Department of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
J Vasc Surg. 2021 Aug;74(2):478-486.e11. doi: 10.1016/j.jvs.2020.11.054. Epub 2021 Feb 16.
To compare the efficacy and safety between drug-coated devices (DCDs) and bypass surgery with saphenous vein graft (BSV) in femoropopliteal arterial occlusive disease.
A Bayesian network meta-analysis and indirect comparison were performed. Randomized controlled trials of BSV, bypass surgery with prosthetic graft, bare metal stents, endoluminal bypass (covered stent), percutaneous transluminal angioplasty, and DCDs treating femoropopliteal arterial occlusive disease were collected. The primary end point was target lesion revascularization/target vessel revascularization, and secondary end points were all-cause mortality, limb salvage, and early complications (PROSPERO registry number: CRD42019136530).
Forty-two trials and 6867 patients were included. The comparison of DCDs and BSV revealed no significant difference in the 1-year target lesion revascularization/target vessel revascularization (DCDs vs BSV: odds ratio [OR], 0.60; 95% credible interval [CrI], 0.16-2.39). Total early complications from BSV were significantly higher than those from DCDs (DCDs vs BSV: OR, 0.14; 95% CrI, 0.05-0.45), and the main complications of BSV were not death related. There was also no significant difference in systemic early complications (DCDs vs BSV: OR, 0.19; 95% CrI, 0.00-7.82) and 1-year amputation rate (DCDs vs BSV: OR, 2.81; 95% CrI, 0.16-89.53). The 30-day (DCDs vs BSV: OR, 0.38; 95% CrI, 0.00-110.46), 1-year (DCDs vs BSV: OR, 0.96; 95% CrI, 0.24-3.29), 2-year (DCDs vs BSV: OR, 1.60; 95% CrI, 0.64-4.95), and 5-year all-cause mortality rates (DCDs vs BSV: OR, 2.05; 95% CrI, 0.92-4.39) showed no significant differences between DCDs and BSV, although there was a noticeable tendency toward significant results of a higher 5-year mortality rate.
There is no significant difference between DCDs and BSV in short-term efficacy or short- and long-term mortality. Despite traditional BSV remaining the gold standard, DCDs provide a reasonable alternative therapy. In addition, the DCDs have a lower short-term morbidity associated with the procedure at the cost of the possible risk of higher long-term mortality. Clinical trials with more validity are required for a direct comparison between BSV and DCDs.
比较药物涂层球囊（DCD）与带蒂静脉旁路移植术（BSV）治疗股腘动脉闭塞性疾病的疗效和安全性。
进行贝叶斯网络荟萃分析和间接比较。收集了带蒂静脉旁路移植术、人工移植物旁路移植术、裸金属支架、腔内旁路（覆膜支架）、经皮腔内血管成形术和 DCD 治疗股腘动脉闭塞性疾病的随机对照试验。主要终点为靶病变血运重建/靶血管血运重建，次要终点为全因死亡率、肢体存活率和早期并发症（PROSPERO 注册编号：CRD42019136530）。
共纳入 42 项试验和 6867 例患者。DCD 与 BSV 的比较显示，1 年靶病变血运重建/靶血管血运重建无显著差异（DCD 与 BSV：比值比[OR]，0.60；95%可信区间[CrI]，0.16-2.39）。BSV 的总早期并发症显著高于 DCD（DCD 与 BSV：OR，0.14；95% CrI，0.05-0.45），BSV 的主要并发症与死亡无关。系统早期并发症（DCD 与 BSV：OR，0.19；95% CrI，0.00-7.82）和 1 年截肢率（DCD 与 BSV：OR，2.81；95% CrI，0.16-89.53）也无显著差异。30 天（DCD 与 BSV：OR，0.38；95% CrI，0.00-110.46）、1 年（DCD 与 BSV：OR，0.96；95% CrI，0.24-3.29）、2 年（DCD 与 BSV：OR，1.60；95% CrI，0.64-4.95）和 5 年全因死亡率（DCD 与 BSV：OR，2.05；95% CrI，0.92-4.39）无显著差异，但 5 年死亡率有较高的显著趋势。
DCD 与 BSV 在短期疗效或短期和长期死亡率方面无显著差异。尽管传统的 BSV 仍然是金标准，但 DCD 提供了一种合理的替代治疗方法。此外，DCD 与手术相关的短期发病率较低，但长期死亡率可能较高。需要进行更有效的临床试验，以直接比较 BSV 和 DCD。
