SirPAD: beyond patency

During a short interview recorded at Charing Cross 2026 exclusively for PVI online, Dr Stefano Barco reviews the rationale, design and key findings of the SirPAD trial, which evaluated whether a sirolimus-coated balloon could improve clinically relevant outcomes compared with an uncoated balloon in patients undergoing endovascular treatment for PAD.

This all-comer trial randomised 1,252 patients based on a single inclusion criterion: the need for endovascular treatment, with no additional restrictions related to PAD severity, anatomical location or patient characteristics. Nearly 45% of the study population presented with critical limb ischemia.

At one year, the primary composite endpoint of unplanned major target limb amputation or urgent target lesion revascularisation for critical limb ischemia occurred in 8.8% of patients in the sirolimus group versus 15% in the control group, meeting both non-inferiority and superiority criteria.

Dr Barco also highlights the consistency observed across secondary outcomes, including reductions in amputations and target lesion revascularisations, as well as the absence of any difference in all-cause mortality at one year.

Watch the interview to explore the clinical significance of the SirPAD findings.