Paclitaxel-coated devices did not improve disease-specific quality of life at 1 year in patients with intermittent claudication undergoing infrainguinal endovascular revascularisation.
Long-term mortality over a median of 7.1 years was not significantly different; however, 5-year mortality was higher in the paclitaxel-coated device group compared to uncoated devices.
The study’s findings challenge the routine use of paclitaxel-coated devices in this patient population given the lack of quality of life benefit and potential mortality risk.
The SWEDEPAD 2 trial employed a pragmatic, multicentre, registry-based randomized controlled design with robust follow-up data on over 1100 patients.
