Evidence map›Paper›PMID 38816504›Full record

ArticleCardiovascular and interventional radiology2024

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

Yoshimitsu Soga, Osamu Iida, Shu-Ichi Seki, Daizo Kawasaki, Hitoshi Anzai, Hiroshi Ando, Tatsuya Nakama, Norihiko Shinozaki, Amane Kozuki, Masaharu Ishihara and 15 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cardiovascular and interventional radiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
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

25 authors.

Yoshimitsu SogaDepartment of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan. soga@circulation.jp.ORCID http://orcid.org/0000-0003-1931-5769
Osamu IidaDivision of Cardiology, Cardiovascular Center, Osaka Police Hospital, Osaka, Japan.
Shu-Ichi SekiDepartment of Medicine and Cardiology, Chikamori Hospital, Kochi, Japan.
Daizo KawasakiDepartment of Cardiology, Morinomiya Hospital, Osaka, Japan.
Hitoshi AnzaiDepartment of Cardiology, SUBARU Health Insurance Ota Memorial Hospital, Gunma, Japan.
Hiroshi AndoHeart Center, Kasukabe Chuo General Hospital, Saitama, Japan.
Tatsuya NakamaDepartment of Cardiology, Tokyo Bay Medical Center, Chiba, Japan.
Norihiko ShinozakiDepartment of Cardiology, Tokai University Hospital, Kanagawa, Japan.
Amane KozukiDivision of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.
Masaharu IshiharaDepartment of Cardiovascular and Renal Medicine, School of Medicine, Hyogo Medical University, Hyogo, Japan.
Kazushi UrasawaCardiovascular Center, Tokeidai Memorial Hospital, Hokkaido, Japan.
Satoru ToiDivision of Minimally Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Hiroaki TsujitaDivision of Cardiology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Kazuki TobitaCardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kanagawa, Japan.
Kenji OgataDepartment of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan.
Kazunori HorieDepartment of Cardiovascular Medicine, Sendai Kousei Hospital, Miyagi, Japan.
Naoki HayakawaDepartment of Cardiovascular Medicine, Asahi General Hospital, Chiba, Japan.
Shinsuke MoriDepartment of Cardiology, Saiseikai Yokohama City Eastern Hospital, Kanagawa, Japan.
Masahiko FujiharaDepartment of Cardiology, Kishiwada Tokushukai Hospital, Osaka, Japan.
Takao OhkiDivision of Vascular Surgery, Department of Surgery, Jikei University School of Medicine, Tokyo, Japan.
Kenichiro YubaDepartment of Cardiology, Tokushima Red Cross Hospital, Tokushima, Japan.
Toshiaki ManoCardiovascular Center, Kansai Rosai Hospital, Hyogo, Japan.
Kenji AndoDepartment of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.
Masato NakamuraDivision of Minimally Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
TCD-17187 Japan Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.

methodsThis was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.

resultsAge was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.

conclusionThis trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL

trial registrationURL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

Indexed as

Angioplasty, BalloonCoated Materials, BiocompatibleFemoral ArteryPeripheral Arterial DiseasePopliteal ArteryVascular PatencyAgedAged, 80 and overFemaleHumansJapanMaleProspective StudiesTreatment OutcomeCoated Materials, BiocompatibleClinically driven target lesion revascularizationDrug-coated balloonEndovascular therapyPeripheral artery diseasePrimary patencySuperficial femoral and proximal popliteal lesions

Identifiers

PMID38816504
PMCPMC11164795

What Socratic holds

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LicenceCC BY
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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 Socratic graph.