Transcript

And now we're going to ask Jacques if with the HT Supreme stent, we can further reduce the duration of dual antiplatelet therapy. Thank you, Hakeem. So I'm going to talk to you about the HT Supreme, a stent that's a bit confidential at the moment. There's nothing very original about the metallic stent platform itself. It's an 80 Micron cobalt chromium platform with an illusion of sirolimus drug from a dual layer based on a biodegradable polymer coating. But but this dual layer is really unique. It is this dual layer that renders this new drug eluting stent very original versus existing products. This French innovation borrows from a breakthrough in the field of polymer science. This innovation involves a new and specific dual polymeric stack in which each polymer layer has a very specific role to play. Of these two layers of polymer, the first one is obtained by Electro grafting. I won't go into the technical aspects of Electro grafting as I'm not qualified to do so, but this. Original process uses an electric current to create a polymer brush 150 nanometer thick that is covalently bound to the surface and then which will act as a Velcro fastener enabling the attachment of the second layer are biodegradable polymer on which will be embedded the sirolimus molecule. The huge differentiation is that the biodegradable matrix has been tailored to release sirolimus extremely early and that's what's important because what we want to do is inhibit. Smooth muscle cell proliferation that provokes restenosis. And so we're going to inhibit smooth muscle cells very early on because this is currently the platform that enables us to achieve the earliest release. On the other hand, we're also going to put a time limit on the release of the sirolimus because this sirolimus drug is also toxic at some point because it prevents the desirable proliferation and migration of endothelial cells and full recovery. By endothelial cells drives the healing of the artery. So we're going to have a double beneficial effect with a polymer that will then resolve very rapidly in less than 60 days. So in summary, short release of sirolimus hit SMC proliferation and then disappear rapidly to promote healing. This will enable us to consider a reduction in dual therapy for these patients. As Claremont said, this is one of the alternatives, the less time we spend on dual antiplatelet. Therapy, the better patients will do with fewer bleeding side effects. So do we have any scientific proofs of the benefits of this technology? Yes, with two major studies already completed and growing the Pioneer 3 pivotal study which compared this device with Everolimus and Stantec Science. Pioneer 4 innovates by using DAPT for one month only for all COMMA patients switching to all COMMA P2Y12 monotherapy. Afterwards, we leave these patients on antiplatelet aggregation monotherapy with ticagrelor. In fact, when you take a global look at these two studies based on HT Supreme, the patients have statistically benefited from the implantation of this very stent. The Pioneer Three study showed excellent results at five years when compared with the Xience stent. But what's much more interesting which was presented at the ESC. In Madrid this year is the bleeding rate. We have very little bleeding, which is extremely reassuring. But above all, we have very little Mace. And when we compare an attitude with monotherapy and an attitude with dual therapy, we can see that monotherapy actually does better in terms of Mace. So the effect is indeed very encouraging. So we haven't yet reached the threshold of superiority, but that's probably because we're still missing patients. From Pioneer four who haven't yet been included in this subgroup analysis. Above all, there's still a lot to come behind the HT Supreme and this concept of dual layer based on Electro grafting with CD31 on the second generation, we can likely restrict thrombo inflammation and notably lower thrombosis risk. Above all, we may be able to avoid revascularize using these patients with long term aspirin. In other words, we'll give them a shot of aspirin to start with, and then no more aspirin. We'll just leave them on antiplatelet monotherapy with a P2Y12 inhibitor. That's what I wanted to tell you about this stent, which also has a structure that adapts perfectly to complex lesions. Opening the mesh is a simple task, and the level of safety provides is excellent. Thank you very much. Thank you very much, Chuck. We'll now move on to randomized and registry data. We're fortunate to have Shields with us to enlighten us. Hello everyone. Thank you for having me. I'm delighted to be here discussing technology. So as you can see, in fact the CEA in Grenoble and alcohol medics developed the particular structure at the technological level, which is now distributed by Sino Med. And so we saw all these little particularities, the Electro grafted layer. In fact we also saw that the monolayer that remains after a very rapid release, the endothelial cells in fact on the test bench go much faster. And on the bear stands, which were normally without Electro grafting, yeah, bare stents that were normally drug free. So it's very interesting, something that has been observed. So I have to ask you, do all these technological peculiarities have any repercussions on our practice? Well, actually there's a program, a big program as we've seen, of development. And as you know, our technologies and advances have to be found through clinical studies. This has been the case with the various studies we're going to see, which will quickly go through and then we'll get to the hard register. So the first study is a fairly simple one. It uses Oct technology to see the recovery rate in relation to the sciences. And in the end, if I show you the 16 patients, as you can see it was really proof of concept and we can see that in fact the speed of recovery which we had seen on endothelial cells is found on real humans with Oct technologies. Secondly, we compared ourselves to the best stand on the market, oxygens with a comparative study with a normal. Endpoint, IE cardiovascular death, nonfatal infarction and emergency revascularization. And we can see that there is no difference with the conventional biante alization at the time of the study at 5 years as I showed you there was no difference. We have a non inferiority which is continued at five years with analysis. So we're on the safe side compared with the best and with that instinct that you know very, very well. And then there's Pioneer 4 which is really interesting, Pioneer four since here we come up with the theory of saying. Well, well, we're going to do a short aggregation with one month aspirin P2Y12 and leave the P2Y12. You know that some people are going to push this as we said earlier that finally there was this strategy that was possible. Some believe in it more than others and that's what this study is all about endpoint in non inferiority for always the same and something of analysis on our first analysis with the heart beating score score which predicts the risk of thrombosis. And the risk of bleeding depending on patient characteristics. This analysis of people already included shows that in the end, the thrombosis rate cannot be predicted, IE it is much lower. It is not at all related to the thrombosis score, IE there is an effect. There's something that takes them out of the usual event. So very interesting signal and hemorrhages, we can predict them. On the other hand, there are fewer than usual. So that's very interesting. Of course, I've included the Pioneer Four study. Why was there an interim study presented by Mr. Sirois at the ESC? Because it was the Europe and Japan. Favor alert. In the end they stopped the study. We stopped to see if there was any danger to QFR. There was none. We're continuing and we'll have the final results. And so we were asked to work on the high bleeding risks. That's what we did. We've designed a single arm study on a registry to identify high risk patients. And so on Monday we started at our center. We put up signs everywhere. You know you have the ark bleeding risk gap. Finally, the app when you're in the Cath lab. Doesn't work at all. I can tell you that. Put up signs everywhere with what the minor risks are. You need 2 minor risks who you're at high risk of bleeding. So a 75 year old patient with an onset of less than 60mm milliliters per minute is at high risk. So you find them fairly quickly. And these are patients who have events in the studies. We follow them for a year. We took the master adaptive composite criterion to be on the cutting edge of randomized studies to have an event rate which occurrences of ischemic. And hemorrhagic events. So we're going to include 1200 patients and we've calculated non inferiority, non inferiority and above all superiority. So it's not a study with comparable arms, but we'll still have thrombosis rates and so on. And hopefully we anticipate we may witness it happening a very abnormally low rate of thrombosis on bleeding complications compared with patients at risk of bleeding. That's our risk. Will conduct the study and update you appreciation to all the centers that agreed to be part of it. Thank you. Thank you very much for this very fine presentation and I'll leave it to Jacques to conclude this three-part session. Hemodynamics for the most complex plastic issues, pharmacology to try and reduce the risk of bleeding and ischemia in patients undergoing surgery. And lastly, how we can use strategies, molecules and stents we can further improve the risk of bleeding. And exposed patients. Jacques, I'd just like to thank everyone. It's been a bit of an uphill battle against the clock. Claire, I'm sorry, she's in the control room. We were only 9 minutes, 44 minutes late, but we left 5 minutes late. So I think we made it. And we hope to stay on top of the podium. Thanks to all of you. The Congress isn't over yet. There's a buzz at 2:00 PM. There's another studio coming up soon. And above all, there's a final live report from Marseille on a live coroner in a patient at risk of bleeding. So let's talk about it again. Thank you all very much.