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我如何解读颈动脉血管成形术/支架置入术与动脉内膜切除术的随机试验。

How I interpreted the randomised trials of carotid angioplasty/stenting versus endarterectomy.

作者信息

Hankey Graeme J

机构信息

Stroke Unit, Department of Neurology, Royal Perth Hospital, Perth, Australia.

出版信息

Eur J Vasc Endovasc Surg. 2008 Jul;36(1):34-40. doi: 10.1016/j.ejvs.2008.04.001. Epub 2008 May 15.

DOI:10.1016/j.ejvs.2008.04.001
PMID:18485759
Abstract

Carotid endarterectomy (CEA) for carotid stenosis is effective in preventing ipsilateral carotid territory ischaemic stroke. Paradoxically however, it causes a stroke (the event it is trying to prevent) in about 5% or more of cases. If carotid angioplasty/stenting (CAS) is to have a place in the management of patients with carotid stenosis (beyond those who are not suitable for CEA), it has to demonstrate that it is also effective and safe. Limited data from 12 randomised trials comparing CAS with CEA (the current "gold standard") in a total of 3227 patients with carotid stenosis (90% symptomatic) question the safety of CAS and suggest that it may cause more non-fatal, procedural strokes than CEA despite similar mortality rates and a much lower immediate local complication rate (eg cranial neuropathy). However, the published trials are rather heterogeneous (clinically and methodologically), none is large enough to provide robust and convincing data and long-term follow-up is very limited. Accordingly, it remains unknown whether CAS is effective in preventing recurrent stroke among patients with carotid stenosis, or whether it is safe. More data (from at least another 3,000 patients) are needed from the ongoing randomised trials before it can reliably be concluded whether CAS is inferior to, non-inferior to, or more effective than, CEA. More importantly, it will be possible to determine which patients should be treated preferentially with CAS, which patients with CEA, and which patients should not undergo either revascularisation procedure.

摘要

颈动脉内膜切除术(CEA)治疗颈动脉狭窄在预防同侧颈动脉区域缺血性卒中方面是有效的。然而,矛盾的是,在约5%或更多的病例中,它会引发卒中(正是它试图预防的事件)。如果颈动脉血管成形术/支架置入术(CAS)要在颈动脉狭窄患者的治疗中占有一席之地(不包括那些不适合CEA的患者),就必须证明其同样有效且安全。12项随机试验对总共3227例颈动脉狭窄患者(90%有症状)进行了CAS与CEA(当前的“金标准”)的比较,所提供的有限数据对CAS的安全性提出了质疑,并表明尽管死亡率相似且即时局部并发症发生率低得多(如颅神经病变),但CAS可能比CEA导致更多非致命性的术中卒中。然而,已发表的试验在临床和方法学上差异很大,没有一项规模大到足以提供有力且令人信服的数据,长期随访也非常有限。因此,CAS在预防颈动脉狭窄患者复发性卒中方面是否有效,或者是否安全,仍然未知。在能够可靠地得出CAS是否劣于、不劣于或比CEA更有效的结论之前,还需要正在进行的随机试验提供更多数据(至少来自另外3000名患者)。更重要的是,将有可能确定哪些患者应优先接受CAS治疗,哪些患者应接受CEA治疗,以及哪些患者不应接受任何一种血运重建手术。

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