An Indirect Comparison by Bayesian Network Meta-analysis of Drug-coated Devices versus Saphenous Vein Graft Bypass in Femoropopliteal Arterial Occlusive Disease.

Abstract

OBJECTIVE\nTo compare the efficacy and safety between drug-coated devices (DCDs) and bypass surgery with saphenous vein graft (BSV) in femoropopliteal arterial occlusive disease.\n\n\nMETHODS\nBayesian network meta-analysis and indirect comparison were performed. Randomized controlled trials (RCTs) 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 endpoint was target lesion revascularization/target vessel revascularization (TLR/TVR), and secondary endpoints were all-cause mortality, limb salvage, and early complications. (PROSPERO registry number: CRD42019136530).\n\n\nRESULTS\nForty-two trials and 6,867 patients were included. The comparison of DCDs and BSV revealed no significant difference in one-year TLR/TVR (DCDs vs. BSV: odds ratio 0.60, 95% credible interval: 0.16 to 2.39). Total early complications from BSV were significantly higher than those from DCDs (DCDs vs. BSV: OR 0.14, 95% Crl: 0.05 to 0.45), and the main complications of BSV were non-death related. There was also no significant difference in systemic early complications (DCDs vs. BSV: OR 0.19, 95% Crl: 0.00 to 7.82) and one-year amputation rate (DCDs vs. BSV: OR 2.81, 95% Crl: 0.16 to 89.53). Thirty-day (DCDs vs. BSV: OR 0.38, Crl: 0.00 to 110.46), one-year (DCDs vs. BSV: OR 0.96, 95% Crl 0.24 to 3.29), two-year (DCDs vs. BSV: OR 1.60, 95% Crl 0.64 to 4.95) and five-year all-cause mortality rates (DCDs vs. BSV: OR 2.05, 95% Crl 0.92 to 4.39) showed no significant differences between DCDs and BSV, although there was a noticeable tendency toward significant results of a higher five-year mortality rate.\n\n\nCONCLUSIONS\nThere is no significant difference between DCDs and BSV in short-term efficacy, short- and long-term mortality. Despite traditional BSV remaining the gold standard, DCDs provide a reasonable alternative therapy. Besides, the DCDs have 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 direct comparison between BSV and DCDs.