TRANSFORM II Compares Concept’s MagicTouch SCB to DES in De Novo Coronary Lesions

November 1, 2026—Results from the open-label, randomized, noninferiority TRANSFORM II trial demonstrated noninferiority with use of a sirolimus-coated balloon (SCB) versus everolimus drug-eluting stents (DES) after successful lesion preparation in patients with de novo coronary artery lesions. The findings were presented by Bernardo Cortese, MD, at TCT 2026.

The TCT press release stated that TRANSFORM II is an investigator-driven study sponsored by the nonprofit Fondazione Ricerca e Innovazione Cardiovascolare ETS in Milan, Italy. The study, which received an unrestricted grant from Concept Medical, USA, is evaluating the safety and efficacy of the company’s MagicTouch SCB.

“TRANSFORM II provides robust randomized evidence from a large, contemporary international population undergoing percutaneous coronary interventions (PCI) for de novo coronary artery disease,” commented Dr. Cortese in the TCT press release. “When considered alongside the available literature, a drug-coated balloon–based approach is a safe and effective alternative to stenting in selected patients with de novo lesions.”

According to the TCT press release, between December 2021 and June 2025, the study screened 2,699 patients and randomized 1,842 patients 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. to 3.5 mm and a lesion length ≤ 50 mm.

After successful lesion preparation (residual stenosis ≤ 30%, thrombolysis in myocardial infarction grade 3 flow, absence of dissection ≥ type C), patients were randomized 1:1 to SCB (n = 922) or DES (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 there were slight differences in lesion length, reference vessel diameter, and total study device length between the two groups. Bailout stenting occurred in 7.6% of SCB-treated patients, noted TCT.

The TCT press release reported that the following 12-month findings from TRANSFORM II were presented by Dr. Cortese:

• 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 DES group (hazard ratio [HR], 0.86; 95% CI, 0.47-1.59; P = .004 for noninferiority).
• The key secondary endpoint of net adverse clinical events (all-cause death, myocardial infarction, ischemic stroke, or Bleeding Academic Research Consortium major bleeding) occurred in 4.1% of the SCB group compared with 5.3% of the DES group (HR, 0.77; 95% CI, 0.50-1.17).