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.
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Rissanen, T. T. et al. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet https://doi.org/10.1016/S0140-6736(19)31126-2 (2019)
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Lim, G.B. Drug-coated balloons for high-bleeding-risk PCI. Nat Rev Cardiol 16, 516 (2019). https://doi.org/10.1038/s41569-019-0237-7
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DOI: https://doi.org/10.1038/s41569-019-0237-7