Conditional power analysis of the DEBUT trial

Tuomas Rissanen and colleagues reported a statistically significantly reduced incidence of major adverse cardiac events in patients with de-novo coronary artery lesions at a high risk of bleeding treated with a drug-coated balloon compared with those treated with a bare-metal stent. In this study, the absolute difference in major adverse cardiac events at 9 months was reported as −13·2 percentage points (95% CI −6·2 to −21·1). Therefore, the authors claimed that percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stent in patients at risk of bleeding. However, we believe that these results should be interpreted with caution.