首页> 外文期刊>Lancet Neurology >Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial
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Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial

机译:有症状重度颈动脉狭窄(EVA-3S)试验患者的内膜切除术与血管成形术:一项随机,多中心试验的结果长达4年

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Summary:Background Carotid stenting is a potential alternative to carotid endarterectomy but whether this technique is as safe as surgery and whether the long-term protection against stroke is similar to that of surgery are unclear. We previously reported that in patients in the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with endarterectomy. We now report the results up to 4 years.Methods In this follow-up study of a multicentre, randomised, open, assessor-blinded, non-inferiority trial, we compared outcome after stenting with outcome after endarterectomy in 527 patients who had carotid stenosis of at least 60% that had recently become symptomatic. The primary endpoint of the EVA-3S trial was the rate of any periprocedural stroke or death (ie, within 30 days after the procedure). The prespecified main secondary endpoint was a composite of any periprocedural stroke or death and any non-procedural ipsilateral stroke during up to 4 years of follow-up. Other trial outcomes were any stroke or periprocedural death, any stroke or death, and the above endpoints restricted to disabling or fatal strokes. This trial is registered with ClinicalTrials.gov,number NCT00190398.
机译:简介:背景颈动脉支架置入术是颈动脉内膜切除术的一种潜在替代方法,但尚不清楚该技术是否像手术一样安全,长期预防中风的保护措施是否与外科手术相似。我们先前曾报道,在有症状的严重颈动脉狭窄患者(EVA-3S)中,在接受内膜切除术与血管成形术的患者中,使用支架置入术后30天内任何中风或死亡的发生率均高于使用内膜切除术。现在,我们报告长达4年的结果。方法在这项针对多中心,随机,开放,评估者盲,非劣效性试验的随访研究中,我们比较了527例颈动脉狭窄患者的支架置入术后和动脉内膜切除术后的结果。至少有60%的人最近出现了症状。 EVA-3S试验的主要终点是任何围手术期中风或死亡的发生率(即手术后30天内)。预先确定的主要次要终点是在长达4年的随访中,所有围手术期卒中或死亡以及任何非围手术期同侧卒中。其他试验结果是任何中风或过程中死亡,任何中风或死亡,并且上述终点仅限于致残或致命中风。该试验已在ClinicalTrials.gov上注册,编号为NCT00190398。

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