Sirolimus Coated Balloon Matches Everolimus-Eluting Stents After One Year

New Clinical Breakthrough: Sirolimus Coated Balloons Outperform Stents in Heart Disease Treatment

A major clinical trial has presented groundbreaking findings that could reshape the future approach to treating coronary artery diseases. Published on November 1, 2026, at the TCT conference, results from the TRANSFORM II study indicate that the use of sirolimus-coated balloons (SCBs) reaches performance levels comparable to those of the widely used everolimus-eluting stent (EES) after a one-year period.

The TRANSFORM II study was a randomized, open-label trial involving 1,842 patients across 53 medical centers spanning 11 countries in Europe, Asia, and South America. Participants had new-onset coronary artery lesions with specific characteristics, and they were treated using either the MagicTouch SCB (developed by Concept Medical) or the EES. The trial was unique in its design, ensuring that randomization only occurred after successful lesion preparation, fostering a more tailored approach to patient treatment.

Clinical Outcomes

Twelve months after the procedure, instances of target lesion failure (TLF)—a composite indicator comprising cardiac death, myocardial infarction related to the target vessel, and ischemia-driven target lesion revascularization—were reported in 2.1% of patients in the SCB group compared to 2.4% in the EES group. The results showcased a risk ratio of 0.86, with confidence limits confirming that the SCB method was non-inferior to the stent treatment. This finding is particularly significant considering the pre-established margin for non-inferiority was set at 1.5 percentage points. Such promising results not only reflect on the efficacy of the MagicTouch SCB but also highlight its potential benefits in minimizing the need for stent implantation, which was required in only 7.6% of SCB patients compared to higher rates in previous studies.

Furthermore, the incidence of any complications—such as thrombosis and major bleeding—was notably lower for the SCB group than for the EES group. With no recorded instances of defined or probable thrombosis in the SCB cohort versus 0.2% in the EES group, the safety profile was further validated.

Implications for Clinical Practice

Dr. Bernardo Cortese, the study’s lead investigator and president of the Fondazione Ricerca e Innovazione Cardiovascolare, emphasized the importance of meticulous lesion preparation to maximize treatment success with SCBs. He stated, “The TRANSFORM II study demonstrates that SCBs can provide clinical outcomes comparable to modern drug-eluting stents without implanting a permanent metallic structure.” This not only demonstrates a pivotal shift for coronary intervention tactics but also provides a fresh perspective on managing coronary artery disease, as reliance on stents may be reduced.

The video highlights and implications of this study will continue to resonate as it fuels further exploration into SCB use, particularly as it can help improve patient outcomes without the risks associated with permanent metal implants. The potential for a shift in daily clinical practice is promising, given these results, which indicate the possible future adoption of SCBs as a default treatment procedure for appropriate lesion categories, especially those with suitable preparations.

The TRANSFORM II findings also underline the necessity of continued patient monitoring for up to five years following treatment to evaluate long-term outcomes and the overall ramifications of eliminating permanent implants on late event occurrences.

Research Sponsorship and Acknowledgments

The study was sponsored by the Fondazione Ricerca e Innovazione Cardiovascolare, with a research grant from Concept Medical. The company did not influence the trial’s design or outcome presentation, ensuring the findings maintain integrity and scientific value.

In light of its encouraging results, the MagicTouch SCB, which has already received a CE mark in Europe and has been recognized by FDA as an innovative device, shows vast potential for broadening treatment modalities in coronary artery diseases, enhancing both safety and effectiveness for patients globally.

For further insights and updates on this emerging technology and research, visit Concept Medical's official site.