford University

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.

Treatment Details

Interventions

• CABG
• FFR guided PCI
• Resolute Integrity Stent
• Resolute Onyx Stent

Trial Overview 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.

Participant Groups

Group I: FFR guided PCI Active Control 3 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: CABG Active Control 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Golden Jubilee National Hospital

Collaborator

Trials

48

Recruited

14,200+

Genae

Industry Sponsor

Trials

9

Recruited

2,300+

Catharina Ziekenhuis Eindhoven

Collaborator

Trials

154

Recruited

130,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Houston Methodist DeBakey Heart and Vascular Center, Houston

Collaborator

Trials

1

Recruited

1,500+

King's College Hospital NHS Trust

Collaborator

Trials

267

Recruited

505,000+

Houston Methodist DeBakey Heart & Vascular Center

Collaborator

Trials

1

Recruited

1,500+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

VZW Cardiovascular Research Center Aalst

Collaborator

Trials

11

Recruited

9,000+