Mortality, Safety and Efficacy of Paclitaxel-containing Balloons and Stents in the Femoropopliteal Artery: Systematic Review and Meta-Analysis of Randomized Controlled Trials since 2018.

INTRODUCTION: Endovascular therapy is an established revascularization option for lower limb arterial stenosis with drug-eluting therapy demonstrating promising findings in inhibiting vessel restenosis and improving clinical outcomes post-intervention. However, a 2018 meta-analysis raised considerable concerns for an increased risk of death with paclitaxel-containing balloons and stents. The present study aims to provide an updated systematic review and meta-analysis of safety and efficacy outcomes with paclitaxel-containing devices.

MATERIALS & METHODS: A systematic review and meta-analysis of RCTs investigating paclitaxel-containing balloons or stents in the treatment of femoropopliteal disease was performed. Pooled risk ratio (RR) was calculated using inverse variance, random effects model in the assessment of primary patency, all-cause mortality, target limb major-amputation, target lesion revascularization (TLR) and thrombosis.

RESULTS: In total, 19 RCTs were included comprising 4,284 participants. All-cause mortality rates did not differ significantly between the two arms at 12 months (RR 1.06; 95% CI 0.66-1.72; P=0.80), 24 months (RR 0.92; 95% CI 0.56-1.50; P=0.73), 36 months (RR 1.21; 95% CI 0.65-2.25; P=0.55) or 48-60 months post-intervention (RR 0.95; 95% CI 0.66-1.39; P=0.81). Primary patency was significantly higher at 12 months in the paclitaxel-containing arm: 80.92% (1,438/1,777) versus 57.48% (607/1056) in the control arm (RR 1.44; 95% CI 1.30-1.59; P<0.00001).

CONCLUSION: The present study demonstrates no statistically significant difference in all-cause mortality, target limb major amputation or thrombosis with paclitaxel drug-eluting therapy to the femoropopliteal region. Additionally, improved and durable patency rates with a statistically significant lower risk of clinically driven-TLR with paclitaxel drug-eluting therapy have been demonstrated.