Objective: The best management of patients with femoropopliteal and infrapopliteal artery occlusion disease is not clear. This study aimed to compare the efficacy of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal or infrapopliteal arterial occlusive disease.
Methods: Medline, Cochrane, Embase, and Google Scholar databases were searched for randomized controlled trials from 1 January 2000 until 30 June 2016.
Results: Compared with PTA, significant benefits in favor of DCB and DES were found for target lesion revascularization (TLR) (OR = 0.38, 95% CI = 0.22 to 0.66, p = .001 for DCB; OR = 0.51, 95% CI = 0.32 to 0.81, p < .001 for DES). Primary patency rate was greater with DCB (p = .001) and DES (p < .001) than PTA. Compared with PTA, a significant reduction in mortality was observed in the DCB group (p = .039) but not in the DES group. Subgroup analysis found a lower rate of TLR and a higher rate of primary patency in the active group (DCB and DES) compared with the control group (PTA) in patients with femoropopliteal arterial occlusion (p ≤ .016) but not in patients with infrapopliteal arterial occlusion (p ≥ .063). Mortality was similar between active replacement and control groups both in the femoropopliteal arterial occlusion and the infrapopliteal arterial occlusion subgroups (all p > .05).
Conclusions: Significantly better TLR and primary patency rate were found in the drug-delivering endovascular treatments compared with the PTA group for patients with femoropopliteal arterial occlusion but not for patients with infrapopliteal arterial occlusion.
Keywords: Drug-eluting stent; angioplasty; drug-coated balloon; femoral artery; paclitaxel; peripheral arterial disease; popliteal artery.