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Author Interview

Editor's 2024 Top 10: Comparison of Angiographic Result and Long-Term Outcome in Patients With In-Stent Restenosis Treated With Cutting Balloon or With Scoring Balloon Angioplasty


Dr Deepak L. Bhatt catches up with Dr Juergen Leick about his Editor’s 2024 Top 10 article, “Comparison of Angiographic Result and Long-Term Outcome in Patients With In-Stent Restenosis Treated With Cutting Balloon or With Scoring Balloon Angioplasty.” 

 


Transcript:

Dr Bhatt: Welcome everyone, I'm Dr. Deepak Bhatt, Editor-in-Chief of the Journal of Invasive Cardiology, and we are highlighting the top 10 articles from 2024.

I'm fortunate today to have with me Dr Juergen Leick, who is the head of the Cath Lab at Heart Centre Trier in Trier, Germany. And he and his colleagues have put together a really interesting paper looking at cutting balloons and scoring balloons and how they might compare. Not a lot of randomized data, unfortunately, on this topic, but fortunately, he and his group put together some observational data. So, maybe we can just start with why you did the study and what it was about.

Dr Leick: Thanks a lot for the introduction and I'm happy to present our study here. So, a couple of years ago, we were investigating intravascular lithotripsy compared to modified balloon angioplasty. And when we did this study, we were wondering that there is no randomized data and also no observational data investigating the effectiveness of a modified balloon, especially cutting balloon against the scoring balloon. And these balloon types are often mentioned together as a modified balloon. And that was the intention to create this study; it's an analysis of the patients which were prospectively included in our study. But it is a non-randomized study, it's an observational study. 

Dr Bhatt: Of course, you looked at patients with calcified in-stent restenosis and those who happened to get cutting balloon or scoring balloon treatment as part of that. And what was it then you found?

Dr Leick: We observed that we had no differences in the baseline characteristics in our cohorts and that these 2 groups were comparable to each other, so we did not have to do a propensity score matching or an inverse probability treatment weighting analysis. And we observed that the patients in the cutting balloon group, that the angiographic results was the primary endpoint, and it was defined as a residual stenosis less than 20%. And we observed that numerous patients in the cutting balloon group received this primary endpoint less often compared to the scoring balloon. But when we looked at the multivariate regression analysis, we could identify that other factors, not the intervention group, that other factors such as the grade of calcification as well as the time interval between the initial procedure and from the first stent implantation to the now-done procedure, that these were predictors of the angiographic results.

Dr Bhatt: There were some differences in baseline characteristics, weren't there, in terms of the cutting balloon group having a bit more severely calcified lesions and multiple stent layers?

Dr Leick: Yeah, that's true, but the baseline characteristics, these differences were in the lesion characteristics, the baseline characteristics were the same. The lesion characteristics could also be ruled out in the regression analysis and that these have an effect on the angiographic result. That was also the main reason why we did further regression analysis to exclude that these factors have a result or an influence on the primary endpoint.

Dr Bhatt: Perfect. So, what are the clinical implications of your findings?

Dr Leick: So, the clinical implication is that we are convinced that both balloon types are really effective and that they are really safe and that both are equal in terms of angiographic results and the effectiveness, as well as safety, and that both balloon types can be used for in-stent restenosis. However, guideline recommendations do not clearly choose one or the other balloon so you can choose the one you want or do you like.

Dr Bhatt: Yeah, no, that's useful because then really it's up to the operator based on their preference, based on what's available in their Cath lab, based on cost perhaps though, really useful information. Related, let me ask in your study, what was the use of intravascular imaging and what would your recommendations be in these sorts of lesions?

Dr Leick: I think that’s the major limitation of our study, that our rate of intravascular imaging was 10% to 12% and in in-stent restenosis, we improved the rate after this study in our Cath lab, and I think that in approximately all in-stent restenosis, intravascular imaging is mandatory to understand why the in-stent restenosis occurs in the patient. And nevertheless, when we look at meta-analysis, that worldwide, the intravascular imaging rate is 4%. And so, in our study, it's a little bit more than 4%, but we could not do a meaningful analysis here due to the small number of patients with intravascular imaging. But it's highly recommended to do this in approximately all patients with in-stent restenosis or complex PCI.

Dr Bhatt: Yeah, I agree. I mean, unless it can't be done for some technical or logistic reason. I think it's a good idea and can provide useful adjunctive information that may then determine exactly what interventional approach is used. Speaking of interventional approaches for these sorts of lesions, highly calcified in-stent restenosis type lesions, what would you recommend? You've shown here in your study that scoring balloon, cutting balloon perform pretty similarly, but what do you think is the next best step? Is it drug-eluting stent implantation? Is it drug-coated balloon these days? Is it just be happy with the high-pressure balloon inflation and image and if it looks good? And if the initial issue was just lack of stent expansion to just be happy and stop there, what do you recommend?

Dr Leick: So, I think it depends on the location of the lesion. In my personal point of view, and also it depends on the time between the first stent implantation and the now-done procedure, and I think, my personal point of view is when I'm working or do a reintervention in a bifurcation, I try to fix this with a drug-coated balloon instead of a new drug-eluting stent to keep the side branch open. But I don't know how it is in the United States of America, so, in Germany, there's not that much discrepancy between the costs of DES or a DCB, but I think in the United States, it's a little bit more than in Germany.

Dr Bhatt: Oh yeah, right now to use a drug-coated balloon in the coronary arteries is quite expensive and not really well reimbursed and that has greatly limited uptick in the US.

Dr Bhatt: Any final comments that you want to make for our audience?

Dr Leick: So, I think that when we are looking at in-stent restenosis, approximately 10% of all coronary interventions are due to an in-stent restenosis. But when we are looking at all the data or the randomized trials and all trials together, this population is understudied. So, we need more studies investigating the treatment options in these patients to create a clear recommendation that can be used for the guidelines. But when we look at the guidelines, there are no clear recommendations for which plaque modification technique we use or which device after the modification we have to use. So, we have to address the in-stent restenosis in our research.

Dr Bhatt: Well, thank you for this great article. Congratulations on making the top 10 articles of last year in the Journal of Invasive Cardiology. I think it's really a very clinically actionable-type article where there was a data gap. So, thanks for your work and your contribution to the journal.

Dr Leick: Yeah, thank you very much.

Dr Bhatt: All the best.

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