FAME 2 global ischemic risk score and clinical outcome in patients with stable coronary disease receiving medical therapy alone

Abstract

Purpose: We sought to investigate the relationship between global ischemia and clinical outcome in patients with stable coronary disease. Methods: This FAME 2 sub-analysis was conducted in 607 patients (pts) with at least one diseased major coronary artery, and receiving medical therapy (MT) alone (441 pts in the randomized trial and 166 pts with follow-up in the registry). We analyzed the rate of a composite of cardiovascular death, myocardial infarction, and ischemia-driven target lesion revascularization (MACE) in relation to a FAME 2 global ischemic risk score, defined as the sum of the individual risks of MACE for each target lesion and calculated as following: ∑1.3(1-FFRlesion)/0.05. Results: At least one MACE occurred in 95 pts (15.7%) at a median follow-up of 172 (80-284) days. Mean FAME 2 score was significantly higher in pts with MACE than in pts w/o MACE (16.2±18.7 vs. 9.4±12.1, p<0.0001). At multivariate Cox regression analysis (adjusted for age, hypertension, hypercholesterolemia, CCS class, silent ischemia and the number of vessel disease), FAME 2 score as a continuous variable was significantly associated with MACE (p=0.001, HR [95% CI]: 1.019 [0.008-0.030]). Kaplan-Meier analysis of 1-year MACE-free survival showed a significant difference between the three tertiles of the FAME 2 score (Log-rank 32.88, p<0.0001). Taking into account the localization of the stenotic segment, as weighted by the Leaman score, did not improve the predictive value of the FAME 2 score for MACE. Conclusions: The FAME 2 global ischemic risk score is an independent predictor of clinical outcome at 1-year follow-up. The data also suggest that, in the short term, the severity of ischemia (depth) is prognostically more important than its extent (breadth).