Trial Overview
The investigator‑initiated, open‑label, non‑inferiority TRANSFORM II trial randomised 1,842 patients with de novo native coronary lesions (vessel diameter 2.0–3.5 mm, lesion length ≤50 mm) at 53 centres in 11 countries across Europe, Asia and South America. Patients were allocated 1:1 after successful lesion preparation to either the MagicTouch Sirolimus‑Coated Balloon (SCB) from Concept Medical, with bailout stenting if required, or to a contemporary everolimus‑eluting stent (EES). The study population was highly complex: nearly 50 % presented with acute coronary syndrome, more than one‑third had diabetes, and about one‑third were at high bleeding risk.
Primary Endpoint Results
At 12 months, target lesion failure (TLF) occurred in 2.1 % of the SCB group versus 2.4 % of the EES group, yielding a hazard ratio of 0.86 (95 % CI 0.47–1.59). The absolute risk difference was –0.40 percentage points, with a one‑sided upper bound of 0.78 points, comfortably below the prespecified non‑inferiority margin of 1.5 points (P = 0.004). These findings were consistent in per‑protocol and device‑received analyses and across all prespecified subgroups.
Safety Outcomes
Bailout stenting was required in only 7.6 % of patients assigned to the SCB arm, markedly lower than in earlier large trials where randomisation preceded lesion preparation. No definite or probable lesion thrombosis was observed in the SCB cohort, compared with 0.2 % in the EES cohort. Net adverse clinical events, including bleeding, were 4.1 % with SCB versus 5.3 % with EES (HR 0.77; 95 % CI 0.50–1.17). Rates of death, myocardial infarction, stroke and major bleeding were low and similar between groups. Any target lesion revascularisation was higher with SCB (2.5 % vs 1.1 %), but ischaemia‑driven revascularisation was comparable (0.9 % vs 0.8 %).
Investigator Comments
"TRANSFORM II shows that when a lesion is well prepared, treating it with a sirolimus‑coated balloon, without leaving a permanent metal implant, gives one‑year clinical outcomes comparable to a modern drug‑eluting stent," said Dr Bernardo Cortese, MD, Principal Investigator and Study Chair at Fondazione Ricerca e Innovazione Cardiovascolare, Milan. He added that drug‑coated balloon angioplasty should be viewed as a strategy rather than a simple device swap, emphasizing the importance of meticulous lesion preparation and readiness to stent when needed.
Limitations and Follow‑up
The investigators noted that event rates were lower than expected and that the results apply only to lesions amenable to successful preparation; severely calcified, left‑main, thrombotic or STEMI lesions were excluded. All participating centres were experienced in drug‑coated balloon PCI. Follow‑up is planned for five years to assess whether avoiding a permanent implant reduces very late device‑related events.
Sponsorship and Regulatory Status
The trial was sponsored by Fondazione Ricerca e Innovazione Cardiovascolare ETS, Milan, with an unrestricted research grant from Concept Medical. Concept Medical had no role in trial design, data analysis, or reporting. The study is registered on ClinicalTrials.gov (NCT04893291). Results were presented as a Late‑Breaking Clinical Trial at the TCT USA Conference on 1 November 2026 and have been accepted for publication in The Lancet.
About the Companies
Concept Medical Inc. – Headquartered in Tampa, Florida, Concept Medical develops drug‑delivery platforms such as the MagicTouch family of sirolimus‑coated balloons. The MagicTouch SCB utilizes proprietary Nanoluté technology, holds CE‑Mark approval in Europe, and has received Breakthrough Device Designation from the U.S. FDA for small coronary vessels and in‑stent restenosis, along with IDE approvals for those indications.
Fondazione Ricerca e Innovazione Cardiovascolare (Fondazione RIC) – An independent nonprofit founded in 2020, supporting investigator‑driven cardiovascular research worldwide. To date, it has designed and conducted 19 clinical trials across 187 centres, enrolling over 8,000 patients, making it one of the largest cardiovascular research organisations globally.
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