Evidence map›Paper›PMID 39316099›Full record

Observational studyHeart and vessels2025

Efficacy of a novel method: VaSodilator injection via the Over-the-wire lumen during drug-coated balloon dilatation to Prevent the slow-flow phenomenon in treatment of femoropopliteal lesions.

Yuki Kozai, Shinsuke Mori, Masafumi Mizusawa, Shigemitsu Shirai, Yohsuke Honda, Masakazu Tsutsumi, Norihiro Kobayashi, Masahiro Yamawaki, Yoshiaki Ito

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Heart and vessels, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Yuki KozaiDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan. y.kozai0721@gmail.com.ORCID http://orcid.org/0009-0000-2004-2740
Shinsuke MoriDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Masafumi MizusawaDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Shigemitsu ShiraiDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Yohsuke HondaDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Masakazu TsutsumiDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Norihiro KobayashiDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Masahiro YamawakiDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.
Yoshiaki ItoDepartment of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi Ward, Yokohama City, Kanagawa Prefecture, 230-8765, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In drug-coated balloon (DCB) angioplasty for femoropopliteal lesions, there are adverse effects of drug embolization on downstream non-target organs following the slow-flow phenomenon. We devised a novel method, known as VaSodilator injection via the Over-the-wire lumen during DCB dilatation to Prevent the slow-flow phenomenon in treatment of femoropopliteal lesions (V.S.O.P.), and evaluated its efficacy and safety. This single-center, retrospective, observational study analyzed 196 femoropopliteal lesions treated with IN.PACT Admiral between April 2018 and July 2023. The IN.PACT Admiral is a DCB consisting of a 0.035-inch over-the-wire (OTW) lumen balloon coated with high-dose paclitaxel. Regarding the V.S.O.P. method, we injected vasodilators through the OTW lumen during DCB dilation of the lesions. The cohort was classified into two groups according to the use of the V.S.O.P. method (V.S.O.P. group: n = 53; non-V.S.O.P. group: n = 143). The V.S.O.P. group had lower rates of hemodialysis (21% vs. 43%, p = 0.01) and higher rates of critical limb-threatening ischemia (56% vs. 23%, p < 0.01) and severe calcification lesions (Peripheral Arterial Calcium Scoring Systems score 3/4) (53% vs. 34%, p = 0.01) than the non-V.S.O.P. group. The occurrence of the slow-flow phenomenon was significantly lower in the V.S.O.P. group than in the non-V.S.O.P. group. The V.S.O.P. method could be an effective method for preventing the slow-flow phenomenon after DCB angioplasty for femoropopliteal lesions.

Indexed as

Angioplasty, BalloonCoated Materials, BiocompatibleFemoral ArteryPaclitaxelPeripheral Arterial DiseasePopliteal ArteryVasodilator AgentsAgedAged, 80 and overFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeCoated Materials, BiocompatiblePaclitaxelVasodilator AgentsDrug-coated balloonEndovascular therapyPeripheral artery diseaseSuperficial femoral artery

Identifiers

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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.