Abstract：
OBJECTIVE: BEST-CLI, an international randomised trial, compared bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated.
METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated.
RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74).
CONCLUSIONS: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.
METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated.
RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74).
CONCLUSIONS: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.
摘要：
目标：BEST-CLI，一项国际随机试验，在慢性威胁肢体缺血（CLTI）中比较了旁路手术和血管内治疗。在这项子研究中，评估了作为初始或后续结局的总体截肢率和严重截肢风险.
方法：共有1830例患者随机接受手术或血管内治疗：（1）单段大隐静脉（SSGSV）患者（n=1434）；（2）无SSGSV患者（n=396）。评估到第一次事件的时间和截肢次数的差异。
结果：在队列1中，手术组发生了410（45.6％）截肢事件。在平均2.7年的随访期间，血管内组（p=.001）为490（54.4%）。三分之一的患者在索引血运重建后进行了轻微的截肢：手术组的31.5％与血管内组为34.9%（p=0.17）。与血管内组相比，手术组需要随后的大截肢的频率明显较低（15.0％vs.25.6%；p=.002）。首次截肢手术的患者占5.6％，血管内组的患者占6.0％（p=0.72）。手术组10.3%(n=74/718)的患者需要大截肢，血管内组14.9%(n=107/716)(p=.008)。在队列2中，在平均1.6年的随访期间，132例（33.3％）患者发生了199起截肢事件：手术和手术中的95例（47.7％）血管内组104例（52.3%）（p=0.49）。手术组患者中有15.2%(n=30/197)需要大截肢，血管内组患者中有14.1%(n=28/199)需要大截肢(p=0.74)。
结论：在CLTI患者中，在预防大截肢方面,使用SSGSV的外科搭桥术比血管内治疗更有效,因为小截肢后的大截肢减少.
方法：共有1830例患者随机接受手术或血管内治疗：（1）单段大隐静脉（SSGSV）患者（n=1434）；（2）无SSGSV患者（n=396）。评估到第一次事件的时间和截肢次数的差异。
结果：在队列1中，手术组发生了410（45.6％）截肢事件。在平均2.7年的随访期间，血管内组（p=.001）为490（54.4%）。三分之一的患者在索引血运重建后进行了轻微的截肢：手术组的31.5％与血管内组为34.9%（p=0.17）。与血管内组相比，手术组需要随后的大截肢的频率明显较低（15.0％vs.25.6%；p=.002）。首次截肢手术的患者占5.6％，血管内组的患者占6.0％（p=0.72）。手术组10.3%(n=74/718)的患者需要大截肢，血管内组14.9%(n=107/716)(p=.008)。在队列2中，在平均1.6年的随访期间，132例（33.3％）患者发生了199起截肢事件：手术和手术中的95例（47.7％）血管内组104例（52.3%）（p=0.49）。手术组患者中有15.2%(n=30/197)需要大截肢，血管内组患者中有14.1%(n=28/199)需要大截肢(p=0.74)。
结论：在CLTI患者中，在预防大截肢方面,使用SSGSV的外科搭桥术比血管内治疗更有效,因为小截肢后的大截肢减少.
