Three-year results from the SIRONA trial show that sirolimus-coated balloons outperform paclitaxel-coated balloons in maintaining freedom from clinically driven target-lesion revascularization for femoropopliteal artery disease, achieving an 88.2% success rate compared to 80.2%, according to findings presented at TCT 2026 and published in JACC: Cardiovascular Interventions.
SIRONA Trial Evaluates 482 Patients Across Angioplasty Devices
Patients treated for symptomatic femoropopliteal artery disease experienced higher freedom from clinically driven target-lesion revascularization when receiving sirolimus-coated balloon angioplasty rather than paclitaxel-coated balloon treatment. Ulf Teichgräber, MD, MBA, and fellow researchers randomized 482 patients following successful lesion predilation between April 2021 and September 2022.
The randomized trial tracked patient-reported walking capacity, health-related quality of life, clinically driven target-lesion revascularization, clinically driven target-vessel revascularization, and amputation-free survival over a three-year period. Investigators evaluated whether the choice of antiproliferative drug coating on the angioplasty balloons altered long-term clinical outcomes for peripheral artery disease.
Divergence in Target-Lesion Revascularization After the First Year
While short-term outcomes remained similar between the two groups, statistical separation emerged as time progressed. Three-year freedom from clinically driven target-lesion revascularization reached 88.2% with a 95% confidence interval ranging from 83.1% to 91.9% in the sirolimus-coated balloon group. By comparison, the paclitaxel-coated balloon group recorded an 80.2% rate with a 95% confidence interval spanning from 72.1% to 85%, yielding a hazard ratio of 0.6 and a p-value of 0.03.
Researchers noted that the treatment effect varied over time, displaying a distinct divergence after the initial twelve months with a treatment-by-period interaction p-value of 0.006. SIRONA provides complementary long-term evidence, showing a temporal pattern of clinically driven TLR that differed between treatment groups, with little separation during the first year and divergence thereafter,
study authors stated in their published findings.
Similar Outcomes Observed in Walking Distance and Quality of Life
Despite the differences in target-lesion revascularization, the trial found no statistically significant variations between the two cohorts regarding functional capacity or overall well-being. Changes in pain-free walking distance and maximum walking distance remained comparable throughout the three-year evaluation window.
Health-related quality of life, measured via the EQ-5D-EL questionnaire, showed no measurable divergence between patients receiving sirolimus-coated balloons and those treated with paclitaxel-coated balloons. Furthermore, analyses of clinically driven target-vessel revascularization and amputation-free survival revealed no significant differences between the two treatment arms.
Mechanistic Differences Remain Hypothesis Generating
The biological mechanisms driving the divergence in long-term vessel patency between the two drug coatings continue to be studied by the cardiovascular research community. Although biological differences in vascular responses to sirolimus and paclitaxel offer potential mechanistic explanations, these remain hypothesis generating,
the authors observed regarding the cellular interactions behind the trial results.
The data were presented at the Transcatheter Cardiovascular Therapeutics conference, known as TCT 2026, and released simultaneously through JACC Journals’ TCT 2026 Coverage. Clinicians seeking further updates from the meeting can consult ACC’s TCT Meeting Coverage for additional expert insights and trial analyses.
Frequently Asked Questions About the SIRONA Trial
What patient population did the SIRONA trial examine?
The trial evaluated 482 patients diagnosed with symptomatic femoropopliteal artery disease who underwent successful lesion predilation prior to balloon angioplasty between April 2021 and September 2022.
What were the exact freedom-from-TLR rates at three years?
Freedom from clinically driven target-lesion revascularization was observed in 88.2% of patients in the sirolimus-coated balloon group and 80.2% of patients in the paclitaxel-coated balloon group over the three-year study period.
Where were the complete SIRONA trial results published?
The findings were presented at the TCT 2026 conference and simultaneously published in JACC: Cardiovascular Interventions.
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