SAN DIEGO –  Results from the open-label, randomized, noninferiority TRANSFORM II trial demonstrated noninferiority of a sirolimus-coated balloon (SCB) strategy to everolimus drug-eluting stents (EES) after successful lesion preparation in patients with de novo coronary artery lesions.

Findings were reported today at TCT® 2026, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. 

Drug-eluting stents are the standard treatment for de novo coronary artery disease (CAD), however, permanent metallic coronary stents carry a 2-3% annual risk of target-lesion failure after the first year. Drug-coated balloons, by contrast, deliver an antiproliferative drug without leaving permanent implants behind. While favorable outcomes have been demonstrated with drug-coated balloons in small vessels, randomized evidence supporting their use in larger vessels and broader de novo populations remains limited.

Between December 2021 and June 2025, 2,699 patients were screened and 1,842 randomized at 53 sites across Europe, Southeast Asia, and Brazil. Enrolled patients were undergoing PCI for acute or chronic coronary syndrome and had a de novo lesion in a native coronary artery, with a reference vessel diameter of 2.0–3.5 mm and a lesion length of 50 mm or less. Following successful lesion preparation (residual stenosis ≤30%, TIMI grade 3 flow, and absence of dissection ≥type C), patients were randomized 1:1 to SCB (n=922) or EES (n=920). Baseline and angiographic characteristics were similar between the two groups, although multivessel PCI was more common in the SCB group (40.3% vs. 33.7%) and slight differences in lesion length, reference vessel diameter, and total study device length were noted between groups. Bailout stenting occurred in 7.6% of SCB-treated patients.

At 12 months, the primary endpoint of target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) occurred in 2.1% of patients in the SCB group and 2.4% in the EES group [HR 0.86 (95% CI: 0.47–1.59), p = 0.004 for non-inferiority]. At one year, the key secondary endpoint of net adverse clinical events (all-cause death, myocardial infarction, ischemic stroke, or BARC major bleeding) occurred in 4.1% of the SCB group compared with 5.3% of the EES group [HR 0.77 (95% CI: 0.50–1.17)].

“TRANSFORM II provides robust randomized evidence from a large, contemporary international population undergoing PCI for de novo coronary artery disease,” said Bernardo Cortese, MD, MSc, interventional cardiologist at Case Western Reserve University School of Medicine and president of Fondazione Ricerca e Innovazione Cardiovascolare. “When considered alongside the available literature, a DCB-based approach is a safe and effective alternative to stenting in selected patients with de novo lesions.”

The investigator-driven study was sponsored by the nonprofit foundation Fondazione Ricerca e Innovazione Cardiovascolare ETS in Milan, Italy and received an unrestricted grant from Concept Medical, USA.

Dr. Cortese disclosed participation in a company sponsored speaker's bureau with Cordis, Concept Medical, Angiodynamics and Cardionovum; grants/research support from B.Braun Melsungen AG, iVascular, Cordis, Concept Medical and ANT; and honoraria or consultation fees from iVascular, Concept Medical, Boston Scientific, Abbott Vascular, Cordis, Cardionovum, ANT, Abbott, Angiodynamics and Gentuity.

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The results of the study will be presented on Sunday, November 1 at 11:07 AM PT in the Main Arena at the San Diego Convention Center during TCT 2026.