This study compared 9-month angiographic and physiologic results in patients with high bleeding risk treated with either paclitaxel-coated balloon (PCB) or bare-metal stent (BMS). A total of 40 patients with high bleeding risk who underwent successful balloon angioplasty with fractional flow reserve (FFR) after balloon angioplasty more than 0.80 were randomized 1 : 1 to treatment with PCB versus BMS. There was no significant difference in the postprocedural FFR (0.87±0.06 in PCB vs. 0.89 ± 0.06 in BMS, P=0.254). At 9 months, late luminal loss was significantly lower in the PCB group (0.2 ±0.3 vs. 1.2 ±0.8 mm, P<0.001). Restenosis only occurred in the BMS group (0 vs. 25.0%, P=0.049). In patients with high bleeding risk, FFR-guided PCB treatment showed superior efficacy in terms of angiographic and physiologic patency compared with BMS at mid-term follow-up.