Recent ingestion of a DOAC does not appear to increase the risk of symptomatic intracranial haemorrhage (sICH) following intravenous thrombolysis in adult patients with ischaemic stroke.
An international study, published in JAMA Neurology [link here], compared the safety of DOAC therapy within the previous 48 hours of thrombolysis in 832 patients with no recent DOAC use in 32,375 controls.
The patients, from 64 primary and comprehensive stroke centres across Europe, Asia, Australia and New Zealand, were mostly male (56.5%), with a median age of 73 years, and a median NIHSS score of 9.
In patients receiving anticoagulation, prevention of stroke in AF was the most common indication. Dabigatran (41%), rivaroxaban (31%) and apixaban (20%) were the most commonly used anticoagulants.
The study found the unadjusted rate of sICH within 36 hours of thrombolysis was 2.5% in patients with prior DOAC use compared with 4.1% in control patients using no anticoagulants.
“After adjustment for stroke severity and other baseline sICH predictors, patients with recent ingestion of DOACs who received IVT had lower odds of developing sICH (adjusted OR, 0.57; 95% CI, 0.36-0.92; P = .02),” the study said.
In secondary outcomes, there was no difference between patient groups in the rate of any ICH within 36 hours or in functional outcomes at 90 days.
“Given the established benefits of IVT and the absence of any signal for harm in our study or in other clinical studies or pre-clinical investigations, future guideline updates need to re-consider recent DOAC ingestion as a contraindication to IVT for acute ischaemic stroke,” the investigators said.
An accompanying editorial in the journal [link here] said nearly 20% of acute ischaemic stroke patients were undergoing DOAC treatment at the time of their stroke.
It said the retrospective observational study “lays the foundation for prospective, well-powered studies that definitively determine the safety of thrombolysis in this population.”
“In summary, the study provides time-critical, preliminary data for thrombolysis (primarily using alteplase) among patients with AIS [acute ischaemic stroke] with recent DOAC use presenting within the standard thrombolysis time window.”
It commended the investigators for comparing three distinct patient selection strategies for thrombolysis – DOAC reversal in dabigatran users, DOAC level measurement, or neither.
“Notwithstanding the small number of patients in each group, it is reassuring to see that rates of sICH were comparable among these selection strategies.”
“However, the study lacks data on recently emerging anti Xa measurement-based selection for thrombolysis. Anti-Xa level measurement is potentially more widely available compared to DOAC level measurement and correlates well with drug levels.”
Australian investigators on the study were Dr Logesh Palanikumar from the Royal Adelaide Hospital and Dr James Beharry from the Melbourne Brain Centre.