Paclitaxel-coated balloons have demonstrated improved patency in peripheral arterial disease (PAD), although questions remain regarding safety and applicability across different vascular territories. In this context, there is growing interest in alternative technologies such as sirolimus-coated balloons.
The SirPAD trial was a randomized study conducted in Switzerland between 2020 and 2024, including 1,252 patients with symptomatic infrainguinal PAD (≥50% stenosis) eligible for endovascular angioplasty. Patients were assigned in a 1:1 ratio to sirolimus-coated balloon angioplasty (n=626) or conventional uncoated balloon angioplasty (n=626). Treated territories included both the femoropopliteal and infrapopliteal segments. Bailout stenting was allowed in both groups when angiographic results were suboptimal.
Regarding outcomes, the sirolimus-coated balloon demonstrated non-inferiority for the primary endpoint (a composite of unplanned major amputation or target lesion revascularization [TLR] due to critical limb ischemia), achieving the main objective of the study, with signals toward superiority in some components. In the individual component analysis, unplanned major amputation occurred in 1.3% vs 2.7% (absolute difference −1.4%), while TLR due to critical limb ischemia was significantly lower in the sirolimus group (8.3% vs 13.3%; difference −5.0%).
In the secondary endpoint (a broader composite of amputation or TLR due to any degree of ischemia), a reduction in events was also observed: unplanned amputation 5.9% vs 8.8% (−2.9%) and TLR for any ischemia 19.8% vs 25.9% (−6.1%).
Regarding safety, no relevant differences were observed in all-cause mortality between the two groups.
Reduction in revascularization and ischemic events without increased mortality in the SirPAD trial
In conclusion, the SirPAD trial demonstrates that sirolimus-coated balloon angioplasty in patients with infrainguinal peripheral arterial disease is a safe and non-inferior strategy compared with conventional balloons in terms of major limb events, with signals of clinical benefit in reducing revascularizations and ischemic events.
Original Title: Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease: Primary Efficacy and Safety Results of the SirPAD Trial.
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