Evidence map›Paper›PMID 40704838›Full record

Observational studyCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025

Impact of Femoropopliteal Drug-Coated Balloon Use on Clinical Outcomes in Patients With Chronic Limb-Threatening Ischemia.

Haruya Yamane, Yosuke Hata, Osamu Iida, Yasunori Ueda, Kuniyasu Ikeoka, Taku Toyoshima, Motoki Yasunaga, Hiroaki Nohara, Akito Kawamura, Sho Nakao and 2 more

Abstract readObservational StudyMulticenter StudyComparative Study
In one paragraph

Observational study in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 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

12 authors.

Haruya YamaneCardiovascular Division, NHO Osaka National Hospital, Osaka, Japan.ORCID 0009-0005-8665-2820
Yosuke HataKansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.
Osamu IidaCardiovascular Division, Osaka Police Hospital, Osaka, Japan.
Yasunori UedaCardiovascular Division, NHO Osaka National Hospital, Osaka, Japan.ORCID 0000-0002-0514-106X
Kuniyasu IkeokaCardiovascular Division, NHO Osaka National Hospital, Osaka, Japan.
Taku ToyoshimaCardiovascular Division, Osaka Police Hospital, Osaka, Japan.ORCID 0000-0003-1590-5227
Motoki YasunagaCardiovascular Division, Osaka Police Hospital, Osaka, Japan.
Hiroaki NoharaDivision of Cardiology, Osaka Rosai Hospital, Sakai, Japan.
Akito KawamuraDivision of Cardiology, Osaka Rosai Hospital, Sakai, Japan.
Sho NakaoKansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.
Yohei SotomiDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.ORCID 0000-0002-7564-2978
Yasushi SakataDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.

Funding

The authors received no specific funding for this work.
6 · The paper itself

Abstract

backgroundDrug-coated balloons (DCBs) for femoropopliteal (FP) lesions have demonstrated superiority over standard percutaneous transluminal angioplasty (PTA) in maintaining vessel patency. However, data on whether the good durability of DCBs translates into improved wound outcome in chronic limb-threatening ischemia (CLTI) patients are limited.

aimsThe aim of this study was to compare the effectiveness of FP-DCBs with that of standard PTA in achieving superior wound healing outcomes in CLTI patients.

methodsThis was a sub-analysis of the multicenter, retrospective, observational SAPLING (SAtellite database of Patients with chronic Limb-threateniNG Ischemia) registry. CLTI patients with tissue loss who underwent endovascular therapy for FP lesions with either DCBs or PTA were analyzed using propensity score matching. Patients were classified into the DCB group or the PTA group. The primary outcome measure was 2-year wound healing.

resultsA total of 701 limbs were included in this study. After propensity score matching, the 2-year cumulative incidence of wound healing was not significantly different between the DCB and PTA group (76.7% vs. 67.5%; hazard ratio: 1.129; 95% confidence interval: 0.861-1.480, p = 0.382). Interaction analysis demonstrated that DCB use was associated with a higher wound healing rate in patients with Wound grade 2 or 3 (p for interaction = 0.002) and foot Infection grade 2 or 3 (p for interaction = 0.03) in the Wound, Ischemia, and foot Infection classification.

conclusionsDCB use for FP lesions was not significantly associated with superior wound healing in patients with CLTI. However, DCB may offer benefits for patients with higher wound and foot infection grades.

Indexed as

Angioplasty, BalloonCardiovascular AgentsChronic Limb-Threatening IschemiaCoated Materials, BiocompatibleFemoral ArteryIschemiaPeripheral Arterial DiseasePopliteal ArteryVascular Access DevicesAgedAged, 80 and overChronic DiseaseEquipment DesignFemaleHumansLimb SalvageCardiovascular AgentsCoated Materials, Biocompatiblechronic limb‐threatening ischemiadrug‐coated balloonendovascular therapyfemoropopliteal lesion

Identifiers

PMID40704838
PMCPMC12412346

What OpenQuestion holds

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Registered trials

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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.