#Italy #Milan #MagicTouch SCB #TRANSFORM II #DES

Major Breakthrough in Cardiovascular Treatment: Completion of TRANSFORM II Patient Enrollment

The recent accomplishment by Fondazione Ricerca e Innovazione Cardiovascolare in successfully concluding patient enrollment in the TRANSFORM II randomized controlled trial (RCT) heralds a pivotal advancement in cardiovascular medicine. This landmark study, which engages over 1,800 patients worldwide, focuses on studying the efficacy and safety of the MagicTouch Sirolimus Coated Balloon (SCB) against the commonly utilized Drug Eluting Stents (DES) in native coronary arteries.

Background of the Study

The TRANSFORM II study is designed to critically assess the performance of the MagicTouch SCB, which employs Sirolimus, a drug known for its potential benefits in cardiovascular procedures. The principal investigator, Dr. Bernardo Cortese from the University Hospitals Harrington Heart and Vascular Institute in Cleveland, USA, led this expansive undertaking that enlisted patients from 52 centers across Europe, Asia, and South America.

With recruitment wrapping up on June 6, 2025, TRANSFORM II is making waves as one of the largest RCTs in the world specifically aimed at evaluating the capacity of drug-coated balloons to effectively treat coronary artery disease in real-world settings.

Objectives and Methodology

The study's objectives are clear and ambitious:

• - Primary Endpoint: Valve failure after 12 months with a non-inferiority design, comparing MagicTouch SCB and EES.
• - Follow-up: Participants will be monitored over a period of up to 60 months (5 years) to grasp long-term effects and outcomes.
• - Additionally, an ancillary study using Optical Coherence Tomography (OCT) will be conducted on 70 patients after nine months to evaluate the angiographic results.

Dr. Cortese expressed pride in the swift recruitment process within less than three and a half years, highlighting the dedication of the study team and participating centers. He mentioned, "Our aim is to push the adoption of drug-coated balloons in coronary applications by rigorously testing the MagicTouch SCB against the most studied and widely used DES in the field."

Challenges in Treating Coronary Arteries

Coronary vessels larger than 2.0 mm and less than or equal to 3.5 mm, which account for about 80% of interventions, present significant treatment challenges. Current practice necessitates the use of permanent implants which could lead to complications over time. In contrast, the trial directly compares a drug-coated balloon against the current standard, potentially revolutionizing treatment approaches by validating less invasive solutions for patients suffering from coronary artery disease.

The implications of this research extend far beyond providing direct comparisons; they pave the way for changing the landscape of how interventional cardiologists approach treatment decisions, especially in cases that are currently treated with more invasive stents.

Outlook for Drug-Coated Balloons

Drug-coated balloon technology has been recognized as a promising alternative for newly formed coronary lesions. With Sirolimus presenting as a feasible alternative to Paclitaxel, the TRANSFORM II study aims to validate the clinical effectiveness and safety, encouraging wider adoption of this technology in practice.

The first set of 12-month outcomes is expected to yield critical insights into the long-term advantages of avoiding permanent implants in coronary arteries. A significant paradigm shift towards frequent use of these balloons could arise from the findings.

Commitment to Excellence in Cardiovascular Treatments

Dr. Manish Doshi, the founder and Managing Director of Concept Medical Group, expressed enthusiasm for the trial's milestones, underlining the importance of innovative technologies in interventional cardiology and confirming their pledge to enhance patient care through scientific rigor and clinical excellence.

MagicTouch SCB, developed utilizing Nanoluté technology, ensures the effective delivery of Sirolimus particles within compliance framework, which has attained CE approval in Europe alongside breakthrough designations by the FDA. This advancement reflects the commitment towards providing safer, more effective treatment modalities for patients worldwide.

Conclusion

The TRANSFORM II study stands as a testament to collaborative effort across various heart institutes. As the trial progresses, it could potentially redefine future practices for treating coronary artery diseases, specifically for patients with small, newly formed lesions. The long-term data expected from this study may usher in a new era in cardiovascular intervention, benefiting a global community of patients and healthcare providers.