Comparison of Drug-Eluting Stent with Bare-Metal Stent Implantation in Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis.

BACKGROUND: This study aimed to perform a systematic review and meta-analysis of current evidence comparing the drug-eluting stent (DES) with the bare-metal stent (BMS) in the treatment of femoropopliteal artery disease (FPAD).

METHODS: All relevant articles reporting the results of DES versus BMS implantation in FPAD were systematically searched in MEDLINE, EMBASE, and Cochrane database. Randomized controlled trial (RCT), cohort, and retrospective study were all included. The efficacy end points included late lumen loss (LLL), binary restenosis, primary patency rate, freedom from target lesion revascularization (TLR), and stent fracture. Related data of the follow-up outcomes were extracted and pooled. For each end point, odds ratios (ORs) and 95% confidence intervals (CIs) were calculated.

RESULTS: A total of 9 studies with 776 patients were included in this meta-analysis. There was no statistically significant difference between the DES and BMS groups in terms of LLL at 6 months (standard mean difference = -0.37, P = 0.07); binary restenosis at 6, 12, and 24 months (OR = 0.44, P = 0.20; OR = 0.75, P = 0.74; and OR = 0.62, P = 0.36; respectively); primary patency rate at 6, 12, and 24 months (OR = 1.18, P = 0.73; OR = 1.43, P = 0.70; OR = 1.25, P = 0.68, respectively); freedom from TLR at 12 months (OR = 1.13, P = 0.79); and stent fracture at 6 months (OR = 1.67, P = 0.38). A sensitivity analysis demonstrated that there was a significant benefit in the DES group over the BMS group in binary restenosis at 6 months (OR = 0.22, P = 0.008) after excluding a retrospective study, whereas no significant difference was observed when eliminating any other study. A subgroup analysis did not reveal any significant difference between a subgroup (sirolimus-eluting stent or paclitaxel-eluting stent) and the BMS group in FPAD.

CONCLUSIONS: According to current evidence, DES was not superior to BMS in the treatment of FPAD. Further larger RCTs are needed to provide more evidence in the comparison between DES and BMS for FPAD.