Background

Drug‐coated balloons (DCB) are frequently used during percutaneous coronary intervention. Despite this there are limited data from studies comparing different types of DCB, particularly for a paclitaxel‐coated balloon (PCB) using urea as the excipient. This study aimed to assess the clinical efficacy of the PCB with urea compared with other frequently used DCB, attempting to emulate a target trial using observational data.

Methods

SCAAR (Swedish Coronary Angiography and Angioplasty Registry) is a nationwide registry including data on all patients in Sweden undergoing coronary angiography. For this study, all procedures with DCB in Sweden between August 2021 and May 2024 were included. Propensity score weighted multivariable Cox regression analysis and Kaplan–Meier estimates were used to assess outcomes through 2 years.

Results

A total of 1797 (27.7%) procedures with the PCB with urea and 4691 (72.3%) procedures with Other DCB were eligible for this analysis. DCB treatment was performed in a variety of patients and lesions including 32.4% diabetes, 64.2% acute coronary syndrome, 20.5% bifurcations and 33.0% in‐stent restenosis. After 2 years, the event rates for the PCB with urea and Other DCB were 16.4% versus 18.4% for major adverse cardiovascular events (hazard ratio [HR] 1.01 [95% CI 0.84–1.22]), 7.2% versus 8.2% for all‐cause mortality (HR 1.05 [95% CI 0.80–1.39]), 6.1% versus 8.0% for myocardial infarction (HR 0.81 [95% CI 0.59–1.11]), 14.6% versus 14.9% for new revascularization with percutaneous coronary intervention (HR 1.02 [95% CI 0.83–1.25]), 0.8% versus 1.3% for target lesion definite thrombosis (HR 0.93 [95% CI 0.41–2.11]), 7.4% versus 8.7% for target lesion revascularization (HR 0.95 [95% CI 0.70–1.29]), and 10.5% versus 11.3% for target vessel revascularization (HR 0.99 [95% CI 0.76–1.29]).

Conclusions

In this analysis evaluating 2‐year clinical outcomes after DCB, in a broad patient population, the PCB with urea had comparable outcomes with other contemporary DCB. This data further support the safety and efficacy of the PCB with urea.