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颈动脉内膜切除术与支架置入术试验(CREST)的批判:CREST 及其解释中的缺陷。

Critique of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): flaws in CREST and its interpretation.

机构信息

Department of Vascular Surgery, Red Cross Hospital, Athens, Greece.

出版信息

Eur J Vasc Endovasc Surg. 2013 Jun;45(6):539-45. doi: 10.1016/j.ejvs.2013.03.014. Epub 2013 Apr 19.

Abstract

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) has been used to support the equivalence of carotid artery stenting (CAS) and carotid endarterectomy (CEA) in the treatment of carotid stenosis in both symptomatic and asymptomatic patients. This inclusion of two different forms of the disease decreased the power and significance of the CREST results and weakened the trial. Other flaws in CREST were the equal weighting of mostly minor myocardial infarctions (MIs) with strokes and death in the peri-procedural, composite 'end' point, but not in the 4-year, long-term 'end' point. Although CAS was associated with 50% fewer peri-procedural MIs compared with CEA, there were >2.5-fold more MIs after CAS than CEA at 4 years. The 4-year MI rate, however, was not a component of the primary 'end' point. Additionally, although the initial CREST report indicated that there was no difference in the outcomes of CAS and CEA according to symptomatic status or sex, subsequent subgroup analyses showed that CAS was associated with significantly higher stroke and death rates than CEA in symptomatic patients, in females and in individuals ≥ 65 years of age. The present article will examine these and other flaws and the details of CREST's results derived from the trial's preplanned subanalyses to show why the claims that CREST demonstrates equivalence of the two therapeutic procedures are unjustified.

摘要

颈动脉血运重建内膜切除术与支架置入术试验(CREST)被用于支持颈动脉内膜切除术(CEA)和颈动脉支架置入术(CAS)在治疗症状性和无症状性颈动脉狭窄中的等效性。该试验纳入了两种不同形式的疾病,降低了 CREST 结果的效力和意义,并削弱了试验。CREST 的其他缺陷包括,在围手术期复合终点(“终点”)中同等重视大多数轻微心肌梗死(MI)与中风和死亡,但在 4 年长期终点中则不然。尽管与 CEA 相比,CAS 围手术期 MI 发生率降低了 50%,但 4 年后 CAS 后的 MI 发生率却比 CEA 高 2.5 倍以上。然而,4 年 MI 发生率并不是主要“终点”的组成部分。此外,尽管最初的 CREST 报告表明,根据症状状态或性别,CAS 和 CEA 的结果没有差异,但随后的亚组分析表明,在症状性患者、女性和≥65 岁的患者中,CAS 与 CEA 相比,中风和死亡率显著更高。本文将探讨这些和其他缺陷以及 CREST 试验的预先计划的亚组分析得出的试验结果的细节,以说明为什么 CREST 证明两种治疗方法等效的说法是不合理的。

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