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
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
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DOI：
10.1016/j.jcin.2010.02.009
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发表时间：
2010-05-01
影响因子：
11.3
通讯作者：
Cohen, David J.
中科院分区：
文献类型：
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作者：
Stolker, Joshua M.;Mahoney, Elizabeth M.;Cohen, David J.
目的本研究比较了接受颈动脉支架植入术（CAS）和外科动脉内膜切除术（CEA）患者的健康相关生活质量。背景颈动脉支架植入术在美国被批准用于治疗高手术风险患者的颈动脉狭窄。CAS是否提供优势，在其他以患者为中心的outcome.Methods的SAPPHIRE（支架和血管成形术与保护患者在高风险的内膜切除术）试验，随机334高风险患者颈动脉狭窄CAS与CEA的健康相关的生活质量进行了评估。在基线、血运重建后2周、1个月、6个月和12个月进行健康状况评估。通用指标包括SF-36（0 - 100量表）、一般健康评分和EuroQol（EQ-5D）。此外，我们使用6种疾病特异性改良的Likert量表来评估行走、进食/吞咽、驾驶、头痛、颈痛和腿痛的困难。（n = 159例CAS; n = 151例CEA），CAS患者在2周时SF-36角色身体量表评分较好（平均差异：9.0; 95%置信区间：0.9 - 17.1; p = 0.031），但这些差异在1个月随访时消退。对于疾病特异性量表，CAS患者报告2周时进食/吞咽困难减少，2周时驾驶困难减少，2周时颈部疼痛减少; 1个月时，组间的这些差异均不再存在。在任何时间点组间无其他评分差异。结论在高手术风险的患者中，CAS与CEA相比，在恢复的前2周内健康状况损害较少。然而，这些差异在手术后1个月时消失，并且在健康相关生活质量方面未发现血运重建策略之间的其他差异（J Am科尔Cardiol Intv 2010;3：515-23）（C）2010年，美国心脏病学会基金会
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. (J Am Coll Cardiol Intv 2010;3:515-23) (C) 2010 by the American College of Cardiology Foundation