Introduction: Endovascular treatment represents nowadays the preferred therapeutic approach for disabling femoro-popliteal arterial occlusive disease in fit patients. In the latest years, in order to improve short- and long-term outcomes, drug eluting devices have been developed. Drug coated balloons (DCB) and drug eluting stents (DES) are today employed in clinical practice, and several studies has been completed to assess their performance in different clinical scenarios. Objective of the present review and meta-analysis is to compare clinical results of different endovascular treatment modalities in the published literature in the last 10 years.
Evidence acquisition: A systematic review and meta-analysis following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement on the literature regarding direct comparisons between DCB, DES, bare metal stents (BMS) and Plain Old Balloon Angioplasty (POBA) has been conducted. Primary outcomes were considered Primary Patency and Target Lesion Revascularization (TLR) at 12 months. Analysis of late survival in different treatment groups was outside the scope of the present study and was therefore not included as main end point.
Evidence synthesis: Meta analysis results confirm that DCB outperforms POBA in both primary patency (estimate OR=3.17, 95% CI: 2.10-4.76) and TLR (POBA estimate OR=3.59, 95% CI= 2.31-5.56). No clear evidences emerged comparing DES and BMS; however, DES were shown to fare better than BMS in terms of TLR when analyzing lesions <15 cm (OR 0.36, 95% CI: 0.35-0.36). Comparison of DCB and DES revealed higher rates of TLR for DES (OR 1.26 95% CI: 1.07-1.49), however no significant differences have been found regarding primary patency analyzing such long lesions (range 14-19.4 cm) as those included in the studies.
Conclusions: While confirming that DCB outperforms POBA in terms of primary patency and TLR at 12 months, only TLR benefits are noted for DES vs. BMS and DCB vs. DES in limited clinical settings. Further RCTs are needed to strongly assess the compared performance of drug eluting devices in relation to lesion length and controlling possible confounders.