Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results

Background: Fractional flow reserve (FFR) and optical coherence tomography (OCT) may help both in assessment and in percutaneous coronary intervention optimization of angiographically intermediate coronary lesions. We designed a prospective trial comparing the clinical and economic outcomes associated with FFR or OCT in angiographically intermediate coronary lesions. Methods and Results: Three hundred fifty patients with angiographically intermediate coronary lesions (n=446) were randomized to FFR or OCT guidance. In the FFR arm, percutaneous coronary intervention was performed if FFR was ≤0.80 aiming for a postprocedure FFR >0.90. In the OCT arm, percutaneous coronary intervention was performed if percentage of area stenosis was ≥75% or 50% to 75% with minimal lumen area <2.5 mm2 or plaque ulceration. Costs, angina frequency, and major adverse cardiac events were assessed at 1 month and at 13 months. We present early data at 1 month consistent with a prespecified analysis of secondary end points. Patients randomized to FFR, as compared with OCT, were significantly more commonly managed with medical therapy alone (67.7% versus 41.1%; P<0.001), required less contrast media (245±137 versus 280±129 mL; P=0.004), and exhibited a lower occurrence of contrast-induced acute kidney injury (1.7% versus 8.6%; P=0.034). At 1 month, in comparison to FFR, OCT was associated with increased total costs (2831±1288 versus 4292±3844 euros/patient; P<0.001) whereas occurrence of major adverse cardiac events or significant angina was similar. Conclusions: In patients with angiographically intermediate coronary lesions, a functional guidance by FFR, as compared with OCT, increased the rate of patients treated with medical therapy alone. This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR. Clinical Trial Registration: URL: http://www.clinicaltrialsgov. Unique identifier: NCT01824030.