BACKGROUND:In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL).METHODS:Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression.RESULTS:A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, –0.14 [95% CI, –0.25 to –0.02]; P=0.02), SF-12 MCS (difference, –1.03 [95% CI, –1.89 to –0.18]; P=0.02), SF-6D R2 (difference, –0.01 [95% CI, –0.02 to –0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, –0.01 [95% CI, –0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, –0.41 [95% CI, –1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure.CONCLUSIONS:Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

中文翻译：

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接受血运重建治疗的慢性肢体威胁性缺血患者的生活质量

背景：在 BEST-CLI 试验（慢性肢体威胁性缺血患者的最佳血管内治疗与最佳手术治疗）中，预先设定的次要目标是评估血运重建策略对健康相关生活质量 (HRQoL) 的影响。方法：在两项平行试验中，患有慢性肢体威胁性缺血的患者被随机分配接受手术搭桥（Bypass）或血管内介入治疗（Endo）。第 1 组包括单段大隐静脉患者；第二组包括那些缺乏合适的单段大隐静脉的患者。在试验期间使用血管生活质量 (VascuQoL)、欧洲生活质量-5D (EQ-5D)、简表 12 (SF-12) 物理成分摘要 (SF-12 PCS) 评估 HRQoL )、SF-12 心理成分摘要 (SF-12 MCS)、效用指数评分 (SF-6D R2) 和疼痛数字评级量表。按队列总结 HRQoL，并使用混合模型线性回归在组内和组间进行比较。结果：分析了队列 1 和队列 2 中总共 1193 名患者和 335 名患者，平均随访时间分别为 2.9 年和 2.0 年。在队列 1 中，两组的 HRQoL 从基线到随访的所有指标均显着改善。例如，基线时 Bypass 和 Endo 的平均 (SD) VascuQoL 评分分别为 3.0 (1.3) 和 3.0 (1.2)，随访期间分别为 4.7 (1.4) 和 4.8 (1.5)。当使用 VascuQoL（差异，–0.14 [95% CI，–0.25 至 –0.02]；P = 0.02）、SF-12 MCS（差异，–1.03 [95% CI，–1.89 至–0.18]；P =0.02），SF-6D R2（差异，–0.01 [95% CI，–0.02 至 –0.001]；P =0.03），目前疼痛数字评定量表（差异，0.26 [95% CI， 0.03 至 0.49]；P = 0.03），前一周的正常水平（差异，0.26 [95% CI，0.04 至 0.48]；P = 0.02），以及前一周的最差水平（差异，0.29 [95% CI，0.02）至0.56]；P =0.04)。根据 EQ-5D（差异，–0.01 [95% CI，–0.03 至 0.004]；P = 0.12）或 SF-12 PCS（差异，–0.41 [95% CI，– 1.2至0.37]；P =0.31)。在队列 2 中，根据所有指标，两组的 HRQoL 从基线到随访结束也显着改善，但 Bypass 和 Endo 在任何指标上均无差异。 结论：在被认为符合条件的慢性肢体威胁性缺血患者中无论是旁路手术还是远藤手术，血运重建都导致 HRQoL 显着且具有临床意义的改善。在具有可用于搭桥的单节大隐静脉的患者中，但在没有单节大隐静脉的患者中，Endo 在某些 HRQoL 测量方面具有统计学优势；然而，这些差异低于有临床意义的差异的阈值。