In a broad real-world patient population, the paclitaxel-coated balloon with urea had comparable 2-year clinical outcomes with other contemporary drug-coated balloons across all measured endpoints.
Major adverse cardiovascular events (MACE) at 2 years were similar between the PCB with urea and other DCB.
All-cause mortality at 2 years was not significantly different between the two DCB groups.
Myocardial infarction rates at 2 years showed a numerically lower but non-significant trend favoring PCB with urea.
Target lesion revascularization rates at 2 years were comparable between the two groups.
Target lesion definite thrombosis rates at 2 years were low and similar between the two groups.
New revascularization with PCI at 2 years was not significantly different between groups.
The study population represented a broad, complex real-world patient and lesion mix treated with DCB.
PCB with urea represented a minority of total DCB use in Sweden during the study period.
This research suggests that a specific type of drug-coated balloon (DCB) used during heart procedures — one that uses a drug called paclitaxel combined with a substance called urea — performs similarly to other commonly used drug-coated balloons over a 2-year period. The study analyzed over 6,000 real-world procedures performed across Sweden, drawing from a comprehensive national registry. Patients treated included many with complex conditions such as diabetes, acute heart attacks, and previously placed stents that had become blocked again. Across every outcome measured — including death from any cause, heart attacks, need for repeat procedures, and rare but serious complications like clot formation at the treated site — there were no statistically significant differences between the paclitaxel-urea balloon and the other drug-coated balloons. The event rates were numerically similar or slightly lower for the paclitaxel-urea group in several categories, but the differences were small enough that they could be due to chance. This research matters because drug-coated balloons are widely used alternatives to permanent stents during heart procedures, yet head-to-head comparison data between different balloon types are limited. By using a large national registry and advanced statistical methods to account for differences between patient groups, this study provides real-world evidence supporting the safety and effectiveness of the paclitaxel-urea balloon as comparable to other available options. This information could help guide clinicians when choosing between different DCB products.
von Koch S, Frank E, Gabrysch K, James S, Götberg M, Mohammad M, et al.. (2026). Real-World Usage of a Paclitaxel-Coated Balloon With Urea Compared With Other Contemporary Drug-Coated Balloons: A 2-Year Analysis From SCAAR in Over 6000 Patients.. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.125.045621