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A novel low-density lipoprotein/fibrinogen apheresis method for chronic limb-threatening ischemia in patients with poor options for revascularization: A multicenter, single-arm clinical trial.
Kobayashi, Shuzo; Furukawa, Masahide; Ichioka, Shigeru; Horiuchi, Katsumi; Kitano, Ikuro; Fujii, Miki; Ayabe, Shinobu; Tanaka, Rica; Ohura, Norihiko; Ohura, Takehiko.
Afiliación
  • Kobayashi S; Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
  • Furukawa M; Department of Plastic Surgery, Oita Oka Hospital, Oita, Japan.
  • Ichioka S; Department of Plastic and Reconstructive Surgery, Saitama Medical University, Moroyama, Japan.
  • Horiuchi K; Department of Plastic and Reconstructive Surgery, Sapporo City General Hospital, Sapporo, Japan.
  • Kitano I; Department of Vascular Surgery, Shinsuma General Hospital, Kobe, Japan.
  • Fujii M; Department of Plastic and Reconstructive Surgery, Critical Limb Ischemia Center, Kitaharima Medical Center, Ono, Japan.
  • Ayabe S; Department of Plastic and Reconstructive Surgery, Yao Tokushukai General Hospital, Osaka, Japan.
  • Tanaka R; Department of Plastic and Reconstructive Surgery, Juntendo University School of Medicine, Tokyo, Japan.
  • Ohura N; Department of Plastic and Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan.
  • Ohura T; Pressure Ulcers and Wound Healing Research Center, Sapporo, Japan.
Ther Apher Dial ; 27(2): 361-369, 2023 Apr.
Article en En | MEDLINE | ID: mdl-36858047
INTRODUCTION: Low-density lipoprotein (LDL) apheresis is a treatment option for patients with unhealed chronic limb-threatening ischemia (CLTI) after revascularization. The newly developed AS-25 is a direct hemoperfusion-type apheresis device that differs from conventional LDL apheresis therapy and is designed to specifically adsorb both LDL-C and fibrinogen. We evaluate the efficacy and safety of AS-25. METHODS: This study included 61 patients whose ulcers failed to heal after revascularization or were ineligible for revascularization. Of these, 50 were undergoing hemodialysis. The primary endpoint was the healing rate of a target lesion of interest (ulcer), using historical data as control. RESULTS: The ulcer healing rate of 45.9% was significantly higher than the historical data. No significant safety concerns were observed. CONCLUSIONS: AS-25 was effective in healing ulcers and preventing major amputation even in CLTI refractory patients on hemodialysis, thus showing potential clinical applicability and high significance. CLINICAL TRIAL REGISTRATION: UMIN study ID UMIN000020336.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Eliminación de Componentes Sanguíneos / Fibrinógeno Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Ther Apher Dial Asunto de la revista: HEMATOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Australia
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Eliminación de Componentes Sanguíneos / Fibrinógeno Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Ther Apher Dial Asunto de la revista: HEMATOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Australia