The impact of renal function on clinical outcomes of patients with cancer-associated isolated distal deep vein thrombosis : Insights from the ONCO DVT study
Copyright © 2024 Elsevier Ltd. All rights reserved..
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: 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: 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: 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: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:235 |
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| Enthalten in: |
Thrombosis research - 235(2024) vom: 08. März, Seite 107-115 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sueta, Daisuke [VerfasserIn] |
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| Links: |
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| Themen: |
Cancer-associated thrombosis |
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| Anmerkungen: |
Date Completed 04.03.2024 Date Revised 04.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.thromres.2024.01.021 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368250601 |
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| 245 | 1 | 4 | |a The impact of renal function on clinical outcomes of patients with cancer-associated isolated distal deep vein thrombosis |b Insights from the ONCO DVT study |
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| 500 | |a published: Print-Electronic | ||
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| 520 | |a Copyright © 2024 Elsevier Ltd. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a OBJECTIVES: 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 650 | 4 | |a Renal function | |
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| 700 | 1 | |a Muraoka, Nao |e verfasserin |4 aut | |
| 700 | 1 | |a Umetsu, Michihisa |e verfasserin |4 aut | |
| 700 | 1 | |a Nishimoto, Yuji |e verfasserin |4 aut | |
| 700 | 1 | |a Takada, Takuma |e verfasserin |4 aut | |
| 700 | 1 | |a Ogihara, Yoshito |e verfasserin |4 aut | |
| 700 | 1 | |a Nishikawa, Tatsuya |e verfasserin |4 aut | |
| 700 | 1 | |a Ikeda, Nobutaka |e verfasserin |4 aut | |
| 700 | 1 | |a Otsui, Kazunori |e verfasserin |4 aut | |
| 700 | 1 | |a Tsubata, Yukari |e verfasserin |4 aut | |
| 700 | 1 | |a Shoji, Masaaki |e verfasserin |4 aut | |
| 700 | 1 | |a Shikama, Ayumi |e verfasserin |4 aut | |
| 700 | 1 | |a Hosoi, Yutaka |e verfasserin |4 aut | |
| 700 | 1 | |a Tanabe, Yasuhiro |e verfasserin |4 aut | |
| 700 | 1 | |a Chatani, Ryuki |e verfasserin |4 aut | |
| 700 | 1 | |a Tsukahara, Kengo |e verfasserin |4 aut | |
| 700 | 1 | |a Nakanishi, Naohiko |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kitae |e verfasserin |4 aut | |
| 700 | 1 | |a Ikeda, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Mo, Makoto |e verfasserin |4 aut | |
| 700 | 1 | |a Kimura, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Tsujita, Kenichi |e verfasserin |4 aut | |
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