EuroPCR 2022: Late-breaking Science Video Collection

Published: 13 May 2022

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Full programme

Part 2 of 2

EuroPCR 22: EASTBOURNE Registry indicates Satefy of Sirolimus-Coated Balloon

Bernardo Cortese

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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.
19 sessions
EuroPCR 22: AQVA Study Shows Superiority in QFR-Based Virtual PCI Arm Watch now
EuroPCR 22: Patient-Level Pooled Analysis of Ultrasound RDN in radiance-HTN SOLO & Trio Watch now
EuroPCR 22: Optimize PRO Interim Analysis Finds New Technique is "Best-in-Class" Watch now
EuroPCR 22: MASTER-DAPT Sub-Analysis Shows Consistent Results in Complex PCI Patients Watch now
EuroPCR 22: CRUZ-HBR Indicates Use Of Supraflux™ Cruz Stent Is Favourable Watch now
EuroPCR 22: ASTRO-TAVI Shows Improved Neurological Outcomes With Neurointervention Watch now
EuroPCR 22: Short-Term Clinical Outcomes of ACURATE neo2™ Watch now
EuroPCR 22: DECISION QFR Shows Increased Practicability and Shorter Procedure Time for Revasc. Watch now
EuroPCR 22: SYNERGY™ Non-inferior to BioMatrix NeoFlex in OCT SORT-OUT VIII Watch now
EuroPCR 22: ROLEX Study Finds Promising Results in CAD Pts With the Resolute Onyx Watch now
EuroPCR 22: Balloon Vs Self-Expanding Valves in Valve-in-Valve TAVI Watch now
EuroPCR 22: MitraClip in Atrial Functional Mitral Regurgitation Watch now
EuroPCR 22: SCB with Micro-Reservoir Technology in Coronary Lesions Watch now
EuroPCR 22: FORWARD PRO Study Shows No Durability Issues After 3 Years Watch now
EuroPCR 22: DEB & DES in the Treatment of Diffuse CAD Watch now
EuroPCR 22: EASTBOURNE Registry indicates Satefy of Sirolimus-Coated Balloon Watch now
EuroPCR 22: JenaValve TAVR System for the Treatment of Aortic Regurgitation Watch now
EuroPCR 22: Transcatheter Tricuspid Valve Repair with PASCAL System Watch now
EuroPCR 2022: ALIGN-EFS Finds 100% Procedural Success Rate Using JenaValve Trilogy in Pts With AS Watch now

Faculty Biographies

Bernardo Cortese

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- 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.