The primary results of the TRANSFORM II trial were presented as a Late-Breaking Clinical Trial at TCT 2026 on 1 November, and the study has been accepted in The Lancet.
TRANSFORM II is an investigator-driven, randomised trial comparing the MagicTouch sirolimus-coated balloon (SCB) with an everolimus-eluting stent (EES) in de novo native coronary vessels. It enrolled 1,842 patients across 53 sites in 11 countries.
Key findings at 12 months:
• Target-lesion failure: 2.1% with MagicTouch SCB vs 2.4% with EES (HR 0.86; 95% CI 0.47–1.59; p=0.004 for non-inferiority)
• Non-inferiority was demonstrated in both analyses:
– Intention-to-treat: 2.1% vs 2.4% (p=0.004)
– Per-protocol: 2.13% vs 2.50% (p=0.004)
• Non-inferiority margin of 1.5 percentage points; the upper 95% bound of the difference was 0.78 points
• Bailout stenting was needed in just 7.6% of patients
Why this matters:
MagicTouch is the only sirolimus-coated balloon to prove non-inferiority against an everolimus-eluting stent in both ITT and per-protocol analyses. The trial used a fair randomisation strategy: patients were randomised only after lesion preparation, once residual stenosis was ≤30% with TIMI 3 flow and no major dissection.
