Sirolimus-coated balloon shows 8-percentage-point advantage in three-year peripheral artery trial

Patients treated with a sirolimus-coated balloon had a higher likelihood of remaining free from repeat procedures to reopen treated arteries than those receiving a paclitaxel-coated balloon, according to three-year results from the SIRONA clinical trial presented at TCT 2026.

The findings, published simultaneously in JACC: Cardiovascular Interventions, showed that 88.2 per cent of patients treated with MagicTouch PTA, a sirolimus-coated balloon (SCB), remained free from clinically driven target lesion revascularisation (cdTLR) at three years, compared to 80.2 per cent of patients treated with paclitaxel-coated balloons (PCB).

The absolute difference was 8 percentage points (95 per cent confidence interval: 1.0-14.8; P=0.01), with a hazard ratio of 0.60 (95 per cent CI: 0.36-0.97). The difference between the treatment groups emerged after the first year of follow-up, according to a press statement.


However, the two groups recorded similar improvements in walking capacity and quality of life, with no significant differences in clinical safety outcomes.

The results were presented as a late-breaking clinical science study at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) conference by SIRONA principal investigator Professor Ulf Teichgraber of Jena University Hospital, Germany. The study is the first randomised comparison of sirolimus- and paclitaxel-coated balloons to report outcomes beyond two years.

SIRONA was an investigator-initiated, multicentre randomised trial conducted across 25 centres in Germany and Austria. It enrolled 482 patients with symptomatic femoropopliteal artery disease, 96.3 per cent of whom had intermittent claudication, a condition characterised by leg pain during walking due to reduced blood flow.

Participants were randomly assigned in a 1:1 ratio to receive either sirolimus-coated or paclitaxel-coated balloon angioplasty following successful lesion predilation. The trial had previously met its 12-month primary non-inferiority endpoints for vessel patency and safety.

At three years, patient-reported walking distance and quality of life had improved in both groups, with the gains sustained over the follow-up period.

Safety outcomes were also comparable. All-cause mortality was 7.4 per cent in both groups, while major amputations were uncommon, affecting one patient in the sirolimus group and two in the paclitaxel group. Amputation-free survival was 92.1 per cent and 92.2 per cent, respectively.

The proportion of patients remaining free from clinically driven target vessel revascularisation was 83.8 per cent in the sirolimus group and 79.1 per cent in the paclitaxel group, a difference that was not statistically significant (P=0.27).

The findings come amid continued scrutiny of paclitaxel-coated devices used to treat peripheral artery disease. The SWEDEPAD 2 trial and subsequent updates to European Society for Vascular Surgery guidance in 2026 have contributed to a more cautious approach towards the use of these devices in patients with intermittent claudication.

The SIRONA results add longer-term comparative evidence on sirolimus-coated balloons, although the investigators cautioned against drawing definitive conclusions from the three-year findings.

The trial was powered to assess its primary endpoints at 12 months, making the three-year analyses exploratory. The investigators said the apparent reduction in repeat target-lesion procedures with sirolimus-coated balloons requires confirmation through longer-term follow-up.

"Patients in both groups did well; those treated with the sirolimus-coated balloon needed fewer repeat procedures at the target lesion, with the difference emerging after the first year. Five-year follow-up will tell us whether this benefit holds," said Professor Teichgraber.

Dr Manish Doshi, Founder and Managing Director of Concept Medical, said: "We thank the SIRONA investigators and patients. These results add to the randomised evidence for MagicTouch PTA, which is more validation of product and technology, and we remain committed to rigorous long-term data for sirolimus-coated balloons in peripheral artery disease".

The trial was funded by Concept Medical Inc, the developer of MagicTouch PTA. According to the study disclosure, the company had no role in data analysis, interpretation or manuscript preparation.

The findings could inform future evaluation of drug-coated balloon technologies for peripheral artery disease, particularly as clinicians assess the durability of treatment benefits and the need for repeat interventions. However, the exploratory nature of the three-year analysis means that the observed advantage for sirolimus-coated balloons will require validation through the planned five-year follow-up and further clinical evidence.