Five-Year Outcomes After Fractional Flow Reserve–Based Deferral of Revascularization in Chronic Coronary Syndrome: Final Results From the J-CONFIRM Registry

Abstract

Background: Little large-scale data is available about the long-term (beyond 3 years) clinical outcomes after fractional flow reserve (FFR)–based deferral of revascularization in clinical practice. We sought to assess the 5-year 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 from 28 Japanese centers. The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), including cardiac death, target vessel–related myocardial infarction, and clinically driven target vessel revascularization. Results: Five-year follow-up was completed in 92.2% of patients. The 5-year TVF rate was 11.6% in deferred lesions, mainly driven by clinically driven target vessel revascularization (9.8%). Cardiac death and target vessel–related myocardial infarction were 1.9% and 0.95%, respectively. Cumulative 5-year incidence of TVF was similar between the FFR 0.75 to 0.80 and 0.81 to 0.85 groups even after adjustment for baseline characteristics (12.2% versus 13.0%, inverse probability–weighted hazard ratio, 0.86 [95% CI, 0.46–1.60]; P =0.63). Compared with the almost normal FFR (0.86–1.00) group, the significant (<0.75) and borderline (0.75–0.85) FFR groups showed a higher incidence of TVF at 5 years (29.9% versus 12.8% versus 8.6%, P <0.001). Independent predictors of the 5-year TVF were hemodialysis, FFR value, left main coronary artery lesion, prior percutaneous coronary intervention, and male sex. Conclusions: The 5-year TVF rate was 11.6% in deferred lesions, mainly driven by clinically driven target vessel revascularization. Notably, cardiac death and target vessel–related myocardial infarction rarely occurred during the follow-up. Our findings highlight the long-term safety of FFR-based deferral of revascularization in patients with chronic coronary syndrome. REGISTRATION: URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000014473.

Paradigm Shift in Ischemia Evaluation and Accumulating Evidence of Safety of Deferred Coronary Revascularization on the Basis of Invasive Fractional Flow Reserve Measurement

“…The J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in a multicenter registry) enrolled 1,263 consecutive patients with angiographically intermediate coronary lesions and deferred revascularization after FFR assessment in 28 Japanese centers between 2013 and 2015. 8 In this registry, the 5-year cumulative incidences of cardiac death and target vessel-related myocardial infarction (TVMI) were only 1.9% and 0.95%, respectively, confirming the long-term safety of deferral of coronary revascularization based on FFR. 8 In this issue of the Journal, Ueki et al 9 report the outcomes of elderly patients after deferral of coronary revascularization in the J-CONFIRM registry.…”

“…8 In this registry, the 5-year cumulative incidences of cardiac death and target vessel-related myocardial infarction (TVMI) were only 1.9% and 0.95%, respectively, confirming the long-term safety of deferral of coronary revascularization based on FFR. 8 In this issue of the Journal, Ueki et al 9 report the outcomes of elderly patients after deferral of coronary revascularization in the J-CONFIRM registry. The 5-year cumulative incidence of the primary endpoint of target vessel failure was 14.3% in elderly (aged ≥75 years) patients and 10.8% in younger patients (aged <75 years) (P=0.12).…”

Vessel fractional flow reserve-based non-culprit lesion reclassification in patients with ST-segment elevation myocardial infarction: Impact on treatment strategy and clinical outcome (FAST STEMI I study)

“…Whereas prospective randomized data on the superiority of physiology-guided non-culprit vessel PCI in patients presenting with STEMI is lacking, data derived from important registries showed low event rates in vessels with a negative FFR and no subsequent revascularization in patients presenting with stable or unstable angina, supporting a conservative approach. [16,17] A meta-analysis of large national FFR registries extrapolated these findings to patients presenting with acute coronary syndrome (ACS) by demonstrating that FFR-based deferral to medical treatment was as safe as in patients with non-ACS (major cardiovascular event, 8.0% vs. 8.5%, p = 0.83; revascularization, 3.8% vs. 5.9%, p = 0.24; and freedom from angina, 93.6% vs. 90.2%, p = 0.35). [18] Also in the present study, event rates related to lesions with a vFFR >0.80 were low irrespective of subsequent revascularization.…”

Long-Term Outcomes in Elderly Patients After Deferral of Coronary Revascularization Guided by Fractional Flow Reserve

“…Cox regression analysis was performed to evaluate the prognostic signifi-of coronary intervention based on fractional flow reserve in multicenter registry) has reported the low incidence of target vessel failure (TVF) after deferral of revascularization based on FFR among patients with chronic coronary syndrome (CCS), highlighting the safety of FFR-based deferral of revascularization in real-world practice. 6,7 Elderly patients are more dominant in the CCS population and often present with atypical symptoms than younger patients; therefore, assessing myocardial ischemia should be encouraged in elderly patients. Previous studies have consistently demonstrated that elderly patients have higher FFR values than younger patients despite a similar degree of coronary stenosis 8-10 due to several potential mechanisms, such as a loss of functional cardiomyocytes, microvascular dysfunction resulting from long-standing hypertension and diastolic dysfunction, 11,12 and a decreased response to vasodilator drugs.…”