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Stroke reperfusion therapy following dabigatran reversal with idarucizumab in a national cohort
P Alan Barber1, Teddy Y Wu1, Annemarei Ranta2
1From the Department of Neurology (P.A.B.), Auckland City Hospital; Department of Neurology (T.Y.W.), Christchurch Hospital; Department of Neurology (A.R.), Wellington Regional Hospital; and Department of Medicine (A.R.), University of Otago, Wellington, New Zealand.
Insights
Idarucizumab use in thrombolyzed stroke patients increased significantly from 2017 to 2018. This reversal agent demonstrated safety and similar outcomes to routine care, despite a slight delay in treatment time.
Area of Science:
- Neurology
- Cardiology
- Pharmacology
Background:
- Dabigatran is an anticoagulant used to prevent stroke.
- Reversal agents like idarucizumab are crucial for patients requiring urgent procedures.
- Understanding idarucizumab's role in thrombolysis for stroke patients is essential.
Purpose of the Study:
- To evaluate the frequency and trends of dabigatran reversal with idarucizumab in thrombolyzed stroke patients.
- To compare complications, outcomes, and door-to-needle times between idarucizumab-exposed and unexposed patients.
- To assess the safety and efficacy of idarucizumab in a nationwide cohort.
Main Methods:
- Observational cohort study using a mandatory national registry of stroke patients in New Zealand.
- Data collected included demographics, treatment delays, complications, and 7-day outcomes.
- Analysis compared patients who received idarucizumab prior to thrombolysis with those who did not.
Main Results:
- Idarucizumab use rose from 1.3% in 2017 to 6% in 2018 among thrombolyzed patients.
- Idarucizumab-treated patients had longer door-to-needle times (83 vs. 61 minutes).
- Symptomatic intracerebral hemorrhage rates (3.9% vs. 3.8%) and 7-day mortality (5.9% vs. 7.9%) were similar between groups.
Conclusions:
- Idarucizumab use in thrombolyzed stroke patients is increasing.
- Idarucizumab appears safe, with comparable outcomes to standard care despite a minor delay in door-to-needle time.
- This agent can facilitate thrombolysis in stroke patients taking dabigatran.
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 < 0.001). Over the same 24-month period, 386 patients had stroke clot retrieval, of whom 8 (2.1%) were first treated with idarucizumab. Idarucizumab-treated patients had slower door-to-needle times (83 [54-110] minutes vs 61 [43-85] minutes, 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.
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