Summary

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• Praxbind (idarucizumab) is indicated for patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery, urgent procedures, or life-threatening or uncontrolled bleeding.
• This summary is based on the review of 10 systematic review(s)/meta-analysis(es). ^[1-10]
• Hemostatic Effectiveness: Idarucizumab achieved a hemostatic effectiveness rate of 77.7% (95% CI 66.7%-87.2%), with peri-procedural hemostasis being normal in 98.5% of patients (95% CI 86.6%-100%).
• Intracranial Hemorrhage (ICH): In patients with dabigatran-related ICH, in-hospital mortality ranged from 9.7% to 11.4%, with hemorrhages stabilizing or resolving in 87% of cases and worsening in 13%.
• Comparative Effectiveness: Idarucizumab showed a lower thromboembolism rate of 4.6% compared to 10.7% with andexanet and provided optimal perioperative hemostasis in up to 93% of patients, while andexanet was associated with unresponsiveness to heparin.
• Effectiveness in Specific Populations: In AIS patients treated with dabigatran, idarucizumab enabled intravenous thrombolysis with outcomes comparable to non-anticoagulated patients.
• The pooled incidence of all-cause mortality was 13.6% (95% CI 9.6%-17.9%), with a thromboembolism rate of 4.6% (95% CI 3.3%-6.0%) and particularly high at 10.7% when andexanet was used.
• Rebleeding occurred in 13.2% (95% CI 5.5%-23.1%) of cases, with 78% of these incidents occurring after the resumption of anticoagulation.
• Thrombotic events after dabigatran reversal had a pooled incidence rate of 5.5% within 30-90 days post-reversal, and rebound in dabigatran concentration was notably higher in patients with impaired renal function (GFR <30 mL/min).
• Specific population types or subgroups included patients with an average age of 74 years for AIS and 76.2 years for ICH, with 39.9% females in AIS and 43% females in ICH. Patients with impaired renal function (GFR <30 mL/min) had a higher risk of dabigatran concentration rebound post-idarucizumab. Outcomes were separately reported for intracranial and extracranial hemorrhages, with acceptable therapeutic effects and safety profiles observed in specific populations, particularly in AIS and ICH cases. Monitoring for dabigatran rebound is critical in patients with severe renal dysfunction, where additional idarucizumab doses may be necessary.