TREAT-CAD试验的6个月随访：阿司匹林与抗凝治疗对颈动脉夹层患者预防卒中的效果比较
The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection.
作者信息
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
机构信息
Department of Neurology and Stroke Center, University Hospital Basel and University of Basel, Basel, Switzerland.
Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
出版信息
Eur Stroke J. 2025 Feb 5:23969873251315362. doi: 10.1177/23969873251315362.
INTRODUCTION
Cervical artery dissection is a major cause of stroke in the young. The optimal choice and duration of antithrombotic treatment for stroke prevention are debated, particularly beyond 3 months after symptom onset.
PATIENTS AND METHODS
TREAT-CAD (ment of ervical rtery issection) 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 ( = 1) and MRI-outcomes ( = 2) between 3 and 6 months while 1/29 (3.4%) anticoagulated participants had an MRI-outcome ( = 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%, = 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.
引言
颈内动脉夹层是年轻人中风的主要原因。对于预防中风的抗栓治疗的最佳选择和持续时间存在争议，尤其是在症状出现3个月后。
患者与方法
TREAT-CAD（颈内动脉夹层治疗）是一项随机对照试验，采用盲法评估结果，比较阿司匹林与抗凝治疗（维生素K拮抗剂）对有症状、经磁共振成像（MR）证实的颈内动脉夹层参与者的非劣效性。TREAT-CAD未能证实阿司匹林在3个月时相对于抗凝治疗的非劣效性。此后，参与者可继续接受抗栓药物治疗，并在3至6个月期间接受临床和MR成像结果的标准化评估。由于有可能交叉到另一个治疗组，我们进行了意向性分析作为主要分析。主要结局为新的临床结局（缺血性中风、颅内/主要颅外出血或死亡）和新的MR成像结局（缺血性或出血性脑病变）。
结果
在意向性分析的122名参与者中，93名接受阿司匹林治疗的参与者中有3名（3.2%）在3至6个月期间出现了新的临床结局（n = 1）和MRI结局（n = 2），而29名接受抗凝治疗的参与者中有1名（3.4%）出现了MRI结局（n = 1）。所有结局事件均为出血性，无缺血性事件。无死亡发生。这产生了0.2%的绝对差异（95%CI -8.0%至7.5%，p = 1.0）。
讨论与结论
在一项比较阿司匹林与抗凝治疗颈内动脉夹层的对照随机试验的延长随访期内，随机分组后3至6个月的结局很少发生，两组发生频率相似，且均为出血性事件。因此，有必要开展研究以权衡3个月以上抗栓治疗的利弊。注册信息：ClinicalTrials.gov：NCT02046460。https://clinicaltrials.gov/ct2/show/NCT02046460 。
Zotero 插件