In the single-blind DEBUT trial, the use of balloons coated with paclitaxel and iopromide was compared with the use of bare-metal stents for percutaneous coronary intervention (PCI) in patients at high risk of bleeding. After successful predilatation of the target lesion, a total of 208 patients were randomly assigned to PCI with a drug-coated balloon or bare-metal stent. The primary outcome (major adverse cardiac event at 9 months) occurred in 1% and 14% of patients in each group, respectively (risk ratio 0.07, 95% CI 0.01–0.52, P < 0.00001 for noninferiority, P = 0.00034 for superiority). Two definite stent thrombosis events occurred with bare-metal stents, whereas no acute vessel closures occurred with drug-coated balloons. In future studies, drug-coated balloons should be compared with drug-eluting stents in patients at high risk of bleeding.