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左主干病变经依维莫司洗脱支架或旁路手术后的生活质量:EXCEL 试验结果。

Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

机构信息

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

Piedmont Heart Institute, Atlanta, Georgia.

出版信息

J Am Coll Cardiol. 2017 Dec 26;70(25):3113-3122. doi: 10.1016/j.jacc.2017.10.036. Epub 2017 Oct 30.

Abstract

BACKGROUND

The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group.

OBJECTIVES

To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial.

METHODS

Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models.

RESULTS

Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG.

CONCLUSIONS

Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

摘要

背景

EXCEL(依维莫司洗脱支架治疗非保护左主干冠状动脉疾病的疗效比较:冠状动脉旁路移植术与经皮冠状动脉介入治疗的评估)试验比较了接受冠状动脉旁路移植术(CABG)或经皮冠状动脉介入治疗(PCI)的无保护左主干冠状动脉疾病(LMCAD)患者的结局。尽管在 36 个月时死亡、卒中和心肌梗死的发生率相似,但治疗组之间的事件时间和再次血运重建率存在差异。

目的

为了从患者的角度了解血运重建策略的效果,在 EXCEL 试验的同时进行了一项前瞻性生活质量(QoL)亚研究。

方法

2010 年 9 月至 2014 年 3 月,1905 例 LMCAD 患者被随机分为 CABG 或 PCI 组,其中 1788 例患者参加了 QoL 亚研究。使用西雅图心绞痛问卷、12 项简短健康调查问卷、玫瑰呼吸困难量表、患者健康问卷-8 和 EQ-5D 在基线和 1、12 和 36 个月评估 QoL。使用纵向随机效应增长曲线模型评估 PCI 和 CABG 之间的差异。

结果

在 36 个月的随访中,与基线相比,PCI 和 CABG 均与 QoL 的显著改善相关。在 1 个月时,PCI 与更好的 QoL 相关。然而,到 12 个月时,这些差异基本减弱,到 36 个月时,PCI 和 CABG 之间没有显著的 QoL 差异。

结论

在选择的 LMCAD 患者中,尽管 PCI 早期获益更大,但 PCI 和 CABG 在 36 个月内均可导致 QoL 相似的改善。与 EXCEL 的 3 年临床结果相结合,这些发现表明,PCI 和 CABG 为 LMCAD 患者提供了相似的中期结果。(依维莫司洗脱支架治疗非保护左主干冠状动脉疾病的疗效比较:冠状动脉旁路移植术与经皮冠状动脉介入治疗的评估[EXCEL];NCT01205776)。

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