Sirolimus-coated balloon angioplasty associated with lower one-year TLR rate in SirPAD secondary analysis

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Stefano Barco presents SirPAD data at VIVA 2026

Among patients with femoropopliteal artery disease and no tissue loss, angioplasty with the MagicTouch PTA sirolimus-coated balloon (Concept Medical) was associated with a lower one-year rate of target-lesion revascularisation (TLR) compared with uncoated balloon angioplasty in a secondary analysis of the SirPAD trial.

Stefano Barco (University Hospital Zurich, Zurich, Switzerland) presented this conclusion yesterday at Vascular InterVentional Advances (VIVA; 4–7 October, Las Vegas, USA), with results of the secondary analysis simultaneously published online in the Journal of the American College of Cardiology (JACC).

Primary results of SirPAD—published earlier this year—showed that angioplasty with MagicTouch led to a lower incidence of major adverse limb events (MALE) at one year than angioplasty with uncoated balloons among patients undergoing endovascular treatment for infrainguinal artery disease.

This secondary analysis of the trial evaluated patients with femoropopliteal target lesions and no tissue loss. Patients had been randomised 1:1 to angioplasty with MagicTouch or a standard uncoated balloon. The main analysis included 597 patients; median age was 71 years, 34.7% were women, median target-lesion length was 150mm, and 53.8% of lesions were total occlusions.

Barco reported at VIVA 2026 that, at one year, TLR occurred in 17% of patients treated with MagicTouch vs. 27.1% with uncoated balloons. MALE occurred in 4.1% vs. 8.9%, and the composite of any unplanned amputation or TLR occurred in 17.7% vs. 27.1%.

In addition, he shared that target-limb revascularisation occurred in 19.4% vs. 28.4%; clinical improvement by at least one Rutherford category occurred in 76.2% vs. 70%; and all-cause mortality was similar (3.7% vs. 5.3%). He also noted that findings were consistent in the more restrictive lower-disease-burden subgroup.

The presenter concluded that these results suggest sirolimus-coated balloon angioplasty reduces repeat revascularisation and improves clinical outcomes compared with uncoated balloon angioplasty in patients with femoropopliteal artery disease without tissue loss.


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