Sirolimus-coated balloon demonstrates non-inferiority to drug-eluting stents
Results from the TRANSFORM-II study show an implant-free strategy for de novo coronary artery disease matches the performance of traditional stents at one year.
The TRANSFORM-II clinical trial, results of which were presented at TCT 2026 and published in The Lancet, indicates that the MagicTouch sirolimus-coated balloon (SCB) is non-inferior to drug-eluting stents (EES) in treating de novo coronary artery lesions. The 12-month data suggests that avoiding permanent metal implants is a viable strategy for many patients.
Researchers analyzed 1,842 patients across 53 centers in 11 countries. Target Lesion Failure (TLF) occurred in 2.1% of the SCB cohort compared to 2.4% in the EES cohort. These findings confirm the device's efficacy when integrated into standard PCI practice, provided that lesion preparation is performed correctly.
Lead investigator Dr. Bernardo Cortese stated that the results highlight the importance of vessel preparation. Notably, only 7.6% of patients in the SCB group required a bailout stent, reflecting the efficacy of the balloon-only approach in this patient population, which included individuals with diabetes and high bleeding risks.
The study will continue monitoring patients for five years to determine if the absence of a permanent implant yields long-term benefits regarding late-stage device-related complications. Investigators noted the study applies to lesions amenable to thorough preparation, excluding certain high-risk categories such as STEMI.