Why is this study important?
FAME 3 shows that, in select patients with angiographic 3 vessel disease, CABG results in superior outcomes as compared to FFR-guided PCI using contemporary drug-eluting stents.
Should I change my practice because of these findings?
No. CABG is currently considered preferable to PCI in patients with angiographically complex disease. FAME 3 adds to the body of evidence that CABG is superior in select patients with multivessel disease.
What question was this study supposed to answer?
Prior trials of PCI vs. CABG for complex multivessel disease suggest CABG is superior, but treatment of stenoses that don't induce ischemia and/or use of first-generation stents with inferior performance properties could have tainted results. FAME 1 & 2 showed the value of FFR in identifying flow-limiting stenoses for stent treatment. FAME 3 used that knowledge and a second-generation zotarlimus-eluting stent (ZES) to challenge the results of earlier PCI vs. CABG studies.
What did the study show?
1500 patients with angiographic 3 vessel disease (> 50% stenosis) were randomized to CABG vs. FFR-guided PCI with ZES. The composite of all-cause death, MI, CVA, or revascularization at one year occurred 1.5 times as often after FFR-directed PCI with ZES than after CABG (6.9 vs 10.7%, HR 1.6, 95% CI 1.1-2.2). The upper boundary of confidence around that measure exceeded the threshold for non-inferiority, so PCI was judged “not non-inferior.” Secondary endpoints except stroke, including the individual components of the primary endpoint, also occurred more often in PCI patients. However, pre-defined safety measures (bleeding, AKI, new AF, repeat hospitalization, occlusion of stent or graft) were all lower among PCI patients. Subgroup analyses suggested particular benefit with CABG in men, age >65, diabetics, prior PCI, and higher SYNTAX scores. The authors note that compared with SYNTAX, results have improved markedly for both groups.
How good was the approach/methodology?
FAME 3 was a well-designed trial run by expert investigators. About 30% of patients were diabetic, about 20% had LVEF <50%, and about 40% had UA/NSTEMI (LM disease, STEMI, and LVEF <30% excluded), so this is a fair sample of typical patients. Factors that may have been important include (1) use of 3.7 stents (80mm)/person on average; (2) CTO in > 20%, (3) the use of intravascular imaging to guide stenting in 12% of patients, and (4) at least 1 bifurcation lesion in >2/3 of the PCI patients. It also is important to note that although 1-year results are of interest, longer follow-up is both planned and of great clinical importance.
All editors: S. Tanveer Rab, MD, FSCAI; Kreton Mavromatis, MD, FSCAI; Kirk N. Garratt, MD, MSc, MSCAI; and David A. Cox, MD, MSCAI
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