Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)—The REPAIR Trial: An Interview With J. Ribamar Costa, Jr, MD, PhD

Dr Deepak L. Bhatt catches up with Dr J. Ribamar Costa about his Editor’s 2023 Top 10 article, “Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)—The REPAIR Trial.” Read the article here.

Transcript:

Dr Bhatt: Hello, I'm Dr. Deepak Bhatt, editor-in-chief of the Journal of Invasive Cardiology, and we're going to discuss a really interesting paper here about the Repair Trial. This made the list of the top 10 JIC articles last year for 2023, and I'm going to be interviewing Dr. Costa, who is the senior author of this paper and is an interventional cardiologist at the Dante Pazzanese Hospital. It's really a privilege to have you here.

Dr Costa: It's an honor for us to be here, Dr. Deepak, and I need to start by saying that I've been submitting and publishing papers in the Journal of Invasive Cardiology since I was a fellow, and now this is a great honor for me to have one of my PhD students having published a Top 10 paper in your journal. So, it was a great experience for me and for the institution I represent.

Dr Bhatt: Oh, that's terrific to hear. Thank you for saying that. Well, this was really interesting, I thought, the Repair Trial. Perhaps you can just tell our audience what led to the trial and what it found.

Dr Costa: Well, I can briefly describe what the trial is, the design —it's a mechanistic trial. It's about 60 patients, a bit more than 60 patients, divided in 3 groups. They were all not complex lesions treated, guided by OCT, and our idea was to have the first 20 patients followed with OCT with 3 months at baseline and repeated at 3 months. The second group, the second cohort of 20 patients: OCT at baseline and repeated at 2 months. And the last cohort of 20 patients: OCT at baseline and then repeated at 1 month. Our objective there was to show the healing process of the novel generation of drug-eluting stents. We wouldn’t, of course, for ethical questions submit the same patients to OCT analysis at 3 points, at 1, 2, and 3 months, so we divided into cohorts. They are not the same patients, they're the ones that did it at 1, 2, and 3 months. But they all did the baseline, and they did it at 1 month, 2, and 3 months. So, we can see not only the healing process but the impact of having imaging to guide the healing process because I think there are some insights that we can take from this trial about this.

Dr Bhatt: Yeah, I was really amazed to see how much strut coverage there was even just at 1 month.

Dr Costa: Yes, it's impressive. Just to let the audience know, the stent we used, it was a stent called Inspiron. It is a Brazilian stent, it's produced in Brazil, cobalt chromium, thin strut, 75 micrometers, a thin polymer, 4.5 micrometers of diameter with sirolimus, 80% released in 1 month and 100% released after 3 months. It's conventional, what we can call current generation drug-eluting stent, like the ones that we have available for our daily practice. And it's very interesting, the point you marked that at 1 month, barely 90% of the struts were covered. And most of the struts that were not covered, if we get in details about the OCT, are at the edges and are minimal, that were already there from the beginning. Because at the procedure, the baseline procedure, there was some incomplete opposition at the edges and probably those ones were late to heal. And that's why we probably didn't have more than 90% healed or covered, not healed, but covered at 1 month. We can never say healed with OCT, but at least we can say covered.

Dr Bhatt: No, that's terrific. And, of course, here you are really using OCT more for research purposes. What do you think the role of OCT is in general in interventional cardiology practice?

Dr Costa: It's a, I mean, imaging itself, not only OCT, but IVUS and OCT are fundamental if you want to have a fast-reading process. Because as this trial points very clearly, the more you expand and oppose the struts, the faster is the healing, or the coverage, process of the struts. So, if you do a good job at the beginning, the response will be soon. Even in the case where there were large malpositions—I don't know, it's a multicentric trial, I don't know the reasons the operators leave these large malpositions at the edges —but we can see that at 3 months most of the 97% are covered also, but if you do the job well in the beginning, at 1 month you have 90% of them covered. So, the way you implant the stent, the way you guide the implant, the more expanded, the more you oppose, the faster is the healing, the coverage response.

Dr Bhatt: No, that's terrific. And you did mention this is a Brazilian stent and you did mention a little bit about other drug-eluting stents. But do you think then these results that you've seen here can be extrapolated to other drug-eluting stents that are more commonly used on a global basis?

Dr Costa: I think if we follow the medicine basis, we have to say that we need to test everything, but it's common sense that it's the same material, it's cobalt chromium, the same polymer, PLLA, and sirolimus. So, I would say that I would be I'm very confident that the results are reproducible with the current generation of FDA approval, the stents that you have also in the US or the European, the C-Mark approved —actually, the Inspiron has C-Mark approval as well. So, it's approved in Europe. One good thing of this stent is that it's probably the only one that has the 58-mm extension. So, they have very long extension to cover long lesions. So, it's an interesting feature that for us, especially in developing countries, that we try to use the least as possible and of course avoid overlap in these kinds of things. It's a good feature to have 48- and 58-mm stents.

Dr Bhatt: Yeah, that seems like it could be really useful, even in the US. We've had longer stents introduced into the cath lab in the past couple years. Well, this has been a really interesting conversation. Any final points that you want to leave the audience with?

Dr Costa: First of all, to finalize again, I'd like to thank you and the editorial board for choosing us and reinforce the importance of using the novel generation stents, especially guiding by imaging, because even in pretty simple lesions, not complex lesions, because here you're not talking about CTOs, you're not talking about bifurcations. We have one-third of the population of acute coronary syndrome, which is also very interesting, and 42% of diabetics. But overall, if you have a good implantation, the good job at baseline, the results will come sooner than we imagined. And this is the support for this trial of a single therapy from the beginning or dual therapy for 1 month. I think they are kind of a rationale to support the clinical hypothesis of short, very, very short GAPT or only SAPT.

Dr Bhatt: Yeah, that's a great point. And in the next year, there's going to be even more information in terms of shorter durations of that, in some cases with adjunctive images. helping to guide those decisions. So, a really important study that you and your colleagues have done, congratulations on that. Really a pleasure getting a chance to chat with you about it.

Dr Costa: Thank you, it's an honor for us.