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
The Lancet Jun 19, 2019
Rissanen TT, et al. - Via the DEBUT trial, a randomized, single-blind non-inferiority trial with 220 patients, researchers hypothesized that percutaneous coronary intervention with drug-coated balloons was non-inferior to percutaneous coronary intervention with bare-metal stents in a population with high bleeding risk. In patients at bleeding risk, percutaneous coronary intervention with the drug-coated balloon was superior to bare-metal stents. Major adverse cardiac events were seen in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group at 9 months.
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