Idarucizumab use prior to thrombolysis in stroke patients was associated with similar rates of symptomatic intracerebral hemorrhage (3.9% vs 3.8%, p=0.97) compared to non-exposed patients.
Observational (n=1,336)
Yes
Does idarucizumab prior to thrombolysis in stroke patients taking dabigatran result in similar safety and clinical outcomes compared to patients not exposed to idarucizumab?
Idarucizumab appears safe and facilitates thrombolysis in stroke patients taking dabigatran, with similar early outcomes to routinely managed patients despite a delay in door-to-needle time.
Absolute Event Rate: 3.9% vs 3.8%
p-value: p=0.97
Objective To assess the frequency and utilization trends of dabigatran reversal with idarucizumab and compare associated complications, outcomes, and door-to-needle times to those of patients not exposed to idarucizumab in a nationwide cohort of thrombolyzed patients over a 24-month period. Methods This is an observational cohort study of all New Zealand patients with stroke treated with stroke reperfusion entered into a mandatory online national registry. Each hospital records data including patient demographics, treatment delays, complications, 7-day outcomes, and idarucizumab use. Results Between 1 January 2017 and 31 December 2018, 1,336 patients received thrombolysis. Fifty-one patients received idarucizumab prior to thrombolysis (median interquartile range age 73 57–83 years): 8 (1.3%) in 2017 and 43 (6%) in 2018 (p p = 0.0006). Symptomatic intracerebral hemorrhage occurred in 2 (3.9%) of the idarucizumab-treated patients and 49 (3.8%) of the other thrombolyzed patients (p = 0.97). None of the idarucizumab-treated patients had significant thrombotic complications. At 7 days, 3 (5.9%) idarucizumab-treated and 101 (7.9%) of the other thrombolyzed patients had died (p = 0.61). Conclusion Idarucizumab was used in 6% of all thrombolyzed patients in a national cohort during 2018, up from 1.3% in 2017. Idarucizumab appeared to be safe with similar clinical outcomes to routinely managed patients, despite a 22-minute door-to-needle time delay. Idarucizumab can facilitate thrombolysis in patients with stroke taking dabigatran. Classification of evidence This study provides Class III evidence that idarucizumab use is associated with similar early post-thrombolysis outcomes compared with patients not exposed to this drug.
Barber et al. (2020) conducted an observational in Stroke (n=1,336). Idarucizumab vs. No idarucizumab was evaluated on Symptomatic intracerebral hemorrhage (p=0.97). Idarucizumab use prior to thrombolysis in stroke patients was associated with similar rates of symptomatic intracerebral hemorrhage (3.9% vs 3.8%, p=0.97) compared to non-exposed patients.