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Paclitaxel-coated balloons with different drug-excipient formulations appear to provide comparable outcomes in coronary interventions. A head-to-head study published in Clinical Research in Cardiology compared one-year results between urea-based and iopromide-based paclitaxel-coated balloons in 448 patients treated between 2021 and 2024 across two centers.

At one year, both groups showed identical TLF (8.1%), which included target lesion revascularization, target vessel myocardial infarction, and cardiac death. The adjusted hazard ratio for TLF was 0.90 (95% CI, 0.27–3.00). Secondary endpoints were similar, and subgroup analyses showed no significant differences by lesion type.

These findings indicate that both paclitaxel-coated balloon formulations achieve consistent efficacy and safety in real-world coronary angioplasty. The evidence supports flexible device selection based on procedural needs and availability rather than formulation type.
 

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Key highlights
  • One-year target lesion failure (TLF) was identical at 8.1% for both urea- and iopromide-based paclitaxel-coated balloons.
  • Adjusted hazard ratio: 0.90 (95% CI, 0.27–3.00); no significant difference in secondary endpoints.
  • No subgroup variation observed by lesion type, including de novo and in-stent restenosis.
Source

Gitto M, Tartaglia F, Leone PP, et al. Paclitaxel-coated balloon with urea or iopromide as the excipient for treatment of coronary artery disease. Clin Res Cardiol. Published online October 27, 2025. doi:10.1007/s00392-025-02758-6

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Paclitaxel-Coated Balloons Show Similar One-Year Outcomes Across Drug Formulations
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Head-to-head comparison finds no safety or efficacy difference between urea- and iopromide-based devices in coronary interventions

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