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Revolutionary Results from the TRANSFORM II Trial

In a groundbreaking presentation at the TCT 2026 conference, researchers unveiled data from the large international TRANSFORM II trial, demonstrating that sirolimus-coated balloons (SCB) can achieve clinical outcomes comparable to contemporary everolimus-eluting stents (EES) in treating de novo coronary artery disease after a year. This randomized trial involved 1,842 patients across 53 centers in 11 countries, including regions in Europe, Asia, and South America.

The uniqueness of the TRANSFORM II trial lies in its non-inferiority design, which aimed to determine if the SCB can match the clinical effectiveness of EES without the need for permanent implants. In this trial, patients with newly diagnosed lesions in coronary arteries were assigned either the MagicTouch SCB from Concept Medical or EES. Patients assigned to the SCB group could receive a rescue stent if needed, but only after the lesion was adequately prepped, following guidelines set by the Drug-Coated Balloon Academic Research Consortium.

Key Findings of the Study

After 12 months of follow-up, results showed a target lesion failure (TLF) rate of 2.1% in the SCB group, compared to 2.4% in the EES group, with a risk ratio of 0.86 (95% CI, 0.47–1.59). Notably, the predefined non-inferiority margin was surpassed, with a significant p-value of 0.004 for achieving this criterion. In simpler terms, the SCB strategy proved just as effective at preventing adverse cardiovascular events compared to the EES strategy.

Additionally, complications such as stent thrombosis were notably rare in the SCB group, with no occurrences compared to 0.2% in the EES group. The overall incidence of net adverse clinical events was also lower in the SCB group (4.1% vs 5.3% for EES), with rates of major cardiovascular incidents remaining low and consistent across both groups.

Dr. Bernardo Cortese, the principal investigator and chairman of the study, remarked, "TRANSFORM II illustrates that when a lesion is meticulously prepared, treating it with a sirolimus-coated balloon—without leaving behind a permanent metallic implant—can yield comparable one-year clinical outcomes akin to those of modern drug-eluting stents."

Patient Profiles and Outcome Disparities

The study population presented complexities with nearly half of the patients experiencing acute coronary syndrome, over a third being diabetic, and about one-third having a high hemorrhagic risk, emphasizing the real-world applicability of these findings. Interestingly, the need for rescue stenting was significantly lower at 7.6% in the SCB group, signifying a less invasive approach compared to other large-scale studies where lesion preparation occurred post-randomization.

While it was noted that target revascularizations occurred more frequently with SCB (2.5%) compared to EES (1.1%), the rate of ischemia-induced revascularizations was nearly identical (0.9% vs 0.8%). However, the context of overall patient outcomes positions the SCB as a favorable option.

The Future of Coronary Intervention

As the medical community shifts its focus towards innovative coronary intervention techniques, the TRANSFORM II trial sheds light on the potential of balloon angioplasty with drug-coated balloons as a viable alternative to traditional stenting, stressing that meticulous lesion preparation is crucial for success. Notably, the study's corresponding robust data and results provide a framework for refining coronary intervention practices moving forward.

With plans for a five-year follow-up to assess long-term outcomes and risks associated with the absence of permanent implants, the insights from this trial could signal a significant turning point in the treatment of coronary artery disease, reshaping established practices that have relied heavily on stenting solutions. "This is not merely a change in device selection but a new strategy that warrants significant consideration in clinical practice," Cortese added.

The TRANSFORM II trial was fully funded by the Fondazione Ricerca e Innovazione Cardiovascolare ETS in Milan, Italy, supported by a research grant from Concept Medical. For more information about the MagicTouch SCB, which has received CE marking and notable FDA breakthrough device designations for coronary treatment, visit Concept Medical.

Overall, the findings from the TRANSFORM II study mark a promising advancement in cardiovascular healthcare, offering hope for improved patient outcomes through innovative treatment strategies.