Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial
RCT (n=173 per protocol) did not show that aspirin was non-inferior to vitamin K antagonists (VKAs) in treatment of cervical artery dissection (primary endpoint in 21 [23%] of 91 patients on aspirin vs. 12 [15%] of 82 on VKA (absolute difference 8%, non-inferiority p=0.55).
Source:
The Lancet Neurology
SPS commentary:
The primary endpoint was a composite of clinical outcomes (stroke, major haemorrhage, or death) and MRI outcomes (new ischaemic or haemorrhagic brain lesions) in the per-protocol population, assessed at 14 days (clinical and MRI outcomes) and 90 days (clinical outcomes only) after commencing treatment
According to a commentary, the cervical artery dissection in stroke study (CADISS) was the first trial to compare anticoagulation with antiplatelet therapy using a randomised open-label design. The choice of antiplatelet regimen was at the discretion of the local investigators and about half of the participants received dual antiplatelet therapy, whereas the anticoagulant regimen was warfarin. Subsequent stroke rates were lower than expected in both groups, and no winning treatment was declared. It notes the current trial was designed before the results of CADISS were published and in anticipation of the challenge of low event rates, the investigators selected a composite outcome, with the hope that measuring MRI outcomes would augment the power of the study; no winner or even a tie could be declared in that study. It discusses why the subsequent stroke risk was higher in the antiplatelet group of the TREAT-CAD trial than in CADISS and suggests that perhaps the difference relates to the choice of antiplatelet therapy. The TREAT-CAD trial used aspirin only, whereas CADISS permitted alternative antiplatelet agents as well as dual antiplatelet therapy, which has been shown to reduce the risk of early stroke recurrence in people with TIA or minor stroke. It concludes that based on these indirect comparisons, there is not enough evidence to provide a specific directive for the treatment of patients with cervical artery dissection. It advises clinicians to rely on the consistent findings of the large trials and use dual antiplatelet therapy for approximately 21 days for most patients presenting with acute TIA or minor stroke.