3-Year Comparison of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease: The SIRONA 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 Trial investigators

doi:10.1016/j.jcin.2026.10.020

Aortic & peripheral vascular disease

3-Year Comparison of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease: The SIRONA Trial

JACC Cardiovasc IntervPublished 2 Nov 2026prospective, multicenter, randomized controlled trial

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Authors' conclusion

Through 3 years, no between-group differences were observed in walking capacity and health-related quality of life or clinical safety outcomes between SCB angioplasty and the PCB strategy. Three-year freedom from cdTLR was higher with SCB angioplasty, with treatment effect that varied over time. Given the exploratory, nonmultiplicity-adjusted 3-year analysis, the cdTLR difference requires confirmation.

Study context

Population: Patients with symptomatic femoropopliteal artery disease
Participants: 482 randomized patients

Comparison: SCB angioplasty vs a PCB strategy
SCBn = 238
PCBn = 244reference

Methodological detailsrandomized 1:1 after successful predilation

Randomized 1:1 after successful predilation

Primary result

As reported in the abstract

Changes in patient-reported walking distances

Did not differ between-groups

Further findings

Outcome		HR (95% CI)	P value
Freedom from cdTVR	0.512	0.78 (0.50–1.21)	nominal P = 0.27
	0.512Hazard ratio (log scale)

Outcome	SCB	PCB	HR (95% CI)	P value
Freedom from cdTLR · 3 years	88.2% (95% CI 83.1%–91.9%)	80.2% (95% CI 74.1%–85.0%)	0.60 (0.36–0.97)	nominal log-rank P = 0.03

Freedom from cdTLR: Post-hoc analysis suggested time-varying treatment effects (treatment-by-period interaction P = 0.006), with separation after the first year
Freedom from cdTLR: exploratory, nonmultiplicity-adjusted 3-year analysis

Intermittent claudication at baseline

Patients with intermittent claudication: 96.3%

Follow-up completeness · 3 years

3-year follow-up was completed by 76.5% (SCB) and 79.6% (PCB)

Safety

Outcome		HR (95% CI)	P value
Amputation-free survival	0.512	1.09 (0.57–2.09)	nominal P = 0.79
	0.512Hazard ratio (log scale)

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 Trial investigators
Journal: JACC: Cardiovascular Interventions
Published: 2 Nov 2026
DOI: 10.1016/j.jcin.2026.10.020
PubMed: 42975386

Topic: Aortic & peripheral vascular disease
Also indexed: Interventional cardiology

Intervention details

SCB: SCB angioplasty (sirolimus-coated balloons)
PCB: PCB strategy (paclitaxel-coated balloons)

Original publication

3-Year Comparison of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease: The SIRONA Trial. JACC Cardiovasc Interv. Published 2 November 2026. doi:10.1016/j.jcin.2026.10.020

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