FLAVOUR Compares FFR-Guided and IVUS-Guided PCI in Intermediate Coronary Stenosis

April 4, 2022—In patients with intermediate coronary stenosis, fractional flow reserve- (FFR-) guided percutaneous coronary intervention (PCI) was noninferior to intravascular ultrasound- (IVUS-) guided PCI, according to findings from the FLAVOUR trial that were presented at ACC.22, the 71st annual scientific session of the American College of Cardiology (ACC), held April 2-4 in Washington, DC.

According to the ACC press release, 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 FLAVOUR study abstract is available online on the ACC.22 website.

In the FLAVOUR study, the average age of patients was 65 years; 71% were men. Approximately half of patients had blockages in multiple arteries supplying blood to the heart; approximately one-third had diabetes in addition to cardiovascular disease; 6% of patients had previously had a myocardial infarction (MI); and 30% of patients were at high risk for an MI.

As summarized in the ACC press release, all patients were randomly assigned to undergo evaluation for PCI using either FFR or intravenous ultrasound. 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 6 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 investigator reported that the study met its primary endpoint, which was a composite of death from any cause, MI, or the need for a repeat stenting procedure after 2 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 2 years, 8.1% of the patients evaluated by FFR had died, had an MI, or needed a repeat stenting procedure, compared with 8.5% of those evaluated by IVUS; the statistical difference was not significant.

In patients who received PCI versus those who remained on medical therapy, there was no statistically significant differences in the rates of death, MI, or repeat procedures in either the FFR or IVUS group.

Bon-Kwon Koo, MD, Principal Investigator for the study, commented in the ACC press release, “Despite the fact that FFR-evaluated patients received significantly fewer stents than IVUS-evaluated patients, they were no more likely to experience adverse events. 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.”