Safety and efficacy of idarucizumab-assisted thrombolysis in dabigatran-related acute ischemic stroke: a systematic review and single-arm meta-analysis.

BACKGROUND

Intravenous thrombolysis (IVT) in patients with acute ischemic stroke (AIS) related to dabigatran use requires prior anticoagulation reversal. This study aimed to evaluate the safety and efficacy of IVT following idarucizumab-mediated reversal through a systematic single-arm meta-analysis.

METHODS

We systematically searched multiple databases. Single-arm studies (≥5 patients) on idarucizumab-facilitated IVT for dabigatran-related AIS were included. Outcome data from DOAC patients without reversal in the Meinel 2023 cohort (n = 580) served as a descriptive external reference. Pooled proportions for safety (symptomatic intracranial hemorrhage, sICH) and efficacy (90-day good functional outcome, mRS 0-2) were calculated using a random-effects GLMM.

RESULTS

Eleven single-arm studies (226 patients) were included. The pooled sICH rate was 5.4% (95% CI 2.6-10.6%; τ 2 = 0.362, Q p = 0.12). The pooled 90-day good functional outcome rate was 66.6% (95% CI 54.2-77.1%; τ 2 = 0.116). In the external reference cohort, the sICH rate was 3.1% and the good outcome rate was 42.4%. Due to baseline imbalances and lack of confounder adjustment, descriptive comparisons were hypothesis-generating only. The certainty of evidence was rated very low (GRADE).

CONCLUSION

Current evidence is insufficient to guide routine clinical practice. However, these findings provide useful effect-size estimates (sICH ~5%, good outcome ~67%) for designing future randomised controlled trials. Multicenter prospective registries or pragmatic RCTs are warranted.