Evidence map›Paper›PMID 42216271›Full record

Observational studyJournal of the American Heart Association2026

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.

Sacharias von Koch, Erika Frank, Katja Gabrysch, Stefan James, Matthias Götberg, Moman A Mohammad, David Erlinge

Abstract readComparative StudyObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Sacharias von KochDepartment of Cardiology, Clinical Sciences Lund University, Skåne University Hospital Lund Sweden.ORCID 0009-0005-8398-4221
Erika FrankUppsala Clinical Research Center Uppsala University Uppsala Sweden.ORCID 0009-0005-5625-4995
Katja GabryschUppsala Clinical Research Center Uppsala University Uppsala Sweden.ORCID 0009-0003-4234-8814
Stefan JamesUppsala Clinical Research Center Uppsala University Uppsala Sweden.ORCID 0000-0003-4413-9736
Matthias GötbergDepartment of Cardiology, Clinical Sciences Lund University, Skåne University Hospital Lund Sweden.ORCID 0000-0002-0912-7927
Moman A MohammadDepartment of Cardiology, Clinical Sciences Lund University, Skåne University Hospital Lund Sweden.ORCID 0000-0003-4242-9801
David ErlingeDepartment of Cardiology, Clinical Sciences Lund University, Skåne University Hospital Lund Sweden.ORCID 0000-0003-3042-5766

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug-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.

methodsSCAAR (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.

resultsA 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]).

conclusionsIn 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.

Indexed as

Angioplasty, Balloon, CoronaryCardiac CathetersCoated Materials, BiocompatibleCoronary Artery DiseasePaclitaxelUreaAgedCardiovascular AgentsCoronary AngiographyEquipment DesignFemaleHumansMaleMiddle AgedRegistriesSwedenCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxelUreadrug‐coated balloonspaclitaxelpercutaneous coronary intervention

Identifiers

PMID42216271
PMCPMC13315143

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.