Evidence map›Paper›PMID 38506736›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024

Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.

Kazuki Aihara, Sho Torii, Masatoshi Ito, Kaito Koseki, Manabu Shiozaki, Yu Sato, Norihito Nakamura, Ayako Yoshikawa, Yuji Ikari, Gaku Nakazawa

Registry-linked trialOpen access · greenAbstract readComparative Study
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06373601 (Selution Sirolimus Coated Balloon), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
9.2field-weighted citation impact, top 2% of its field
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.

NCT06373601 narecruitingnot on this map

Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.

TypeinterventionalSponsorFondazione Evidence per Attività e Ricerche Cardiovascolari ONLUSRan2024 to 2027Enrolled140ConditionsCoronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion, Percutaneous Coronary InterventionArmssirolimus-eluting balloon (Selution), paclitaxel-eluting balloon (SeQuent Please Neo)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Enhanced Drug Effect With Cutting Balloon Followed by Drug Coated Balloon in a Rabbit Model.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Article
  6. Article
  7. Article
  8. Reply: Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  9. Letter: Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  10. Comparative preclinical assessment of drug-coated balloons: a blessing and a curse for clinical translation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    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

10 authors at 2 institutions in 1 country.

Kazuki AiharaDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Sho ToriiDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Masatoshi ItoSupport Center for Medical Research and Education, Tokai University, Isehara, Japan.
Kaito KosekiDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Manabu ShiozakiDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Yu SatoDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Norihito NakamuraDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Ayako YoshikawaDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Yuji IkariDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Gaku NakazawaDepartment of Cardiology, Kindai University Faculty of Medicine, Osaka, Japan.
Tokai University · JPKindai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug-coated balloons (DCBs) are important treatment options for coronary artery disease; however, randomised controlled trials comparing various DCB technologies are sparse, and further investigations are needed.

aimsThis preclinical study aimed to histologically and biologically compare the drug effects and safety of a low-dose paclitaxel-coated DCB (PCB; AGENT), a regular-dose PCB (SeQuent Please NEO) and a sirolimus-coated DCB (SCB; MagicTouch).

methodsThe DCBs were inflated in the healthy iliac arteries of 18 rabbits, which were euthanised after 28 days. The treated iliac arteries and distal skeletal muscles were histopathologically evaluated, and drug concentrations were measured.

resultsIn the histopathological evaluation, the medial smooth muscle cell loss score regarding depth, an indicator of drug efficacy, was significantly higher with AGENT and SeQuent Please NEO than with MagicTouch (4.0 [3.6-4.0] vs 3.7 [3.7-4.0] vs 2.2 [2.0-2.4]), with significant differences in comparisons between AGENT and MagicTouch (p<0.01) and between SeQuent Please NEO and MagicTouch (p<0.01). AGENT and SeQuent Please NEO showed comparable drug concentrations in the treated artery (p=0.61). In contrast, the drug concentrations in distal skeletal muscles were the highest for MagicTouch, followed by SeQuent Please NEO and AGENT (28.07 [13.19-52.46] ng/mg vs 0.66 [0.22-3.76] ng/mg vs 0.25 [0.04-3.23] ng/mg, respectively).

conclusionsThis study demonstrated that PCBs might have higher efficacy and lower drug concentrations in distal skeletal muscles than the MagicTouch SCB. The efficacy of the AGENT low-dose PCB and the SeQuent Please NEO regular-dose PCB was comparable.

Indexed as

PaclitaxelSirolimusAngioplasty, Balloon, CoronaryAnimalsCardiovascular AgentsCoated Materials, BiocompatibleCoronary Artery DiseaseDisease Models, AnimalIliac ArteryMaleRabbitsCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxelSirolimus

Identifiers

PMID38506736
PMCPMC10941670
OpenAlexW4392848288

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.