Fractional Flow Reserve and Adverse Outcomes
Is fractional flow reserve (FFR) associated with clinical outcomes?
Data from the FAME 2 (Fractional Flow Reserve vs. Angiography for Multivessel Evaluation 2) trial were used for the present analysis. Patients with one or more coronary artery stenosis demonstrated with an FFR of 0.80 or lower were randomized to percutaneous coronary intervention or medical therapy alone. Patients with FFRs <0.80 but angiographically significant stenosis were treated with medical therapy and followed in a prospective registry. For the present analysis, only participants who received medical therapy alone were included. The primary outcome of interest was major adverse cardiovascular events (MACE) defined as cardiovascular death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization (both urgent and nonurgent) at 2 years.
A total of 607 patients who received medical therapy alone were included in this analysis. Risk factors for coronary artery disease were common in the study population. No significant differences in risk factors were experienced between patients who experienced MACE or not, with the exception of angina class. MACE was associated with increased complex stenosis. FFR values were mostly distributed in the range between 0.70 and 0.90. MACE occurred in 272 (26.5%) out of 1,029 lesions. Target lesions with diameter stenosis ≥70% were more frequent in the MACE group (p < 0.01). Median FFR was significantly lower in the MACE group versus the non-MACE group (0.68 [interquartile range, 0.54-0.77] vs. 0.80 [interquartile range, 0.70-0.88]; p < 0.01). The cumulative incidence of MACE significantly increased with increasing FFR quartiles. An average decrease in MACE per 0.05 unit increase in FFR was statistically significant even after adjustment for all clinical and angiographic features (odds ratio, 0.81; 95% confidence interval [CI], 0.76-0.86]). The strongest increase in MACE occurred for FFR values between 0.80 and 0.60. In multivariable analysis, FFR was significantly associated with MACE up to 2 years (hazard ratio, 0.87; 95% CI, 0.83-0.91).
The investigators concluded that among patients with stable coronary disease, stenosis severity as assessed by FFR is a major and independent predictor of lesion-related outcome.
These data suggest that FFR may assist in risk stratification of patients undergoing coronary angiography.
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