Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial
Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial
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DOI：
10.1016/s1474-4422(15)70018-9
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发表时间：
2015-04-01
期刊：
影响因子：
48
通讯作者：
Delcourt, Candice
中科院分区：
文献类型：
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作者：
Markus, Hugh S.;Hayter, Elizabeth;Delcourt, Candice
研究背景颅外颈动脉和椎动脉夹层是脑卒中的重要原因，尤其是在年轻人中。在一些观察性研究中，它与复发性卒中的高风险相关。抗血小板药物和抗凝药物都用于降低卒中风险，但其中一种治疗策略是否比另一种更有效尚不清楚。我们比较了他们的疗效在颈动脉夹层中风研究（CADISS），额外的目的是建立真正的风险复发stroke.Methods我们做了这项随机试验，在医院专门中风或神经科服务（39在英国和7在澳大利亚）。我们纳入了在过去7天内出现症状的颅外颈动脉和椎动脉夹层患者。通过自动电话随机化服务将患者随机分配（1：1）接受抗血小板药物或抗凝药物（由当地临床医生决定的特定治疗），持续3个月。患者和临床医生对分配不设盲，但评估终点的研究者对分配设盲。主要终点是意向治疗人群中的同侧卒中或死亡。该试验注册EUDract（2006-002827-18）和ISRN（CTN 44555237）。结果我们招募了250名参与者（118颈动脉，132椎骨）。至随机化的平均时间为3.65天（SD 1.91）。主要症状为卒中或短暂性脑缺血发作（n=224）和局部症状（头痛、颈痛或Homer综合征; n=26）。126名参与者被分配接受抗血小板治疗，124名参与者接受抗凝治疗。总体而言，250例患者中有4例（2%）发生卒中复发（均为同侧）。126例患者中有3例（2%）发生卒中或死亡，而124例患者中有1例（1%）发生卒中或死亡（比值比[OR] 0.335，95% CI 0.006-4.233; p=0.63）。抗凝剂组无死亡，但有1例大出血（蛛网膜下腔出血）。影像学中心审查未能确认52例患者的夹层。对这些患者进行的预先计划的符合方案分析显示，抗血小板组101例患者中有3例（3%）发生卒中或死亡，而抗凝组96例患者中有1例（1%）发生卒中或死亡（OR 0.346，95% CI 0-006-4.390; p=0-66）我们发现抗血小板和抗凝药物在预防有症状的脑卒中和死亡方面的疗效没有差异。颈动脉和椎动脉夹层，但中风在两组中都很罕见，而且比一些观察性研究报告的要罕见得多。在许多病例中，经复查后，夹层的诊断没有得到证实，这表明放射学标准在常规临床实践中并不总是正确应用。版权所有（C）Markus等人。根据CC BY的条款分发的开放获取文章。
Background Extracranial carotid and vertebral artery dissection is an important cause of stroke, especially in young people. In some observational studies it has been associated with a high risk of recurrent stroke. Both antiplatelet drugs and anticoagulant drugs are used to reduce risk of stroke but whether one treatment strategy is more effective than the other is unknown. We compared their efficacy in the Cervical Artery Dissection in Stroke Study (CADISS), with the additional aim of establishing the true risk of recurrent stroke.Methods We did this randomised trial at hospitals with specialised stroke or neurology services (39 in the UK and seven in Australia). We included patients with extracranial carotid and vertebral dissection with onset of symptoms within the past 7 days. Patients were randomly assigned (1:1) by an automated telephone randomisation service to receive antiplatelet drugs or anticoagulant drugs (specific treatment decided by the local clinician) for 3 months. Patients and clinicians were not masked to allocation, but investigators assessing endpoints were. The primary endpoint was ipsilateral stroke or death in the intention-to-treat population. The trial was registered with EUDract (2006-002827-18) and ISRN (CTN44555237).Findings We enrolled 250 participants (118 carotid, 132 vertebral). Mean time to randomisation was 3.65 days (SD 1.91). The major presenting symptoms were stroke or transient ischaemic attack (n=224) and local symptoms (headache, neck pain, or Homer's syndrome; n=26). 126 participants were assigned to antiplatelet treatment versus 124 to anticoagulant treatment. Overall, four (2%) of 250 patients had stroke recurrence (all ipsilateral). Stroke or death occurred in three (2%) of 126 patients versus one (1%) of 124 (odds ratio [OR] 0.335, 95% CI 0.006-4.233; p=0.63). There were no deaths, but one major bleeding (subarachnoid haemorrhage) in the anticoagulant group. Central review of imaging failed to confirm dissection in 52 patients. Preplanned per-protocol analysis exduding these patients showed stroke or death in three (3%) of 101 patients in the antiplatelet group versus one (1%) of 96 patients in the anticoagulant group (OR 0.346,95% CI 0-006-4.390; p=0-66).Interpretation We found no difference in efficacy of antiplatelet and anticoagulant drugs at preventing stroke and death in patients with symptomatic carotid and vertebral artery dissection but stroke was rare in both groups, and much rarer than reported in some observational studies. Diagnosis of dissection was not confirmed after review in many cases, suggesting that radiographic criteria are not always correctly applied in routine clinical practice.Funding Stroke Association. Copyright (C)Markus et al. Open Access article distributed under the terms of CC BY.