ACC.22: FAME 3 shows FFR-guided PCI leads to a faster recovery versus surgery

Frederik M Zimmerman

Percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) leads to a faster improvement in quality of life, with similar outcomes at 12-month follow-up compared with coronary artery bypass graft (CABG) surgery.

This was the conclusion of an analysis of the FAME 3 (Fractional flow reserve versus angiography for multivessel evaluation) trial, presented by Frederik Zimmermann (Catharina Hospital Eindhoven, Eindhoven, The Netherlands) during the American College of Cardiology’s annual scientific sessions (ACC 2022, 2–4 April, Washington DC, USA) and published simultaneously in the journal Circulation.

William Fearon (Stanford University, Stanford, USA) presented primary results of the trial at the 2021 Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA), where he revealed that FFR-guided PCI for three-vessel coronary artery disease had failed to meet non-inferiority for one-year adverse events compared to CABG. The finding led Fearon to remark that in patients with more complex, three-vessel coronary artery disease, CABG remains the treatment of choice.

The latest analysis focuses on the impact of FFR guidance used in conjunction with current generation, zotarolimus drug-eluting stents on quality of life after PCI compared to CABG.

FAME 3 was a multicentre, international, randomised, controlled non-inferiority trial in which patients with three-vessel CAD warranting revascularisation were randomly assigned to PCI or CABG.

A total of 1,500 patients were randomised 1:1 to either CABG based on coronary angiogram or FFR-guided PCI in all lesions with an FFR ≤0.80 at 48 centres in Europe, North America, Australia, and Asia. For inclusion in the trial, patients had three-vessel CAD, defined as ≥50% diameter stenosis by visual estimation in each of the three major epicardial vessels, but not involving the left main coronary artery, and amenable to revascularisation by both PCI and CABG as determined by the heart team. A total of 757 patients underwent FFR-guided PCI and 743 received CABG.

For the latest analysis, quality of life was measured using the European Quality of Life-5 Dimensions (EQ-5D-3L) questionnaire at baseline, one, and 12 months. The primary objective of the study was to compare EQ-5D summary index at 12 months.

Results of the study, presented by Zimmermann, showed that the EQ-5D summary index at 12 months did not differ between the PCI and CABG groups (difference=0.001, confidence interval (CI) -0.016 to 0.017).

The trajectory of EQ-5D differed (p<0.001) between PCI and CABG: at one month, EQ-5D was 0.063 (CI 0.047 to 0.079) higher in the PCI group. A similar trajectory was found for the EQ visual analogue scale.

The proportion of patients with Canadian Cardiovascular Class 2 or greater angina—the study’s secondary endpoint—were also broadly similar between the groups at 12 months. Younger patients (<65 years-old) also had higher odds of working at 12 months in the PCI group (3.9, CI 1.7 to 8.8)

Writing in Circulation, Fearon and colleagues note that the analysis shows earlier improvement in quality of life after FFR-guided PCI with current generation drug-eluting stents  compared with CABG, as shown in previous studies, but now also shows similar quality of life and degree of angina at one year, as well as improved working status after FFR-guided PCI.

“Although FFR-guided PCI did not meet the criterion set for non-inferiority regarding major adverse clinical events at one year compared with CABG, the difference was smaller than in previous studies,” the authors write. “In this setting, other factors like quality of life, degree of angina and returning to work can be important considerations for both patients and physicians when evaluating revascularisation strategies.”


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