FFR-guided PCI for three-vessel CAD not noninferior to surgery at 1 year: FAME 3
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In the FAME 3 trial, PCI guided by fractional flow reserve failed to meet noninferiority for reduction of MACCE at 1 year compared with CABG in patients with three-vessel CAD.
The trial involved 1,500 patients with three-vessel CAD at 48 sites worldwide who were randomly assigned to undergo CABG or an FFR-guided PCI in which all lesions were stented if FFR was 0.8 or less.
The primary endpoint of death, MI, stroke or repeat revascularization at 1 year occurred in 10.6% of the FFR-guided PCI group compared with 6.9% of the CABG group (HR = 1.5; 95% CI, 1.1-2.2). The P value for noninferiority was .35, meaning that FFR-guided PCI was not found to be noninferior to CABG, William F. Fearon, MD, professor of medicine and director of interventional cardiology at Stanford University School of Medicine and chief of the cardiology section at VA Palo Alto Health Care System, said during a TCT 2021 press conference.
Results showed no difference in individual components of the primary endpoint. The composite of death, MI or stroke was numerically lower in the CABG group but not significantly different, Fearon said.
Patients assigned CABG had higher incidence of major bleeding, arrhythmia, acute kidney injury and rehospitalization within 30 days. Rates of definite stent thrombosis and symptomatic graft occlusion were low.
In a prespecified subgroup analysis based on SYNTAX score, FFR-guided PCI outperformed CABG in patients with the lowest scores (< 23), with a 1-year MACCE rate of 5.5% vs. 8.6% with CABG. In patients with intermediate and high SYNTAX scores, 1-year MACCE was lower with CABG.
FAME 3 “provide[s] physicians and patients [with] more contemporary data and information on options and expected outcomes in patients with multivessel disease, so that if you’re a patient who has 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, bypass outperformed PCI,” Fearon said during the press conference.
FAME 3 involved all-comers with at least 50% diameter stenosis in all three major epicardial vessels but not involving the left main coronary artery. The patients’ mean age was 65 years and 82% were men. Forty percent presented with an ACS, 30% had diabetes and 15% underwent prior PCI. PCI was performed with a Resolute stent (Medtronic) only if FFR was 0.8 or lower as measured with the Abbott pressure wire. Patients were preloaded with a P2Y12 inhibitor and high-dose statin and received dual antiplatelet therapy for at least 6 months. In the CABG group, FFR guidance was not mandated, but FFR information from diagnostic angiogram could be used. Patients were pretreated with aspirin and a high-dose statin. Complete arterial revascularization was recommended. Patients in the PCI group received a mean of 3.7 stents, and those in the CABG group received 3.4 distal anastomoses.
During a discussion after the presentation, Ran Kornowski, MD, director of interventional cardiology at Rabin Medical Center, Israel, said: “The message is that we’re getting very good results with three-vessel PCI, but better results with surgery. No doubt about it, based on the current results. I think also the certification based on SYNTAX (score) is also very important, and probably we can use this subanalysis for our clinical decisions with our patients.
“It will be extremely important to look at two things: One is the long-term outcome beyond 1 year ... [and] second is the impact of completeness of revascularization.”
The researchers will follow patients out to 3 and 5 years. Fearon said they are currently analyzing quality of life data, which will also be reported at a later date.
Reference:
Perspective
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Joseph Cleveland, MD
In patients with severe three-vessel coronary disease, CABG still appears to be the best revascularization strategy. For all the other groups in this study, it is still a question mark as to whether FFR-guided PCI is noninferior to surgery.
There are a lot of nuances in this trial. FFR-guided PCI is still an acceptable option for selected patients, provided there is also adherence to medical therapy; the trial does not condemn that as a strategy. The follow-up time of 1 year is short. Properly defining MI is still challenging, and there is a question of how the definition impacts the outcomes seen here. While the hard endpoints draw the most attention, other factors such as quality of life and cost-effectiveness are also important to address. The results allow us to sit with patients and give them yet another piece of counseling that FFR-guided PCI, while not meeting the noninferiority criteria, appears to be a viable option in some patients with less severe CAD, and some cardiologists believe it is the best option for those patients.
Things are likely to stay much the same in clinical practice. The event rates in the CABG group were lower than predicted, which is one reason why the results did not reach the noninferiority margin. The PCI results were better than in the SYNTAX trial, but the CABG results were a lot better. There is still a signal that when decisions are made with appropriate guidance, either strategy probably can be employed for patients with single- and two-vessel CAD. Even for patients with three-vessel-disease and lower SYNTAX scores, FFR-guided PCI produced decent results. As we saw in SYNTAX, for the more complex patients with three-vessel coronary disease, CABG stands out as the treatment of choice. That has been our approach since SYNTAX.
We need to see results out to 3 to 5 years. There also needs to be an analysis of the completeness of revascularization in both groups to see if that contributed to the results. Women and persons of color were underrepresented, and we need more information about how they may or may not fit the results.
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Fearon WF. Late-Breaking Clinical Trials Session I. Presented at: TCT Scientific Symposium; Nov. 4-6, 2021; Orlando (hybrid meeting).
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