报告比较旁路手术（BS）和血管内治疗（ET）在腹股沟下外周动脉疾病（PAD）的几个终点的所有随机对照试验（RCT）的回顾和荟萃分析，如主要和次要截肢，主要不良肢体事件（MALE），溃疡愈合，时间愈合，和全因死亡率，以支持意大利糖尿病足综合征治疗指南（DFS）的制定。进行MEDLINE和EMBASE搜索以识别RCT，自1991年以来发表至2023年6月21日，招募因动脉粥样硬化疾病引起的下肢缺血患者（RutherfordI-VI）。允许任何手术BS或ET，无论采用何种方法,路线,或移植，从髂关节到膝盖以下区域.主要终点是主要截肢率。次要终点是无截肢生存主要不良肢体事件（MALEs），轻微截肢率,全因死亡率,溃疡愈合率，时间愈合，疼痛,经皮氧分压（TcPO2）或踝肱指数（ABI），生活质量,需要一个新的程序，围手术期严重不良事件（SAE；手术后30天内），住院时间，和手术时间。包括十二个RCT，其中一个纳入了两个独立的患者队列，因此,纳入分析的研究为13.接受ET治疗的参与者的大截肢率与接受BS治疗的参与者相似（MH-OR0.85[0.60,1.20]，p=0.36)；只有一项试验单独报告了糖尿病患者的数据(N=1)，ET和BS之间无显着差异（MH-OR：0.67[0.09，5.13]，p=0.70）。对于轻微截肢，两组间无显著差异：ET与BS的MH-OR：0.83[0.21,3.30]，p=0.80）。两种治疗方式的无截肢生存率无显著差异(MH-OR0.94[0.59,1.49],p=0.80)；只有一项研究报告了糖尿病的亚组分析，具有有利于ET的降低的非统计趋势(MH-OR0.62[0.37，1.04]，p=0.07)。对于全因死亡率，治疗之间没有显着差异（ET与BS的MH-OR：0.98[0.80，1.21]，p=0.88）。据报道，接受ET治疗的参与者的男性发生率明显更高（MH-OR：1.44[1.05,1.98]，p=0.03）；在糖尿病亚组分析中，该结果在组间没有差异（MH-OR：1.34[0.76,2.37]，p=0.30)。ET的手术时间和住院时间明显缩短（WMD：-101.53[-127.71，-75.35]分钟，p<0.001，并且，-4.15[-5.73，-2.57]天，p<0.001=，分别)。与BS相比，ET与30天内任何SAE的风险显着降低相关（MH-OR：0.60[0.42,0.86]，p=0.006)。ET与明显较高的再干预风险相关(MH-OR：1.57[1.10,2.24]，p=0.01)。溃疡愈合无显著组间差异(MH-OR:1.19[0.53,2.69],p=0.67)，虽然愈合时间较短（-1.00[0.18,1.82]个月，p=0.02）与BS。在生活质量和疼痛方面没有发现差异。研究结束时的ABI有7项研究报告，表明BS与ET相比具有显着优势（WMD：0.09[0.02;0.15]分，p=0.01)。这项荟萃分析的结果表明，在糖尿病患者中，ET或BS在治疗腹股沟下PAD方面也没有明显的优势。需要进一步的高质量研究，专注于临床结果，包括对特定类别患者的预先计划的亚组分析，例如糖尿病患者，详细介绍多学科团队方法和结构化随访。
To report a review and meta-analysis of all randomized controlled trials (RCTs) comparing
bypass surgery (BS) and endovascular treatment (ET) in infrainguinal peripheral arterial disease (PAD) for several endpoints, such as major and minor amputation, major adverse limb events (MALEs), ulcer healing, time to healing, and all-cause mortality to support the development of the Italian
Guidelines for the Treatment of Diabetic Foot Syndrome (DFS). A MEDLINE and EMBASE search was performed to identify RCTs, published since 1991 up to June 21, 2023, enrolling patients with lower limb ischemia due to atherosclerotic disease (Rutherford I-VI). Any surgical BS or ET was allowed, irrespective of the approach, route, or graft employed, from iliac to below-the-knee district. Primary endpoint was major amputation rate. Secondary endpoints were amputation-free survival major adverse limb events (MALEs), minor amputation rate, all-cause mortality, ulcer healing rate, time to healing, pain, transcutaneous oxygen pressure (TcPO2) or ankle-brachial index (ABI), quality of life, need for a new procedure, periprocedural serious adverse events (SAE; within 30 days from the procedure), hospital lenght of stay, and operative time. Twelve RCTs were included, one enrolled two separate cohorts of patients, and therefore, the studies included in the analyses were 13. Participants treated with ET had a similar rate of major amputations to participants treated with BS (MH-OR 0.85 [0.60, 1.20], p = 0.36); only one trial reported separately data on patients with diabetes (N = 1), showing no significant difference between ET and BS (MH-OR: 0.67 [0.09, 5.13], p = 0.70). For minor amputation, no between-group significant differences were reported: MH-OR for ET vs BS: 0.83 [0.21, 3.30], p = 0.80). No significant difference in amputation-free survival between the two treatment modalities was identified (MH-OR 0.94 [0.59, 1.49], p = 0.80); only one study reported subgroup analyses on diabetes, with a non-statistical trend toward reduction in favor of ET (MH-OR 0.62 [0.37, 1.04], p = 0.07). No significant difference between treatments was found for all-cause mortality (MH-OR for ET vs BS: 0.98 [0.80, 1.21], p = 0.88). A significantly higher rate of MALE was reported in participants treated with ET (MH-OR: 1.44 [1.05, 1.98], p = 0.03); in diabetes subgroup analysis showed no differences between-group for this outcome (MH-OR: 1.34 [0.76, 2.37], p = 0.30). Operative duration and length of hospital stay were significantly shorter for ET (WMD: - 101.53 [- 127.71, - 75.35] min, p < 0.001, and, - 4.15 [- 5.73, - 2.57] days, p < 0.001 =, respectively). ET was associated with a significantly lower risk of any SAE within 30 days in comparison with BS (MH-OR: 0.60 [0.42, 0.86], p = 0.006). ET was associated with a significantly higher risk of reintervention (MH-OR: 1.57 [1.10, 2.24], p = 0.01). No significant between-group differences were reported for ulcer healing (MH-OR: 1.19 [0.53, 2.69], p = 0.67), although time to healing was shorter (- 1.00 [0.18, 1.82] months, p = 0.02) with BS. No differences were found in terms of quality of life and pain. ABI at the end of the study was reported by 7 studies showing a significant superiority of BS in comparison with ET (WMD: 0.09[0.02; 0.15] points, p = 0.01). The results of this meta-analysis showed no clear superiority of either ET or BS for the treatment of infrainguinal PAD also in diabetic patients. Further high-quality studies are needed, focusing on clinical outcomes, including pre-planned subgroup analyses on specific categories of patients, such as those with diabetes and detailing multidisciplinary team approach and structured follow-up.
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