Details

Autor(en) / Beteiligte

• van der Horst, S.F.B.
• Martens, E.S.L.
• den Exter, P.L.
• Bos, M.H.A.
• van Mens, T.E.
• Huisman, M.V.
• Klok, F.A.

Titel

Idarucizumab for dabigatran reversal: A systematic review and meta-analysis of indications and outcomes

Ist Teil von

• Thrombosis research, 2023-08, Vol.228, p.21-32

Ort / Verlag

United States: Elsevier Ltd

Erscheinungsjahr

2023

Quelle

Access via ScienceDirect (Elsevier)

Beschreibungen/Notizen

• Idarucizumab has been approved to reverse the anticoagulant effect of dabigatran. However, there is little knowledge of the effectiveness and safety of idarucizumab in daily practice. This systematic review and meta-analysis aims to evaluate the use, effectiveness and outcomes of idarucizumab. A systematic literature search was performed up to September 8th 2022. Original studies including patients prescribed idarucizumab, evaluating prescription indications, prescription appropriateness, haemostatic efficacy and/or the occurrence of adverse events were eligible. Case-reports and studies performed in patients ≤18 years or in healthy volunteers were excluded. Study selection and data extraction were performed by two independent reviewers. Pooled estimates were calculated using the random-effects model, after Freeman-Tukey double-arcsine transformation. Thirty studies comprising 3602 patients were included. Idarucizumab was prescribed for bleeding (63.1 %, 95%CI 57.0 %–69.0 %), invasive procedures (30.5 %, 95%CI: 24.1 %–37.2 %), to enable thrombolysis (range: 2.0 %–27.3 %), dabigatran intoxication without bleeding (range: 3.6 %–7.0 %) or unspecified reasons (range: 0.4 %–18.8 %). Overall, 2.8 % (95%CI 0.5 %–6.2 %) of prescription indications were reported to be inappropriate upon post-hoc evaluation. Hemostatic effectiveness was achieved in 77.7 % (95%CI 66.7 %–87.2 %) and peri-procedural haemostasis was normal in 98.5 % (95%CI 86.6 %–100 %) of patients. The pooled incidences of all-cause mortality and thromboembolic events at any follow-up duration were 13.6 % (95%CI 9.6 %–17.9 %) and 2.0 % (95%CI 0.8 %–3.4 %), respectively. Idarucizumab was mainly prescribed in the setting of bleeding. The reported hemostatic effectiveness was good, especially perioperatively, and the incidence of thromboembolic events was low. Patients with dabigatran-associated bleeding or requiring an urgent procedure nonetheless face a high mortality risk. •Idarucizumab is mainly prescribed in the context of bleeding.•The hemostatic efficacy of idarucizumab is good, especially peri-operatively.•The incidence of thromboembolic events after idarucizumab administration is low.•Patients prescribed idarucizumab still face a high mortality risk.•Re-initiation of anticoagulant therapy needs to be monitored.