Sirolimus-coated balloon matches drug-eluting stents in clinical trial
The TRANSFORM II trial results show that sirolimus-coated balloons are non-inferior to traditional drug-eluting stents for treating coronary artery disease after one year.
Findings from the TRANSFORM II clinical trial, presented at the TCT 2026 conference, indicate that a sirolimus-coated balloon (SCB) strategy performs as well as conventional everolimus-eluting stents (EES) in patients with de novo coronary artery disease. The study, involving 1,842 patients across 11 countries, was simultaneously published in The Lancet.
In the trial, patients were randomized to receive either the MagicTouch SCB or a standard EES following successful lesion preparation. At 12 months, the rate of Target Lesion Failure was 2.1% in the SCB group compared to 2.4% in the EES group, meeting the criteria for non-inferiority. Notably, only 7.6% of patients in the SCB group required a backup stent, suggesting the implant-free approach is viable for many patients.
Principal investigator Dr. Bernardo Cortese noted that success with this strategy relies heavily on the quality of lesion preparation before treatment. The researchers intend to continue monitoring the participants for five years to determine if avoiding permanent metallic implants leads to better long-term clinical outcomes.
The study was sponsored by the Fondazione Ricerca e Innovazione Cardiovascolare. Concept Medical provided an unrestricted research grant but held no role in the study design, data analysis, or reporting.