The use of drug-eluting stents in infrapopliteal arteries: an updated systematic review and meta-analysis of randomized trials.

Introduction: Endovascular treatment below-the-knee is safe and effective but limited by poor patency. Coronary drug-eluting stents (DES) may play a role in providing mechanical scaffolding and deliver anti-proliferative drug to the site of vascular barotrauma to reduce the incidence of restenosis. Our aim was to evaluate and compare the use of contemporary DES with standard endovascular-therapies for atherosclerotic disease of infrapopliteal arteries.

Evidence Acquisition: We performed a meta-analysis of randomized controlled trials comparing DES with conventional treatment for symptomatic peripheral artery disease (search date 30 August 2017). The primary endpoint was primary patency. Secondary endpoints were freedom from target lesion revascularization (TLR), major amputation, sustained Rutherford class improvement and mortality.

Evidence Synthesis: We identified 7 trials enrolling 801 randomly assigned patients (392 DES, 409 control). At the median follow-up of 12-months DES improved rates of primary patency (OR 3.49, 95%CI 2.38-5.12, I2=0%, P<0.00001), freedom from TLR (OR 2.19, 95%CI 1.30-3.69, I2=38%, P=0.003), major amputation (OR 0.56, 95%CI 0.31-0.99, I2=0%, P=0.049), and Rutherford class improvement (OR 1.62, 95%CI 1.01-2.59, I2=65%, P=0.046), but not mortality (OR 1.05, 95%CI 0.68-1.62; I2 =0%, P=0.91) compared to control. Subgroup analysis of primary patency favoured DES coated in sirolimus analogues compared to paclitaxel (Test for subgroup differences, Chi2=6.51, df=1, P=0.01, I2=84.6%).

Conclusions: At midterm follow-up DES significantly improved rates of primary patency, re-intervention, Rutherford class improvement and major amputation for the treatment of atherosclerotic disease of infrapopliteal arteries compared to control therapy, with no effect on patient survival. Stents coated in sirolimus analogues were more effective than paclitaxel.