My name is Duk-Woo Park, DW Park,
from the Asan Medical Centre.
So I'm going to very happy to discuss our ADAPT-TAVR trial,
will be presented at ACC 2022, late-breaking clinical trial.
Yes, so, and our ADAPT-TAVR trial
has a very important study hypothesis.
You know, on the basis of current available data
and the subclinical leaflet thrombosis after TAVR
is a really issue in daily TAVR practise.
So what is known, what is unknown?
Usually we know the leaflet thrombosis,
and that if you're going to use the oral anticoagulation
rather than the antiplatelet therapy,
and the significantly reduced overall instance
of leaflet thrombosis.
However, we don't know real the causal relationship
of leaflet thrombosis and the cerebral thromboembolism.
Also, we don't know in that if you're going to use
the oral anticoagulation rather than antiplatelet therapy,
the OAC can reduce the leaflet thrombosis
associate the cerebral thromboembolism or stroke or TIA.
Our study is just targeting
the TAVR recipient
and the patient who underwent successful TAVR procedure,
also without any clinical indication
for long-term use of oral anticoagulation,
such as HR fibrillation.
So, and we include 220 patient.
In the randomization, one arm is Edoxaban,
60 or 30 milligramme once daily,
versus the other arm is dual antiplatelet therapy,
aspirin plus clopidogrel.
When we enroll the patient at the time,
the aspirin plus clopidogrel
was default the recommendation strategy.
So our trial include nearly 220 patient,
and we defined the primary clinical endpoint
at six months a CT scan redefine the overall instance
of leaflet thrombosis between two group.
Also key secondary endpoint, we measure the serial MRI
at baseline and six months follow up.
Also, we measure the neurological
and the neurocognitive function test
at baseline and six months.
Also, we measured echocardiographic parameter
and any clinical event, bleeding,
or the ischemic event between two groups.
So our key result is very interesting,
and the primary endpoint of leaflet thrombosis
and the edoxaban group at six months
occurred 9.8%.
And the dual therapy group, DAPT group, occurred 18.4%.
ITT population P value was 0.076.
So we did not achieve the statistical significance.
And PP pop protocol analysis,
Edoxaban group leaflet thrombosis instance 9.1%
and DAPT group 19.1%.
And the P value was 0.047 in PP population.
We achieved the statistical significance.
The key secondary endpoint
and the reevaluated MRI, serial MRI finding,
and between two group the presence
of a new cerebral lesion on MRI
and occurred 25% in edoxaban group.
In DAPT group is 20.2% in DAPT group.
We didn't find any difference the new MRI lesion.
Also, we did not find any difference overall
number of total new lesion over volume of total new lesion,
although we achieved
some significant reduction
of over leaflet thrombosis with Edoxaban
rather than DAPT therapy,
and the leaflet new cerebral lesion on MRI,
absolutely no difference at all.
Also we measure the neurological and neurocognitive function
between two group, and the worsening of NHISS scale.
This is a conventional neurological endpoint.
Also worsening of modified Rankin scale
and worsening of a Montreal Cognitive Assessment,
absolutely no difference between two group.
Also another key finding, we did not find
any causal relationship, any significant association,
between the HALT and the leaflet thrombosis severity
and the new lesion on brain MRI,
we did not find any causal association.
Also, we did not find any association
in the leaflet thrombosis severity
and the neurological assessment outcome
like NHISS, modified Rankin scale,
and Montreal Cognitive dysfunction.
I think our trial has a very important clinical implication
in daily TAVR practise.
And first, leaflet thrombosis has not been proven
to affect clinical outcome for TAVR patient.
And therefore, this imaging phenomenon
should not dictate antithrombotic therapy
for its prevention after TAVR.
And second, the absence of evidence
of temporarily related adverse clinical sequelae
of imaging-detected subclinical leaflet thrombosis
absolutely does not support routine imaging screening tests
for detection of this phenomenon.
Also, imaging-guided antithrombotic strategy
in case without hemodynamic or clinical significance
should not be recommended.
Yeah, I think it's the take-home message.
You know, we found some class effect
if you're going to use the oral anticoagulation like edoxaban,
our previous study, rivaroxaban, also the ATLANTIS apixaban
shows the overall instance of leaflet thrombosis.
However, we did not find, although we achieve
the lower instance of leaflet thrombosis
with oral anticoagulation instead of antiplatelet therapy,
it does not associate any reduction
of the thromboembolism on MRI
and any change of neurocognitive dysfunction.
So our finding absolutely support, then,
the current guideline, updated guideline
in European guideline and US guideline,
and the patient without any indication
of the oral anticoagulation,
the single antiplatelet therapy,
or aspirin monotherapy should be the choice
of treatment at the TAVR procedure.