Evidence map›Paper›PMID 23584359›Full record

ArticleCirculation2013

Mechanisms of tissue uptake and retention in zotarolimus-coated balloon therapy.

Vijaya B Kolachalama, Stephen D Pacetti, Joseph W Franses, John J Stankus, Hugh Q Zhao, Tarek Shazly, Alexander Nikanorov, Lewis B Schwartz, Abraham R Tzafriri, Elazer R Edelman

Open access · bronzeAbstract read
In one paragraph

Article in Circulation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
7.6field-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.

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

31 citing papers in PubMed, 81 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Outcomes of atherectomy in patients undergoing lower extremity revascularisation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  14. Article
  15. Review
  16. The factors influencing the efficiency of drug-coated balloons.Frontiers in cardiovascular medicine · 2022
    Review
  17. Article
  18. Article
  19. Article
  20. Taking paclitaxel coated balloons to a higher level: Predicting coating dissolution kinetics, tissue retention and dosing dynamics.Journal of controlled release : official journal of the Controlled Release Society · 2019
    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.

Vijaya B KolachalamaHarvard–MIT Division of Health Sciences and Technology, Cambridge, MA, USA. vkolachalama@draper.com
Stephen D Pacetti
Joseph W Franses
John J Stankus
Hugh Q Zhao
Tarek Shazly
Alexander Nikanorov
Lewis B Schwartz
Abraham R Tzafriri
Elazer R Edelman
Draper Laboratory · USUniversity of South Carolina · US

Funding

Medical Scientist Training ProgramT32GM007753 · NIGMS · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI WALENSKY, LOREN DAVID · 1985 to 2021
$50.0M
Vascular Drug Delivery - Supplement for EquipmentR01GM049039 · NIGMS · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI EDELMAN, ELAZER R · 1994 to 2019
$8.9M
NIGMS NIH HHS R01 GM049039NIGMS NIH HHS R01 GM-49039NIGMS NIH HHS T32 GM007753
6 · The paper itself

Abstract

backgroundDrug-coated balloons are increasingly used for peripheral vascular disease, and, yet, mechanisms of tissue uptake and retention remain poorly characterized. Most systems to date have used paclitaxel, touting its propensity to associate with various excipients that can optimize its transfer and retention. We examined zotarolimus pharmacokinetics. METHODS AND

resultsAnimal studies, bench-top experiments, and computational modeling were integrated to quantify arterial distribution after zotarolimus-coated balloon use. Drug diffusivity and binding parameters for use in computational modeling were estimated from the kinetics of zotarolimus uptake into excised porcine femoral artery specimens immersed in radiolabeled drug solutions. Like paclitaxel, zotarolimus exhibited high partitioning into the arterial wall. Exposure of intimal tissue to drug revealed differential distribution patterns, with zotarolimus concentration decreasing with transmural depth as opposed to the multiple peaks displayed by paclitaxel. Drug release kinetics was measured by inflating zotarolimus-coated balloons in whole blood. In vivo drug uptake in swine arteries increased with inflation time but not with balloon size. Simulations coupling transmural diffusion and reversible binding to tissue proteins predicted arterial distribution that correlated with in vivo uptake. Diffusion governed drug distribution soon after balloon expansion, but binding determined drug retention.

conclusionsA large bolus of zotarolimus releases during balloon inflation, some of which pervades the tissue, and a fraction of the remaining drug adheres to the tissue-lumen interface. As a result, the duration of delivery modulates tissue uptake where diffusion and reversible binding to tissue proteins determine drug transport and retention, respectively.

Indexed as

Angioplasty, BalloonAnimalsDrug Delivery SystemsFemaleFemoral ArteryMaleOrgan Culture TechniquesPaclitaxelSirolimusSwineTissue DistributionPaclitaxelSirolimuszotarolimusanimal modelbindingcomputational modelingdiffusiondrug-coated balloonperipheral vascular diseasezotarolimus

Identifiers

PMID23584359
PMCPMC3748613
OpenAlexW2009086730

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.