#USA #Tampa #Sirolimus #MagicTouch #TRANSFORM-II

Sirolimus-Coated Balloon Matches Drug-Eluting Stents in International Study

Recent results from the international TRANSFORM II study have demonstrated that the Sirolimus-coated MagicTouch Balloon is as effective as drug-eluting stents (DES) for patients with de novo coronary artery disease after one year. This important research was presented at the TCT 2026 and emphasized the significance of an implant-free approach in managing coronary artery disease, particularly in complex patient situations.

Study Overview

The TRANSFORM II trial is a multi-center, randomized, open-label trial that involved 1,842 patients across 53 clinical sites in multiple countries encompassing Europe, Asia, and South America. The study aimed to evaluate the non-inferiority of the MagicTouch Sirolimus Coated Balloon against contemporary everolimus-eluting stents (EES) in terms of Target Lesion Failure (TLF) within a 12-month period. Patients who had a de novo lesion in a native coronary artery with specific size requirements were randomly assigned to receive either the MagicTouch balloon treatment or the EES implantation.

The results showed that TLF occurred in 2.1% of patients treated with the Sirolimus-coated balloon, compared to 2.4% in the EES group. This indicated that the SCB strategy was statistically non-inferior, confirming its potential as an effective treatment for coronary artery disease.

Key Findings

Dr. Bernardo Cortese, the principal investigator, noted that these findings suggest that utilizing a well-prepared lesion with a Sirolimus-coated balloon provides clinical outcomes comparable to those of modern drug-eluting stents. Importantly, this study highlighted that 7.6% of patients using the SCB required bail-out stenting, which is a lower number than previously reported in large-scale trials.

Furthermore, the study reported no instances of probable or definitive lesion thrombosis in the SCB group compared to 0.2% in the EES cohort, highlighting the SCB's safety profile. Importantly, the rate of adverse events, including bleeding and other cardiovascular events, was numerically lower in the SCB group, suggesting a favorable risk-benefit ratio.

Implications for Practice

This research underscores the potential shift in coronary intervention strategies. With a focus on less invasive approaches, treatment with a Sirolimus-coated balloon should not merely be seen as a substitute for implantable devices but as a progressive strategy in itself. Proper lesion preparation and readiness to employ stenting as necessary emerged as crucial components for achieving successful clinical outcomes.

The trial's researchers have also indicated that the event rates from the study were lower than expected. Consequently, ongoing follow-up will continue for five years to assess the long-term effectiveness of this non-implant strategy and to further investigate whether it may significantly reduce late device-related events.

Conclusion

The findings from the TRANSFORM II study represent a significant step forward in the understanding of coronary treatments. As current practices continue to evolve, the insights gained from this trial emphasize that reliance on stents alone may need reevaluation, encouraging a broader adoption of non-invasive strategies, fostering innovation in how cardiovascular conditions are addressed effectively.

This research was conducted by the Fondazione Ricerca e Innovazione Cardiovascolare in Milan, Italy, with funding from Concept Medical. They provided an unrestricted research grant and did not influence the study's design, analysis, or reporting.