SCB angioplasty resulted in sustained patient-reported and clinical outcomes comparable to PCB angioplasty through 2 years, with similar patency, revascularization, and safety.
Improvements in vascular quality of life were sustained through 2 years and were similar between sirolimus-coated balloon and paclitaxel-coated balloon groups.
Clinical improvement of at least 1 Rutherford category occurred at similar rates in both treatment groups at 2 years.
Primary patency rates at 2 years were similar between SCB and PCB angioplasty groups.
Freedom from clinically driven target lesion revascularization was comparable between SCB and PCB groups at 2 years.
Major amputation was rare and occurred at identical rates in both treatment groups.
All-cause mortality occurred more frequently in the SCB group than the PCB group at 2 years, though the difference was not statistically significant.
The SIRONA trial was designed as a prospective, multicenter, randomized, controlled, noninferiority trial comparing SCB with PCB angioplasty in femoropopliteal artery disease.
This research compared two types of drug-coated balloons used to treat narrowed leg arteries — one coated with sirolimus (a newer drug) and one coated with paclitaxel (the more established drug). Both types of balloons are used during a minimally invasive procedure called angioplasty to open blocked or narrowed arteries in the thigh and knee region. The SIRONA trial enrolled 482 patients across multiple centers and followed them for 2 years to compare how well each treatment worked and how safe each was. The study found that both treatments produced very similar results across all measured outcomes at 2 years. About 88-89% of patients in both groups experienced meaningful improvement in their symptoms, and quality of life improvements were sustained and statistically indistinguishable between groups. The rates of the artery staying open (primary patency) were approximately 65-67% in both groups, and freedom from needing a repeat procedure on the same artery segment was around 88-91% in both groups — none of these differences were statistically significant. Major amputations were rare (0.4%) in both groups. All-cause mortality was numerically higher in the sirolimus group (6.3% vs. 3.7%), but this difference was not statistically significant, and no deaths were attributed to the devices or procedures themselves. This research suggests that sirolimus-coated balloons may be a viable alternative to paclitaxel-coated balloons for treating femoropopliteal artery disease, which is relevant given ongoing concerns about the long-term safety profile of paclitaxel-coated devices that have been discussed in the medical community. The investigators noted that longer-term follow-up of up to 5 years is still ongoing, which will provide additional data on durability and safety of both approaches.
Teichgräber U, Ingwersen M, Lehmann T, Platzer S, Kunstmann I, Steiner S, et al.. (2026). 2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease.. JACC. Cardiovascular interventions. https://doi.org/10.1016/j.jcin.2026.06.021