Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.
Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.
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DOI：
10.1016/s1474-4422(09)70228-5
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发表时间：
2009-10
期刊：
影响因子：
48
通讯作者：
Brown, Martin M.
中科院分区：
文献类型：
--
作者：
Ederle, Joerg;Bonati, Leo H.;Dobson, Joanna;Featherstone, Roland L.;Gaines, Peter A.;Beard, Jonathan D.;Venables, Graham S.;Markus, Hugh S.;Clifton, Andrew;Sandercock, Peter;Brown, Martin M.
血管内治疗(血管成形术加或不加支架)是颈动脉狭窄的颈动脉内膜切除术的替代方法，但很少有长期疗效数据表明它能预防中风。因此，我们报告了颈动脉和椎动脉腔内血管成形术研究(CAVATAS)的长期结果。在1992年3月至1997年7月期间，在参与中心就诊的颈内动脉狭窄被认为同样适合颈动脉内膜切除术或血管内治疗的患者被随机分配到通过电话或英国牛津临床试验单位随机服务的传真进行同等比例的治疗。患者在治疗后1个月和6个月接受独立神经科医生的检查，然后在随机分组后每年进行检查，时间尽可能长，最长可达11年。主要预后事件为短暂性脑缺血发作、非致残性、致残性和致命性中风、心肌梗死和任何其他原因死亡。结果由戴着面具接受治疗的调查人员决定。分析采用意向治疗。这项研究已注册，编号为ISRCTN 01425573。504例颈动脉狭窄患者(90%有症状)随机分为血管内治疗组(251例)和手术治疗组(253例)。在治疗30天内，血管内治疗组持续时间少于7天的轻微卒中较多(8比1)，但任何区域或死亡的其他卒中数量相同(25比25)。动脉内膜剥脱术组脑神经麻痹发生率(22vs0)明显高于血管内膜切除术组。两组的中位随访期均为5年(IQR2~6年)。治疗后30d血管内膜剥脱术与血管内膜剥脱术比较，同侧非围手术期卒中患者8年的发生率和危险比分别为11.3%和8.6%(HR 1.22，95%CI为0.59~2.54)，非围手术期卒中或TIA患者的8年发生率和危险比分别为19.3%和17.2%(1.29，0.78~2.14)；任何非围手术期卒中的发生率分别为21.1%和15.4%(1.66，0.99~2.80)。血管内治疗组在随访期发生卒中的患者多于手术组，但两组患者的同侧非围手术期卒中发生率均较低，且两组卒中结局指标的差异无统计学意义。然而，这项研究的动力不足，可信区间很大。正在进行的支架植入与动脉内膜切除术对比试验需要更多的长期数据。英国心脏基金会；英国国家卫生服务管理主管；英国中风协会。
Endovascular treatment (angioplasty with or without stenting) is an alternative to carotid endarterectomy for carotid artery stenosis but there are scarce long-term efficacy data showing that it prevents stroke. We therefore report the long-term results of the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS). Between March, 1992, and July, 1997, patients who presented at a participating centre with a confirmed stenosis of the internal carotid artery that was deemed equally suitable for either carotid endarterectomy or endovascular treatment were randomly assigned to either treatment in equal proportions by telephone or fax from the randomisation service at the Oxford Clinical Trials Unit, UK. Patients were seen by an independent neurologist at 1 and 6 months after treatment and then every year after randomisation for as long as possible, up to a maximum of 11 years. Major outcome events were transient ischaemic attack, non-disabling, disabling, and fatal stroke, myocardial infarction, and death from any other cause. Outcomes were adjudicated on by investigators who were masked to treatment. Analysis was by intention to treat. This study is registered, number ISRCTN 01425573. 504 patients with stenosis of the carotid artery (90% symptomatic) were randomly assigned to endovascular treatment (n=251) or surgery (n=253). Within 30 days of treatment, there were more minor strokes that lasted less than 7 days in the endovascular group (8 vs 1) but the number of other strokes in any territory or death was the same (25 vs 25). There were more cranial nerve palsies (22 vs 0) in the endarterectomy group than in the endovascular group. Median length of follow up in both groups was 5 years (IQR 2–6). By comparing endovascular treatment with endarterectomy after the 30-day post-treatment period, the 8-year incidence and hazard ratio (HR) at the end of follow-up for ipsilateral non-perioperative stroke was 11·3% versus 8·6% (HR 1·22, 95% CI 0·59–2·54); for ipsilateral non-perioperative stroke or TIA was 19·3% versus 17·2% (1·29, 0·78–2·14); and for any non-perioperative stroke was 21·1% versus 15·4% (1·66, 0·99–2·80). More patients had stroke during follow-up in the endovascular group than in the surgical group, but the rate of ipsilateral non-perioperative stroke was low in both groups and none of the differences in the stroke outcome measures was significant. However, the study was underpowered and the confidence intervals were wide. More long-term data are needed from the on going stenting versus endarterectomy trials. British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.