Why is this study important?
The long-term efficacy of endovascular intervention for infrainguinal peripheral artery disease (PAD) is limited by restenosis. Paclitaxel-coated balloons (PCB) have been utilized to reduce the incidence of restenosis, but the extent of improvement over uncoated balloons (UB) remains unclear.1 Furthermore, paclitaxel-coated balloons have not demonstrated efficacy below-the-knee (BTK).2 Sirolimus-coated balloons (SCB) are a potential alternative to PCB.
What question was the study supposed to answer?
Open-label, all-comers trial with blinded outcome adjudication. Symptomatic infrainguinal PAD. MagicTouch PTA sirolimus-coated balloon (Concept Medical) compared to any approved uncoated balloon, randomized 1:1. Initial analysis was noninferiority for major adverse limb events (MALE), defined as 1) unplanned major target-limb amputation or 2) target lesion revascularization (TLR) for critical limb ischemia.
There was a prespecified secondary analysis of superiority for MALE. Additionally, a secondary endpoint was any unplanned target-limb amputation or TLR. Safety was evaluated with all-cause death and serious adverse events. Enrollment was at two centers in Switzerland.
What did the study show?
The trial successfully enrolled 1,252 patients (90% of those screened).
Patient characteristics:
| Sirolimus-Coated Balloon | Uncoated Balloon | |
| Median Age | 75.5 | 75.0 |
| Female Sex | 35.8% | 34.3% |
| Fontane class: Stage III to IV | 34.5% | 34% |
| Rutherford class (chronic): 4 to 6 | 40.3% | 41.4% |
| Rutherford class (acute): stage IIa to III | 7.2% | 6.9% |
Key Lesion/procedural characteristics:
| Sirolimus-Coated Balloon | Uncoated Balloon | |
| Median Length | 150 mm | 143 mm |
| Total occlusion | 56.3% | 57.9% |
| Below the Knee | 30.55% | 30% |
| Bail-out stenting | 35.5% | 39.9% |
The trial showed superiority for the primary endpoint of MALE (SCB 8.8%, UB 15.0%, p superiority = 0.009) as well as the secondary endpoint (SCB 23.0%, UB 30.8%, p superiority = 0.002). No difference was observed in safety.
Perspective
This positive study is an exciting advance in the treatment of peripheral artery disease. By demonstrating the efficacy of a new DCB agent in a patient population similar to what is seen in clinical practice, SirPAD introduces a potentially valuable new tool for the endovascular specialist. It will require head-to-head trials, but the potential to improve results over current PCB technology while maintaining safety would immediately impact device selection.
References
- Falkenberg, M., et al., Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet, 2025. 406(10508): p. 1103–1114.
- Liistro, F., et al., Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial. EuroIntervention, 2022. 17(17): p. e1445–e1454.
Simultaneous Publication: Barco S, Engelberger RP, Held U, Fumagalli RM, Grigorean A, Hayoz D, Münger M, Sebastian T, Stadler R, Voci D, Wolf S, Baumann F, Tritschler T, von Stempel C, Périard D, Kucher N; SirPAD Investigators. Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease. N Engl J Med. 2026; DOI: 10.1056/NEJMoa2600360.
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