Abstract
Original language | English |
---|---|
Pages (from-to) | 3008-3017 |
Number of pages | 10 |
Journal | Journal of thrombosis and haemostasis |
Volume | 19 |
Issue number | 12 |
Early online date | 2021 |
DOIs | |
Publication status | Published - Dec 2021 |
Keywords
- factor Xa Inhibitors
- gastrointestinal neoplasms
- hemorrhage
- risk factors
- venous thrombosis
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In: Journal of thrombosis and haemostasis, Vol. 19, No. 12, 12.2021, p. 3008-3017.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban
AU - Bosch, Floris T. M.
AU - Mulder, Frits I.
AU - Huisman, Menno V.
AU - Zwicker, Jeffrey I.
AU - di Nisio, Marcello
AU - Carrier, Marc
AU - Segers, Annelise
AU - Verhamme, Peter
AU - Middeldorp, Saskia
AU - Weitz, Jeffrey I.
AU - Grosso, Michael A.
AU - Duggal, Anil
AU - Büller, Harry R.
AU - Wang, Tzu-Fei
AU - Garcia, David
AU - Kamphuisen, Pieter Willem
AU - Raskob, Gary E.
AU - van Es, Nick
N1 - Funding Information: This study received financial support from Daiichi Sankyo Global. We would like to acknowledge Sandro Aquilanti, Lisa Baumann Kreuziger, Aart Beeker, Jan Beyer‐Westendorf, Zoltan Boda, Marianne Brodmann, Patrick Carroll, Ad Dees, Antoine Elias, Anna Falanga, Carme Font Puig, Enruiqe Gallardo, Fernando Garcia‐Bragado, Angelo Ghirarduzzi, Mihály Gurzó, Chirstiam Rojas Hernandez, Thomas Horacek, Davide Imberti, Agnes Lee, Corrado Lodigiani, Rien van Marwijk‐Kooy, Ara Metjian, Guy Meyer, Patrick Mismetti, Ingrid Pabinger, Ettore Porreca, Amparo Santamaria, Piet Vercauter, Adriana Visonà, Peter Westerweel and Erik Yeo for providing additional data. Funding Information: Floris T.M. Bosch reports no conflicts of interest. Frits I. Mulder reports no conflicts of interest. Menno V. Huisman reports Grants ZonMw Dutch Healthcare Fund. Grants and consultation fees from Boehringer‐Ingelheim, Pfizer‐BMS, Bayer Health Care, Aspen, and Daiichi‐Sankyo, to the hospital. Jeffrey I. Zwicker reports research funding from Incyte and Quercegen; consultancy services to Sanofi, CSL, and Parexel; and honoraria from advisory board participation with Pfizer/Bristol Myers Squibb (BMS), and Portola. Marcello Di Nisio reports personal fees from Bayer, Daiichi Sankyo, Sanofi, Pfizer, Leo Pharma, and Aspen outside the present work. Marc Carrier reports Research Funding: BMS, Pfizer and Leo Pharma. Honoraria: Bayer, BMS, Pfizer, Leo Pharma, Sanofi and Servier. Annelise Segers reports grants from Daiichi Sankyo Pharma, during the conduct of the study; grants from Anthos Therapeutics, grants from Janssen Pharmaceuticals, grants from Tetherex, outside the submitted work. Peter Verhamme reports Honoraria for lectures/consultancy: Bayer, Boehringer, BMS, Pfizer, Daiichi‐Sankyo, Leo Pharma, Anthos Pharmaceuticals. Saskia Middeldorp reports grants and fees paid to her institution from GlaxoSmithKline, BMS/Pfizer, Aspen, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Sanofi, and Portola. Jeffrey I. Weitz was a consultant for and received honoraria from Anthos, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi‐Sankyo, Ionis, Janssen, Novartis, and Pfizer. Michael A. Grosso is employed by Daiichi Sankyo. Anil Duggal is employed by Daiichi Sankyo. Harry R. Büller reports research support from Sanofi‐aventis, Bayer HealthCare, Bristol‐Myers Squibb, Daiichi‐Sankyo, GlaxoSmithKline, Pfizer, Roche, IONIS, Boehringer Ingelheim, Eli Lilly, Novartis. Consultant from Sanofi‐aventis, Bayer HealthCare, Bristol‐Myers Squibb, Daiichi‐Sankyo, GlaxoSmithKline, Pfizer, Roche, IONIS, Boehringer Ingelheim, Eli Lilly, Novartis. Scientific advisory board from Sanofi‐aventis, Bayer HealthCare, Bristol‐Myers Squibb, Daiichi‐Sankyo, GlaxoSmithKline, Pfizer, Roche, IONIS, Boehringer Ingelheim, Eli Lilly, Novartis. Tzu‐Fei Wang reports advisory board honoraria from Servier and grants from Leo Pharma. Frits I. Mulder and David Garcia report no conflicts of interest. Pieter Willem Kamphuisen reports research funding from Daiichi Sankyo. Gary E. Raskob reports payment for consultant services from the following companies: AMAG Pharma, Anthos Therapeutics, Bayer Healthcare, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Itreas, Janssen, Novartis, Pfizer, Portola, Tetherex, XaTek. Nick van Es reports advisory board fees from Bayer, Daiichi Sankyo, and LEO Pharma, which were transferred to his institution. Funding Information: This study received financial support from Daiichi Sankyo Global. We would like to acknowledge Sandro Aquilanti, Lisa Baumann Kreuziger, Aart Beeker, Jan Beyer-Westendorf, Zoltan Boda, Marianne Brodmann, Patrick Carroll, Ad Dees, Antoine Elias, Anna Falanga, Carme Font Puig, Enruiqe Gallardo, Fernando Garcia-Bragado, Angelo Ghirarduzzi, Mih?ly Gurz?, Chirstiam Rojas Hernandez, Thomas Horacek, Davide Imberti, Agnes Lee, Corrado Lodigiani, Rien van Marwijk-Kooy, Ara Metjian, Guy Meyer, Patrick Mismetti, Ingrid Pabinger, Ettore Porreca, Amparo Santamaria, Piet Vercauter, Adriana Vison?, Peter Westerweel and Erik Yeo for providing additional data. Publisher Copyright: © 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - factor Xa Inhibitors
KW - gastrointestinal neoplasms
KW - hemorrhage
KW - risk factors
KW - venous thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85114733407&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/jth.15516
DO - https://doi.org/10.1111/jth.15516
M3 - Article
C2 - 34455706
SN - 1538-7933
VL - 19
SP - 3008
EP - 3017
JO - Journal of thrombosis and haemostasis
JF - Journal of thrombosis and haemostasis
IS - 12
ER -