Three-Year Results of SIRONA Study: Sirolimus-Coated Balloons Provide Better Outcomes Than Paclitaxel-Coated Balloons

SIRONA Study: Three-Year Efficacy Results

The SIRONA study, a randomized clinical trial, offers groundbreaking insights into the treatment of femoropopliteal artery disease. Recently presented at the TCT 2026 conference, the three-year results demonstrate that patients treated with sirolimus-coated balloons (SCB) significantly benefit in terms of freedom from clinically indicated target lesion revascularization (cdTLR) when compared to those receiving paclitaxel-coated balloons (PCB).

Overview of the SIRONA Study

Conducted across 25 centers in Germany and Austria, the trial included 482 participants suffering from symptomatic femoropopliteal arterial disease, predominantly affecting those with intermittent claudication (96.3%). After successful balloon angioplasty, subjects were randomly assigned to receive either SCB or PCB. Previous results had already established the primary 12-month endpoints for non-inferiority concerning patency and safety, leading to significant interest in the longer-term data.

Key Findings

The data showed that after three years, 88.2% of patients treated with SCB remained free from clinically indicated revascularization, compared to 80.2% for those treated with PCB. This reflects an absolute difference of 8.0 percentage points (95% CI 1.0–14.8; P = 0.01; Hazard Ratio 0.60, 95% CI 0.36–0.97).

Interestingly, improvements in self-reported walking distance and quality of life were similar across both groups, with no significant disparities noted.

The safety profiles were also encouraging, showing similar overall mortality rates of 7.4% in each cohort, with serious amputations occurring in only one patient within the SCB group compared to two in the PCB group. The rates of amputation-free survival were nearly identical, at 92.1% for the SCB group and 92.2% for the PCB group.

Implications for Clinical Practice

These results come in light of a critical reassessment of paclitaxel-coated devices as evidenced in recent studies like SWEDEPAD-2, which has prompted caution in their use according to the latest guidelines from the European Society for Vascular Surgery (ESVS) 2026. As such, the findings from SIRONA suggest a potential shift in treatment protocols, favoring sirolimus-coated balloons over traditional paclitaxel-coated options.

Following these findings, Prof. Ulf Teichgräber, the study's lead investigator, emphasized the effective outcomes for patients treated with SCB, particularly highlighting their reduced need for reinterventions. This critical observation was marked by the evident divergence in results appearing just one year after treatment.

The SIRONA study is designed to continue its follow-up for up to five years to assess the durability of these findings comprehensively.

Future Directions

Dr. Manish Doshi, CEO and Founder of Concept Medical, expressed deep gratitude toward the researchers and participating patients, highlighting that this study complements previously randomized evidence supporting the efficacy of MagicTouch PTA. As the study continues, further insights will undoubtedly bolster evidence for the long-term use of sirolimus-coated balloons in the management of peripheral artery disease.

Concept Medical remains committed to obtaining rigorous long-term data to ensure the best patient outcomes with their innovative technologies.