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SIRONA Study: Three-Year Results Highlight Effectiveness of Sirolimus-Coated Balloons

In a significant advancement for treating femoropopliteal artery disease, the SIRONA study has released its three-year results, demonstrating that patients treated with MagicTouch PTA, a sirolimus-coated balloon developed by Concept Medical, showed a higher rate of freedom from repeat revascularization compared to those treated with paclitaxel-coated balloons. This finding was presented at the recent TCT 2026 conference and published in the JACC Cardiovascular Interventions.

Study Overview and Methodology

Dr. Ulf Teichgräber, lead investigator and professor at the University Hospital of Jena, Germany, shared that the SIRONA trial was a multicenter, randomized, investigator-initiated study conducted across 25 centers in Germany and Austria. A total of 482 patients suffering from symptomatic femoropopliteal artery disease, primarily with intermittent claudication, were randomly assigned to receive either a drug-coated balloon (PCB) or a conventional balloon following successful lesion predilation.

The study initially met its primary endpoint of non-inferiority regarding patency and clinical safety at the 12-month mark, setting the stage for long-term analysis.

Key Findings After Three Years

At the three-year follow-up, patients receiving the sirolimus-coated balloon reported an 88.2% absence of clinically indicated target lesion revascularization (cdTLR), while only 80.2% of the paclitaxel group achieved the same outcome. This translates to a substantial 8.0% difference, highlighting the superior efficacy of the sirolimus-coated treatment. The hazard ratio stood at 0.60, indicating a significant reduction in the risk of needing additional procedures in the sirolimus group. Reports suggest that the curves of the two groups began to diverge after the one-year mark.

Patients across both treatment groups showed similar improvements in walking distance and overall quality of life throughout the three years, emphasizing that the enhanced technical efficacy of sirolimus-coated balloons does not compromise other clinical outcomes. Both categories recorded a 7.4% all-cause mortality rate, confirming that safety profiles were aligned as well.

Implications for Future Treatment

These findings come at a pivotal time, as the medical community has witnessed increased scrutiny surrounding paclitaxel-coated devices following the SWEDEPAD 2 trial. The 2026 update to the European Society of Vascular Surgery guidelines calls for a more cautious approach in employing paclitaxel therapies for patients with claudication. Dr. Teichgräber noted, “Patients in both groups fared well; however, those treated with the sirolimus-coated balloon required fewer additional procedures at the lesion site, showing the differences emerging after the first year.”

Next Steps

The SIRONA study was specifically designed with 12-month goals in mind, which means the three-year findings are exploratory and need further validation. The ongoing follow-up will extend to the five-year mark, with researchers eager to confirm whether the observed benefits persist over time.

Dr. Manish Doshi, founder and CEO of Concept Medical, expressed gratitude to all participating researchers and patients, stating, “These results add to the evidence from randomized trials regarding MagicTouch PTA, reinforcing the product’s validity and technology. We remain dedicated to obtaining rigorous long-term data on sirolimus-coated balloons for treating peripheral artery disease.”

Concept Medical’s MagicTouch PTA, employing patented Nanolute technology, delivers submicronic sirolimus particles in a biocompatible vehicle for deep vascular wall penetration. The device holds the CE mark in Europe and has received FDA designation as an innovative device for treating infra-patellar artery health conditions. Currently, it is undergoing IDE authorization for both superficial femoral artery (SFA) and infra-patellar treatment procedures in ongoing clinical trials.

In conclusion, the implications of the SIRONA study's findings suggest a promising future for the application of sirolimus-coated balloons in treating vascular diseases, potentially allowing for better patient outcomes and reduced need for additional procedures.

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