The Sirolimus-Coated Balloon (SCB) strategy has demonstrated non-inferiority to contemporary Everolimus-Eluting Stents (EES) in the treatment of de novo coronary artery disease, according to findings from the TRANSFORM 2 randomised clinical trial. Presented as a Late-Breaking Clinical Trial at TCT 2026 and accepted for publication in The Lancet, the study reported comparable clinical outcomes between Concept Medical’s MagicTouch Sirolimus-Coated Balloon and contemporary drug-eluting stents at the 12-month follow-up.

The investigator-initiated, open-label, non-inferiority trial enrolled 1,842 patients across 53 centres in 11 countries spanning Europe, Asia and South America. Participants with de novo native coronary lesions measuring 2.0–3.5 mm in vessel diameter and up to 50 mm in length were randomly assigned to receive either the MagicTouch SCB, with bailout stenting if required, or EES implantation.

Randomisation was conducted only after successful lesion preparation, in accordance with recommendations from the Drug-Coated Balloon Academic Research Consortium. The study also included a high-risk patient population, with nearly half of the participants presenting with acute coronary syndrome, more than one-third having diabetes and approximately one-third classified as being at high bleeding risk.

At the 12-month follow-up, Target Lesion Failure (TLF) was reported in 2.1 percent of patients in the SCB group, compared with 2.4 percent in the EES group. TLF was defined as a composite of cardiac death, target-vessel myocardial infarction and ischaemia-driven target lesion revascularisation.

The risk difference was -0.40 percentage points, with a one-sided upper confidence bound of 0.78 percentage points, remaining below the prespecified non-inferiority margin of 1.5 percentage points. The findings remained consistent across per-protocol and device-received analyses, as well as the prespecified patient subgroups.

Bailout stenting was required in only 7.6 percent of patients assigned to the SCB group, considerably lower than the rates reported in earlier large-scale trials where randomisation was conducted before lesion preparation. Additionally, no definite or probable lesion thrombosis was reported in the SCB group, compared with 0.2 percent in the EES group.

Net adverse clinical events, including bleeding, were numerically lower among patients receiving the sirolimus-coated balloon, at 4.1 percent, compared with 5.3 percent in the EES group. Rates of death, myocardial infarction, stroke and major bleeding were low and comparable between the two groups.

While the rate of any target lesion revascularisation was higher in the SCB group at 2.5 percent, compared with 1.1 percent in the EES group, rates of ischaemia-driven target lesion revascularisation remained similar at 0.9 percent and 0.8 percent respectively.

Commenting on the findings, Bernardo Cortese, Principal Investigator and Study Chair at Fondazione Ricerca e Innovazione Cardiovascolare, Milan, said the trial demonstrated that following appropriate lesion preparation, treatment with a sirolimus-coated balloon could deliver one-year clinical outcomes comparable to those achieved with contemporary drug-eluting stents, without leaving behind a permanent metallic implant.

Cortese also emphasised that drug-coated balloon angioplasty should be considered a treatment strategy rather than simply an alternative device. He highlighted that careful lesion preparation and the availability of bailout stenting, where necessary, were central to achieving successful clinical outcomes.

The investigators noted that the observed event rates were lower than anticipated and cautioned that the findings apply to coronary lesions suitable for successful preparation. They stated that the results should not be extrapolated to severely calcified, left main, thrombotic or ST-segment Elevation Myocardial Infarction (STEMI) lesions. The investigators also acknowledged that participating centres had considerable experience in drug-coated balloon Percutaneous Coronary Intervention (PCI).

Patient follow-up will continue for five years to evaluate whether avoiding permanent metallic implants can reduce very late device-related complications. The findings could have implications for the future of coronary intervention by strengthening clinical evidence supporting drug-coated balloons as an alternative to permanent stent implantation in appropriately selected patients.