"Well, hello everybody, from Paris, France, and another edition of EuroPCR 2024.
You know, there were some very interesting clinical trials that were presented here.

IRONMAN 2 Study

One of the ones that really is thinking outside the box, and I thought was very interesting was the IRONMAN 2 study, which was an ultra-thin scaffold that really used iron as the basis for it. And they reported the twelve-month outcomes, which was very promising in terms of target lesion failure. Now, obviously, we're going to need to see a little more outcome data and look at the durability, but it was actually non-inferior to the standard of care, which is now drug eluting stents.

DESyne BDS Plus Trial

Still talking about thinking outside the box, there was the DESyne BDS Plus trial that looked at targeted and very focal delivery of anticoagulants and antiplatelets. They did involve patients with acute coronary syndromes. The trial results were very promising. Again, they were just looking at safety endpoints here. But it would be very interesting if they can enrol a larger number of patients in longer follow-up, in particular to address patients with high thrombus burden and those with acute coronary syndrome. At this point in time, the majority were chronic coronary syndromes.

NOTION-2 Trial

And just shifting gear to the structural space, the NOTION-2 trial was presented. The NOTION-2 trial really for the first time looked at young patients who had severe asymptomatic aortic stenosis and had received transcatheter aortic valve or surgical aortic valve, and they looked at the results in comparators. It was very equivocal. The outcomes, I don't think they will be changing practice at this time. I would caution from being overzealous about using TAVR in young patients, because the rate of paravalvular leaks in pacemakers was still slightly higher compared with the patients who had surgical aortic valve replacement.

Myval Landmark Trial

More exciting news actually came from Myval in terms of the structural space. The LANDMARK trial was presented by Patrick Serruys, who actually reported the BARC 330 day safety endpoints for this balloon expandable valve. And they looked at the comparator, Washington, the Evolut self-expanding and the Sapien balloon expandable valves, where this met the non-inferiority in terms of safety, as I mentioned, at 30 days. We just need to take that with a pinch of salt, because it is 30 days at the end of the day, it doesn't really tell you a lot about efficacy. We are unable to do head-to-head comparisons with different platforms because they were really bundled into one. Interestingly, they did report an Ero that was better than the Sapien balloon expandable valve, but it was actually comparable to the Evolut self-expanding valve. I think we're going to need to dive into that a little bit more, look at the valve sizes and so on. But perhaps it's not necessarily the valve structure, but really looking at the range of sizes that were available and the oversizing that was done during deployment.

PINNACLE Trial

I think some of the other technologies that are worthwhile looking at that are beyond heart valves and beyond stents was actually looking at technologies such as the PINNACLE trial that looked at a novel lithotripsy technique. It was just, again, a safety endpoint. 60 patients that were enrolled and looked at 30 days safety endpoints, they were able to show feasibility that a range of calcified lesions were treated, including nodules and deep calcium. There was an OCT sub-study that actually confirmed lumen gain and fractures that subsequently permitted adequate stent deployment. I think these are early phase trials and it's important again to get larger series and longer-term follow up to look at major adverse cardiovascular events.

Conclusion

So thank you for joining me and hope that was just a bite-sized coverage of the late-breakers presented at EuroPCR this year.”