Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.
Clinical Effectiveness Unit, Royal College of Surgeons of England, London, UK.
Br J Surg. 2018 Aug;105(9):1145-1154. doi: 10.1002/bjs.10823. Epub 2018 Apr 25.
The aim of this study was to estimate separate risks of major lower limb amputation and death following revascularization for peripheral artery disease (PAD) using competing risks analysis.
Routinely collected data from Hospital Episode Statistics (HES) were used to identify patients who underwent endovascular or open lower limb revascularization for PAD in England from 2005 to 2015. The primary outcomes were major lower limb amputation and death within 5 years of revascularization. Cox proportional hazards and Fine-Gray competing risks regression were used to examine the competing risks of these outcomes.
Some 164 845 patients underwent their first lower limb revascularization for PAD during the study interval. Most were men (64·6 per cent) and the median age was 71 (i.q.r. 62-78) years. Following endovascular revascularization, the 5-year cumulative incidence of amputation was 4·2 per cent in patients with intermittent claudication and 18·0 per cent in those with a record of tissue loss. The corresponding rates were 10·8 and 25·3 per cent respectively after open revascularization, and 8·1 and 25·0 per cent after combined procedures. The 5-year cumulative incidence of death varied from 24·5 to 39·8 per cent, depending on procedure type. Competing risks methods consistently produced lower estimates than standard methods.
The 5-year risk of major amputation following lower limb revascularization for PAD appears lower than estimated previously. Patients undergoing revascularization for tissue loss and those who require an open procedure are at highest risk of limb loss.
本研究旨在通过竞争风险分析估计外周动脉疾病(PAD)血管重建后主要下肢截肢和死亡的单独风险。
使用来自医院病例统计数据(HES)的常规收集数据,确定 2005 年至 2015 年间在英格兰接受血管内或开放下肢血运重建术治疗 PAD 的患者。主要结局为血管重建后 5 年内主要下肢截肢和死亡。使用 Cox 比例风险和 Fine-Gray 竞争风险回归来检查这些结局的竞争风险。
在研究期间,约有 164845 名患者接受了首次 PAD 下肢血运重建术。大多数患者为男性(64.6%),中位年龄为 71(IQR62-78)岁。血管内血管重建后,间歇性跛行患者 5 年累积截肢发生率为 4.2%,有组织损失记录的患者为 18.0%。开放血管重建后,相应的发生率分别为 10.8%和 25.3%,联合手术后分别为 8.1%和 25.0%。血管重建后 5 年的死亡率各不相同,取决于手术类型,范围为 24.5%至 39.8%。竞争风险方法产生的估计值始终低于标准方法。
PAD 下肢血管重建后主要截肢的 5 年风险似乎低于之前的估计。因组织损失而行血运重建的患者和需要开放手术的患者有更高的肢体丧失风险。