TRANSFORM II Trial Delivers Landmark Results for MagicTouch Sirolimus-Coated Balloon at TCT 2026

New clinical evidence presented at the prestigious Transcatheter Cardiovascular Therapeutics (TCT) 2026 congress has marked an important milestone for coronary drug-coated balloon (DCB) technology.

The TRANSFORM II trial has demonstrated that a sirolimus-coated balloon (SCB) strategy using the MagicTouch Sirolimus-Coated Balloon, developed by Concept Medical, was non-inferior to contemporary everolimus-eluting stents (EES) in patients undergoing PCI for de novo coronary artery disease at 12 months.

Presented as a Late-Breaking Clinical Trial by Principal Investigator Professor Bernardo Cortese on 1 November 2026, the results provide compelling new evidence supporting an implant-free approach to coronary intervention in appropriately selected patients.

A major international randomised clinical trial

TRANSFORM II was an investigator-initiated, multicentre, multinational, randomised clinical trial involving:

• 1,842 patients randomised.
• 53 clinical centres across 11 countries.
• Patients with de novo coronary lesions in native vessels measuring 2.0–3.5 mm.
• Lesion lengths of up to 50 mm.
• Randomisation to MagicTouch Sirolimus-Coated Balloon or contemporary everolimus-eluting stent treatment.

The study included a clinically relevant population, with approximately half of participants presenting with acute coronary syndromes, more than one-third having diabetes and approximately one-third classified as being at high bleeding risk.

Importantly, patients were randomised only after successful lesion preparation, allowing investigators to assess the effectiveness of a DCB-based strategy in lesions demonstrating an acceptable initial angiographic result.

Primary endpoint achieved: non-inferiority to drug-eluting stents

The primary endpoint was Target Lesion Failure (TLF) at 12 months, comprising cardiac death, target-vessel myocardial infarction and ischaemia-driven target lesion revascularisation.

The results demonstrated:

• MagicTouch Sirolimus-Coated Balloon: 2.1%
• Everolimus-Eluting Stent: 2.4%

The difference met the prespecified non-inferiority criterion (hazard ratio 0.86; 95% CI 0.47–1.59; p=0.004 for non-inferiority).

Importantly, the findings were consistent across intention-to-treat, per-protocol and device-received analyses, providing further confidence in the robustness of the results.

These findings establish that, following successful lesion preparation, a MagicTouch-based treatment strategy can achieve comparable one-year clinical outcomes to contemporary drug-eluting stent implantation.

Low requirement for bailout stenting

One of the notable procedural findings was the low rate of bailout stenting.

Only 7.6% of patients assigned to the MagicTouch strategy required additional stent implantation.

This means that more than 92% of patients in the SCB arm were managed without requiring a permanent metallic implant.

The finding reinforces the importance of appropriate lesion preparation, careful patient selection and a structured DCB treatment strategy.

As Professor Cortese emphasised during the presentation, drug-coated balloon angioplasty should be considered a complete revascularisation strategy rather than simply an alternative device to a coronary stent. Successful lesion preparation and readiness to implant a bailout stent when clinically necessary remain fundamental to procedural success.

Encouraging safety outcomes

The trial also demonstrated encouraging safety findings.

No definite or probable lesion thrombosis was reported in the MagicTouch group, compared with 0.2% in the drug-eluting stent group.

Net Adverse Clinical Events (NACE), comprising all-cause death, myocardial infarction, ischaemic stroke and major bleeding, occurred in:

• MagicTouch SCB: 4.1%.
• Everolimus-eluting stent: 5.3%.

Although numerically favouring the SCB strategy, this difference was not statistically significant.

Rates of ischaemia-driven target lesion revascularisation were also similar between the two groups (0.9% versus 0.8%).

These results provide further encouraging evidence for the safety and effectiveness of sirolimus-coated balloon treatment in appropriately selected patients.

Moving towards an implant-free future in coronary intervention

Traditional coronary PCI relies heavily on permanent metallic drug-eluting stents. While DES technology has transformed the treatment of coronary artery disease, leaving a permanent metallic implant within the vessel can introduce challenges associated with long-term vessel healing, future interventions and device-related complications.

Drug-coated balloons offer an alternative approach, delivering an antiproliferative drug directly to the vessel wall without leaving a permanent metallic scaffold.

MagicTouch utilises Concept Medical's proprietary Nanoluté drug-delivery technology, designed to facilitate the transfer of sirolimus into the arterial wall during balloon inflation.

The TRANSFORM II findings represent an important addition to the growing clinical evidence supporting sirolimus-coated balloons in de novo coronary disease.

The investigators will continue clinical follow-up for up to five years to establish whether avoiding a permanent metallic implant can translate into additional long-term clinical benefits.

APR Medtech: supporting the advancement of coronary DCB technology in the UK

As the UK distributor of Concept Medical's MagicTouch Sirolimus-Coated Balloon, APR Medtech welcomes these important findings and the continued development of clinical evidence supporting sirolimus-coated balloon technology.

TRANSFORM II represents a significant milestone in the evolution of coronary intervention, demonstrating the potential for an implant-free treatment strategy to achieve clinical outcomes comparable to contemporary drug-eluting stents in appropriately selected patients.

With increasing interest in DCB-based PCI strategies, the results provide further momentum for the adoption and clinical understanding of coronary sirolimus-coated balloon technology.

The future of coronary intervention is continuing to evolve, and TRANSFORM II represents another important step towards a more implant-free approach to patient care.

ClinicalTrials.gov: NCT04893291.

The TRANSFORM II trial was sponsored by Fondazione Ricerca e Innovazione Cardiovascolare ETS and received an unrestricted research grant from Concept Medical. The sponsor reports that Concept Medical had no role in the trial's design, analysis or reporting.

The reported results represent 12-month clinical outcomes. Five-year follow-up is ongoing. Non-inferiority does not establish superiority over drug-eluting stents.

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