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Two PCI Guidance Strategies on Par for Intermediate Coronary Stenosis

— FLAVOUR trial weighs in on FFR versus IVUS

MedpageToday

For stenting decisions in intermediate coronary stenosis, fractional flow reserve (FFR) guidance led to outcomes that were similar to those with intravascular ultrasound (IVUS) guidance, but with more procedures safely deferred, the FLAVOUR trial showed.

FFR-guided percutaneous coronary intervention (PCI) led to a noninferior rate for the composite primary endpoint of all-cause mortality, myocardial infarction, or any revascularization at 2 years compared with IVUS-guided PCI (8.1% vs 8.5%, P=0.015 for noninferiority), reported Bon-Kwon Koo, MD, PhD, of Seoul National University Hospital in South Korea.

Each individual component likewise came out similar, as did stroke and cardiac death, he noted at the American College of Cardiology (ACC) meeting in Washington, D.C.

However, only 44.4% of patients in the FFR guidance group underwent PCI, compared with 65.3% of patients in the IVUS guidance group.

"Really practical. I think this is going to influence how we approach patients in the lab," said ACC Interventional Council chair Frederick Welt, MD, of the University of Utah in Salt Lake City, who served as the discussant for the trial at an ACC press conference.

While there hadn't been a lot of data available for comparison, the similar outcomes with less stenting in the FFR group "confirms the way a lot of us feel about the two technologies ... that FFR should be used to decide who should get an intervention and then IVUS be used to optimize the intervention," he noted.

Roxana Mehran, MD, of Mount Sinai School of Medicine in New York City, agreed.

"We needed a positive study for FFR after ," she said during the press conference. "We're having the exact same clinical outcomes but much [fewer] patients needing to undergo stent implantation with FFR guidance. ... It's really telling me that's the way to start, at least for guidance."

"The textbook-like answer would be start with physiology, and if you have to do PCI, imaging-guided PCI should be performed," Koo said. "But from a practical point of view, it's not easy to use both. ... In the intermediate stenosis setting, if you have to choose one, you'd better choose physiology. But the best may be using imaging and physiology."

The trial included 1,682 patients at 18 centers in China and Korea with suspected ischemic heart disease and intermediate coronary stenosis on coronary angiography, with a de novo target vessel that would be of a size eligible for PCI. Mean age among patients was 65, and 70.6% were men.

Outcomes were similar among those selected for medical treatment and in PCI-treated patients in both groups.

Given how well the medically treated FFR group did, with event rates even numerically lower than those in the IVUS-guided group (5.0% vs 5.9%), "it again tells me that deferring the lesion through FFR guidance is extremely safe, [and] associated with very low events," Mehran said.

While the trial didn't look specifically at FFR for stent optimization after placement, a lot more information is needed on such a strategy. "Don't leave the lab without knowing you're optimized," Mehran added.

However, Welt noted that about 30% of the trial participants had acute coronary syndrome. "There's a little bit of discomfort in the interventional community about using FFR in [ACS] patients," he said, adding that subgroup analyses will be welcome.

Disclosures

This trial was supported by research grants from Boston Scientific.

Primary Source

American College of Cardiology

Koo B-K, et al "Fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention: the FLAVOUR trial" ACC 2022.