The impact of renal function on clinical outcomes of patients with cancer-associated isolated distal deep vein thrombosis: Insights from the ONCO DVT study.

Cancer-associated thrombosis Renal function Venous thromboembolism

Journal

Thrombosis research
ISSN: 1879-2472
Titre abrégé: Thromb Res
Pays: United States
ID NLM: 0326377

Informations de publication

Date de publication:
02 Feb 2024
Historique:
received: 12 12 2023
revised: 15 01 2024
accepted: 25 01 2024
medline: 10 2 2024
pubmed: 10 2 2024
entrez: 9 2 2024
Statut: aheadofprint

Résumé

The multicenter, open-label, randomized clinical trial ONCO DVT compared 3-month and 12-month edoxaban treatment regimens for isolated distal deep vein thrombosis (DVT) and suggested potential benefits of prolonged edoxaban treatment in terms of thrombotic risk. However, the risk-benefit balance of prolonged edoxaban treatment in patients with renal function remains unclear. To compare the safety and efficacy of 3-month and 12-month edoxaban treatment regimens in patients with cancer-associated isolated distal DVT and different renal functions. This pre-specified subgroup analysis of the ONCO DVT study included 601 patients divided into subgroups according to renal function using a 50 mL/min creatinine clearance (Ccr) cutoff. The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) and VTE-related death at 12 months and the major secondary endpoint was major bleeding at 12 months. Among the 601 patients, 131 (21.8 %) comprised the renal dysfunction subgroup. The primary endpoint occurred in 6 (9.7 %) and 1 (1.4 %) patients in the 3-month and 12-month edoxaban groups in the renal dysfunction subgroup, respectively, and in 16 (6.6 %) and 2 (0.9 %) patients in the no renal dysfunction subgroup, respectively. The major secondary endpoint occurred in 9 (14.5 %) and 7 (10.1 %) patients in the 12-month and 3-month edoxaban groups in the renal dysfunction subgroup, and in 13 (5.3 %) and 21 (9.3 %) patients in the no renal dysfunction subgroup, respectively. A 12-month edoxaban regiment was superior to a 3-month treatment in terms of thrombotic risk irrespective of renal function. A higher bleeding risk was not identified in patients with renal dysfunction who received prolonged edoxaban treatment.

Sections du résumé

BACKGROUND BACKGROUND
The multicenter, open-label, randomized clinical trial ONCO DVT compared 3-month and 12-month edoxaban treatment regimens for isolated distal deep vein thrombosis (DVT) and suggested potential benefits of prolonged edoxaban treatment in terms of thrombotic risk. However, the risk-benefit balance of prolonged edoxaban treatment in patients with renal function remains unclear.
OBJECTIVES OBJECTIVE
To compare the safety and efficacy of 3-month and 12-month edoxaban treatment regimens in patients with cancer-associated isolated distal DVT and different renal functions.
METHODS METHODS
This pre-specified subgroup analysis of the ONCO DVT study included 601 patients divided into subgroups according to renal function using a 50 mL/min creatinine clearance (Ccr) cutoff. The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) and VTE-related death at 12 months and the major secondary endpoint was major bleeding at 12 months.
RESULTS RESULTS
Among the 601 patients, 131 (21.8 %) comprised the renal dysfunction subgroup. The primary endpoint occurred in 6 (9.7 %) and 1 (1.4 %) patients in the 3-month and 12-month edoxaban groups in the renal dysfunction subgroup, respectively, and in 16 (6.6 %) and 2 (0.9 %) patients in the no renal dysfunction subgroup, respectively. The major secondary endpoint occurred in 9 (14.5 %) and 7 (10.1 %) patients in the 12-month and 3-month edoxaban groups in the renal dysfunction subgroup, and in 13 (5.3 %) and 21 (9.3 %) patients in the no renal dysfunction subgroup, respectively.
CONCLUSIONS CONCLUSIONS
A 12-month edoxaban regiment was superior to a 3-month treatment in terms of thrombotic risk irrespective of renal function. A higher bleeding risk was not identified in patients with renal dysfunction who received prolonged edoxaban treatment.

Identifiants

DOI: 10.1016/j.thromres.2024.01.021 PMID: 38335565
pubmed: 38335565
pii: S0049-3848(24)00027-6
doi: 10.1016/j.thromres.2024.01.021
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

107-115

Informations de copyright

Copyright © 2024 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest Dr. Yamashita received lecture fees from Bayer Healthcare, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo, and grant support from Bayer Healthcare and Daiichi Sankyo. Dr. Morimoto reports lecturer's fees from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Pfizer and Tsumura; manuscript fees from Bristol-Myers Squibb and Pfizer; advisory board for Novartis and Teijin. Dr. Nishimoto received lecture fees from Bayer Healthcare, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo. Dr. Ogihara received lecture fees from Bayer Healthcare, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo, and research funds from Bayer Healthcare and Daiichi Sankyo. Dr. Dohi received lecture fees from Bayer Healthcare, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo, and research funds from Daiichi Sankyo. Dr. Ikeda N. received lecture fees from Bayer Healthcare, Bristol-Myers Squibb, and Daiichi Sankyo. Dr. Tsubata received lecture fees from AstraZeneca, Chugai Pharmaceutical, Bristol-Myers Squibb, Kyowa Kirin, Pfizer, Taiho Pharmaceutical, Takeda Pharmaceutical and Daiichi Sankyo, and grant support from Daiichi Sankyo, AstraZeneca and Ono Pharmaceutical. Dr. Ikeda S. received lecture fees from Bayer Healthcare, Bristol-Myers Squibb and Daiichi Sankyo. Dr. Mo received lecture fees from Bayer Healthcare. Dr. Tsujita received significant research grant from AMI Co., Ltd., Bayer Yakuhin, Ltd., Bristol-Myers K.K., EA Pharma Co., Ltd., MOCHIDA PHARMACEUTICAL CO., LTD., and scholarship fund from AMI Co., Ltd., Bayer Yakuhin, Ltd., Boehringer Ingelheim Japan, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Edwards Lifesciences Corporation, Johnson & Johnson K.K., ONO PHARMACEUTICAL CO., LTD., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and honoraria from Amgen K.K., Bayer Yakuhin, Ltd., Daiichi Sankyo Co., Ltd., Kowa Pharmaceutical Co. Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., and belongs to the endowed departments donated by Abbott Japan Co., Ltd., Boston Scientific Japan K.K., Fides-one, Inc., GM Medical Co., Ltd., ITI Co., Ltd., Kaneka Medix Co., Ltd., NIPRO CORPORATION, TERUMO Co, Ltd., Abbott Medical Co., Ltd., Cardinal Health Japan, Fukuda Denshi Co., Ltd., Japan Lifeline Co., Ltd., Medical Appliance Co., Ltd., Medtoronic Japan Co., Ltd. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Daisuke Sueta (D)

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. Electronic address: sueta-d@kumamoto-u.ac.jp.

Yugo Yamashita (Y)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Takeshi Morimoto (T)

Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan.

Nao Muraoka (N)

Division of Cardiology, Shizuoka Cancer Center, Shizuoka, Japan.

Michihisa Umetsu (M)

Division of Vascular Surgery, Department of Surgery, Tohoku University Hospital, Sendai, Japan.

Yuji Nishimoto (Y)

Division of Cardiology, Osaka General Medical Center, Osaka, Japan.

Takuma Takada (T)

Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.

Yoshito Ogihara (Y)

Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan.

Tatsuya Nishikawa (T)

Department of Onco-Cardiology, Osaka International Cancer Institute, Osaka, Japan.

Nobutaka Ikeda (N)

Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.

Kazunori Otsui (K)

Division of General Internal Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.

Yukari Tsubata (Y)

Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty of Medicine, Izumo, Japan.

Masaaki Shoji (M)

Department of Cardiovascular Medicine, National Cancer Center Hospital, Tokyo, Japan.

Ayumi Shikama (A)

Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.

Yutaka Hosoi (Y)

Department of Cardiovascular surgery, Kyorin University, Tokyo, Japan.

Yasuhiro Tanabe (Y)

Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.

Ryuki Chatani (R)

Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan.

Kengo Tsukahara (K)

Division of Cardiology, Fujisawa City Hospital, Fujisawa, Japan.

Naohiko Nakanishi (N)

Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Kitae Kim (K)

Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.

Satoshi Ikeda (S)

Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.

Makoto Mo (M)

Department of Cardiovascular Surgery, Yokohama Minami Kyosai Hospital, Yokohama, Japan.

Takeshi Kimura (T)

Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.

Kenichi Tsujita (K)

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.

Classifications MeSH