Background: Long-term clinical outcomes of real-world use of fractional flow reserve (FFR), including the decisions against FFR, have not been fully evaluated in the era of drug-eluting stent (DES) implantation.
Methods: A total of 1294 patients who underwent FFR measurement for de novo coronary lesions were included. FFR measured lesions (n = 1628) were divided into FFR-defer or FFR-stent lesions according to the treatment strategy selected after FFR measurement. Clinical outcomes were assessed by patient-related major adverse cardiac event (a composite of all-cause death, myocardial infarction, and any revascularization) and target-lesion related event (target-lesion related myocardial infarction and revascularization).
Results: Mean FFR was 0.80 ± 0.12, and FFR was ≤0.8 in 728 lesions (44.7%). Five-year cumulative all-death rate was 6.3%, myocardial infarction rate was 1.5%, and rate of any revascularization was 12.5%. Among 797 deferred lesions, 105 lesions had FFR ≤0.8 and those lesions had a higher risk of 5-year target-lesion related events than the lesions with FFR >0.8 (21.2% vs 6.6%, respectively; P=.03). By multivariate analyses, the determinant for the 1-year target-lesion related events was the presence of diabetes (hazard ratio, 3.74; 95% confidence interval, 1.45-9.67; P=.01), while the determinant for delayed events at 1-5 years was FFR ≤0.8 (hazard ratio, 4.50; 95% confidence interval, 1.65-12.28; P=.01). Angiographic lesion severity was not an independent predictor for clinical events during follow-up among deferred lesions.
Conclusion: The deferral of stenting according to FFR was associated with favorable long-term outcomes. Presence of diabetes and low FFR (≤0.8) increased the risk of clinical events in deferred lesions.