Clinical Implementation of Angiography-Derived Fractional Flow Reserve for Revascularization Guidance: Initial...

Real-world data on the adoption and clinical performance of angiography-derived physiology in the United States (U.S.) remain limited. We evaluated the implementation of FFRangio (CathWorks, Tel Aviv, Israel) and associated clinical outcomes across a multicenter U.S. healthcare system. We performed a multicenter observational cohort study across 4 centers involving consecutive adult patients undergoing invasive coronary angiography in whom FFRangio was performed in at least 1 coronary vessel based on clinical indication. The primary endpoint was target-vessel failure (TVF), defined as a composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization during follow-up, stratified by FFRangio values >0.80 versus ≤0.80. A total of 675 vessels in 469 patients were assessed by FFRangio; 240 (36%) had values ≤0.80 and 435 (64%) >0.80. Among lesions with FFRangio ≤0.80, 182 (76%) underwent PCI, 27 (11%) CABG, and 32 (13%) were managed medically. Among lesions with FFRangio >0.80, revascularization was deferred in 406 (92%), with 22 (5%) undergoing PCI and 12 (3%) CABG. The LAD was the most frequently treated vessel (51%). At a median follow-up of 10.2 months, the incidence rate of TVF was 1.55% per 100 lesion-years (95% confidence interval [CI]: 0.57-3.36) in the FFRangio >0.80 group versus 6.30 per 100 lesion-years (95% CI, 3.25-11.0) in the FFRangio ≤0.80 group (hazard ratio [HR] 4.61, 95% CI: 1.61-13.2; p=0.002). Among deferred lesions with FFRangio >0.80, TVF rate was 1.73 per 100 lesion-years (95% CI: 0.64-3.77). In conclusion, FFRangio supported safe deferral of revascularization and risk-stratification, with low event rates among lesions with values >0.80.