Risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries: A systematic review and meta-analysis of randomised controlled trials.

Eur J Vasc Endovasc Surg 2022; 63: 60-71.

This analysis included 21 RCTs with 3760 treated legs. Amputation was increased in the paclitaxel group: 4 versus 2.7%, hazard ratio 1.66, 95 per cent confidence interval 1.14 to 2.42, P=0.008.

Comment: a previous review suggested an increased death rate; this study suggests amputations are increased too with paclitaxel balloons.