Comparative data between different drug-coated balloon (DCB) technologies remain limited, particularly for paclitaxel-coated balloons (PCBs) using urea as an excipient. A real-world analysis published in the Journal of the American Heart Association evaluated the long-term clinical performance of a urea-based PCB compared with other commonly used DCBs in routine percutaneous coronary intervention (PCI) practice.

The study used data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and included all PCI procedures performed with DCBs in Sweden between August 2021 and May 2024. Propensity score-weighted multivariable Cox regression and Kaplan-Meier analyses were used to assess outcomes through 2 years of follow-up.

Findings

• The analysis included 6,488 DCB procedures, including 1,797 procedures with the PCB using urea and 4,691 procedures with other DCBs.
• The study population included high-risk and complex lesions, including 32.4% with diabetes, 64.2% with acute coronary syndrome, 20.5% bifurcation lesions, and 33.0% in-stent restenosis.
• At 2 years, major adverse cardiovascular events occurred in 16.4% of patients treated with the PCB using urea and 18.4% treated with other DCBs (HR 1.01; 95% CI 0.84–1.22).
• All-cause mortality (7.2% vs 8.2%; HR 1.05; 95% CI 0.80–1.39) and myocardial infarction rates (6.1% vs 8.0%; HR 0.81; 95% CI 0.59–1.11) were comparable between groups.
• Rates of repeat coronary intervention remained similar between the PCB using urea and other DCB groups, including new PCI (14.6% vs 14.9%), target lesion revascularization (7.4% vs 8.7%), and target vessel revascularization (10.5% vs 11.3%).
• Definite target lesion thrombosis occurred infrequently and was similar between groups (0.8% vs 1.3%; HR 0.93; 95% CI 0.41–2.11).

The findings showed that the paclitaxel-coated balloon with urea excipient achieved comparable 2-year clinical outcomes to other contemporary DCB technologies across a broad real-world PCI population.