Dabigatran safe for acute noncardioembolic ischaemic stroke treatment
Early dabigatran administration does not contribute to an excess risk of haemorrhagic transformation (HT) as compared with aspirin in patients with acute minor noncardioembolic ischaemic stroke/transient ischaemic attack, according to the results of the phase II DATAS II* study.
DATAS II randomized 305 patients (mean age, 66.59 years) who had National Institutes of Health Stroke Scale [NIHSS] score of ≤9 and infarct volume of ≤25 mL to dabigatran or aspirin a mean of 42 hours after symptom onset. Treatment was indicated for a transient ischaemic attack in 21 percent of patients and ischaemic stroke in 79 percent. All patients underwent magnetic resonance imaging at baseline and day 30.
Median NIHSS score of the population was 1, while mean infarct volume was 3.2 mL. None of the patients developed symptomatic HT within 37 days of randomization, the primary study endpoint.
Meanwhile, asymptomatic petechial HT occurred in 11 of 142 dabigatran-treated patients and in 5 of 142 of those on aspirin (7.8 percent vs 3.5 percent; relative risk, 2.301, 95 percent confidence interval [CI], 0.778–6.802). Baseline infarct volume was a significant predictor of incident asymptomatic HT (odds ratio, 1.07, 95 percent CI, 1.03–1.12]; p=0.0026).
Incident covert infarcts on day 30 imaging occurred in nine patients in the dabigatran group and in 14 in the aspirin group (6.3 percent vs 9.8 percent; relative risk, 0.62, 95 percent CI, 0.26–1.48).
The findings show the feasibility and safety of acute dabigatran administration following undifferentiated minor ischaemic stroke or transient ischaemic attack, the researchers said.
*Dabigatran Treatment of Acute Stroke II