Background: The safety of fractional flow reserve (FFR)-based deferral of revascularization remains to be fully established in real-world practice. We sought to assess clinical outcomes after deferral of revascularization based on FFR.
Methods: The J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry) prospectively enrolled 1263 patients with 1447 lesions in whom revascularization was deferred based on FFR at 28 Japanese centers. The primary study end point was the cumulative 2-year incidence of target vessel failure, including cardiac death, target-vessel related myocardial infarction, and clinically driven target vessel revascularization.
Results: The mean FFR was 0.86±0.06. At 2 years, the target vessel failure rate was 5.5% in deferred lesions, mainly driven by a high rate of clinically driven target vessel revascularization (5.2%), and significantly increased with decreasing FFR, especially in the proximal location. Cardiac death and target-vessel related myocardial infarction rarely occurred during the 2-year follow-up (0.41% and 0.41%, respectively). Independent predictors of 2-year target vessel failure were FFR value (per 0.01 decrease; hazard ratio [HR] 1.07 [95% CI, 1.04-1.11], P<0.001), left main coronary artery lesion (HR, 5.89 [95% CI, 2.72-12.8], P<0.001), moderately to severely calcified lesion (HR, 2.49 [95% CI, 1.36-4.58]; P=0.003), hemodialysis (HR, 2.90 [95% CI, 1.11-7.58]; P=0.03), and right coronary artery lesion (HR, 1.78 [95% CI, 1.02-3.11], P=0.042).
Conclusions: The J-CONFIRM registry demonstrated the 2-year target vessel failure rate was 5.5% in deferred lesions, highlighting the safety of FFR-based deferral of revascularization in daily practice.
Clinical trial registration: URL: http://www.umin.ac.jp. Unique identifier: UMIN000014473.
Keywords: coronary artery disease; death; myocardial infarction; risk; safety.