Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease: The SIRONA Randomized Noninferiority Trial

Teichgräber, U; Ingwersen, M; Lehmann, T; Platzer, S; Kunstmann, I; Steiner, S; Schmidt, A; Wittig, T; Zeller, T; Thieme, M; Krankenberg, H; Werner, M; Brodmann, M; Malyar, N; Müller-Hülsbeck, S; de Paoli, L; Schlager, O; Austermann, M; Tepe, G; Erbel, C; Ito, W; Waßmer, R; Maiwald, L; Aschenbach, R; Wissgott, C; Andrassy, M; Wolf, F; Beschorner, U; Pech, M; Katsanos, K; Scheinert, D; SIRONA Study Group

doi:10.1016/j.jacc.2025.12.017

Aortic & peripheral vascular disease

Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease: The SIRONA Randomized Noninferiority Trial

J Am Coll CardiolPublished 18 Feb 2026Randomised controlled trial

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Authors' conclusion

Among patients with femoropopliteal artery disease, SCBs demonstrated noninferior clinical important outcomes and comparable improvement in vascular quality of life compared with PCBs.

Study context

Population: Patients ≥18 years with symptomatic femoropopliteal artery disease and a single target lesion
Participants: 482 patients

Comparison: Sirolimus-coated balloon vs paclitaxel-coated balloon angioplasty
Sirolimus-coated balloon (SCB)n = 238
Paclitaxel-coated balloon (PCB)n = 244reference
Primary endpoint: Primary patency; and composite clinical endpoint of freedom from clinically driven target vessel revascularization, major target limb amputation, and device- or procedure-related death
Follow-up: 12 months

Methodological detailsmulticentre, non-inferiority, masked participants and outcome assessors, 25 centres in Germany and Austria

Multicentre
Non-inferiority
Masked participants and outcome assessors
25 centres in Germany and Austria

Primary result

As reported in the abstract

SCB

Primary patency: 150 of 203 (73.9%)
Primary clinical endpoint: 199 of 220 (90.5%)

PCB

Primary patency: 149 of 199 (74.9%)
Primary clinical endpoint: 202 of 218 (92.7%)

Primary patency

SCB150 of 203 (73.9%)

PCB149 of 199 (74.9%)

Primary clinical endpoint

SCB199 of 220 (90.5%)

PCB202 of 218 (92.7%)

SCB vs PCBRisk difference (95% CI)P value

Primary patency; noninferiority not statistically robust in sensitivity analyses

−1.0%(−9.6% to 7.6%)

P = 0.019for non-inferiority

Primary clinical endpoint; confirmed by sensitivity analyses

−2.2%(−7.7% to 3.2%)

P = 0.003for non-inferiority

Reference

Authors: Teichgräber U, Ingwersen M, Lehmann T, Platzer S, Kunstmann I, Steiner S, et al.
All 32 authors
Teichgräber U, Ingwersen M, Lehmann T, Platzer S, Kunstmann I, Steiner S, Schmidt A, Wittig T, Zeller T, Thieme M, Krankenberg H, Werner M, Brodmann M, Malyar N, Müller-Hülsbeck S, de Paoli L, Schlager O, Austermann M, Tepe G, Erbel C, Ito W, Waßmer R, Maiwald L, Aschenbach R, Wissgott C, Andrassy M, Wolf F, Beschorner U, Pech M, Katsanos K, Scheinert D, SIRONA Study Group
Journal: JACC
Published: 18 Feb 2026
DOI: 10.1016/j.jacc.2025.12.017
PubMed: 41706076
Registration: NCT04475783; DRKS00022452

Countries: Austria and Germany
Topic: Aortic & peripheral vascular disease
Also indexed: Interventional cardiology

Key notes

Available case intention-to-treat analysis
Noninferiority margins 10%

Original publication

Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease: The SIRONA Randomized Noninferiority Trial. J Am Coll Cardiol. Published 18 February 2026. doi:10.1016/j.jacc.2025.12.017

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