TRANSFORM II Selected as a Late-Breaking Clinical Trial at TCT 2026

TRANSFORM II randomized trial Selected as a Late-Breaking Clinical Trial at TCT 2026

International randomized trial investigating a drug-coated balloon strategy vs. stents in de novo coronary artery disease

San Diego, USA - October 2026 - TRANSFORM II, a large investigator-driven multinational randomized clinical trial investigating the safety and performance of a sirolimus-coated balloon strategy compared with contemporary drug-eluting stents in a broad population of patients with de novo coronary artery disease, has been selected for presentation as a Late-Breaking Clinical Trial at TCT 2026 in San Diego.

The results of the 1-year primary endpoint will be presented on November 1, 2026, by Prof. Bernardo Cortese, Principal Investigator and Study Chair.

TRANSFORM II is an investigator-initiated, open-label, randomized non-inferiority trial sponsored by Fondazione RIC - Fondazione Ricerca e Innovazione Cardiovascolare ETS, Italy.

The study screened and enrolled 2,699 patients across 53 centers in 11 countries in Europe, Asia and South America. Patients with de novo native coronary lesions were randomized to a sirolimus-coated balloon strategy, or to contemporary everolimus-eluting stent implantation.

TRANSFORM II was designed to evaluate whether a drug-coated balloon-based strategy could provide short-term clinical outcomes comparable to contemporary drug-eluting stent treatment while avoiding a permanent metallic implant, also hypothesizing potential superiority on the long term, given the already known drawbacks of stents after >3 years.

The presentation at TCT 2026 represents an important milestone for Fondazione RIC and its international network of investigators, highlighting the foundation's commitment to investigator-driven clinical research and the advancement of innovative strategies in interventional cardiology.

The full results of TRANSFORM II will be presented at TCT 2026.

The study's primary endpoint results have been accepted for publication in The Lancet.

About Fondazione RIC

Fondazione RIC - Fondazione Ricerca e Innovazione Cardiovascolare ETS is an independent nonprofit foundation dedicated to advancing investigator-driven cardiovascular research worldwide. Founded in 2020, RIC supports high-quality clinical trials and international research collaborations in cardiovascular and interventional cardiology.