FFR may predict 1-year outcomes, target vessel failure after PCI for multivessel CAD
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BOSTON — Addition of fractional flow reserve to the classic SYNTAX score enabled researchers to identify patients with multivessel CAD undergoing PCI who would have similar 1-year outcomes as those who received CABG, a speaker reported.
Moreover, low FFR after FFR-guided PCI for multivessel CAD with a drug-eluting stent was associated with elevated risk for target vessel failure.
Researchers presented two FAME 3 subanalyses at TCT 2022.
In the original FAME trial, researchers determined that use of a functional SYNTAX score — classic SYNTAX score plus FFR — better predicted risk for adverse events in patients with multivessel CAD undergoing PCI compared with the classic SYNTAX score.
In FAME 3, presented at the 2021 American Heart Association Scientific Sessions, researchers found that FFR-guided PCI failed to meet noninferiority for reduction of MACCE at 1 year compared with CABG in patients with three-vessel CAD.
In the first of two FAME 3 substudies presented at TCT, researchers conducted an analysis to determine whether the functional SYNTAX score could identify patients with multivessel CAD who would have comparable outcomes to CABG after PCI.
The primary composite endpoint of MACCE included death, MI, stroke and repeat revascularization.
The researchers found that a similar proportion of patients who underwent CABG experienced MACCE at 1 year compared with those with a low functional SYNTAX score who underwent PCI (CABG, 6.9%; PCI, 6.5%; P = .77). Patients with a high functional SYNTAX score who underwent PCI experienced greater incidence for MACCE (15.1%) compared with those with a low functional SYNTAX score or those who underwent CABG (P for all < .001).
“Those patients with a low functional SYNTAX score had comparable MACCE rate with surgery, whereas those in a high functional SYNTAX score had a much higher rate,” Zsolt Piróth, MD, PhD, FESC, FACC, interventional cardiologist at Gottsegen National Cardiovascular Center in Budapest, Hungary, said during a press conference. “By measuring the functional SYNTAX score, one can identify 50% of the complex multivessel coronary artery disease patients who have similar outcomes at 1 year with PCI compared with CABG.”
In the second FAME 3 substudy, the researchers evaluated prognostic value of measuring FFR after DES implantation in 757 patients with multivessel CAD.
The results of this substudy were simultaneously published in Circulation: Cardiovascular Interventions.
“The impact of intravascular imaging is also poorly defined in this setting,” Piróth said during the press conference. “Investigators were requested to measure post-PCI FFR and the IVUS/OCT guidance was tracked.”
The primary endpoint was TVF at 1 year, defined as cardiac death, target vessel MI or target vessel revascularization.
The researchers observed that every 0.01 increase in FFR following PCI was associated with an approximately 4% reduced risk for TVF and served as an independent predictor of vessel failure (HR = 0.96; 95% CI, 0.92-1; P = .03).
Piróth added that intravascular imaging was completed in just 11% of patients, and there were no more granular data regarding the use of imaging.
“In patients undergoing FFR-guided PCI with current-generation drug-eluting stents for anatomically defined three-vessel disease, a low post-PCI FFR was associated with a significantly higher rate of TVF both on a vessel and patient level,” Piróth said during the press conference. “Post-PCI FFR was an independent predictor of target vessel failure. And the limited use of intravascular imaging did not affect outcomes.”
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Ten years ago, FAME showed that in doing revascularization, SYNTAX guided by FFR could have led to completely different results. Now we have the real outcome that show these positive results the other way around. There were a few substudies that were meaningless, like the IVUS substudy, because numbers for IVUS were so low that obviously the patient receiving IVUS had a worse outcome than the others; those were probably the most difficult patients with the most difficult lesions and characteristics that explain the difference.
Concerning the other points that were explored, for this functional SYNTAX score, the finding that patients having a lower score indicated PCI was as good as surgery is somewhat expected. You may also argue how much of this might be due to the fact that the surgeon didn’t do functional FFR and just grafted everything, including probably unnecessary lesions.
Overall, it’s not an easy try to understand and, as it been pointed out, it’s difficult to do a perfect job with PCI unless you use all the tools at your disposal. Definitely, the FAME 3 investigators were somewhat obsessed by the value of limiting treatment only to the critical lesions and forgot, for instance, to use the information that they achieved after the treatment. They had a lot of lesions that still were far from normalization of FFR and still they did nothing about it. I think that explains why these patients tend to remain more symptomatic or require more targeted revascularization and at the end have worse outcomes than with surgery.
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Kobayashi Y, et al. Late-Breaking Clinical Science in Coronary Artery Disease: Session V, in Collaboration With The Lancet. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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