Concept Medical announces the successful completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels Randomised controlled trial FORMagicTouch Sirolimus Coated Balloon).

The Randomised Controlled Trial (RCT) was conceptualised with the aim of understanding how the treatment indications and applications of Drug-Coated Balloon (DCB) in coronary artery disease (CAD) can be broadened.

This prospective, randomised, multi-centre, RCT focusing on small vessels, de-novo coronary lesion treatment enrolled the culminating 114th patient on the 31st of August at Heartlands Hospital, Birmingham by Dr Sandeep Basavarajaiah and the team completed the enrollment target with ease.

The first of its kind angiographic RCT enrolled 114 patients with a head-to-head comparison between paclitaxel and sirolimus in small vessels (=2.75 mm), de-novo coronary artery lesions. Patients were randomized in a 1:1 fashion between Magic Touch (Concept Medical) and SeQuent Please Neo (B. Braun Melsungen AG). The RCT cruised under the leadership of Co-chairs Prof. Patrick W. Serruys, Ireland and Dr Bernardo Cortese, Italy alongside PI Prof. Antonio Colombo, Italy.

"45 years after the first balloon angioplasty, 36 years after the introduction of stenting and 22 years after the first implantation of bioresorbable scaffolds, the dream of 'leaving' nothing behind is still very much alive in the mind of the interventional cardiologists if sub-acute occlusion and late restenosis rates are competitive with permanently implanted prosthesis.

This trial, testing DCB in small vessels has (re)discovered the basic mechanism of balloon angioplasty, beautifully documented by OCT prior to the application of the drug coating and will provide a wealth of mechanistic factors determining the angiographic and clinical outcomes of this treatment. OCT with machine learning will tell us what the impact is on tissue composition and the prognostic significance of the 'therapeutic dissection', a ubiquitous phenomenon after balloon angioplasty. I am more than ever excited and anxious to see the angiographic results," Prof. Patrick Serruys (Co-chair) quoted.

TRANSFORM 1 RCT is exploring the uncharted field of small vessels. The primary objective of the study is to assess angiographic outcomes with respect to the Net Gain (mm) at 6 months. Optical Coherence Tomography (OCT) was conducted at baseline along with Quantitative Coronary Angiography (QCA) assessment which was performed pre and post-procedure and at 6 months follow-up.

"Small coronary vessels PCI should not be considered futile, in fact prognostically they are important and associated with short and mid-term adverse events, and DES is associated with double risk of TLF in this setting, as compared to larger vessels. For the first time, we will be able to see if sirolimus, with its safety and wider therapeutic window, can match paclitaxel as regards its recognised lumen enlargement effects," quoting Co-chair Dr Bernardo Cortese, who is also the Chairman of the World's largest DCB prospective registry EASTBOURNE.

DCBs have long been used to treat in-stent restenosis (ISR) in CAD and have been doing so fairly well and securing a place for themselves. Placing metal or rather caging small vessels is something any physician would prefer avoiding and so would the patient, considering the heavy metal load as well as the future risk of re-narrowing due to ISR.

DCBs can compliment small vessels but what is, and, was required, was an RCT. TRANSFORM 1 with its OCT and mechanistic approach allowed the physician at targeting the lesion by measuring the precise calibre of the vessel and then proceeding with the appropriately selected diameter of the DCB to ensure full apposition to the vessel wall and effective drug transfer.

The documented Core Lab results (CORRIB Core Lab at NUI Galway, Ireland) which are eagerly awaited, will surely provide a sound foundation for the use of DCB in small vessels Dr Sandeep Basavarajaiah, the UK who has a wide experience with the Magic Touch device, shares his opinion,

"We are now slowly moving away from long layers of stenting and evidence from such trials will further strengthen the belief among cardiologists that 'less metal is better. It's a bold step to embark on comparing MagicTouch SCB with the widely used Paclitaxel coated balloon (SeQuent Please Neo) currently available. Our unit (Heartlands Hospital) is one of the largest recruiting sites for the trial and we have thoroughly enjoyed the experience and eagerly looking forward to the results and taking part in future trials with MagicTouch"

The results of TRANSFORM 1 will play a major role in deciding the future treatment options in CAD treatment as they may imply the potential to widen the use of DCB in more indications.

Sirolimus-coated balloons are already looked at as a better option than paclitaxel in CAD and this study just might open a fresher perspective for the community to move on from the contemporary DCB application as well. Magic Touch SCB has already been granted breakthrough device designation for ISR and Small Vessels, by the FDA and TRANSFORM 1 may act as the best catalyst for its future potential.

"The Transform 1 will give the needed angiographic follow-up about the performance of Sirolimus-eluting balloons versus Paclitaxel eluting balloons evaluated in a scientific way. This type of information is a seminal contribution in the field of Interventional Cardiology," said Prof. Antonio Colombo, who has always been at the front when it comes to the usage of DCB in present-day PCI practice.