Evidence map›Paper›PMID 34121951›Full record

ArticleJournal of interventional cardiology2021

In Vitro and In Vivo Comparative Evaluation of a Shellac-Ammonium Paclitaxel-Coated Balloon versus a Benchmark Device.

Congying Xia, Yunhan Jiang, Shuangshuang Li, Dan Xiong, Xiaojie Chen, Yufang Chen

Open access · goldAbstract read
In one paragraph

Article in Journal of interventional cardiology, 2021. 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
0.4field-weighted citation impact, top 38% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

6 authors at 1 institution in 1 country.

Congying XiaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, China.ORCID https://orcid.org/0000-0003-4304-5965
Yunhan JiangDepartment of Cardiovascular Surgery, West China Hospital of Sichuan University, Chengdu, China.
Shuangshuang LiDepartment of R & D, Cardionovum Co, Ltd, Wuhan, China.
Dan XiongDepartment of R & D, Cardionovum Co, Ltd, Wuhan, China.
Xiaojie ChenDepartment of R & D, Cardionovum Co, Ltd, Wuhan, China.
Yufang ChenDepartment of Medical Affair, Cardionovum Co, Ltd, Wuhan, China.ORCID https://orcid.org/0000-0002-3106-5961
Sichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe present study was designed to compare the characteristics and performance regarding drug delivery of a novel drug-coated balloon (DCB) to a benchmark device (Restore® versus SeQuent® Please) in an in vitro and in vivo model.

backgroundAlthough Restore® and SeQuent® are both paclitaxel-coated, they use different coating excipient, shellac-ammonium salt and iopromide, respectively. Preclinical study comparing these two different commercial DCBs regarding their characteristics and effects on early vascular response is sparse.

methodsRestore® and SeQuent® DCBs were scanned with electron microscopy for surface characteristic assessment. Both DCBs were transported in an in vitro vessel model for the evaluation of drug wash-off rate and particulate formation. Eighteen coronary angioplasties with either Restore® or SeQuent® DCBs were conducted in 6 swine (three coronary vessels each). Histopathological images of each vessel were evaluated for vessel injury.

resultsThe surface of Restore® DCB was smooth and evenly distributed with hardly visible crystal, while SeQuent® DCB showed a rougher surface with relatively larger apparent crystals. Restore® DCB had a lower drug wash-off rate and fewer large visible particles, compared to the SeQuent® DCB. No significant difference in mean injure score was found between Restore® and SeQuent® group.

conclusionOur results suggest that Restore® is better in preclinical performance regarding less release of particles and lower drug wash-off rate as compared to SeQuent® Please. The Restore® DCB, using stable amorphous coating and shellac-ammonium salt as an excipient, appears to provide an advantage in drug delivery efficacy; however, further clinical studies are warranted.

Indexed as

Cardiac CathetersAmmonium CompoundsAngioplasty, Balloon, CoronaryAnimalsAntineoplastic Agents, PhytogenicCoated Materials, BiocompatibleCoronary VesselsDrug Delivery SystemsMaterials TestingPaclitaxelResins, PlantSurface PropertiesSwineAmmonium CompoundsAntineoplastic Agents, PhytogenicCoated Materials, BiocompatiblePaclitaxelResins, Plantshellac

Identifiers

PMID34121951
PMCPMC8172300
OpenAlexW3165719034

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.