Key result
A baseline plasma dabigatran level ≥264 ng/mL before reversal with idarucizumab was predictive of ineffective hemostasis and dabigatran rebound in patients with major bleeding.
Why the study?
Guidelines recommend idarucizumab for dabigatran-treated patients facing bleeding or surgery without biological monitoring, leaving unclear whether baseline dabigatran levels predict hemostatic efficacy.
Does baseline dabigatran plasma level predict the hemostatic effectiveness of idarucizumab in patients requiring dabigatran reversal?
Observational (n=87)
Yes
Does baseline dabigatran plasma level predict the hemostatic effectiveness of idarucizumab in patients requiring dabigatran reversal?
A baseline dabigatran plasma level ≥264 ng/mL before reversal with idarucizumab predicts ineffective hemostasis and a higher risk of dabigatran rebound.
Answers are grounded in this paper and cite their sources.
May identify patients at risk of idarucizumab failure; hypothesis-generating for level-guided reversal, pending prospective validation.
Background: Idarucizumab has been included in guidelines for the management of bleeding or surgical procedure in dabigatran-treated patients without need for biological monitoring. The aim of the study was to assess the prognostic value of dabigatran plasma level before reversal to test the hemostatic efficacy of idarucizumab. The secondary objectives were (i) to analyze plasma dabigatran level according to the risk of rebound and (ii) to evaluate the incidence of post-reversal non-favorable clinical outcomes (including thromboembolism, bleeding, antithrombotic, and death) and antithrombotic resumption. Methods and Results: This was an observational multicentric cohort study, which included all French patients who required idarucizumab for dabigatran reversal. Between May 2016 and April 2019, 87 patients from 21 French centers were enrolled. Patients received idarucizumab for overt bleeding ( n = 61), urgent procedures ( n = 24), or overdose without bleeding ( n = 2). Among patients with major bleeding ( n = 57), treatment with idarucizumab was considered effective in 44 (77.2%) of them. Patients who did not achieve effective hemostasis after reversal had a significantly higher mean level of plasma dabigatran at baseline (524.5 ± 386 vs. 252.8 ng/mL ± 235, p = 0.033). Furthermore, patients who did not achieve effective hemostasis after reversal had less favorable outcomes during follow-up (46.2 vs. 81.8%, p = 0.027). ROC curve identified a cutoff of 264 ng/mL for dabigatran level at admission to be predictive of ineffective hemostasis. No plasma dabigatran rebound was observed after reversal in patients with dabigatran plasma level < 264 ng/mL at baseline. Conclusion: This retrospective study shows that dabigatran level before reversal could predict hemostatic effectiveness and dabigatran plasma rebound after idarucizumab injection.
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Gendron et al. (2020) conducted an observational in Dabigatran-treated patients requiring reversal for bleeding or urgent procedures (n=87). Baseline plasma dabigatran level vs. Dabigatran level ≥264 ng/mL was evaluated on Hemostatic effectiveness (dabigatran level <264 ng/mL vs ≥264 ng/mL) (OR 10.75, 95% CI 1.40-229.83, p=0.046). A baseline plasma dabigatran level ≥264 ng/mL before reversal with idarucizumab was predictive of ineffective hemostasis and dabigatran rebound in patients with major bleeding.
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