Skip to content
Health & Medical

Much Awaited, Much Needed: TRANSFORM II Randomized Controlled Trial, by Fondazione RIC, gets rolling


FONDAZIONE Ricerca e Innovazione
Cardiovascolare, Milano, focused on cardiovascular research, reports the first
patient enrolment of the TRANSFORM II
[] Randomized
Controlled Trial (Sirolimus-coated Balloon Versus Drug-eluting Stent in Native
Coronary Vessels) setting in motion a crucial trial in the Native Coronary
Vessel Treatment domain.

TRANSFORM II RCT, determined to explore and evaluate the treatment options in
native coronary vessels, enrolled the index patient on the 16th December 2021 at
Sandro Pertini Hospital, Rome, by the team of Dr. Alessandro Sciahbasi.

The International, multicentric, prospective, investigator-driven, open-label
randomized trial will observe and evaluate the efficacy of the Magic Touch
[] Sirolimus Coated Balloon
(Concept Medical Inc. []) in a head-to-head
comparison with Everolimus Eluting Stent (EES) considered to be a gold standard
treatment, in 1:1 randomization in the native coronary vessels. This trial is
led by Study Chairman, Dr. Bernardo Cortese of the San Carlo Clinic, Paderno
Dugnano-Milano, Italy. Alongside him in the steering committee are, Dr. Roxana
Mehran, Dr. Alexandre Abizaid, Dr. Stefano Rigattieri, Dr. Fernando Alfonso, Dr.
Jose Maria de la Torre Hernandez and Dr. Peter Smith.

The idea of intervention in small or mid-sized de-novo coronary lesion with a
stent is neither desirable nor efficient, considering the heavy metal
scaffolding of the vessel. Newer generation of interventionalists tend to be
hesitant to load the vessel with a metal scaffold in this setting. Drug Coated
Balloons (DCB) therefore offer a better option while treating native coronary
artery lesions.

A total of 1325 patients will be enrolled. The study population will consist of
patients with age >18 years with clinical indication of a native vessel PCI
eligibility (stable CAD or Acute coronary syndrome). Native coronary artery
lesion in a vessel with diameter >2.0 mm and <=3.0 mm will be included with a maximum lesion length of 40 mm (an achievement for this type of trial) further randomized for intervention with Magic Touch or EES. The trial aims to evaluate Magic Touch [] versus EES with the primary endpoint of non-inferiority in target lesion failure (TLF), a composite of cardiac death, ischemia-driven target-lesion revascularization (TLR) and, target vessel myocardial infarction (MI), at 12 months. The trial will also go on to verify and measure superiority of the study device in terms of net adverse clinical events (NACE), a composite of all-cause death, MI, ischemic stroke, and major bleeding (BARC - 3 or 5) as a co-primary end point. Follow up will be conducted at 6 months and yearly for 5 years. An OCT sub-study will be performed in a total of 70 patients, which will receive 9-month angio+OCT follow-up with Core-Lab analysis. Over the years, Drug Eluting Stents [] have been the preferred option in native vessels, however, with newer and advanced DCB technologies, operators now have access to an alternative without having to worry about metal in such vessels and can achieve good results. The ongoing TRANSFORM 1 [] RCT comparing Sirolimus and Paclitaxel DCB in small coronary vessels: Magic Touch (Concept Medical Inc) and SeQuent Please NEO (B. Braun) is rapidly progressing with >50% enrollment already done and
follows is the perfect RCT to seek further answers in native coronary vessel

Dr. Bernardo Cortese is optimistic and excited with the onset of the RCT and
briefly explains why this is a much-needed trial and what is expected out of it,
“We do not need to expect a stent-like result when we use a DCB; what we aim to,
is to have similar results to DES, and possibly an improved result on the long
term, since we do not implant metal, and metal from stents is associated with a
small but continuous increase in adverse events year-on-year,” Dr. Cortese
quotes “Regarding DCB, at least when you use a reliable device, we have observed
a flattening of the events curve after 18 months, so why not expect better
results after 3-4 years?”

In essence, TRANSFORM II will bring to light the data suggesting why this
transition from stents to balloons is a necessity for some native coronary
vessels and hopefully in the near future, the data will reveal encouraging and
promising results.

Magic Touch Sirolimus Coated Balloon
[] has already received a
breakthrough device designation from the US FDA for the treatment of small
coronary vessels as well as In-Stent restenosis. This trial may give the
required inclination towards the use of DCB like the Magic Touch. It may
indicate that it is time to transform.

About Magic Touch:

Magic Touch is a CE approved and commercially marketed Sirolimus coated balloon
by Concept Medical, developed using the proprietary Nanolute Technology
[]. Magic Touch has been
deployed in >50,000 patients in major global markets. Nanolute – 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.


Source: Concept Medical Inc.