Primary Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoropopliteal Lesions: A Systematic Review and Meta-Analysis

Abstract

Background: In this systematic review and meta-analysis, we aimed to compare drug-coated balloon (DCB) to drug-eluting stent (DES) angioplasty as a primary option in patients with femoropopliteal lesions in terms of primary patency and freedom from clinically driven target lesion revascularization (cdTLR) and major adverse limb events (MALE).

Methods: A comprehensive literature search was performed using the PubMed and Embase databases. All studies written in English language and reporting data presenting a comparison between patients receiving primary percutaneous balloon angioplasty using the DCB versus primary percutaneous stenting with DES for native femoropopliteal lesions were included in this meta-analysis.

Results: There were 984 patients with 1,078 femoropopliteal lesions, of which procedures with DCB and DES were performed in 514 and 564 lesions, respectively. Overall, majority patients were men with a mean age of 70.9 years, and there were no significant differences between the 2 groups regarding the cardiovascular comorbidities. With regards to the procedural strategy, there was significant heterogeneity in the DCB group. This included adjunctive procedures such as atherectomy besides the angioplasty of the target vessel, which was reported in 1 study as a part of 32.1% of the procedures in the DCB group. Provisional bare metal stents (pBMS) for residual stenosis and dissection were used in 4 studies with a percentage varying from 14.8 to 25.3%. Overall, at 1 year, all outcomes were similar for all the end points; however, where adjunctive procedures were performed (atherectomy + pBMS) in the DCB group, the outcomes were better (primary patency p.001, freedom cdTLR p.001, and freedom form MALE p.002). In studies where no adjunctive procedures were performed in the DCB group, the results favored the DES group for the primary patency (p.026) and freedom from cdTLR (p.044).

Conclusions: DES seems to be superior in terms of cdTLR and primary patency at 1 year when compared to the procedures performed solely with DCB. For DCB to achieve optimal results, further adjunctive procedures such as pBMS and atherectomy are needed. More studies are needed to confirm the superiority of the primary stenting with DES at the femoropopliteal segment.