Sirolimus Balloon Beats Paclitaxel on Repeat Procedures
Three-year SIRONA trial results show a lower rate of repeat target-lesion revascularization with sirolimus-coated balloon angioplasty.
Updated on Nov. 2, 2026 in Heart Disease
Three-year results from the SIRONA trial, presented at TCT 2026, compared sirolimus-coated and paclitaxel-coated balloon angioplasty in 482 patients. Freedom from clinically driven target-lesion revascularization was 88.2% in the sirolimus group versus 80.2% in the paclitaxel group.
Why it matters
Repeat revascularization of a treated artery is a common concern after angioplasty, so a difference in the need for repeat procedures bears directly on patient outcomes. The result also suggests the two drug coatings may affect vascular healing differently over time.
The randomized trial enrolled 482 patients from April 2021 to September 2022 and found three-year freedom from clinically driven target-lesion revascularization of 88.2% for sirolimus versus 80.2% for paclitaxel (hazard ratio 0.6; p=0.03). The treatment effect varied over time (interaction p=0.006), and the mechanism behind the difference remains unconfirmed.
The players
SIRONA trial
A randomized clinical trial comparing sirolimus-coated and paclitaxel-coated balloon angioplasty in patients with lesions treated by balloon procedures.
TCT 2026
The Transcatheter Cardiovascular Therapeutics conference, a major annual meeting where interventional cardiology research is presented.
The details
Patients were randomized after successful lesion predilation to receive either sirolimus-coated or paclitaxel-coated balloon angioplasty and were followed for three years. The divergence between groups in repeat target-lesion revascularization emerged after the first year, while functional measures and quality of life did not differ.
Timeline
Patients were randomized between April 2021 and September 2022.
Three-year follow-up outcomes were reported at TCT 2026 on November 2, 2026.
The divergence in repeat revascularization between groups appeared after the first year of follow-up.
Health Landscape
The SIRONA findings add three-year randomized evidence to the comparison between paclitaxel and sirolimus coatings in balloon angioplasty for coronary and peripheral disease. Because functional and quality-of-life outcomes did not differ, the benefit appears limited to repeat revascularization, which shapes how clinicians weigh the two coatings.
Patients with blocked arteries treated with balloon angioplasty may face a lower chance of needing a repeat procedure in the same vessel if their treatment uses the sirolimus coating. Patients should discuss which balloon type fits their situation with their cardiologist, since the trial did not show a difference in walking distance or quality of life.
The takeaway
The SIRONA trial shows that the choice of drug coating on a balloon can change how often a treated artery needs another procedure over three years. Patients and clinicians should weigh that durability benefit alongside the trial's finding that day-to-day function and quality of life were similar.
Further reading
For more background on treatments for arterial blockage, see Heart Disease.
