TRANSFORM II picked for late-breaking presentation at TCT 2026

TRANSFORM II, a multinational randomized trial of a sirolimus-coated balloon strategy versus contemporary drug-eluting stents in de novo coronary artery disease, will be presented as a late-breaking clinical trial at TCT 2026 in San Diego. The 1-year primary endpoint results will be shared Nov. 1, 2026, and the study's main findings have also been accepted for publication in The Lancet.

Why it matters: - TRANSFORM II tests whether a drug-coated balloon strategy can match short-term outcomes from contemporary stents without leaving a permanent metallic implant. - The trial also explores whether avoiding a stent may offer long-term advantages, given known drawbacks of stents after more than three years. - Acceptance as a late-breaking clinical trial at TCT 2026 puts the results in front of a major interventional cardiology audience.

What happened: - TRANSFORM II was selected for late-breaking presentation at TCT 2026 in San Diego. - The 1-year primary endpoint results will be presented on Nov. 1, 2026, by Prof. Bernardo Cortese, principal investigator and study chair. - The study is an investigator-initiated, open-label, randomized non-inferiority trial sponsored by Fondazione RIC – Fondazione Ricerca e Innovazione Cardiovascolare ETS in Italy.

The details: - TRANSFORM II screened and enrolled 2,699 patients. - The trial ran 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 contemporary everolimus-eluting stent implantation. - The trial is evaluating safety and performance of the sirolimus-coated balloon strategy compared with contemporary drug-eluting stents in a broad population with de novo coronary artery disease. - 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.

Between the lines: - Late-breaking status suggests the cardiology field sees the dataset as potentially practice-relevant. - The trial's design reflects growing interest in reducing long-term device burden while preserving established short-term stent-era outcomes. - Fondazione RIC framed the presentation as a milestone for its international investigator network and for investigator-driven research in interventional cardiology.

What's next: - The trial team will present the 1-year primary endpoint data at TCT 2026. - Additional results from TRANSFORM II are expected to follow in the conference setting and in The Lancet publication pathway. - Fondazione RIC says it will continue supporting investigator-driven cardiovascular research and international collaborations.

The bottom line: - TRANSFORM II is moving into a high-visibility stage that could influence how cardiologists weigh drug-coated balloon strategies against drug-eluting stents in de novo coronary disease.