Sirolimus-coated balloon matches drug-eluting stent performance in TRANSFORM II trial
Clinical data from the TRANSFORM II study suggests that an implant-free strategy using sirolimus-coated balloons is non-inferior to drug-eluting stents in coronary artery disease treatment.
New clinical data presented at the TCT 2026 conference indicates that the MagicTouch sirolimus-coated balloon (SCB) by Concept Medical is as effective as traditional everolimus-eluting stents (EES) in treating de novo coronary artery disease. The TRANSFORM II trial, which involved 1,842 patients across 11 countries, met its primary endpoint of non-inferiority regarding target lesion failure (TLF) at 12 months.
The trial recorded a 2.1% TLF rate for the SCB group compared to 2.4% for the stent group. Researchers noted that the use of a rescue stent was required in only 7.6% of SCB cases, a result attributed to rigorous vessel preparation protocols. The data suggests that for appropriately selected and prepared lesions, avoiding the placement of a permanent metallic implant does not compromise clinical outcomes.
Lead investigator Dr. Bernardo Cortese stated that the results reinforce the importance of lesion preparation rather than just device selection. While the one-year data is positive, researchers plan to conduct a five-year follow-up to determine if avoiding permanent metal implants leads to a reduction in very late device-related complications.