TVD revascularization: CABG better than PCI even after FFR guidance, FAME-3 study.
In a head-to-head comparison of two revascularization strategies for patients with three-vessel coronary artery disease, PCI guided by a functional assessment of ischemia using fractional flow reserve (FFR) failed to match CABG surgery for the reduction of major adverse cardiovascular and cerebrovascular events as shown by the results of FAME-3 trial that were published this week in NEJM.
Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking.
The FAME trials testing the use of FFR in different clinical scenarios go back more than a decade. In 2009, the FAME trial showed that FFR-guided PCI reduced the risk of all-cause mortality, MI, or repeat revascularization when compared with angiography-guided PCI.
In FAME 2, a trial that was stopped early, FFR-guided PCI plus optimal medical therapy was superior to medical therapy alone in patients with stable ischemic heart disease, a benefit that was driven by a lower rate of urgent revascularization.
That set the stage for the FAME 3 study, a noninferiority trial that included 1,500 patients with three-vessel coronary artery disease randomized to CABG surgery or PCI guided by FFR. All patients had angina and/or evidence of myocardial ischemia and were amenable to either surgery or PCI as determined by the heart team.
Patients with left main CAD were not included in the study. With PCI, patients were treated with a zotarolimus-eluting stent (Medtronic) if the FFR measured ≤ 0.80.
At 1 year, the primary composite endpoint of death from any cause, MI, stroke, or repeat revascularization occurred in 10.6% of patients treated with FFR-guided PCI and in 6.9% of those treated with CABG surgery, a difference that failed to demonstrate noninferiority of PCI.
The composite endpoint of all-cause death, MI, or stroke occurred in 7.3% of those treated with PCI and 5.2% of the CABG-treated patients. On the other hand, the risk of major bleeding, arrhythmia, and acute kidney injury were higher with surgery.
With respect to the risk of MACCE according to the SYNTAX score, the composite primary endpoint among those with a low SYNTAX score occurred in 5.5% of those treated with PCI compared with 8.6% in the CABG arm. For those with intermediate and high SYNTAX score, the risk of death from any cause, MI, stroke, or repeat revascularization was higher among those treated with PCI.
"This study provides both physicians and patients more contemporary data and information on options and expected outcomes in patients with multivessel disease," said lead investigator William Fearon, MD. "If you're a patient with less-complex disease, I think you can feel comfortable that you will get an equivalent result with FFR-guided PCI. If you have more-complex disease, at least based on the outcomes here, which included repeat revascularization, bypass outperformed PCI."
In the US guidelines for the treatment of stable ischemic heart disease, CABG is a class 1 recommendation (level of evidence B) for the treatment of patients with three-vessel disease, with the guidelines stating "it is reasonable" to choose CABG over PCI in patients with complex three-vessel CAD (SYNTAX score > 22) who are good candidates for surgery. PCI, in this setting, is a IIb recommendation, meaning it is "of uncertain benefit."
Source: NEJM: DOI: 10.1056/NEJMoa2112299
