Why is this study important?
For revascularization of multivessel disease, percutaneous coronary intervention (PCI) has less morbidity and shorter recovery time than coronary artery bypass graft surgery (CABG), but past studies have shown CABG to have better long-term outcomes. FAME 3 is the first contemporary randomized controlled trial of CABG vs PCI, and it shows no significant difference in the composite of death, stroke, or myocardial infarction at 5 years.
What question was this study supposed to answer?
Technique, technology, and medical therapy have all improved since the last randomized comparisons of CABG versus PCI. The FAME 3 trial was designed to compare PCI—using FFR guidance and contemporary drug-eluting stents—with CABG, on the background of contemporary guideline-directed medical therapy. 1,500 patients with three-vessel coronary disease amenable to both PCI and CABG were randomized. The primary outcome of death, MI, stroke, and repeat revascularization at one year was previously reported. Patients were also followed for the prespecified outcome of death, MI, and stroke at five years.
What did the study show?
At five-year follow-up, there was no significant difference in the composite of death, stroke, or myocardial infarction after fractional flow reserve–guided PCI with contemporary drug-eluting stent (DES) as compared with CABG (16.0% vs 14.1%, HR 1.16 [95% CI 0.89–1.52], p=0.27). The individual outcomes of myocardial infarction and repeat revascularization were higher with PCI (MI: 8.2% vs. 5.3%, HR 1.57 [1.04−2.36]; repeat revascularization: 15.6% vs. 7.8%, HR 2.02 [1.46−2.79]), but there was no difference in death (7.2% vs. 51 7.2%, HR 0.99 [95% CI 0.67−1.46]). Landmark analysis at 1 year showed no sign of delayed benefit with CABG as compared to PCI.
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