Good morning, I'm Dr Michael Reardon. I'm a cardiac surgeon from the Houston Methodist Hospital and the National Surgical PI on the EVOLUT Low Risk trial. And in ACC 2025 we're going to present the five-year outcomes from this low-risk trial.

What is the reasoning behind the trial?

So, as way of background for the EVOLUT Low Risk trial, we all know that based on the low risk randomised trials, TAVR has become the dominant treatment for isolated aortic stenosis no matter what your risk level is. And we've presented this at the initial two years and three years, but I've committed to presenting it every year in a transparent way because in these low-risk patients, for the safety of our patients in the field, we know that we need to know the data on a very consistent basis. So this year we're going to present the five-year data on the low-risk trial to maintain that.

What was the study design and patient population?

So in this low-risk trial, we recruited patients that were at an estimated surgical risk of 3% or less based on SDS, frailty and heart team assessment. They, of course, also had to have an anatomy that was suitable for TAVR or for surgery with the valves chosen. We did allow revascularisation with PCI in the TAVR arm and coronary bypass in the surgical arm. We're going to follow these patients every year for 10 years.

What were the key findings?

The key findings at five years from this trial are that the primary endpoint of all-cause mortality, disabling stroke, remains similar to surgery at every time point across the trial.

If we look at the components of this: disabling stroke remains similar to surgery at every time point across the trial, all-cause mortality remains similar to surgery at every time point across the trial, non-cardiovascular mortality remains similar across the trial and cardiovascular mortality remains similar. But I would note that the delta in favour of EVOLUT, which was 1.1% at the initial two years, is now 2.1% at five years, which gives us confidence since this is related to the function of the valve.

There were no more reinterventions in the TAVR arm than the surgical arm, no more moderate or greater paravalvular leak the TAVR arm than the surgical arm and superior hemodynamics from EVOLUT at every time point tested. So we're really quite pleased that this shows EVOLUT to be a safe and effective treatment for aortic stenosis versus surgical valves at five years.

What are the take-home messages for practice?

At five years, the main take-home are that for populations similar to the ones tested, which was a mean age of 74 with 93% of the people being over 65, which is concurrent with our current US guidelines, the TAVR with EVOLUT remains a good alternative to surgical aortic valve replacement in patients at low surgical risk. We of course will follow this data every year to 10 years because longer-term data is very much needed in this age group.

What is the potential impact of these findings on future guidelines?

Well, I don't think that the five-year data is going to impact the guidelines because guidelines already approved TAVR for people that are between 65 and 85 based on the physiologic risk of surgery, the anatomical risk of TAVR and patient's preference. Under 65, it still says if you're going to live 20 years or more, you should still have surgery.

Concerning is that across the US we see many sites where almost half the people less than 65 with isolated or stenosis are getting TAVR, and this is really a data-free zone. So I don't think this will impact the guidelines, but I do think this will then tell the field that we need more data on younger patients.

What further research is required?

So although this data at five years is extremely encouraging for EVOLUT versus surgery in a population such as the one that's tested, we did not test bicuspid valves. That still needs to be tested and preferably in a randomised trial.

Very few people, less than 10% in both the randomised low risk trials, were less than 65. We need more data on even younger patients. And, of course, concomitant procedures weren't allowed. Concomitant transcatheter procedures need to be tested along with TAVR. So I think the future is bright for TAVR. I think the field will continue to expand.

We saw early TAVR for asymptomatic patients. I think that that will help change the guidelines eventually. And we're starting to see moderate AS with symptoms as a focus of treatment. So this trial, combined with other trials that we're running, I do think over time will change and expand our guidelines.