Evidence map›Paper›PMID 41143901›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2026

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

Mauro Gitto, Francesco Tartaglia, Pier Pasquale Leone, Gianmaria Calamita, Alessandro Gabrielli, Leon Gramss, Marco Luciano Rossi, Damiano Regazzoli, Gabriele Gasparini, Ottavia Cozzi and 5 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Routine versus selective use of a femoral protection wire in transfemoral TAVI: a single-centre analysis of vascular complications.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  2. Article
  3. Article
  4. A novel sirolimus-coated balloon versus a paclitaxel-coated balloon for coronary artery disease: the SELSEQ registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  5. Paclitaxel-coated balloon with urea or iopromide as the excipient for treatment of coronary artery disease.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Mauro Gitto *Department of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Francesco Tartaglia *Department of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Pier Pasquale LeoneDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Gianmaria CalamitaDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Alessandro GabrielliDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Leon GramssDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Marco Luciano RossiEMO-GVM Centro Cuore Columbus, Milan, Italy.
Damiano RegazzoliHumanitas Research Hospital IRCCS, Rozzano - Milan, 20089, Italy.
Gabriele GaspariniHumanitas Research Hospital IRCCS, Rozzano - Milan, 20089, Italy.
Ottavia CozziDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Bernhard ReimersDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Giulio Giuseppe StefaniniDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Antonio MangieriDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy.
Azeem LatibMontefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.
Antonio ColomboDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele - Milan, Italy. ac84344@gmail.com.ORCID http://orcid.org/0000-0002-2940-2455

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug-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.

methodsConsecutive 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. 

resultsA 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; p

Indexed as

Angioplasty, Balloon, CoronaryCoated Materials, BiocompatibleCoronary Artery DiseaseExcipientsIohexolPaclitaxelUreaAgedCoronary AngiographyFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeCoated Materials, BiocompatibleExcipientsIohexoliopromidePaclitaxelUreaDrug-coated balloonPaclitaxelPercutaneous coronary interventionPrevailSequent Please

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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.