CVIR endovascular
August 11, 2026 · via Europe PMC
Subgroup variations in effectiveness of femoropopliteal sirolimus versus paclitaxel-coated balloon angioplasty: post hoc results of the randomised SIRONA trial.
Teichgräber U, Ingwersen M, Lehmann T, +27 more, Scheinert D.
AI summary — for doctors, generated from the abstract only
A post hoc analysis of the SIRONA trial found sirolimus- and paclitaxel-coated balloons performed similarly across most subgroups for femoropopliteal disease.
What was studied
Exploratory post hoc subgroup analysis of the randomized SIRONA trial comparing sirolimus-coated (SCB) and paclitaxel-coated balloons (PCB) for 12-month primary patency (203 vs 199) and cdTLR (238 vs 244).
Key findings
- Primary patency and cdTLR generally consistent across subgroups
- Nominal age interaction for cdTLR (P = .047): HR 0.52 (95% CI 0.16-1.71) favoring SCB in patients > 70
- Nominal interaction by residual stenosis for patency (P = .022): OR 1.67 (95% CI 0.76-3.65) favoring SCB if residual stenosis > 30%
Clinical relevance
This supports the overall SIRONA finding of comparable effectiveness between sirolimus and paclitaxel balloons; nominal subgroup signals are exploratory and should not guide device selection.
Who should care
Limitations
Post hoc, non-prespecified subgroups with multiple comparisons and wide confidence intervals; 12-month follow-up only.
Sirolimus balloons perform like paclitaxel balloons across patient subgroups in the femoropopliteal segment.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Introduction
The randomised SIRONA trial showed that sirolimus-coated balloon (SCB) angioplasty was non-inferior to paclitaxel-coated balloon angioplasty (PCB) regarding femoropopliteal primary patency. There was no difference in clinically driven target lesion revascularisation (cdTLR) rates between the treatment groups. This post-hoc analysis aimed to assess whether the overall results were consistent across different subgroups and selected post-baseline factors.
Methods
Primary patency at 12 months was assessed using duplex ultrasound and adjudicated by a core laboratory for 203 and 199 participants in the SCB and PCB groups, respectively (available-case intention-to-treat analysis). Data on 12-month cdTLR were available for 238 and 244 participants in the SCB and PCB groups, respectively. Odds ratios (ORs) for primary patency and hazard ratios (HRs) for cdTLR after SCB compared to PCB in non-pre-specified subgroups were assessed using generalised linear mixed models to control for centre effects, and Cox proportional hazards models, respectively.
Results
Primary patency and cdTLR were generally consistent across the analysed subgroups. Two nominal interaction signals were observed. For cdTLR, a nominal interaction with age was identified (interaction p = 0.047); among participants older than 70 years, the estimated hazard ratio favoured SCB (HR 0.52, 95% CI 0.16-1.71). For primary patency, treatment effects differed according to residual diameter stenosis (interaction p = 0.022); the estimated treatment effect favoured SCB in participants with residual diameter stenosis > 30% (OR 1.67, 95% CI 0.76-3.65). No other interactions between treatment and subgroup or post-baseline factors were observed.
Conclusion
The effectiveness of SCB compared to PCB was similar and mainly consistent among subgroups. The evaluation should be considered exploratory.
Trial registration
ClinicalTrials.gov, NCT04475783. Registered 17 July 2020, https://clinicaltrials.gov/study/NCT4475783 .
DOI
10.1186/s42155-026-00743-2
PMID
42576093
PMCID
PMC13457751
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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