Abstract Number: OC 12.4
Meeting: ISTH 2021 Congress
Background: In the Hokusai VTE Cancer study, the absolute risk of major bleeding with edoxaban was 2.9% higher than with dalteparin, mainly due to more major gastrointestinal bleeding events. These major bleeding events predominantly occurred in patients with gastrointestinal cancer.
Aims: To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban.
Methods: We performed a case-control study within the Hokusai VTE Cancer database. Patients with gastrointestinal cancer who experienced major or clinically relevant non-major lower or upper gastrointestinal bleeding while receiving edoxaban were included. Patients with gastrointestinal cancer treated with edoxaban who had not experienced gastrointestinal bleeding on the matching date were used as controls. Cases were randomly matched to three controls with days between inclusion and bleeding event as the only matching variable. Additional clinical data in the 4 weeks prior to bleeding were retrospectively collected for both cases and controls. The association between these variables and bleeding events was evaluated by calculating odds ratios (OR) with 95% confidence intervals (CI) using a crude conditional logistic regression model as well as a multivariable model adjusted for age, sex, and gastrointestinal cancer type.
Results: Of the 1,050 patients enrolled, 165 (16%) had gastrointestinal cancer and were assigned to edoxaban. During the 12-month study period, 29 (18%) had on-treatment major or clinically relevant non-major bleeding. Additional data from 24 cases and 64 matched controls could be collected. In the 4 weeks prior to the bleeding event, advanced cancer, defined as regionally advanced or metastatic cancer, was the only variable significantly associated with bleeding (OR 3.6; 95% CI, 1.01-12.6) (Table).
|Gastrointestinal bleeding (n=24)||No gastrointestinal bleeding (n=64)||Univariable analysis
OR (95% CI)
OR (95% CI)
|Tumor present at time of bleeding
(primary or recurrence)
|20 (83.3)||44 (68.8)||2.6 (0.7 – 9.8)||2.7 (0.7 – 9.8)|
|Advanced cancer||19 (79.2)||38 (59.4)||2.7 (0.9-8.7)||3.6 (1.01-12.6)|
|Chemotherapy in 4 weeks prior to bleeding||12 (50.0)||29 (45.3)||1.3 (0.5-3.5)||1.3 (0.5-3.5)|
|NSAIDs in 2 weeks prior to bleeding||1 (4.2)||3 (4.7)||0.7 (0.1-7.4)||0.7 (0.1-7.8)|
|Antiplatelet drug use in 2 weeks prior to bleeding||1 (4.2)||3 (4.7)||1 (0.1-9.6)||0.9 (0.1-9.6)|
|Endoscopy in 4 weeks prior to bleeding||3 (12.5)||3 (4.7)||3.7 (0.6-23.0)||3.8 (0.6-24.6)|
|Full dose edoxaban||16 (66.7)||47 (74.6)||0.6 (0.2-1.8)||0.3 (0.1-1.4)|
|Weight <60kg in 4 weeks prior to bleeding||4 (17.4)||10 (16.7)||1.2 (0.3-4.2)||2.6 (0.4-14.6)|
|eGFR <50ml/min in 4 weeks prior to bleeding||2 (8.7)||2 (3.4)||2.7 (0.4-19.4)||1.5 (0.2-12.58)|
Conclusions: Advanced cancer was associated with gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban, which can be considered when assessing the benefits and risks. We were unable to identify other risk factors for gastrointestinal bleeding, due to limited statistical power.
To cite this abstract in AMA style:Bosch FT, Mulder FI, Huisman MV, Zwicker J, Di Nisio M, Carrier M, Segers A, Verhamme P, Middeldorp S, Weitz JI, Grosso MA, Duggal A, Büller HR, Wang T-, Garcia DA, Raskob GE, van Es N. Risk Factors for Gastrointestinal Bleeding in Patients with Gastrointestinal Cancer Using Edoxaban: Results from the Hokusai VTE Cancer Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/risk-factors-for-gastrointestinal-bleeding-in-patients-with-gastrointestinal-cancer-using-edoxaban-results-from-the-hokusai-vte-cancer-study/. Accessed May 19, 2022.
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