Saint Luke's Mid America Heart and Vascular Institute, 4401 Wornall Road, Kansas City, MO 64111, USA.
J Am Coll Cardiol. 2011 Oct 4;58(15):1557-65. doi: 10.1016/j.jacc.2011.05.054.
The purpose of this study was to compare health-related quality of life (HRQOL) outcomes in patients treated with carotid artery stenting (CAS) versus carotid endarterectomy (CEA).
In CREST (Carotid Revascularization Endarterectomy versus Stenting Trial), the largest randomized trial of carotid revascularization to date, there was no significant difference in the primary composite endpoint, but rates of stroke and myocardial infarction (MI) differed between CAS and CEA. To help guide individualized clinical decision making, we compared HRQOL among patients enrolled in the CREST study. We also performed exploratory analyses to evaluate the association between periprocedural complications and HRQOL.
We measured HRQOL at baseline, and after 2 weeks, 1 month, and 1 year among 2,502 patients randomly assigned to either CAS or CEA in the CREST study. The HRQOL was assessed using the Medical Outcomes Study Short-Form 36 (SF-36) and 6 disease-specific scales designed to study HRQOL in patients undergoing carotid revascularization.
At both 2 weeks and 1 month, CAS patients had better outcomes for multiple components of the SF-36, with large differences for role physical function, pain, and the physical component summary scale (all p < 0.01). On the disease-specific scales, CAS patients reported less difficulty with driving, eating/swallowing, neck pain, and headaches but more difficulty with walking and leg pain (all p < 0.05). However, by 1 year, there were no differences in any HRQOL measure between CAS and CEA. In the exploratory analyses, periprocedural stroke was associated with poorer 1-year HRQOL across all SF-36 domains, but periprocedural MI or cranial nerve palsy were not.
Among patients undergoing carotid revascularization, CAS is associated with better HRQOL during the early recovery period as compared with CEA-particularly with regard to physical limitations and pain-but these differences diminish over time and are not evident after 1 year. Although CAS and CEA are associated with similar overall HRQOL at 1 year, event-specific analyses confirm that stroke has a greater and more sustained impact on HRQOL than MI. (Carotid Revascularization Endarterectomy versus Stenting Trial [CREST]; NCT00004732)
本研究旨在比较颈动脉内膜切除术（CEA）与颈动脉支架置入术（CAS）治疗患者的健康相关生活质量（HRQOL）结局。
在迄今为止最大的颈动脉血运重建随机试验 CREST（颈动脉血管重建内膜切除术与支架置入试验）中，CAS 和 CEA 之间主要复合终点没有显著差异，但卒中率和心肌梗死（MI）率不同。为了帮助指导个体化临床决策，我们比较了 CREST 研究中入组患者的 HRQOL。我们还进行了探索性分析，以评估围手术期并发症与 HRQOL 之间的关系。
我们在 CREST 研究中，对 2502 例随机分配至 CAS 或 CEA 的患者，分别于基线时、2 周时、1 个月时和 1 年后测量 HRQOL。使用医疗结局研究短式 36 健康调查量表（SF-36）和 6 种专门用于研究颈动脉血运重建患者 HRQOL 的疾病特异性量表评估 HRQOL。
在 2 周和 1 个月时，CAS 患者的 SF-36 多个成分的结果更好，其中角色身体功能、疼痛和生理成分综合评分的差异较大（均 p<0.01）。在疾病特异性量表上，CAS 患者报告在驾驶、进食/吞咽、颈部疼痛和头痛方面的困难较少，但在行走和腿部疼痛方面的困难较大（均 p<0.05）。然而，在 1 年时，CAS 和 CEA 之间在任何 HRQOL 测量上均无差异。在探索性分析中，围手术期卒中与所有 SF-36 领域的 1 年 HRQOL 较差相关，但围手术期 MI 或颅神经麻痹则不然。
在接受颈动脉血运重建的患者中，与 CEA 相比，CAS 在早期恢复期间与更好的 HRQOL 相关，特别是在身体限制和疼痛方面，但这些差异随时间而减少，在 1 年后并不明显。尽管 CAS 和 CEA 在 1 年时具有相似的总体 HRQOL，但特定事件的分析证实，卒中对 HRQOL 的影响更大且更持久，而非 MI。（颈动脉血管重建内膜切除术与支架置入试验[CREST]；NCT00004732）
