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Fractional flow reserve (FFR) has been proposed as the gold standard to functional severity of coronary artery stenosis and to stratify which lesions should be subject to percutaneous coronary intervention (PCI). However, the long-term clinical outcomes in patients with deferral of PCI based on FFR in real-world practice have not fully been evaluated yet. We sought to assess the one-year clinical outcomes of patients with deferral of PCI based on FFR as an interim analysis of the J-CONFIRM (long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter) registry.
The J-CONFIRM registry was a prospective, multicenter registry enrolling Japanese patients with deferral of PCI based on FFR, regardless of FFR values. From September 2013 and June 2015, a total of 1160 patients (1278 lesions) with deferral of PCI based on FFR were prospectively enrolled from 28 Japanese institutions. We assessed the cumulative incidence of target vessel failure (TVF) within one year. TVF was defined as a composite of cardiac death related to target vessel, target vessel myocardial infarction (TVMI), and target vessel revascularization (TVR).
Overall, median FFR was 0.85 (interquartile range: 0.82-0.90). FFR <0.80 was found in 147 patients (12.7%) and 153 lesions (12.0%). Of 1160 patients, 352 patients (30.3%) had AHA/ACC type B2 and C lesions. At one year, the cumulative incidence of TVF, TVMI, and TVR were 2.8%, 0.3%, and 2.8%, respectively. Cardiac death related to target vessel occurred only in one patient (0.1%). FFR <0.80 (hazard ratio [HR] 4.05, 95% confidence intervals [CI]: 1.95-8.14, P <0.001) and AHA/ACC type B2 and C lesions (HR 2.37, 95% CI: 1.18-4.34, P=0.015) were predictors of TVF within one year.
One-year clinical outcomes of patients with deferral of PCI based on FFR are acceptable. However, careful clinical follow-up is mandatory in patients with FFR <0.80 and complex lesions.
IMAGING: FFR and Physiologic Lesion Assessment