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颈动脉支架置入术与内膜切除术治疗后与健康相关的生活质量:来自 SAPPHIRE(高内膜切除术风险患者的支架置入和血管成形术伴保护)试验的结果。

Health-related quality of life following carotid stenting versus endarterectomy: results from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy) trial.

机构信息

Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA.

出版信息

JACC Cardiovasc Interv. 2010 May;3(5):515-23. doi: 10.1016/j.jcin.2010.02.009.

DOI:10.1016/j.jcin.2010.02.009
PMID:20488408
Abstract

OBJECTIVES

This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA).

BACKGROUND

Carotid artery stenting is approved in the U.S. for treating carotid stenosis in patients at high surgical risk. Whether CAS offers advantages in terms of other patient-centered outcomes is unknown.

METHODS

We evaluated health-related quality of life in the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial, which randomized 334 high-risk patients with carotid stenosis to CAS versus CEA. Health status assessments were obtained at baseline; 2 weeks; and 1, 6, and 12 months after revascularization. Generic measures included the Short-Form-36 (SF-36) (0 to 100 scale), general health rating, and EuroQol (EQ-5D). In addition, we used 6 disease-specific modified Likert scales to assess difficulty with walking, eating/swallowing, driving, headaches, neck pain, and leg pain.

RESULTS

In patients treated according to protocol (n = 159 CAS; n = 151 CEA), CAS patients had better scores at 2 weeks for the SF-36 role physical scale (mean difference: 9.0; 95% confidence interval: 0.9 to 17.1; p = 0.031), but these differences had resolved by 1-month follow-up. For the disease-specific scales, CAS patients reported less difficulty eating/swallowing at 2 weeks, less difficulty driving at 2 weeks, and less neck pain at 2 weeks; each of these differences between groups was no longer present at 1 month. No other scores differed between groups at any time point.

CONCLUSIONS

Among patients at high surgical risk, CAS was associated with less health status impairment during the first 2 weeks of recovery when compared with CEA. However, these differences had resolved by 1 month after the procedure, and no other differences between revascularization strategies in health-related quality of life were found.

摘要

目的

本研究比较了颈动脉支架置入术(CAS)与颈动脉内膜切除术(CEA)治疗颈动脉狭窄患者的健康相关生活质量。

背景

颈动脉支架置入术在美国获批用于治疗手术高危患者的颈动脉狭窄。但 CAS 是否在其他以患者为中心的结局方面具有优势尚不清楚。

方法

我们评估了 SAPPHIRE(高风险颈动脉狭窄患者支架置入与内膜切除术保护)试验中的健康相关生活质量,该试验将 334 例颈动脉狭窄高危患者随机分为 CAS 组与 CEA 组。在血管重建前、术后 2 周、1、6 和 12 个月时进行健康状况评估。采用健康调查简表 36 项(SF-36)(0 至 100 分制)、一般健康评分和 EuroQol(EQ-5D)进行一般健康评估。此外,我们还使用 6 种疾病特异性改良 Likert 量表评估行走困难、进食/吞咽困难、驾驶困难、头痛、颈部疼痛和腿部疼痛。

结果

根据方案进行治疗的患者(CAS 组 159 例,CEA 组 151 例)中,CAS 组患者在术后 2 周时 SF-36 躯体角色功能量表评分更高(平均差值:9.0;95%置信区间:0.9 至 17.1;p = 0.031),但这些差异在 1 个月随访时已得到解决。对于疾病特异性量表,CAS 组患者在术后 2 周时报告进食/吞咽困难程度较轻,在术后 2 周时报告驾驶困难程度较轻,在术后 2 周时报告颈部疼痛程度较轻;这些组间差异在 1 个月时均不再存在。在任何时间点,其他评分在组间均无差异。

结论

在手术高危患者中,与 CEA 相比,CAS 在血管重建术后前 2 周恢复期间对健康状况的损害较小。然而,这些差异在术后 1 个月时已得到解决,且在健康相关生活质量方面未发现两种血运重建策略之间的其他差异。

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