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Coronary-artery bypass grafting (CABG) is a more appropriate revascularization strategy for three-vessel coronary artery disease (CAD) than percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR), according to a new analysis of 1,500 patients.
The study, published in the New England Journal of Medicine, represents the latest chapter in one of interventional cardiology’s largest ongoing debates.
“FFR-guided PCI results in better short-term and long-term outcomes than does angiography-guided PCI or medical therapy alone,” wrote lead author William F. Fearon, MD, a specialist with Stanford University’s Stanford Cardiovascular Institute, and colleagues. “We sought to evaluate FFR-guided PCI performed with current-generation drug-eluting stents as compared with CABG with respect to the incidence of major adverse cardiac or cerebrovascular events among patients with three-vessel CAD.”
The FAME 3 trial’s 1,500 participants were treated at one of 48 different facilities. All patients presented with three-vessel CAD that did not involve the left main coronary artery. They were randomized to undergo either FFR-PCI or CABG.
Patients from the PCI group received a mean of 3.7 stents. Patients from the CABG group, on the other hand, received a mean of 3.4 distal anastomoses. The study’s primary endpoint, defined as the one-year rate of major adverse cardiac or cerebrovascular events, was seen in 10.6% of PCI patients and 6.9% of CABG patients. The rate of death, myocardial infarction or stroke after one year was 7.3% for the PCI group and 5.2% for the CABG group.
Major bleeding events, arrhythmias and acute kidney injury, on the other hand, were all more common in the CABG group.
“The main finding of our trial is that in patients with angiographically identified three-vessel CAD, FFR-guided PCI did not meet the criterion we set for noninferiority with respect to the primary composite end point,” the authors wrote. “CABG resulted in a lower incidence of the composite of death, myocardial infarction, stroke, or repeat revascularization at one year than FFR-guided PCI in which current-generation zotarolimus-eluting stents were used.”
The team noted that these findings were “consistent” with prior trials comparing PCI and CABG, but the addition of FFR helped their study stand apart from the work of other researchers.
Frederick G.P. Welt, MD, associate chief of the division of cardiovascular medicine at the University of Utah School of Medicine, wrote an editorial reviewing the work of Fearon et al. That analysis, also published in the New England Journal of Medicine, examined the long history of the PCI vs. CABG narrative.
“At each milestone in percutaneous technology, PCI has been tested against the ‘gold standard’ of CABG with respect to effects on mortality and quality of life,” he wrote. “Randomized trials have shown superiority of CABG over PCI in patients with higher disease burden and lesion complexity1 and in the presence of diabetes. However, questions have remained, including those of which populations benefit the most and whether these findings apply to newer PCI strategies.”
Does this latest study end the debate once and for all? That much remains to be seen, but Welt did highlight the importance of this latest chapter.
“The FAME 3 trial bolsters the role of CABG as the benchmark for patients with multivessel coronary disease,” he wrote. “However, a multidisciplinary approach and shared decision making remain fundamental to the management of multivessel coronary disease in our daily practices. Debate often yields to consensus when heart teams work well together.”
The analysis by Fearon et al. was funded by research grants from Stanford University, Medtronic and Abbott Vascular. However, no vendors had any input when it came to the study’s design or completion.
Click here for the full study.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.