Rissanen TT, et al. - Via the DEBUT trial, a randomized, single-blind non-inferiority trial conducted at five sites in Finland including 220 patients who had an ischemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2.5–4.0 mm, researchers tested the premise that percutaneous coronary intervention in this population with drug-coated balloons was not inferior to percutaneous coronary intervention with bare-metal stents. Out of 220 patients, 208 were randomized into percutaneous coronary intervention with a drug-coated balloon (n=102) or bare-metal stent (n=106). At 9 months, in the drug-coated balloon group and in the bare-metal stent group, major adverse cardiac events had occurred in 1 and 15 subjects, respectively. In the bare metal stent group, two definitive stent thrombosis events occurred, however, no acute vessel closures in the drug-coated balloon group were seen. In patients at risk for bleeding, percutaneous coronary intervention with a drug-coated balloon was concluded to be better than bare-metal stents. The drug-coated balloon-only coronary intervention was concluded as a novel approach to treat this population. A comparison of this procedure to the new generation drug-eluting stents is justified.