LAS VEGAS — Among patients with stable CAD or ACS who were given an initial treatment plan after angiography, the plan changed in more than 30% after fractional flow reserve was performed, according to results of the PRESSUREwire study.
In addition, FFR did not cause any serious adverse events, researchers reported at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
The researchers conducted a prospective observational study of 2,217 patients from 70 hospitals in 15 countries with stable CAD or ACS who underwent clinically indicated angiography.
“Our group wanted to document whether or not the advent of this approach had changed how using coronary physiology would still potentially modify how we would treat patients,” presenter Erick Schampaert, MD, head of the division of cardiology at Hopital Sacre-Coeur, Montreal, said in an interview. There had been two similar studies, but they were older and smaller, and each covered only a single country, he said.
After angiography, the initial treatment plan of PCI, CABG or medical therapy was recorded, and then patients underwent FFR (mean of all measurements, 0.84).
After FFR, the treatment plan changed in 34.7% of patients and 29.8% of lesions, according to the researchers.
In a per-patient analysis, FFR resulted in more patients getting medical management (pre-FFR, 61.5%; post-FFR, 66.9%; P = .0017), fewer patients getting PCI (pre-FFR, 32.7%; post-FFR, 27.5%; P = .0004) and no significant change in patients getting CABG (pre-FFR, 5.4%; post-FFR, 5.5%; P = .8951).
Among patients initially slated for medical management, 19.1% were changed to PCI after FFR, and among patients initially slated for PCI, 51.6% were changed to medical management after FFR, according to the researchers.
After FFR, the frequency of intended revascularization fell from 38.1% to 33% per patient (P = .0005) and from 35.5% to 29.6% per lesion (P < .0001), Schampaert and colleagues found.
“We were investigating whether people look at coronary angiography in a somewhat different way than they did 10 years ago, and the short answer is no,” Schampaert told Cardiology Today’s Intervention. “People still misqualify lesion severity based on angiography and therefore offer what would be considered an improper treatment for these lesions being physiologically or not physiologically significant.”
During a presentation at the Society for Cardiovascular Angiography and Interventions Scientific Sessions, Erick Schampaert, MD, head of the division of cardiology at Hopital Sacre-Coeur, Montreal, presented data from the PRESSUREwire study.
Source: Erik Swain
The researchers reported no cases of serious adverse events related to FFR.
“There is a clear demonstration that angiography alone will misguide decisions in one-third of patients,” Schampaert said in an interview. “In most cases, it involves inappropriately treating with angioplasty a lesion that can be handled with medical therapy or treating lesions found to be nonsignificant on angiography with medical therapy that indeed needed revascularization. I’m not saying we should do FFR in every lesion. The lesions in this study were in the intermediate range, with percent diameter stenosis of 30% to 80%. The very severe and very mild lesions do not need FFR interrogation.”
An analysis of 12-month clinical outcomes in the cohort will be presented at a future meeting, Schampaert said. – by Erik Swain
Berry C, et al. Featured Clinical Research II. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2019; Las Vegas.
Disclosure: The study was sponsored by Abbott. Schampaert reports he consults for numerous device companies, including Abbott and Philips/Volcano.
Editor's Note: This article was modified on May 28, 2019 to reflect an update to the data.