FFR Changes Treatment Plan in More Than One-Third of All-Comer Patients

Results from the international, prospective PRESSUREWire registry study support the increased use of FFR, experts say.

FFR Changes Treatment Plan in More Than One-Third of All-Comer Patients

LAS VEGAS, NV—Use of fractional flow reserve (FFR) changes the initial treatment plan in more than one-third of all-comers undergoing clinically indicated angiography, data from a new prospective registry show.

The results provide a contemporary snapshot of FFR’s clinical impact in an environment where its use is established and should encourage more operators to employ the physiological test, say researchers.

“This may actually provide support to increase its use, [but] I don’t know what the right percentage would be,” said Erick Schampaert, MD (Hôpital Sacré-Cœur de Montréal, Canada), who presented the PRESSUREWire results in a featured clinical research session at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI). His lab, for example, tested FFR following 20% of the last 2,000 angiograms they performed.  

“This is a call to do more FFR,” agreed M. Chadi Alraies, MD, MPH (Detroit Medical Center, MI), who moderated the press conference where the results were also presented. “We are underutilizing the technology and are overstenting people,” he said.

Overall Distribution Similar

For the PRESSUREWire registry, researchers prospectively enrolled 2,217 patients with ACS or stable angina who were receiving angiography and FFR for further revascularization consideration at 70 hospitals worldwide between October 2016 and February 2018. The only exclusion criteria were extremely tortuous or calcified vessels and patent CABG to the target vessel. Just over one-quarter of patients had multivessel disease (26.9%) and the target lesion was most often the LAD (54.8%).

The overall mean FFR value was 0.84, and the treatment plan was changed in 34.7% of cases following the invasive physiology assessment.

Specifically, among the 61.5% originally deemed to receive medication only, 19.1% were reallocated to PCI and 2.5% to CABG. Within the 32.7% initially considered for PCI, 51.6% and 2.7% were changed to medical therapy and CABG, respectively, following FFR. Of the 5.4% initially planned for CABG, 30.3% and 56.3% instead were treated with medical therapy or underwent PCI, respectively. Lastly, of the patients who had no treatment plan before FFR (0.5%), five received medical therapy, one received CABG, and three had PCI.

The ultimate distribution of PCI, CABG, and medical therapy was in line with what was seen pre-FFR assessment, but the patients had substantially shifted around among the groups, noted Schampaert.

When analyzing the data on a per-lesion basis, FFR similarly changed the treatment plan in 29.8% of cases. Also, when patients were stratified by diagnosis, the initial treatment plan for nonculprit lesions was less often medical therapy and more often CABG for ACS patients compared with those with stable CAD (P < 0.01 for both). Also, ACS patients were more likely to have their treatment plans change following FFR assessment (35.5% vs 28.4%; P < 0.01), and the final treatment plan for the ACS cohort was more often CABG (P = 0.011) and PCI (P = 0.002) and less often medication alone (P < 0.001) compared with stable angina patients.

Schampaert said his group plans to follow the patients who were switched and present their outcomes at TCT in San Francisco, CA, later this year.

“But we won’t have a comparator,” he said. “We'll only be able to look at the groups between the different treatments hoping that the patients that were moved away from revascularization to medical therapy will be doing as well if not better than the patients that were treated. . . . Best-case scenario, we're going to bring back these patients to the same status as the patients who didn't need intervention and were only treated with medication.”

Erasing the Doubt

Asked whether these data should encourage physicians to use more FFR in the future, press conference panelist Philippe Généreux, MD (Morristown Medical Center, NJ), said yes. “A good practice should involve FFR when there’s a doubt. Absolutely. We’ve known for a long time that angiography can lead to overtreatment and can lead to worse outcomes, so I think in very skilled hands and using FFR we can achieve [an] optimal outcome. Physiology is key to optimization of the outcome.”

Schampaert pointed out, however, that use of FFR is likely unnecessary for patients who present with ACS, localized ECG changes, and no concomitant disease. 

For Abdul Hakeem, MD (Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ), said “the more provocative part of the presentation” related to the reason some physicians say they don’t use FFR: that they feel it will most often deter them from stenting.

“The investigators demonstrated that after medical therapy, a substantial portion of patients actually required PCI, one in five,” he said. “So 20% of patients that you would generally send to medical therapy alone would actually benefit from revascularization.”

  • Schampaert E. A Global registry of fractional flow reserve (FFR)-guided management during routine clinical procedures. Presented at: SCAI 2019. May 22, 2019. Las Vegas, NV.

  • The study was funded by Abbott Vascular.
  • Schampaert reports serving as a consultant for and receiving speaker fees from Abbott Vascular, AstraZeneca, Bayer, Medtronic, Volcano-Philips, Sanofi, and Servier.