Sirolimus-coated balloon matches drug-eluting stent performance in coronary trials

Research findings from the TRANSFORM II clinical trial demonstrate that the MagicTouch sirolimus-coated balloon, developed by Concept Medical, performs comparably to standard everolimus-eluting stents (EES) in treating de novo coronary artery disease. The results, presented at the TCT 2026 congress, suggest that patients can achieve similar clinical outcomes without the permanent implantation of metallic stents.

The trial included 1,842 patients across 53 centers in 11 countries. At the 12-month mark, target lesion failure occurred in 2.1% of the balloon group compared to 2.4% in the stent group. The study, which has been accepted for publication in The Lancet, met its primary endpoint for non-inferiority.

Lead investigator Dr. Bernardo Cortese noted that success with the balloon-based strategy requires meticulous lesion preparation. In the study, only 7.6% of patients treated with the balloon required a rescue stent, indicating that the technology can serve as a robust primary treatment approach in appropriate cases.

While the study confirmed the clinical viability of this implant-free strategy, the researchers noted that the findings apply to lesions where adequate vessel preparation is feasible. The procedure remains a strategic approach that demands surgical precision and the flexibility to deploy a stent if complications arise.