性别对支架置入与内膜切除术治疗效果的影响：Carotid Revascularization Endarterectomy versus Stenting Trial（CREST）的亚组分析。
Influence of sex on outcomes of stenting versus endarterectomy: a subgroup analysis of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).
机构信息
Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.
出版信息
Lancet Neurol. 2011 Jun;10(6):530-7. doi: 10.1016/S1474-4422(11)70080-1. Epub 2011 May 5.
BACKGROUND
In the randomised Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the primary endpoint did not differ between carotid artery stenting and carotid endarterectomy in patients with symptomatic and asymptomatic stenosis. A prespecified secondary aim was to examine differences by sex.
METHODS
Patients who were asymptomatic or had had a stroke or transient ischaemic attack within 180 days before random allocation were enrolled in CREST at 117 clinical centres in the USA and Canada. The primary outcome was the composite of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years. We used standard survival methods including Kaplan-Meier survival curves and sex-by-treatment interaction term to assess the relation between patient factors and risk of reaching the primary outcome. Analyses were by intention to treat. CREST is registered with ClinicalTrials.gov, NCT00004732.
FINDINGS
Between Dec 21, 2000, and July 18, 2008, 2502 patients were randomly assigned to carotid endarterectomy (n=1240) or carotid artery stenting (n=1262), 872 (34.9%) of whom were women. Rates of the primary endpoint for carotid artery stenting compared with carotid endarterectomy were 6.2% versus 6.8% in men (hazard ratio [HR] 0.99, 95% CI 0.66-1.46) and 8.9% versus 6.7% in women (1.35, 0.82-2.23). There was no significant interaction in the primary endpoint between sexes (interaction p=0.34). Periprocedural events occurred in 35 (4.3%) of 807 men assigned to carotid artery stenting compared with 40 (4.9%) of 823 assigned to carotid endarterectomy (HR 0.90, 95% CI 0.57-1.41) and 31 (6.8%) of 455 women assigned to carotid artery stenting compared with 16 (3.8%) of 417 assigned to carotid endarterectomy (1.84, 1.01-3.37; interaction p=0.064).
INTERPRETATION
Periprocedural risk of events seems to be higher in women who have carotid artery stenting than those who have carotid endarterectomy whereas there is little difference in men. Additional data are needed to confirm whether this differential risk should be taken into account in decisions for treatment of carotid disease in women.
FUNDING
National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions (formerly Guidant).
背景
在随机颈动脉血管重建内膜切除术与支架置入术试验（CREST）中，在有症状和无症状狭窄的患者中，颈动脉支架置入术与颈动脉内膜切除术的主要终点没有差异。一个预先指定的次要目标是检查性别差异。
方法
在美国和加拿大的 117 个临床中心，无症状或在随机分配前 180 天内发生中风或短暂性脑缺血发作的患者被纳入 CREST。主要结局是围手术期内的中风、心肌梗死或死亡，或同侧 4 年内中风。我们使用标准生存方法，包括 Kaplan-Meier 生存曲线和治疗与性别相互作用项，评估患者因素与主要结局风险之间的关系。分析采用意向治疗。CREST 在 ClinicalTrials.gov 注册，NCT00004732。
结果
2000 年 12 月 21 日至 2008 年 7 月 18 日，2502 例患者被随机分配至颈动脉内膜切除术（n=1240）或颈动脉支架置入术（n=1262），其中 872 例（34.9%）为女性。颈动脉支架置入术与颈动脉内膜切除术相比，主要终点的发生率在男性中分别为 6.2%和 6.8%（风险比[HR]0.99，95%CI 0.66-1.46），在女性中分别为 8.9%和 6.7%（1.35，0.82-2.23）。性别之间的主要终点无显著交互作用（交互作用 p=0.34）。在接受颈动脉支架置入术的 807 名男性中，35 名（4.3%）发生围手术期事件，而在接受颈动脉内膜切除术的 823 名男性中，40 名（4.9%）发生围手术期事件（HR 0.90，95%CI 0.57-1.41）；在接受颈动脉支架置入术的 455 名女性中，31 名（6.8%）发生围手术期事件，而在接受颈动脉内膜切除术的 417 名女性中，16 名（3.8%）发生围手术期事件（1.84，1.01-3.37；交互作用 p=0.064）。
解释
与接受颈动脉内膜切除术的女性相比，接受颈动脉支架置入术的女性围手术期发生事件的风险似乎更高，而男性之间则没有显著差异。需要更多的数据来证实这种不同的风险是否应该在女性颈动脉疾病治疗决策中考虑。
资金来源
美国国立神经病学与卒中研究所和雅培血管解决方案公司（前身为 Guidant）。
Zotero 插件