Aspirin Noninferior to Vitamin K Antagonists for Cervical Artery Dissection

Aspirin for the treatment of cervical artery dissection was noninferior to vitamin K antagonists, according to results of an open-label, randomized, multicenter trial. The results of this trial were published in The Lancet Neurology.

The biomarkers and antithrombotic treatment in cervical artery dissection (TREAT-CAD) trial recruited patients (N=194) from 10 stroke centers in Switzerland, Germany, and Denmark between 2013 and 2018. Patients were randomly assigned in a 1:1 ratio to receive aspirin (n=100) or vitamin K antagonist (n=94) and were assessed for ischemic stroke, major extracranial or intracranial hemorrhage, new brain lesions, and mortality.

Patients in the aspirin and vitamin K antagonist groups were had a mean age of 46.6 (standard deviation [SD], 10.6) and 45.5 (SD, 11.6) years, 62% and 65% were men, 35% and 28% had artery occlusion, and their modified Rankin Scale scores were 1.8 (SD, 1.2) and 1.8 (SD, 1.3) points. The site of dissection was internal carotid artery (72% vs 62%), vertebral artery (29% vs 40%), and multivessel dissection (9% vs 5%), respectively.

After an average follow-up time of 90 days, the composite endpoint of ischemic stroke, major extracranial or intracranial hemorrhage, and death occurred among 23% of the aspirin and 15% of the vitamin K antagonist cohorts. Among these patients, 97% had clinical ischemic events and/or brain lesions at baseline. There was an 8% (95% CI, -4% to 21%; P =.55) between-group absolute difference in the primary endpoint rate.

Clinical outcomes among the aspirin and vitamin K antagonist groups included new acute ischemic brain lesion (10% vs 7%), ischemic stroke (8% vs 0%), new hemorrhagic brain lesion (10% vs 5%), recurrent dissection (3% vs 2%), new acute ischemic and hemorrhagic lesion (2% vs 1%), increase of vessel wall hematoma (1% vs 1%), major extracranial hemorrhage (0% vs 1%), and transient ischemic attack (0% vs 2%), respectively.

Adverse events occurred among 19 of the aspirin and 26 of the vitamin K antagonist cohorts. All events were rare, each occurring among 3 or fewer patients.

The results from this study should be interpreted with caution because there was a large margin in the noninferiority test and the primary endpoint had a wide confidence interval.

These data indicated that aspirin was noninferior to vitamin K antagonists for the treatment of cervical artery dissection.

Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please refer to the original article for a full list of authors’ disclosures.

Reference

Engelter ST, Traenka C, Gensicke H, et al; TREAT-CAD investigators. Aspirin versus anticoagulation in cervical artery dissection (TREAT-CAD): an open-label, randomised, non-inferiority trial. Lancet Neurol. 2021;20(5):341-350. doi:10.1016/S1474-4422(21)00044-2