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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

von Koch, Sacharias LU orcid ; Frank, Erika ; Gabrysch, Katja ; James, Stefan ; Götberg, Matthias LU ; Mohammad, Moman A LU orcid and Erlinge, David LU orcid (2026) In Journal of the American Heart Association 15(11).
Abstract

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... (More)

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.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of the American Heart Association
volume
15
issue
11
publisher
Wiley-Blackwell
external identifiers
  • pmid:42216271
ISSN
2047-9980
DOI
10.1161/JAHA.125.045621
language
English
LU publication?
yes
id
f1de9623-220e-45ed-998f-94b3f9c944b5
date added to LUP
2026-06-03 09:05:43
date last changed
2026-06-10 09:13:03
@article{f1de9623-220e-45ed-998f-94b3f9c944b5,
  abstract     = {{<p>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.</p><p>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.</p><p>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]).</p><p>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.</p>}},
  author       = {{von Koch, Sacharias and Frank, Erika and Gabrysch, Katja and James, Stefan and Götberg, Matthias and Mohammad, Moman A and Erlinge, David}},
  issn         = {{2047-9980}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{11}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Journal of the American Heart Association}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1161/JAHA.125.045621}},
  doi          = {{10.1161/JAHA.125.045621}},
  volume       = {{15}},
  year         = {{2026}},
}