West China School of Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
Department of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
Ann Surg. 2018 May;267(5):846-857. doi: 10.1097/SLA.0000000000002344.
The aim of our study was to compare percutaneous vascular interventions (PVI) versus bypass surgeries (BSX) in patients with critical limb ischemia (CLI).
Previous relevant reviews with limited numbers of included studies did not strictly confine the inclusion criteria to CLI, also involving patients with severe claudication, which may introduce bias in the decision-making of CLI revascularization. Current treatment strategies for CLI still remain controversial.
We performed a meta-analysis of all available randomized controlled trials and observational clinical studies comparing PVI with BSX in CLI patients. Primary endpoints included overall survival, amputation-free survival, 30-day mortality, and major adverse cardiovascular and cerebrovascular events.
We identified 45 cohorts and 1 RCT in over 20,903 patients. In overall population, PVI reduced the risks of 30-day mortality [odds ratio (OR) 0.69, 95% confidence interval (CI) 0.51-0.95), major adverse cardiovascular and cerebrovascular events (OR 0.42, 95% CI 0.29-0.61), and surgical site infection (OR 0.31, 95% CI 0.19-0.51), but increased the risks of long-term all-cause mortality [hazard ratio (HR) 1.16, 95% CI 1.05-1.27) and primary patency failure (HR 1.31, 95% CI 1.08-1.58). When compared with autogenous BSX, PVI was also associated with additional increased risks of long-term death or amputation (HR 1.41, 95% CI 1.02-1.94) and secondary patency failure (HR 1.51, 95% CI 1.17-1.95). In patients with infrapopliteal lesions, we found PVI had inferior primary patency (HR 1.39, 95% CI 1.10-1.75) compared with BSX.
For patients in good physical condition with long life-expectancy, BSX may represent a better choice compared with PVI, particularly when autogenous bypass is available. While enhanced perioperative care for cardiovascular events and surgical site should be considered in patients underwent BSX to achieve comparable short-term outcomes provided by PVI.
本研究旨在比较经皮血管介入（PVI）与旁路手术（BSX）治疗肢体严重缺血（CLI）患者的疗效。
先前的相关综述纳入的研究数量有限，且并未严格将纳入标准限制在 CLI 患者中，还包括严重跛行患者，这可能会导致 CLI 血运重建的决策产生偏倚。目前 CLI 的治疗策略仍存在争议。
我们对所有比较 CLI 患者中 PVI 与 BSX 的随机对照试验和观察性临床研究进行了荟萃分析。主要终点包括总生存率、无截肢生存率、30 天死亡率和主要心血管和脑血管不良事件。
我们共纳入了 45 项队列研究和 1 项 RCT，共涉及超过 20903 例患者。在总体人群中，PVI 降低了 30 天死亡率（比值比 [OR] 0.69，95%置信区间 [CI] 0.51-0.95）、主要心血管和脑血管不良事件（OR 0.42，95% CI 0.29-0.61）和手术部位感染（OR 0.31，95% CI 0.19-0.51）的风险，但增加了长期全因死亡率（风险比 [HR] 1.16，95% CI 1.05-1.27）和原发性通畅失败（HR 1.31，95% CI 1.08-1.58）的风险。与自体 BSX 相比，PVI 也与长期死亡或截肢（HR 1.41，95% CI 1.02-1.94）和继发性通畅失败（HR 1.51，95% CI 1.17-1.95）的风险增加相关。在腘下病变患者中，我们发现与 BSX 相比，PVI 具有较低的原发性通畅率（HR 1.39，95% CI 1.10-1.75）。
对于身体状况良好、预期寿命较长的患者，BSX 可能优于 PVI，特别是当自体旁路可用时。而对于接受 BSX 的患者，应考虑增强围手术期心血管事件和手术部位的护理，以实现与 PVI 相当的短期疗效。
