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 |
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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 |
format | Article |
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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”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4436-44ce5e8e8604b15fb95706f3031e52e6d3fdf869427f69e5d4b0813d7843f2de3</citedby><cites>FETCH-LOGICAL-c4436-44ce5e8e8604b15fb95706f3031e52e6d3fdf869427f69e5d4b0813d7843f2de3</cites><orcidid>0000-0002-1286-5402 ; 0000-0003-2407-9000 ; 0000-0002-1006-6420 ; 0000-0001-8698-2858 ; 0000-0001-5810-6893 ; 0000-0001-5930-7304 ; 0000-0002-6902-3425</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34455706$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bosch, Floris T. 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. We were unable to identify other risk factors, mainly due to limited statistical power.</description><subject>Anticoagulants - adverse effects</subject><subject>Bleeding</subject><subject>Cancer</subject><subject>Case-Control Studies</subject><subject>Chemotherapy</subject><subject>factor Xa Inhibitors</subject><subject>Factor Xa Inhibitors - adverse effects</subject><subject>Gastrointestinal cancer</subject><subject>Gastrointestinal Hemorrhage - chemically induced</subject><subject>Gastrointestinal Hemorrhage - diagnosis</subject><subject>Gastrointestinal Hemorrhage - epidemiology</subject><subject>gastrointestinal neoplasms</subject><subject>Gastrointestinal Neoplasms - complications</subject><subject>Gastrointestinal Neoplasms - drug therapy</subject><subject>Hemoglobin</subject><subject>hemorrhage</subject><subject>Humans</subject><subject>Metastases</subject><subject>Original</subject><subject>Patients</subject><subject>Pyridines</subject><subject>Retrospective Studies</subject><subject>Risk Factors</subject><subject>Thiazoles</subject><subject>THROMBOSIS</subject><subject>Tumors</subject><subject>Venous Thromboembolism</subject><subject>venous thrombosis</subject><issn>1538-7933</issn><issn>1538-7836</issn><issn>1538-7836</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kU9LxDAQxYMorq4e_AJS8OSha9L8aXMRRNRVBEH0HNJ2spu126xJV91vb9aqKGIuE5gfb97MQ-iA4BGJ72TWTUeEcyI20A7htEjzgorNr7-kdIB2Q5hhTCTP8DYaUMY4z7HYQeW9DU-J0VXnfEiM88lEh84723YQOtvqJikbgNq2k8S2yUJ3FtouJK-2m_5FK91W4JNlWONQuzdd6nYPbRndBNj_rEP0eHnxcD5Ob--urs_PbtOKMSpSxirgUEAhMCsJN6VcOzQUUwI8A1FTU5tCSJblRkjgNStxQWidF4yarAY6RKe97mJZzqGuok-vG7Xwdq79Sjlt1e9Oa6dq4l6UzGRGRB4Fjj4FvHtexp3UzC193CuojMsizsmliNRxT1XeheDBfE8gWK3jUDEO9RFHZA9_Wvomv-4fgZMeeLUNrP5XUjcP417yHTLzlwo</recordid><startdate>202112</startdate><enddate>202112</enddate><creator>Bosch, Floris T. M.</creator><creator>Mulder, Frits I.</creator><creator>Huisman, Menno V.</creator><creator>Zwicker, Jeffrey I.</creator><creator>Di Nisio, Marcello</creator><creator>Carrier, Marc</creator><creator>Segers, Annelise</creator><creator>Verhamme, Peter</creator><creator>Middeldorp, Saskia</creator><creator>Weitz, Jeffrey I.</creator><creator>Grosso, Michael A.</creator><creator>Duggal, Anil</creator><creator>Büller, Harry R.</creator><creator>Wang, Tzu‐Fei</creator><creator>Garcia, David</creator><creator>Kamphuisen, Pieter Willem</creator><creator>Raskob, Gary E.</creator><creator>Es, Nick</creator><general>Elsevier Limited</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1286-5402</orcidid><orcidid>https://orcid.org/0000-0003-2407-9000</orcidid><orcidid>https://orcid.org/0000-0002-1006-6420</orcidid><orcidid>https://orcid.org/0000-0001-8698-2858</orcidid><orcidid>https://orcid.org/0000-0001-5810-6893</orcidid><orcidid>https://orcid.org/0000-0001-5930-7304</orcidid><orcidid>https://orcid.org/0000-0002-6902-3425</orcidid></search><sort><creationdate>202112</creationdate><title>Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4436-44ce5e8e8604b15fb95706f3031e52e6d3fdf869427f69e5d4b0813d7843f2de3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Anticoagulants - adverse effects</topic><topic>Bleeding</topic><topic>Cancer</topic><topic>Case-Control Studies</topic><topic>Chemotherapy</topic><topic>factor Xa Inhibitors</topic><topic>Factor Xa Inhibitors - adverse effects</topic><topic>Gastrointestinal cancer</topic><topic>Gastrointestinal Hemorrhage - chemically induced</topic><topic>Gastrointestinal Hemorrhage - diagnosis</topic><topic>Gastrointestinal Hemorrhage - epidemiology</topic><topic>gastrointestinal neoplasms</topic><topic>Gastrointestinal Neoplasms - complications</topic><topic>Gastrointestinal Neoplasms - drug therapy</topic><topic>Hemoglobin</topic><topic>hemorrhage</topic><topic>Humans</topic><topic>Metastases</topic><topic>Original</topic><topic>Patients</topic><topic>Pyridines</topic><topic>Retrospective Studies</topic><topic>Risk Factors</topic><topic>Thiazoles</topic><topic>THROMBOSIS</topic><topic>Tumors</topic><topic>Venous Thromboembolism</topic><topic>venous thrombosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bosch, Floris T. 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><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of thrombosis and haemostasis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bosch, Floris T. 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. We were unable to identify other risk factors, mainly due to limited statistical power.</abstract><cop>England</cop><pub>Elsevier Limited</pub><pmid>34455706</pmid><doi>10.1111/jth.15516</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-1286-5402</orcidid><orcidid>https://orcid.org/0000-0003-2407-9000</orcidid><orcidid>https://orcid.org/0000-0002-1006-6420</orcidid><orcidid>https://orcid.org/0000-0001-8698-2858</orcidid><orcidid>https://orcid.org/0000-0001-5810-6893</orcidid><orcidid>https://orcid.org/0000-0001-5930-7304</orcidid><orcidid>https://orcid.org/0000-0002-6902-3425</orcidid><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
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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