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Reversal of Dabigatran Bleeding and Coagulopathy Using Idarucizumab in a Patient With Acute Kidney Injury.

ABSTRACT: Idarucizumab is approved for patients treated with dabigatran when reversal of the anticoagulant effects is needed. Like dabigatran, idarucizumab is excreted in the urine. The effect of renal dysfunction on drug elimination is uncertain, as patients in the RE-VERSE AD trial had a median creatinine clearance of 58 mL/min. Also, dabigatran accumulation can occur if the international normalized ratio (INR) is greater than two. A 73-year-old female was admitted for lower extremity edema and increased abdominal girth. On admission, the patient was in acute kidney injury (AKI) with an estimated creatinine clearance of 34.5 mL/min. Her prothrombin time (PT) on admission was 17 seconds, her INR was 1.4, and her hemoglobin was 8.7 gm/dL (12-16 gm/dL). Throughout her admission, she was continued on her home regimen of dabigatran 150 mg twice daily for atrial fibrillation. On day 4, she had rectal bleeding and altered mental status. At this time, her PT was elevated to 25.6 seconds, her INR had increased to 2.3, and her hemoglobin had dropped to 6.8 gm/dL. Two doses of idarucizumab 2.5 gm were administered, and dabigatran was successfully reversed with cessation of bleeding and normalization of the INR to 1.5. An additional dose of idarucizumab was not required. The patient was discharged home two days later. Idarucizumab successfully reversed the bleeding and coagulopathy associated with dabigatran in a patient with AKI.

SUBMITTER: Vidal J

PROVIDER: S-EPMC6281148 | biostudies-other | 2018 Dec

REPOSITORIES: biostudies-other

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Reversal of Dabigatran Bleeding and Coagulopathy Using Idarucizumab in a Patient With Acute Kidney Injury.

Vidal Jennifer J DePalma Richard R Forouzan Leila L

P & T : a peer-reviewed journal for formulary management 20181201 12

Idarucizumab is approved for patients treated with dabigatran when reversal of the anticoagulant effects is needed. Like dabigatran, idarucizumab is excreted in the urine. The effect of renal dysfunction on drug elimination is uncertain, as patients in the RE-VERSE AD trial had a median creatinine clearance of 58 mL/min. Also, dabigatran accumulation can occur if the international normalized ratio (INR) is greater than two. A 73-year-old female was admitted for lower extremity edema and increase ...[more]

PMID: 30559587

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Project description:IMPORTANCE:It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice. OBJECTIVE:To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data. DESIGN, SETTING, AND PARTICIPANTS:In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011. EXPOSURES:Dabigatran users (n = 1302) and warfarin users (n = 8102). MAIN OUTCOMES AND MEASURES:We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities. RESULTS:Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease. CONCLUSIONS AND RELEVANCE:Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.

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Dataset Information

Reversal of Dabigatran Bleeding and Coagulopathy Using Idarucizumab in a Patient With Acute Kidney Injury.

Publications

Reversal of Dabigatran Bleeding and Coagulopathy Using Idarucizumab in a Patient With Acute Kidney Injury.

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