TCT 2021: CABG "remains the treatment of choice" for three-vessel coronary disease
Percutaneous coronary intervention (PCI) guided by the ideal method ie fractional flow reserve (FFR) using the current best stent (durable polymer zotarolimus-eluting stents - Resolute Integrity or Resolute Onyx, Medtronic)did not meet non-inferiority for one-year adverse events compared to coronary artery bypass grafting (CABG) in patients with three-vessel coronary artery disease, primary results of the FAME 3 (Fractional flow reserve versus angiography for multivessel evaluation) trial have shown.
It has been shown in innumerable studies and trials that patients with three-vessel coronary artery disease have been known to have better outcomes with coronary artery bypass grafting (CABG) than patients with percutaneous coronary intervention (PCI). However, studies in which PCI is guided by the measurement of fractional flow reserve (FFR) have been lacking.
In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary endpoint was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization.
The results were presented recently during a late-breaking trial session at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual) by William Fearon (Stanford University School of Medicine, Department of Medicine, Stanford Cardiovascular Institute, Stanford, USA) and published simultaneously in the New England Journal of Medicine. Fearon told TCT attendees that in patients with more complex, three-vessel coronary artery disease, CABG remains the treatment of choice
A total of 1,500 patients were randomized 1:1 to either CABG based on coronary angiogram or FFR-guided PCI in all lesions with an FFR ≤0.80 at 48 centers 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.
The primary endpoint of the one-year rate of death, myocardial infarction, stroke, and repeat revascularization (MACCE) was 10.6% for PCI and 6.9% for CABG (hazard ratio [HR] 1.5, 95% CI 1.1‒2.2, p=0.35 for non-inferiority). The one-year rate of death (1.6% vs. 0.9%), MI (5.2% vs. 3.5%), and stroke (0.9% vs. 1.1%) were not significantly different between the two strategies. Repeat revascularization (5.9% vs. 3.9%) was higher in the PCI group.
When patient data were analyzed based on SYNTAX score, the one-year MACCE rate was higher with PCI compared with CABG for both intermediate (13.7% vs. 6.1%) and high SYNTAX scores (12.1% vs. 6.6%) with p for interaction by SYNTAX score=0.02.
Dr. Fearon concluded that - "In patients with more complex three-vessel coronary artery disease, CABG remains the treatment of choice. If you have the more complex disease, at least based on the outcomes here—which included repeat revascularisation—bypass outperformed PCI."
It may additionally be noted that the surgery was not the off-pump or beating heart (which has been shown to give better results and is used extensively by Indian surgeons) and the trial excluded left main stenosis patients. So as per this latest study, CABG remains the clear-cut procedure of choice. In my opinion, it is not at all that surprising. In fact, it is very consistent with what other studies have shown, that for three-vessel disease, surgery tends to have the edge, even when pitted against FFR-guided PCI. In FAME-3, the 1-year follow-up was the best chance for FFR-PCI to be non-inferior to CABG but it did not happen so. The CABG advantage is only going to get better with time.
Ref: Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery. William F. Fearon, M.D., Frederik M. Zimmermann, M.D., Bernard De Bruyne, M.D., et al., for the FAME 3 Investigators*
NEJM, November 4, 2021. DOI: 10.1056/NEJMoa2112299
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