Three-year results from the SIRONA trial show that sirolimus-coated balloon angioplasty achieves an 88.2% freedom from clinically driven target-lesion revascularization in patients with symptomatic femoropopliteal artery disease, compared with 80.2% for paclitaxel-coated balloons, according to findings presented at TCT 2026 and simultaneously published in JACC: Cardiovascular Interventions.
Researchers Randomize 482 Patients to Compare Drug-Coated Balloons
Ulf Teichgräber, MD, MBA, and fellow researchers randomized 482 patients following successful lesion predilation to receive either sirolimus-coated balloon (SCB) or paclitaxel-coated balloon (PCB) angioplasty. Patient enrollment ran from April 2021 to September 2022. The study tracked several three-year outcomes of interest, including patient-reported walking capacity, health-related quality of life, clinically driven target-lesion revascularization (TLR), clinically driven target-vessel revascularization (TVR), and amputation-free survival.
Walking Capacity and Quality of Life Outcomes
Researchers noted no significant differences between the two treatment groups regarding changes in pain-free walking distance, maximum walking distance, and quality of life. These metrics were measured using the EQ-5D-EL questionnaire over the entire three-year study period. The trial found no statistically significant differences between the SCB and PCB cohorts in terms of clinically driven TVR or amputation-free survival.
Divergence in Target-Lesion Revascularization Over Time
Three-year freedom from clinically driven TLR reached 88.2% in the SCB group (95% CI: 83.1% to 91.9%) compared to 80.2% in the PCB group (95% CI: 72.1% to 85%), yielding a hazard ratio of 0.6 (95% CI: 0.36 to 0.97; p=0.03). Investigators observed that the treatment effect varied over time, with the curves showing notable separation after the first year (treatment-by-period interaction p=0.006).
Did you know? The SIRONA trial data revealed that little separation in clinically driven TLR occurred during the first year post-procedure, with divergence between the sirolimus and paclitaxel groups beginning only thereafter.
Authors Note Biological Differences Offer Potential Mechanistic Explanations
The study authors noted that biological differences in vascular responses to sirolimus and paclitaxel offer potential mechanistic explanations for the observed divergence in long-term outcomes. However, the research team emphasized that these explanations remain strictly hypothesis-generating. Readers can explore related research through JACC Journals’ TCT 2026 Coverage and the broader ACC’s TCT Meeting Coverage.
Common Questions About the SIRONA Trial
What was the primary patient population studied in SIRONA?
The trial evaluated 482 patients diagnosed with symptomatic femoropopliteal artery disease who underwent successful lesion predilation before randomisation.
What specific device comparison did the trial perform?
Researchers compared sirolimus-coated balloons against paclitaxel-coated balloons in angioplasty procedures conducted between April 2021 and September 2022.
Were there any differences in amputation-free survival between the groups?
No significant differences in clinically driven target-vessel revascularization or amputation-free survival were observed between the sirolimus-coated balloon and paclitaxel-coated balloon groups over the three-year duration.
Keep reading