The sirolimus-coated MagicTouch balloon has been shown to be noninferior to current everolimus-eluting stents (EES) in the rate of target lesion failure (TLF) at 12 months in patients with de novo coronary artery disease. These data come from the randomized TRANSFORM II trial, presented as a late-breaking clinical study at the TCT 2026 congress and accepted for publication in The Lancet, confirming that this technology offers clinical performance similar to that of next-generation stents.
TRANSFORM II is a noninferiority, open-label, investigator-initiated trial that included 1,842 patients in 53 hospitals across 11 countries in Europe, Asia, and South America. Participants had a native de novo coronary lesion (vessels 2.0 to 3.5 mm in diameter and lesion length ≤50 mm) and were randomly assigned in a 1:1 ratio to treatment with the MagicTouch SCB drug-coated balloon (Concept Medical), with the option of implanting a rescue stent if necessary, or to implantation of an everolimus-eluting stent (EES). Randomization was carried out only after satisfactory lesion preparation, following the recommendations of the Academic Research Consortium on Drug-Coated Balloons. The cohort was complex: approximately half had an acute coronary syndrome, more than a third had diabetes, and around a third showed high bleeding risk.
At one year of follow-up, TLF was recorded in 2.1% of patients treated with SCB and in 2.4% of those assigned to EES (hazard ratio 0.86; 95% CI: 0.47–1.59). Target lesion failure was defined as a composite endpoint of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. The absolute risk difference was -0.40 percentage points, with a unilateral upper limit of 0.78 points, well below the predefined margin of 1.5 points (P = 0.004 for noninferiority). The results were maintained in the per-protocol analyses, according to the device actually used and in the prespecified subgroups.
In the group assigned to SCB, it was only necessary to resort to a rescue stent in 7.6% of cases, a proportion clearly lower than that described in large previous trials in which randomization was performed before preparing the lesion. No lesion thrombosis (definite or probable) was observed in the SCB arm, versus 0.2% in the EES group. Net adverse clinical events, including hemorrhages, were numerically lower with SCB (4.1% versus 5.3%; HR 0.77; 95% CI: 0.50–1.17), and the rates of mortality, myocardial infarction, stroke, and major hemorrhage remained low and comparable between both groups.
The need to revascularize any target lesion was somewhat higher with SCB (2.5% versus 1.1%). Nonetheless, ischemia-guided revascularization was practically identical in the two groups (0.9% versus 0.8%).
“The TRANSFORM II study shows that, when a lesion is well prepared, its treatment with a sirolimus-coated balloon—without the need to leave a permanent metal implant—offers one-year clinical results comparable to those obtained with a modern drug-eluting stent,” said Dr. Bernardo Cortese, principal investigator and study chair, from the Fondazione Ricerca e Innovazione Cardiovascolare, (Milan). “Drug-coated balloon angioplasty should be considered a strategy, and not a simple device switch. Thorough lesion preparation and the willingness to implant a stent when necessary are fundamental to its success.”
The authors emphasized that event rates were lower than expected; that the conclusions apply to lesions that allow adequate preparation, excluding those with severe calcification, located in the left main, thrombotic, or associated with an ST-elevation myocardial infarction (STEMI); and that the participating centers had experience with drug-coated balloons. Follow-up will extend to five years to clarify whether avoiding a permanent metal implant reduces the occurrence of late device-related complications.
The permanence of a metallic structure characteristic of drug-eluting stents (DES) is an aspect that has been tried to overcome for years; the solid evidence provided by TRANSFORM II represents a possible paradigm shift in percutaneous coronary intervention (PCI), which should not be based exclusively on the use of stents.
The trial was promoted by Fondazione Ricerca e Innovazione Cardiovascolare ETS (Milan, Italy), with an unrestricted research grant from Concept Medical, which did not participate in the design, analysis, or dissemination of the results. ClinicalTrials.gov: NCT04893291.
Source: Data from the TRANSFORM II study, presented as a Late-Breaking Clinical Trial at the TCT USA conference by Professor Bernardo Cortese on November 1, 2026, and accepted for publication in The Lancet.
MagicTouch has CE marking. CAUTION: Investigational device in the United States; its use is restricted by federal law to research purposes only.
About Fondazione Ricerca e Innovazione Cardiovascolare
Fondazione RIC is an independent, non-profit entity, with offices in Italy and the United States, dedicated to promoting global cardiovascular research led by independent investigators. Created in 2020, it provides transparent and robust support for the conduct of high-quality clinical trials. With 19 clinical studies designed and executed, 187 centers involved, and more than 8,000 patients enrolled, Fondazione RIC has established itself as one of the largest cardiovascular organizations with the greatest international impact. For more information, visit its website at https://www.fondazioneric.org or write to segreteria@fondazioneric.org.
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