After providing written informed consent, patients received 5 g of intravenous idarucizumab, which was given as 2 50-ml bolus infusions, each containing 2.5 g of idarucizumab, none >15 min apart. Patients were eligible for inclusion irrespective of their baseline renal function. The study enrolled 2 groups of adults 18 years or older who were taking dabigatran: group A included patients with overt, uncontrolled, or life-threatening bleeding, while group B included patients who required urgent surgery or invasive procedure that could not be delayed for at least 8 h, and for which normal hemostasis was required. The design has been previously published (6). RE-VERSE AD was a prospective cohort study that enrolled 503 patients from 34 countries. The objective of this analysis was to compare clinical characteristics, dabigatran levels, extent of reversal of dabigatran by idarucizumab, and clinical outcomes according to baseline renal function in patients enrolled in RE-VERSE AD. The impact of renal impairment on the extent of dabigatran reversal by idarucizumab and on clinical outcomes has not been published. The RE-VERSE AD (Reversal of Effects of Idarucizumab in Patients on Active Dabigatran) study demonstrated that idarucizumab rapidly and completely reverses the anticoagulant effect of dabigatran in patients presenting with uncontrolled or life-threatening bleeding and in those requiring urgent surgery or an invasive procedure (4,5).īoth dabigatran and idarucizumab are cleared by the kidneys, and many patients presenting with severe bleeding or requiring emergency interventions have acute or chronic renal impairment. Idarucizumab is a humanized monoclonal antibody fragment that binds dabigatran with high affinity (2,3). Dabigatran etexilate (dabigatran) is an oral direct thrombin inhibitor that is licensed for the prevention of stroke in patients with atrial fibrillation, and for the prevention and treatment of venous thromboembolism (1).
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