The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection.
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Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Engelter Stefan T, Enz Lukas S, Ravanelli Flavia, Kaufmann Josefin E, Gensicke Henrik, Schaedelin Sabine, Luft Andreas R, Globas Christoph, Goeggel-Simonetti Barbara, Fischer Urs, Strambo Davide, Kägi Georg, Nedeltchev Krassen, Kahles Timo, Kellert Lars, Rosenbaum Sverre, von Rennenberg Regina, Brehm Alex, Seiffge David, Renaud Susanne, Brandt Tobias, Sarikaya Hakan, Zietz Annaelle, Wischmann Johannes, Polymeris Alexandros A, Fischer Sandro, Bonati Leo H, De Marchis Gian Marco, Peters Nils, Nolte Christian H, Christensen Hanne, Wegener Susanne, Psychogios Marios-Nikos, Arnold Marcel, Lyrer Philippe, Traenka Christopher
Аннотация
PATIENTS AND METHODS: TREAT-CAD (TREATment of Cervical Artery Dissection) was a randomized controlled trial with blinded outcome assessment comparing non-inferiority of aspirin to anticoagulation (Vitamin-K-antagonists) in participants with symptomatic, Magnetic-Resonance-(MR)-imaging-verified cervical artery dissection. TREAT-CAD could not establish non-inferiority of aspirin to anticoagulation at 3 months. Thereafter participants could continue antithrombotic medication and obtained a standardized assessment of clinical and MR-Imaging outcomes between 3 and 6 months. As crossover to the other treatment arm was possible, we performed an as-treated analysis as main analysis. The main outcomes were new clinical (ischemic stroke, intracranial/major extracranial bleeding, or death) and new MR-Imaging outcomes (ischemic or hemorrhagic brain lesions).
RESULTS: Among the 122 participants in the as-treated analysis, 3/93 (3.2%) aspirin-treated participants had new clinical (n = 1) and MRI-outcomes (n = 2) between 3 and 6 months while 1/29 (3.4%) anticoagulated participants had an MRI-outcome (n = 1). All outcome events were hemorrhagic while ischemic events were absent. No deaths occurred. This yields an absolute difference of 0.2% (95% CI -8.0% to 7.5%, p = 1.0).
DISCUSSION AND CONCLUSION: During the extended follow-up period of a controlled randomized trial comparing aspirin to anticoagulation in cervical artery dissection, outcomes between 3 and 6 months after randomization occurred rarely, similarly often in both groups and were exclusively hemorrhagic events. Thus, studies balancing benefits versus harms of antithrombotic treatment beyond 3 months are warranted.
REGISTRATION: ClinicalTrials.gov: NCT02046460. https://clinicaltrials.gov/ct2/show/NCT02046460.