Evidence map›Paper›PMID 38842992›Full record

Trial reportJACC. Cardiovascular interventions2024

A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial.

Osamu Iida, Yoshimitsu Soga, Shigeru Saito, Toshiaki Mano, Naoki Hayakawa, Shigeo Ichihashi, Daizo Kawasaki, Kenji Suzuki, Terutoshi Yamaoka, Masahiko Fujihara and 6 more

Abstract readMulticenter StudyClinical Trial
PubMed Publisher
In one paragraph

Trial report in JACC. Cardiovascular interventions, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
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  4. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Osamu IidaCardiovascular Division, Osaka Police Hospital, Osaka, Japan. Electronic address: iida.osa@gmail.com.
Yoshimitsu SogaDepartment of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Shigeru SaitoDivision of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
Toshiaki ManoCardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
Naoki HayakawaDepartment of Cardioligy, Asahi General Hospital, Asahi, Japan.
Shigeo IchihashiDivision of Radiology and Nuclear Medicine, Nara Medical University, Kashihara, Japan.
Daizo KawasakiDepartment of Cardiology, Morinomiya Hospital, Osaka, Japan.
Kenji SuzukiDepartment of Cardioligy, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Terutoshi YamaokaDepartment of Vascular Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Masahiko FujiharaDepartment of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Japan.
Tatsuya NakamaDepartment of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan.
Masato NakamuraDivision of Less Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Kazunori HorieDepartment of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
Tayyab ShahYale School of Medicine, New Haven, Connecticut, USA.
Alexandra LanskyYale School of Medicine, New Haven, Connecticut, USA.
Amane KozukiDepartment of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising.

objectivesThe authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population.

methodsThis multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data.

resultsThe mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13).

conclusionsThe SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.

Indexed as

Angioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleFemoral ArteryPeripheral Arterial DiseasePopliteal ArterySirolimusVascular Access DevicesVascular PatencyAgedAged, 80 and overEquipment DesignFemaleHumansJapanMaleCardiovascular AgentsCoated Materials, BiocompatibleSirolimusendovascular therapyfemoropopliteal arteryperipheral artery diseasesirolimus-coated balloon

Identifiers

PMID38842992

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.