- I am Bernardo Cortese, an interventional cardiologist from Milano, Italy. My affiliation is Fondazione Ricerca e Innovazione Cardiovascolare from Milano. A foundation which is devoted to clinical research in the cardiovascular arena. Today, we are going to discuss about the late breaking-trial clinical results of EASTBOURNE registry primary endpoint assessment.
Study Background
The background of EASTBOURNE registry is the drug-coated balloon. The novelty in this area is the sirolimus. Sirolimus is a new drug that came out in 2016. So from the very beginning of this new technology by means of Magic Touch DCB we decided to do this prospective registry because we needed to have some good, reliable, clinical data with this new device.
Study Design and Population
The design of the EASTBOURNE study is a prospective registry with central adjudication of all the events, a multi-center study from all around the world. We have enrolled 2,123 patients rendering this the largest study ever done on DCB.
Device Characteristics
The device used in the EASTBOURNE registry is a novel drug-coated balloon eluting sirolimus. And Magic Touch is a DCB which has a new technology, which with the nano-capsule is able to deliver correctly sirolimus to the vessel wall and to keep it there for at least one month. This is the timeline where we want the drug to interrupt the restenotic process.
Key Findings
The key findings are very reassuring in terms of safety and efficacy. We have found the primary endpoint of TLR in 6% of the population with a high variability between in-stent restenosis patients and de novo lesions. Like for PCB, Paclitaxel-coated balloons in-stent restenosis has a higher TLR. Whereas de novo lessions has a very low TLR of 2%. The other endpoints like MACE and bleedings are very low and we are optimistic on the results of this study.
Safety Signals
We have observed no safety signals in terms of bleeding as I was mentioning before, the bleeding rate was very low even because with the DCB technology you may have a very low duration of dual antiplatelet therapy and we have had no thrombotic problems no thrombotic occlusions in our population.
Take-Home Messages
The key take-home message for the clinician regarding EASTBOURNE registry is that, the Sirolimus-coated balloon, this type of Sirolimus-coated balloon is already here showing a very good safety and efficacy profile. So we may want to use these in a real world population. Like the one that has been a role in EASTBOURNE. This is a real world population a lot of calcified lesions, very long lesions. So we can be safe to use this device in this setting.
Next Steps
The next steps are already here because we are running two randomised clinical trials. TRANSFORM I is evaluating this device versus Paclitaxel-coated balloon and TRANSFORM II study is another randomised clinical trial international, which is comparing Magic Touch versus Xience in multivessel diseases. So in the next two years we will have more data on this device.
EuroPCR 2022: Late-breaking Science Video Collection
Published: 13 May 2022
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Overview
Our regular review series View from the Thoraxcenter hosted by Prof Nicolas Van Mieghem and Dr Joost Daemen (Thoraxcentre, Erasmus MC, Rotterdam, NL) provide a concise analysis of the late-breaking science trials and spotlight questions that could change treatment strategies in interventional cardiology.
Short, accessible Expert Interviews will be available with select faculty focusing on the results, applicability, and impact on future research.
More from this programme
Part 1
View from the Thoraxcenter
In this concise episode of View from the Thoraxcenter, Prof Nicolas Van Mieghem and Dr Joost Daemen (Thoraxcentre, Erasmus MC, Rotterdam, NL) offer their take on the most anticipated late-breaking science form EuroPCR 2022.
Part 2
Expert Interviews
Short, accessible Expert Interviews with select faculty focusing on the results, applicability, and impact on future research.
Faculty Biographies
Bernardo Cortese
Dr Bernardo Cortese is Consultant Interventional Cardiologist for coronary and structural heart disease at the Columbus Clinic in Milano, and the Vercelli Hospital in Italy. He is the CEO of the DCB Academy, and Director of Cardiology at Clinical San Carlo in Milano.
Transcript