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Background <p>Drug-coated balloons (DCBs) are increasingly used to treat coronary artery disease, and their safety and efficacy profile can vary based on the eluted drug and excipient. Head-to-head comparisons of paclitaxel-coated balloons (PCBs) according to contemporary excipient formulations are scant.</p> Methods <p>Consecutive patients undergoing DCB angioplasty with either urea PCB (Prevail, Medtronic, Dublin, Ireland) or iopromide PCB (Sequent Please / NEO, B. Braun, Melsungen, Germany) at two Italian institutions from 2021 to 2024 were retrospectively enrolled. The primary endpoint was target lesion failure (TLF), a composite including target lesion revascularization, target vessel myocardial infarction, and cardiac death, at 1&#xa0;year. Clinical endpoints were compared through propensity score adjustment for clinical and angiographic variables.&#xa0;</p> Results <p>A total of 448 patients were included, with 211 patients (240 lesions) treated with urea PCB and 237 patients (287 lesions) treated with iopromide PCB. The prevalence of in-stent restenosis (ISR) was 30% in the urea PCB group and 23% in the iopromide PCB (<i>p</i> = 0.070). At 1&#xa0;year, the cumulative incidence of TLF was 8.1% in both groups (adjusted hazard ratio (HR): 0.90, 95% CI: 0.27–3.00). Rates of secondary endpoints were also similar. Subgroup analyses showed no significant interaction between treatment groups and any of the prespecified subgroups, including lesion type (de novo vs. in-stent restenosis; <i>p</i><sub>interaction</sub> = 0.848).&#xa0;</p> Conclusions <p>In this first head-to-head comparison, the Prevail urea PCB and Sequent Please / NEO iopromide PCB demonstrated comparable clinical safety and efficacy profiles at 1&#xa0;year.&#xa0;</p> Graphical abstract <p>Paclitaxel-coated balloon with urea or iopromide as the excipient for treatment of coronary artery disease: a propensity score-adjusted comparison.</p> <p>CKD, chronic kidney disease; HR, hazard ratio; ISR, in-stent restenosis; IV, intravascular; PCB, paclitaxel-coated balloon; PCI, percutaneous coronary intervention; TLR, target lesion revascularization; TVF, target vessel failure; TVR, target vessel revascularization; TV-MI, target vessel myocardial infarction</p> <p></p>

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Paclitaxel-coated balloon with urea or iopromide as the excipient for treatment of coronary artery disease

  • 期刊论文

  • 发表日期：

    2025年10月27日

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  • Mauro Gitto,
  • Francesco Tartaglia,
  • Pier Pasquale Leone,
  • Gianmaria Calamita,
  • Alessandro Gabrielli,
  • Leon Gramss,
  • Marco Luciano Rossi,
  • Damiano Regazzoli,
  • Gabriele Gasparini,
  • Ottavia Cozzi,
  • Bernhard Reimers,
  • Giulio Giuseppe Stefanini,
  • Antonio Mangieri,
  • Azeem Latib,
  • Antonio Colombo

摘要

Background

Drug-coated balloons (DCBs) are increasingly used to treat coronary artery disease, and their safety and efficacy profile can vary based on the eluted drug and excipient. Head-to-head comparisons of paclitaxel-coated balloons (PCBs) according to contemporary excipient formulations are scant.

Methods

Consecutive patients undergoing DCB angioplasty with either urea PCB (Prevail, Medtronic, Dublin, Ireland) or iopromide PCB (Sequent Please / NEO, B. Braun, Melsungen, Germany) at two Italian institutions from 2021 to 2024 were retrospectively enrolled. The primary endpoint was target lesion failure (TLF), a composite including target lesion revascularization, target vessel myocardial infarction, and cardiac death, at 1 year. Clinical endpoints were compared through propensity score adjustment for clinical and angiographic variables. 

Results

A total of 448 patients were included, with 211 patients (240 lesions) treated with urea PCB and 237 patients (287 lesions) treated with iopromide PCB. The prevalence of in-stent restenosis (ISR) was 30% in the urea PCB group and 23% in the iopromide PCB (p = 0.070). At 1 year, the cumulative incidence of TLF was 8.1% in both groups (adjusted hazard ratio (HR): 0.90, 95% CI: 0.27–3.00). Rates of secondary endpoints were also similar. Subgroup analyses showed no significant interaction between treatment groups and any of the prespecified subgroups, including lesion type (de novo vs. in-stent restenosis; pinteraction = 0.848). 

Conclusions

In this first head-to-head comparison, the Prevail urea PCB and Sequent Please / NEO iopromide PCB demonstrated comparable clinical safety and efficacy profiles at 1 year. 

Graphical abstract

Paclitaxel-coated balloon with urea or iopromide as the excipient for treatment of coronary artery disease: a propensity score-adjusted comparison.

CKD, chronic kidney disease; HR, hazard ratio; ISR, in-stent restenosis; IV, intravascular; PCB, paclitaxel-coated balloon; PCI, percutaneous coronary intervention; TLR, target lesion revascularization; TVF, target vessel failure; TVR, target vessel revascularization; TV-MI, target vessel myocardial infarction