Lyrer P, Engelter S
Neurology, University Hospital Basel, Petersgraben 4, Basel, Switzerland.
Cochrane Database Syst Rev. 2003(3):CD000255. doi: 10.1002/14651858.CD000255.
Extracranial internal carotid artery dissection can lead to occlusion of the artery and hence cause an ischaemic stroke. It is the underlying stroke mechanism in approximately 2.5% of all strokes. It is the second leading cause of stroke in patients younger than 45 years of age. Anticoagulants or antiplatelets may prevent arterial thrombosis in extracranial internal carotid artery dissection, but these benefits may be offset by increased bleeding.
To determine whether antithrombotic drugs (antiplatelet drugs, anticoagulation) are effective and safe in the treatment of patients with extracranial internal carotid artery dissection, and which is the better treatment.
We searched the Cochrane Stroke Group Trials Register (last searched 3 October 2002). In addition we performed comprehensive searches of the Cochrane Central Register of Controlled Trials (Cochrane Library Issue 2, 2002), MEDLINE (January 1966 to May 2002) and EMBASE (January 1980 to June 2002), and checked all relevant papers for additional eligible studies.
Randomised controlled trials, controlled clinical trials assessing the efficacy of anticoagulants or antiplatelets for the treatment of extracranial internal carotid artery dissection, and non-randomised trials, e.g. case series (studies), that reported on any antithrombotic treatment with at least 4 patients, were eligible for inclusion. Data from all eligible studies were extracted independently by two reviewers. Disagreements were resolved by discussion.
Data on the primary outcome measures were extracted systematically. These were: death (all causes) and death or disability. Secondary outcomes were: first stroke occurrence, stroke recurrence, any stroke during reported follow-up, extracranial haemorrhage, and intracranial haemorrhage. The first choice treatment was taken for analyses.
No randomised trials were identified. No reliable comparisons of antiplatelet drugs or anticoagulants with control were available. Twenty-six eligible studies including 327 patients (who either received antiplatelet drugs or anticoagulants) were to be included in the comparative analysis. There was no significant difference in odds of death comparing antiplatelet drugs with anticoagulants (Peto odds ratio (Peto OR) 1.59, 95% CI 0.22-11.59). There was also no significant difference in the odds of being dead or disabled (Peto OR 1.94, 95% CI 0.76-4.91). Few intracranial haemorrhages (0.5%) were reported for patients on anticoagulants, none for patients on antiplatelets.
REVIEWER'S CONCLUSIONS: There were no randomised trials comparing either anticoagulants or antiplatelet drugs with control. There is, therefore, no evidence to support their routine use for the treatment of extracranial internal carotid artery dissection. There were also no randomised trials that directly compared anticoagulants with antiplatelet drugs, and the reported non-randomised studies did not show any evidence of a significant difference between the two. We suggest that a randomised trial including at least 1400 patients in each treatment arm with this condition is clearly needed.
颅外颈内动脉夹层可导致动脉闭塞,进而引起缺血性卒中。它是所有卒中中约2.5%的潜在卒中机制。它是45岁以下患者卒中的第二大主要病因。抗凝剂或抗血小板药物可能预防颅外颈内动脉夹层的动脉血栓形成,但这些益处可能会被出血增加所抵消。
确定抗血栓药物(抗血小板药物、抗凝药物)治疗颅外颈内动脉夹层患者是否有效和安全,以及哪种治疗方法更好。
我们检索了Cochrane卒中组试验注册库(最后检索时间为2002年10月3日)。此外,我们还对Cochrane对照试验中心注册库(2002年第2期Cochrane图书馆)、MEDLINE(1966年1月至2002年5月)和EMBASE(1980年1月至2002年6月)进行了全面检索,并检查了所有相关论文以寻找其他符合条件的研究。
随机对照试验、评估抗凝剂或抗血小板药物治疗颅外颈内动脉夹层疗效的对照临床试验,以及非随机试验,如病例系列研究(至少4例患者的任何抗血栓治疗报告),均符合纳入标准。两名评价员独立提取所有符合条件研究的数据。分歧通过讨论解决。
系统提取主要结局指标的数据。这些指标包括:全因死亡和死亡或残疾。次要结局指标包括:首次卒中发生、卒中复发、随访期间报告的任何卒中、颅外出血和颅内出血。分析采用首选治疗方法。
未检索到随机试验。没有抗血小板药物或抗凝剂与对照的可靠比较。26项符合条件的研究(包括327例接受抗血小板药物或抗凝剂治疗的患者)将纳入比较分析。抗血小板药物与抗凝剂相比,死亡几率无显著差异(Peto比值比(Peto OR)1.59, 95%可信区间0.22 - 11.59)。死亡或残疾几率也无显著差异(Peto OR 1.94, 95%可信区间0.76 - 4.91)。抗凝剂治疗患者报告的颅内出血很少(0.5%),抗血小板药物治疗患者未报告颅内出血。
没有将抗凝剂或抗血小板药物与对照进行比较的随机试验。因此,没有证据支持它们常规用于治疗颅外颈内动脉夹层。也没有直接比较抗凝剂与抗血小板药物的随机试验,且报告的非随机研究未显示两者之间有显著差异的任何证据。我们建议显然需要进行一项随机试验,每个治疗组至少纳入1400例患有这种疾病的患者。