Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels (TRANSFORM II)

TRANSFORM II

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In patients with de novo native coronary lesions in vessels of 2.0 to 3.5 mm, a sirolimus-coated balloon was non-inferior to an everolimus-eluting stent for target lesion failure at 12 months.

N

1 842patients

Schéma

Multicentre, open-label randomised trial (53 sites in Europe, Asia and South America; sponsor Fondazione Ricerca e Innovazione Cardiovascolare). MagicTouch sirolimus-coated balloon versus an everolimus-eluting stent in native coronary lesions of vessels 2.0 to 3.5 mm, lesion length up to 50 mm

Critère

Target lesion failure and net adverse clinical events at 12 months

RésultatTarget lesion failure at 12 months 2.1% with the sirolimus-coated balloon vs 2.4% with the everolimus-eluting stent (hazard ratio 0.86; 95% CI 0.47-1.59). The risk difference of -0.40 percentage points had a one-sided upper bound of 0.78 points against the 1.5 point margin (P=0.004 for non-inferiority). Bailout stenting was needed in 7.6% of the balloon arm. Definite or probable lesion thrombosis 0% vs 0.2%. Net adverse clinical events 4.1% vs 5.3% (HR 0.77; 95% CI 0.50-1.17). Any target lesion revascularisation was more frequent with the balloon (2.5% vs 1.1%), while ischaemia-driven revascularisation was similar (0.9% vs 0.8%).

Concept Medical. Sirolimus-Coated Balloon Matches Drug-Eluting Stent at One Year in Large International TRANSFORM II Trial. Press release, PR Newswire. 2026; published online 2 November.

Discussion et critique

In selected de novo lesions in vessels of 2.0 to 3.5 mm, a sirolimus-coated balloon with bailout stenting met non-inferiority to an everolimus-eluting stent for target lesion failure at 12 months, with a low bailout rate and no lesion thrombosis. The trial was open label, event rates were lower than expected, and the wide confidence interval for the hazard ratio reflects few events, while any target lesion revascularisation was more than twice as frequent with the balloon. The investigators state that the findings apply only to lesions suitable for successful preparation and not to severely calcified, left main, thrombotic or STEMI lesions, and follow-up to five years is still needed for late device-related events. The figures come from a press release by Concept Medical, the device maker and grant funder, rather than the peer-reviewed paper, so full secondary, subgroup and procedural data are not yet available.