Endovascular Treatment Versus Vein Bypass of Infrainguinal Peripheral Artery Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Objectives: Guidelines widely recommend endovascular therapy (ET) for infrainguinal peripheral artery diseases (PAD) despite the lack of adequately powered data. This meta-analysis aimed to directly compare the clinical safety and efficacy of ET versus vein bypass (VBP) in patients with infrainguinal PAD from available randomized controlled trials (RCTs). Methods: We conducted a systematic literature search of MEDLINE, Embase, and the Cochrane databases from inception until 21 July 2023 for RCTs comparing ET and VBP. Treatment effects were expressed as odds ratios (OR) with 95% confidence intervals (CIs), pooled using the Mantel-Haenszel method. Study quality was assessed via the Cochrane Risk of Bias tool. Results: From 2210 identified studies, four low-risk-of-bias RCTs were included. Pooled analysis demonstrated that ET was associated with significantly higher risks of reintervention (OR = 4.69, 3.69-6.04), major reintervention (OR = 2.80, 1.96-4.00), and any reintervention (OR = 1.92, 1.44-2.56) compared to VBP. ET also showed a lower rate of index procedure technical success (OR = 0.13, 0.07-0.25) and site infection (OR = 0.05, 0.01-0.25). However, no significant differences were observed between the two strategies regarding 30-day mortality (OR = 0.66, 0.34-1.29), all-cause mortality (HR = 1.05, 0.90-1.22), index limb amputation (OR = 1.29, 0.90-1.86), MACE (OR = 1.20, 0.94-1.54), or bleeding events (OR = 0.86, 0.30-2.50). Conclusions: This analysis of RCT data still supports VBP, which retained certain advantages over ET for patients with infrainguinal peripheral artery disease in terms of both efficacy and safety. In cases where a suitable vein is available, vein bypass should be considered as the primary treatment option.