Evidence map›Paper›PMID 39070273›Full record

ArticleJACC. Basic to translational science2024

Efficacy and Safety of Dual Paclitaxel and Sirolimus Nanoparticle-Coated Balloon.

Kenji Kawai, Mohammed Tanjimur Rahman, Ryan Nowicki, Frank D Kolodgie, Atsushi Sakamoto, Rika Kawakami, Takao Konishi, Renu Virmani, Vinod Labhasetwar, Aloke V Finn

Registry-linked trialAbstract read
In one paragraph

Article in JACC. Basic to translational science, 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 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Treatment Options in Isolated Atherosclerotic Popliteal Artery Disease.Journal of cardiovascular development and disease · 2025
    Review
  6. Article
  7. Review
  8. Article
  9. 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.

Kenji KawaiCVPath Institute, Gaithersburg, Maryland, USA.
Mohammed Tanjimur RahmanDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Ryan NowickiAdvanced NanoTherapies, Inc, Los Gatos, California, USA.
Frank D KolodgieCVPath Institute, Gaithersburg, Maryland, USA.
Atsushi SakamotoCVPath Institute, Gaithersburg, Maryland, USA.
Rika KawakamiCVPath Institute, Gaithersburg, Maryland, USA.
Takao KonishiCVPath Institute, Gaithersburg, Maryland, USA.
Renu VirmaniCVPath Institute, Gaithersburg, Maryland, USA.
Vinod LabhasetwarDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Aloke V FinnCVPath Institute, Gaithersburg, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated a novel dual active pharmaceutical ingredient (API) drug-coated balloon (DCB), which consists of a coating of nanoparticles encapsulating low-dose paclitaxel (PTX) in combination with sirolimus in a synergistic ratio. Compared to the PTX DCB, the dual API DCB demonstrated similar inhibition of cell proliferation in vitro but at a significantly lower total drug dose (over 13 times lower than sirolimus nanoparticles). Animal experiments demonstrated that the dual API DCB is more effective in inhibiting intimal cell proliferation with insignificant downstream embolic effects and myocardial damage compared to the PTX DCB. These findings indicate that dual API DCBs have a high potential to demonstrate improved clinical outcomes and a greater safety profile than the PTX DCBs.

Indexed as

downstream embolizationdrug-coated balloonmyocardium injurypreclinical researchvascular response

Identifiers

PMID39070273
PMCPMC11282887

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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.