Aspirin not to be preferred over vitamin K antagonists for cervical artery dissection: Study
Switzerland: Aspirin is not non-inferior to vitamin K antagonists for the treatment of cervical artery dissection -- a major cause of stroke among young people aged below 50 years, finds a recent study in the journal Lancet Neurology.
For the treatment of cervical artery dissection, clinicians have preferred the use of oral anticoagulation with vitamin K antagonists. However, based on available evidence from mostly observational studies, some current guidelines have suggested the use of aspirin. If proven to be non-inferior to vitamin K antagonists, aspirin might be preferable, due to its ease of use and lower cost. Prof Stefan T Engelter, University Hospital Basel and University of Basel, Basel, Switzerland, and colleagues, therefore, aimed to test the non-inferiority of aspirin to vitamin K antagonists in patients with cervical artery dissection.
For this purpose, the researchers performed a multicentre, randomized, open-label, non-inferiority trial in ten stroke centres across Switzerland, Germany, and Denmark. It included 194 patients aged older than 18 years who had symptomatic, MRI-verified, cervical artery dissection within 2 weeks before enrolment. They were randomly assigned in the ratio of 1:1 to receive either aspirin 300 mg once daily (n=100) or a vitamin K antagonist (n=94) (phenprocoumon, acenocoumarol, or warfarin; target international normalized ratio [INR] 2·0–3·0) for 90 days.
The primary endpoint was a composite of clinical outcomes (stroke, major hemorrhage, or death) and MRI outcomes (new ischaemic or hemorrhagic brain lesions) in the per-protocol population, assessed at 14 days (clinical and MRI outcomes) and 90 days (clinical outcomes only) after commencing treatment.
Key findings of the study include:
- The per-protocol population included 173 patients; 91 (53%) in the aspirin group and 82 (47%) in the vitamin K antagonist group.
- The primary endpoint occurred in 21 (23%) of 91 patients in the aspirin group and in 12 (15%) of 82 patients in the vitamin K antagonist group (absolute difference 8%). Thus, non-inferiority of aspirin was not shown.
- Seven patients (8%) in the aspirin group and none in the vitamin K antagonist group had ischaemic strokes. One patient (1%) in the vitamin K antagonist group and none in the aspirin group had major extracranial haemorrhage.
- There were no deaths.
- Subclinical MRI outcomes were recorded in 14 patients (15%) in the aspirin group and in 11 patients (13%) in the vitamin K antagonist group.
- There were 19 adverse events in the aspirin group, and 26 in the vitamin K antagonist group.
"Our findings did not show that aspirin was non-inferior to vitamin K antagonists in the treatment of cervical artery dissection," concluded the authors.
The study titled, "Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial," is published in the journal Lancet Neurology.