In patients with intermediate coronary stenosis, fractional flow reserve (FFR)-guided PCI was noninferior to intravascular ultrasound (IVUS)-guided PCI, according to findings from the FLAVOUR trial presented April 4 at ACC.22. The study is the first large, randomized head-to-head comparison of two methods of evaluating patients' need for a stent in their coronary artery.

The study enrolled 1,682 patients with intermediate coronary stenosis from 18 centers in China and Korea. The average age of patients was 65 and 71% were men. Just over half had blockages in multiple arteries supplying blood to the heart and about one-third had diabetes in addition to cardiovascular disease. Six percent of the patients had previously suffered a myocardial infarction (MI) and 30% were at high risk for an MI.

All patients were randomly assigned to undergo evaluation for PCI using either FFR or IVUS. The decision to proceed with PCI was based on each technique's standard criteria. In accordance with standard care after PCI, patients who received PCI took two antiplatelet medications for six to 12 months after their procedure to reduce their risk of adverse events. Patients who did not receive PCI continued to manage their cardiovascular disease with medication.

The study met its primary endpoint – a composite of death from any cause, MI or the need for a repeat stenting procedure after two years of follow-up. Compared with patients who were evaluated by IVUS, significantly fewer patients evaluated by FFR underwent PCI (65.3% vs. 44.4%, respectively). After two years, 8.1% of the patients evaluated by FFR had died, suffered a MI or needed a repeat stenting procedure, compared with 8.5% of those evaluated by IVUS; the statistical difference was not significant. In addition, when the investigators compared patients who received PCI with those who remained on medical therapy, they found no statistically significant differences in the rates of death, MI or repeat procedures in either the FFR or IVUS group.

"Despite the fact that FFR-evaluated patients received significantly fewer stents than IVUS-evaluated patients, they were no more likely to experience adverse events," said Bon-Kwon Koo, MD, FACC, principal investigator for the study. "The rates of adverse outcomes and patients' quality of life were similar in both groups. These results support considering FFR-guided PCI first for patients with intermediate coronary stenosis, as it is associated with a reduced use of medical resources."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: ACC Annual Scientific Session, ACC22, Fractional Flow Reserve, Myocardial, Coronary Stenosis, Percutaneous Coronary Intervention, Ultrasonography, Interventional, Coronary Angiography

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