1. (p < 0.001 for noninferiority)
DEFINE-FLAIR
Trial design: Patients undergoing functional assessment of an indeterminant coronary lesion were randomized to iFR (n = 1,242) versus FFR (n = 1,250).
Results
(p < for noninferiority)
All-cause death, MI, or unplanned revasc. at 12 months: 6.8% of the iFR group versus 7.0% of the FFR group (p < for noninferiority)
Death: 1.9% for iFR vs. 1.1% for FFR
MI: 2.7% for iFR vs. 2.4% for FFR
Unplanned revascularization: 4.0% for iFR vs. 5.3% for FFR
7.0
6.8 %
Conclusions
Among patients undergoing functional determination of an indeterminant coronary stenosis for stable or unstable coronary disease, iFR was noninferior to FFR; threshold to revascularize: ≤0.89 for iFR, ≤0.80 for FFR
Adverse cardiac events were similar between study groups
iFR
FFR
Davies JE, et al. N Engl J Med 2017;Mar 18:[Epub]