Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions.

BACKGROUND In patients with high bleeding risk, percutaneous coronary intervention is still debated. This study compared 9-month angiographic and physiologic results in patients with high bleeding risk and de novo coronary lesions treated with either paclitaxel-coated balloon (PCB) or bare-metal stent (BMS). PATIENTS AND METHODS A total of 40 patients (40 lesions) 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. Dual antiplatelet therapy was limited to 1 month after the procedure. RESULTS Baseline clinical and lesional characteristics were well balanced between the two groups. 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). CONCLUSION 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 with only 1 month of dual antiplatelet therapy (Clinicaltrials.gov identifier, NCT02456402).