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.
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.