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Bernardo Cortese, MD, FESC, FSCAI, presented the Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels (TRANSFORM II) clinical trial at TCT 2026.

TRANSFORM II is an international, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to evaluate the efficacy of the MagicTouch sirolimus-coated balloon (Concept Medical) compared to an everolimus-eluting stent. Only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) were enrolled in this study.

TRANSFORM II assessed whether a stent-free strategy can achieve comparable clinical outcomes to drug-eluting stents in de novo coronary lesions, with target lesion failure at 12 months as the primary endpoint.