Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban

Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding ma...

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Veröffentlicht in:Journal of thrombosis and haemostasis 2021-12, Vol.19 (12), p.3008-3017
Hauptverfasser: Bosch, Floris T. M., Mulder, Frits I., Huisman, Menno V., Zwicker, Jeffrey I., Di Nisio, Marcello, Carrier, Marc, Segers, Annelise, Verhamme, Peter, Middeldorp, Saskia, Weitz, Jeffrey I., Grosso, Michael A., Duggal, Anil, Büller, Harry R., Wang, Tzu‐Fei, Garcia, David, Kamphuisen, Pieter Willem, Raskob, Gary E., Es, Nick
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container_end_page 3017
container_issue 12
container_start_page 3008
container_title Journal of thrombosis and haemostasis
container_volume 19
creator Bosch, Floris T. M.
Mulder, Frits I.
Huisman, Menno V.
Zwicker, Jeffrey I.
Di Nisio, Marcello
Carrier, Marc
Segers, Annelise
Verhamme, Peter
Middeldorp, Saskia
Weitz, Jeffrey I.
Grosso, Michael A.
Duggal, Anil
Büller, Harry R.
Wang, Tzu‐Fei
Garcia, David
Kamphuisen, Pieter Willem
Raskob, Gary E.
Es, Nick
description Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case‐control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4‐week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty‐four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01–12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5–16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1–1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5–3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. We were unable to identify other risk factors, mainly due to limited statistical power.
doi_str_mv 10.1111/jth.15516
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M. ; Mulder, Frits I. ; Huisman, Menno V. ; Zwicker, Jeffrey I. ; Di Nisio, Marcello ; Carrier, Marc ; Segers, Annelise ; Verhamme, Peter ; Middeldorp, Saskia ; Weitz, Jeffrey I. ; Grosso, Michael A. ; Duggal, Anil ; Büller, Harry R. ; Wang, Tzu‐Fei ; Garcia, David ; Kamphuisen, Pieter Willem ; Raskob, Gary E. ; Es, Nick</creator><creatorcontrib>Bosch, Floris T. M. ; Mulder, Frits I. ; Huisman, Menno V. ; Zwicker, Jeffrey I. ; Di Nisio, Marcello ; Carrier, Marc ; Segers, Annelise ; Verhamme, Peter ; Middeldorp, Saskia ; Weitz, Jeffrey I. ; Grosso, Michael A. ; Duggal, Anil ; Büller, Harry R. ; Wang, Tzu‐Fei ; Garcia, David ; Kamphuisen, Pieter Willem ; Raskob, Gary E. ; Es, Nick</creatorcontrib><description>Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case‐control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4‐week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty‐four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01–12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5–16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1–1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5–3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. We were unable to identify other risk factors, mainly due to limited statistical power.</description><identifier>ISSN: 1538-7933</identifier><identifier>ISSN: 1538-7836</identifier><identifier>EISSN: 1538-7836</identifier><identifier>DOI: 10.1111/jth.15516</identifier><identifier>PMID: 34455706</identifier><language>eng</language><publisher>England: Elsevier Limited</publisher><subject>Anticoagulants - adverse effects ; Bleeding ; Cancer ; Case-Control Studies ; Chemotherapy ; factor Xa Inhibitors ; Factor Xa Inhibitors - adverse effects ; Gastrointestinal cancer ; Gastrointestinal Hemorrhage - chemically induced ; Gastrointestinal Hemorrhage - diagnosis ; Gastrointestinal Hemorrhage - epidemiology ; gastrointestinal neoplasms ; Gastrointestinal Neoplasms - complications ; Gastrointestinal Neoplasms - drug therapy ; Hemoglobin ; hemorrhage ; Humans ; Metastases ; Original ; Patients ; Pyridines ; Retrospective Studies ; Risk Factors ; Thiazoles ; THROMBOSIS ; Tumors ; Venous Thromboembolism ; venous thrombosis</subject><ispartof>Journal of thrombosis and haemostasis, 2021-12, Vol.19 (12), p.3008-3017</ispartof><rights>2021 The Authors. published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.</rights><rights>2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.</rights><rights>2021. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). 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M.</creatorcontrib><creatorcontrib>Mulder, Frits I.</creatorcontrib><creatorcontrib>Huisman, Menno V.</creatorcontrib><creatorcontrib>Zwicker, Jeffrey I.</creatorcontrib><creatorcontrib>Di Nisio, Marcello</creatorcontrib><creatorcontrib>Carrier, Marc</creatorcontrib><creatorcontrib>Segers, Annelise</creatorcontrib><creatorcontrib>Verhamme, Peter</creatorcontrib><creatorcontrib>Middeldorp, Saskia</creatorcontrib><creatorcontrib>Weitz, Jeffrey I.</creatorcontrib><creatorcontrib>Grosso, Michael A.</creatorcontrib><creatorcontrib>Duggal, Anil</creatorcontrib><creatorcontrib>Büller, Harry R.</creatorcontrib><creatorcontrib>Wang, Tzu‐Fei</creatorcontrib><creatorcontrib>Garcia, David</creatorcontrib><creatorcontrib>Kamphuisen, Pieter Willem</creatorcontrib><creatorcontrib>Raskob, Gary E.</creatorcontrib><creatorcontrib>Es, Nick</creatorcontrib><title>Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban</title><title>Journal of thrombosis and haemostasis</title><addtitle>J Thromb Haemost</addtitle><description>Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case‐control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4‐week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty‐four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01–12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5–16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1–1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5–3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. 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M.</au><au>Mulder, Frits I.</au><au>Huisman, Menno V.</au><au>Zwicker, Jeffrey I.</au><au>Di Nisio, Marcello</au><au>Carrier, Marc</au><au>Segers, Annelise</au><au>Verhamme, Peter</au><au>Middeldorp, Saskia</au><au>Weitz, Jeffrey I.</au><au>Grosso, Michael A.</au><au>Duggal, Anil</au><au>Büller, Harry R.</au><au>Wang, Tzu‐Fei</au><au>Garcia, David</au><au>Kamphuisen, Pieter Willem</au><au>Raskob, Gary E.</au><au>Es, Nick</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban</atitle><jtitle>Journal of thrombosis and haemostasis</jtitle><addtitle>J Thromb Haemost</addtitle><date>2021-12</date><risdate>2021</risdate><volume>19</volume><issue>12</issue><spage>3008</spage><epage>3017</epage><pages>3008-3017</pages><issn>1538-7933</issn><issn>1538-7836</issn><eissn>1538-7836</eissn><abstract>Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case‐control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4‐week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty‐four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01–12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5–16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1–1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5–3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. 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subjects Anticoagulants - adverse effects
Bleeding
Cancer
Case-Control Studies
Chemotherapy
factor Xa Inhibitors
Factor Xa Inhibitors - adverse effects
Gastrointestinal cancer
Gastrointestinal Hemorrhage - chemically induced
Gastrointestinal Hemorrhage - diagnosis
Gastrointestinal Hemorrhage - epidemiology
gastrointestinal neoplasms
Gastrointestinal Neoplasms - complications
Gastrointestinal Neoplasms - drug therapy
Hemoglobin
hemorrhage
Humans
Metastases
Original
Patients
Pyridines
Retrospective Studies
Risk Factors
Thiazoles
THROMBOSIS
Tumors
Venous Thromboembolism
venous thrombosis
title Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban
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