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TRANSFORM 1 Enrollment Completed: A Crucial RCT Ready to Redefine the DCB Angioplasty Mechanism
BIRMINGHAM, England, Sept. 13, 2022 -- Concept Medical announces the successful completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch Sirolimus Coated Balloon). The Randomized Controlled Trial (RCT) was conceptualized 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, randomized, multi-centre, RCT focusing on small vessels, de-novo coronary lesion treatment enrolled the culminating 114th patient on 31st of August at Heartlands Hospital, Birmingham by Dr. Sandeep Basavarajaiah and team completing 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) or 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.
"Forty-five 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 of 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," said Prof. Patrick Serruys (Co-chair).
TRANSFORM 1 RCT is exploring the uncharted field of small vessels. The primary objective of the study is to assess angiographic outcomes in 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 vessel 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 target lesion failure (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 to its recognized lumen enlargement effects," said 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 to avoid and so would the patient, considering the heavy metal load as well as the future risk of re-narrowing due to instent restenosis. DCBs can complement small vessels but what is, and, was required, was a RCT. TRANSFORM 1 with its OCT and mechanistic approach allowed the physician to target the lesion by measuring the precise caliber 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) are eagerly awaited.
Dr. Sandeep Basavarajaiah, UK who has a wide experience with the Magic Touch device, shares, "It's a great initiative by Concept Medical to sponsor such a detailed RCT, which will have significant impact on the future of angioplasty especially when treating small vessel de novo lesions. 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 are 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 by some as a better option than paclitaxel in coronary artery disease, 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 on the forefront when it comes to the usage of DCB in present-day PCI practice.
About Magic Touch SCB:
Magic Touch is a CE approved and commercially marketed Sirolimus coated balloon by Concept Medical, developed using the proprietary Nanoluté Technology. Magic Touch has been used in >50,000 patients in major global markets. Nanoluté – the unique drug delivery technology platform of Magic Touch balloon, is designed to deliver sub-micron particles of Sirolimus which are then encapsulated in a biocompatible drug carrier. The carrier-complex is designed to reach the deepest layers of the vessel walls. The product is manufactured by Concept Medical.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.
