Fractional flow reserve‐guided paclitaxel‐coated balloon treatment for de novo coronary lesions

OBJECTIVES: To assess the safety and efficacy of fractional flow reserve (FFR) guided paclitaxel-coated balloon (PCB) treatment for de novo coronary artery lesions. BACKGROUND: There is limited data on PCB treatment for de novo lesions especially of major epicardial coronary arteries. METHODS: Sixty-six patients with 67 de novo lesions who underwent successful plain old balloon angioplasty (POBA) were included. If POBA-FFR was favorable (≥ 0.85), PCB was applied and if POBA-FFR was <0.85, stent implantation was preferred over PCB. RESULTS: Forty-five lesions were treated with PCB (67.2%) and 22 lesions with stents (32.8%). Dual antiplatelet therapy duration was 6 weeks. Late luminal loss with PCB was significantly less than stent (0.05 ± 0.27 mm vs. 0.40 ± 0.54 mm, P = 0.022). The baseline FFR of target lesions was 0.69 ± 0.16 in PCB and 0.60 ± 0.11 in stent group (P = 0.015), however, the FFR at 9 months was not different between groups (0.85 ± 0.08 in PCB vs. 0.85 ± 0.05 in stent group, P = 0.973). At 1 year, one myocardial infarction and one target lesion revascularization related to in-stent restenosis were detected, both in the stent group. CONCLUSION: POBA-FFR-guided PCB treatment is safe and effective for de novo coronary lesions with good anatomical and physiological patency at mid-term follow-up. © 2015 Wiley Periodicals, Inc.