Impact for Treatment Decision-Making and Clinical Outcome of Angiography-Derived Fractional Flow Reserve.

Pressure wire-based fractional flow reserve (FFR) is the reference standard for physiologic lesion assessment but remains underutilized owing to the need for hyperemia, procedural complexity, and wire-related risks. Angiography-derived FFR provides a wire- and hyperemia-free assessment derived from routine angiography; however, its clinical impact in guiding treatment remains uncertain. This study aimed to determine whether angiography-derived FFR is noninferior to pressure wire-based FFR in guiding revascularization decisions among patients with stable coronary artery disease. PROVISION (Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance) was a prospective, multicenter, randomized study. Participants were randomized 1:1 to angiography-derived FFR-guided or pressure wire-based FFR-guided revascularization. The primary endpoint was the noninferiority of angiography-derived FFR in terms of revascularization rate, defined as the proportion of patients undergoing percutaneous coronary intervention or coronary artery bypass grafting based on physiologic assessment. Secondary endpoints included the 1-year incidence of major adverse cardiac events (cardiac death, any myocardial infarction, or ischemia-driven target vessel revascularization). Overall, 401 patients (483 vessels) were enrolled at 13 Japanese centers. Revascularization was performed in 41.4% of patients in the angiography-derived FFR group and 37.9% in the pressure wire-based FFR group (absolute difference: 3.5%; 95% CI: -6.0 to 13.1; P for noninferiority = 0.049). At 1 year, major adverse cardiovascular events occurred in 8.4% and 10.1% of patients, respectively (HR: 0.84; 95% CI: 0.44-1.60; P = 0.591). Angiography-derived FFR-guided revascularization was noninferior to pressure wire-based FFR-guided strategy for determining revascularization in patients with stable coronary artery disease. This finding suggests that angiography-derived FFR may serve as a practical, wire-free alternative for physiologic guidance of coronary revascularization, warranting confirmation in larger outcome-driven trials. (PROVISION; UMIN000049230).