February 1, 2023

Mirvat Al Asnag interviews Anna Sonia Petronio (Pisa, Italy) on the results of POPULAR TAVI which showed that in patients not taking oral anticoagulation, aspirin alone compared with aspirin plus clopidogrel following TAVI significantly reduced bleeding rates and did not increase thromboembolic events.

So good afternoon everybody at pcr online um i have with me uh professor anna sonya petronia uh she is an expert uh interventional cardiologist and she will give us her take on the popular tavi trial that was recently presented at the esc congress uh good afternoon professor good afternoon to you so if we can take a little bit of your time to discuss um what are

The differences between the cohort a and the cohort b of the popular tavi well the first the cohort b was published a few months ago and it was the treating patient considering patients that needed a therapy with anticoagulation and the trial wanted to compare the oral anticoagulation against the oral anticoagulation plastering and they were able to demonstrate

That the oral anticoagulation has a less significative readings and has all let’s say non-inferiority and superiority for the end points of the trial for the cohort a it was a similar comparison in the way that it was standard to simplify the therapy and this time in patients that didn’t need anticoagulation and it was comparing the simple antiplatelet drug

With aspirin this single one against the dual antiplatin therapy that was aspirin plus lopidogram the primary endpoints were similar of course to the cohort b and was all bleeding and non-procedural readings while the secondary endpoints were were i say a compositive endpoint of death of myocardial infarction and post procedural bleedings and the second secondary

Endpoint was instead all the ischemic uh complication and that was of course my calculation was ischemic stroke and death now this cohort showed the same significance positive significance as with cohort b for the single anticoagulant so the single antiplatter therapy had high significative reduction in needing for what concerns the secondary end points we saw

A superiority of the composite end point where non-procedural bleeding were considered but instead there were it reached only the non-inferiority with the ischemic events meaning that as spirit as dual and raspberry doesn’t um have more or less incidents they had the same number of events in some way together with the coho uh it uh centrifies the therapy of

Tavi in some way and it’s very nice to see that now we have in some way for uh let us say the seventy percent eighty percent of patients we have now a simple and controlled therapy to do the problem is that while we will go forwards in our experience as we are now probably this therapy will not fit all absolutely so one of the questions that kept coming up during

The esd congress was about the subclinical leaflet thrombosis which is often diagnosed with imaging and there was no imaging as part of this trial design so do you think we are in need of a randomized trial that looks at an abbreviated antiplatelet horse or single antiplatelet horse in tabor with imaging to detect leaflet thrombosis well certainly this kind

Of trial didn’t answer this question the contrary galileo did because galileo had a sub study done on purpose for this this investigation while popular tabby didn’t uh expect some four dimensional uh ct’s forced procedural i think that we need both things in some way we still need to really understand how much is the impact of the thickening of leaflets with

The real clinical event of patients this is one point then of course we can expect to investigate what the single antiplatelet does but uh certainly what galileo told us is that if people have not only one degree thickness but the increase of gradient in the valve than anticoagulation needs to be done because it’s at least from now it’s the only therapy that

Is able to uh reduce the gradient and in some way cancel the effect of those so as you mentioned uh just a few moments ago um there are some patients that may for example about up to 20 of them may develop new atrial fibrillation down the line uh young patients may develop coronary disease requiring pci down the line so you know are we going to be seeing more

Crossovers and more patients requiring more than a single antiplatelet and do you expect more of this kind of a crossover down the line well this is a good question because as i said at the beginning you know we with this trial i think that we are able to cover the 70 percent because of course i think all the centers that perform tavi have at least 50 percent

Of patient and really would need only a single uh therapy antiplatelet because they are simple patients and the more we will increase younger and lower space and the more we will have this kind of patient but we already saw in the population that we had around 20 25 of patients shifting or really not really shifting because we don’t know how the end they were

Treated if they were treated with that circulation only or if anticoagulation was added to the single uh antiplatelet drug so this is one point and probably to these people which another population because getting treating younger patients we will perform more pci in these patients because we will won’t leave uh other you know stenosis as we do in 85 years old

Patients so probably we will i as i told you we would still have to uh adjust our therapy for at least a thirty percent and just a short question here i know there are a lot of discussions ongoing about what appropriate regimen for valve and valve or even if the trials panned out for bicuspid do you think single antiplatelet in your opinion would suffice well

Again here we really don’t know we know that these uh kind of uh of cavis are more complicated and have left uh more uh bulky uh t still around the valve we’ve got the old surgical valve that is there we’ve got a lot of heavy calcified um costs around and certainly the flow is not laminar the risk of promoting it is higher so those could be again a little bit

Of a piece of cake that is the best out of this kind of therapy but nothing has been proven until now about that it is only an empiric uh uh judgment and currently in the market we have several different platforms that translate to heart valves so do you think for low bleeding risk patients we can apply this um you know single anti-platelet regimen for any valve

Whether it’s self-expanding or balloon expandable or is this not answered really by popular tavi well the trial with popular covey was done with more than one kind of valve the uh the main population was treated with both balloon and set expandable with the new generation so i had to say that in some way nobody told us that there was a difference at least

This has not been analyzed and the patient wore a mixture of these valves that are the ones that are more used in the world well and finally when we look at this population population that end up with tabby we know that they also are leading risk and for coronary interventions we calculate that he has blood score or bleeding score for these patients um so do

You think the same conclusion can imply um if we’re talking about different antiplatelets so if we’re not talking about aspirin alone if we’re talking about clopidogrel alone for example um do you think this can be generalized to all antiplatelets um as well well let’s say that aspirin is the one that has been more tested and is the one that has been more used

Because sometimes patients need aspirin for other reasons like several um vascular problems carotid peripheral artery disease so i would say that the aspirin is the one that at the end is more used and more tried it is not not something that we we are not allowed to say that could be the world would not work but has not been tested as much thank you very much for

Your time is there anything else you’d like um well anything i i think it is a very uh well um well thought out and well investigated trial and it was a spontaneous fire and this is another advantage of these trials so i would say that the investigator did a very good work and it will help us certainly at least for the next year we have something uh with which

We can challenge and end this house thank you very much thanks to you you

Transcribed from video
POPULAR TAVI: Aspirin with or without clopidogrel after TAVI – ESC Congress 2020 By PCR