Fractional flow reserve (FFR)-guided deferral of revascularization is safe and feasible for up to 5 years in patients with chronic coronary syndrome, investigators reported in Circulation: Cardiovascular Interventions.
Researchers evaluated 5-year clinical outcomes after deferral of revascularization based on FFR from the J-CONFIRM registry of patients who were enrolled at 28 centers in Japan.
The primary end point was the cumulative 5-year incidence of target vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction (TVMI), and clinically driven target vessel revascularization (CDTVR).
A total of 1263 participants (mean aged, 70.2±9.7 years; 74.5% men) were included. Clinical follow-up was conducted annually up to 5 years after the index procedure and was completed in 92.2% of patients.
TVF rates at 5 years were 11.6% in deferred lesions and 11.8% on a patient basis. They were driven mainly by CDTVR. Cardiac death and TVMI occurred at rates of 1.9% and 0.95%, respectively, during the 5-year follow-up.
The overall cumulative 5-year incidence of TVF increased with decreasing FFR categories, and the incidence was comparable between the FFR 0.75 to 0.80 and 0.81 to 0.85 groups after adjustment for baseline characteristics (12.2% vs 13.0%, P =.63). The FFR 0.75 to 0.85 group had a higher rate of TVF compared with the FFR 0.86 to 1.00 group (12.2% vs 8.6%, P =.02).
The TVF rate increased with decreasing FFR categories in the proximal location of coronary stenosis (P <.001), a correlation that was not observed in the distal location (P =.64).
No correlation was found between FFR and percent diameter stenosis (DS) values (correlation coefficient, -0.004 [95% CI, -0.058 to 0.051]; P =.90). The 5-year TVF rate was higher in lesions with FFR of 0.80 or smaller vs those with FFR larger than 0.80, regardless of percent DS values.
The independent risk factors of 5-year TVF were FFR value (per 0.01 decrease; hazard ratio [HR], 1.05 [95% CI, 1.02-1.08]; P <.001), hemodialysis (HR, 2.68 [95% CI, 1.38-5.22]; P =.004), left main coronary artery lesion (HR, 3.05 [95% CI, 1.39-6.67]; P =.005), male sex (HR, 1.72 [95% CI, 1.01-2.94]; P =.044), and previous percutaneous coronary intervention (HR, 1.59 [95% CI, 1.00-2.53]; P =.048).
Among several study limitations, the researchers could not guarantee consecutive enrollment of eligible patients at all participating centers, which might have biased the conclusions. In addition, revascularization was deferred in 15.4% of lesions, regardless of FFR 0.80 or smaller, and the population did not include patients who underwent PCI based on FFR values. Furthermore, the investigators could not adjust for all confounders and all participants were Japanese.
“Our findings highlight the long-term safety and validity of FFR-based deferral of revascularization in chronic coronary syndrome patients in clinical practice,” the researchers wrote.
Disclosure: This work was supported by Abbott Medical Japan, Boston Scientific Japan, and Philips, Japan. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Kuramitsu S, Matsuo H, Shinozaki T, et al. Five-year outcomes after fractional flow reserve–based deferral of revascularization in chronic coronary syndrome: final results from the J-CONFIRM registry. Circ Cardiovasc Interv. Published online February 8, 2022. doi: 10.1161/CIRCINTERVENTIONS.121.011387