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CRT 23: Coronary Dissections After Sirolimus-Coated Balloon Angioplasty: Sub-Analysis of The EASTBOURNE Trial

Published: 17 Mar 2023

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CRT 23 - In this short interview, we are joined by Dr Bernardo Cortese (Fondazione Ricerca e Innovazione Cardiovascolare, IT, DCB Academy, IT, Cardio Parc, FR) to outline the findings from a prespecified sub-analysis of the EASTBOURNE study. In this trial, investigators aimed to evaluate the performance of a sirolimus-coated balloon to treat coronary lesions. This sub-analysis collected and analysed 73 patients where 2/3 of their lesions were type A and 1/3 were type B.

Questions:

1. What is the background of this study?
2. What are the specifications of this sub-analysis of the EASTBOURNE study?
3. What was the patient population and study design?
4. What are the key findings?
5. What should be the impact of these findings on clinical practice and future research?
6. What are the next steps?

Recorded remotely from Milan, 2023.

Editor: Jordan Rance

Videography: Oliver Miles and Dan Brent

Transcript

"- Welcome everybody, I am Bernardo Cortese, an interventional cardiologist from Milano for Fondazione Ricerca e Innovazione Cardiovascolare and DCB Academy and Cardio Parc, Lyon, France.

What is the background of this trial?

The background of study of EASTBOURNE dissection sub-study is very important from a technical point of view. We're talking about the sub-analysis of the largest study ever done on drug coated balloons addressing the safety and the efficacy of a sirolimus-coated balloon in a broad clinical and lesion type syndications for coronary artery disease.

What is the patient population and study design?

So EASTBOURNE is a large study with more than 2000 patients enrolled, 2123 so far. EASTBOURNE dissection wanted to address the point of is leaving a dissection after sirolimus-coated balloon safe or not? Because we have this information from paclitaxel-coated balloons we have several studies showing how it is safe to leave a dissection after PCB, which is paclitaxel-coated balloon, but we don't have any information regarding its safety and efficacy after sirolimus-coated balloon. So, EASTBOURNE dissection wanted to go through this item. So we collected all of the dissections type A, B and C left after sirolimus-coated balloon angioplasty in the registry. And we collected a number of 73 patients where roughly two thirds of the lesions the dissection left were type A and one third type B with only few type C dissections. You know, if you have a large type C dissection, usually you have to implant a drug or stent because there is a risk of vessel occlusion. What we wanted to show here is the safety of type A and B dissections left.

What are the key findings?

The study is a prospective single arm registry with a newcomer population. This is an international multi-center study. 38 centres did participate to it and as I said, 2,123 patients and 2,440 lesions have been put into the database. We have a CT which adjudicated all of the events and we have a quite strict control of all of the data and information which have been put into the ECRF. The key finding is quite reassuring because we analysed and we compared the outcome at one year of all of the patients left with a dissection to the, not the vessel disease subgroup of the, of the study. You know roughly 55% of all of the patients which have been enrolled into to EASTBOURNE were de novo lesions. So we compare these patients with a patients left with a dissection and what we found at one year follow-up is that there was no differences in terms of safety and efficacy measures of outcome, meaning MACE, TLR, bleedings and so on. This is a quite reassuring finding because it safe to leave a dissection also after sirolimus-coated balloon. And importantly we had zero cases of myocardial infarction in the dissections cohort of patients. So, it's totally safe to leave a dissection after a sirolimus-coated balloon. This is the main finding of the study.

What is the impact of these findings, and what are the next steps?

The impact on everyday practice is quite high. This is not, I would say a meta-analysis or something some quite strange statistical exercise. This is that our findings are something that do really impact on the clinical practice for our patients. So I mean we can, we can, we can be safe. This type of dissection, which will lead for sure to a reduction in the over stenting rate after sirolimus-coated balloon angioplasty. So, if you have a fast flow and the dissection doesn't pave your coronary artery this is the main clinical and technical message that arise from EASTBOURNE dissection. And then which are the next steps you're asking? Yeah, we'll have more informations with a mechanistic study which is transform one. This study has enrolled and randomised patients to a sirolimus versus paclitaxel-coated balloon and all of these patients underwent angiographic follow up. We have an OCT analysis in these patients and for sure this information which will become available by EuroPCR this year it has been accepted as a late breaking trial. We'll have a lot more information about this study.

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