Cerebrovascular Accident Clinical Trial
Official title:
Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence
and independent predictors of reduced leaflet motion and valve thrombosis after TAVI
procedure using multimodality imaging strategy comprising cardiac CT, transesophageal
echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will
assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced
leaflet motion and/or thrombosis when compared with those with normal leaflet function. In
addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to
single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.
The primary outcome of the nested randomized trial will be the presence of reduced leaflet
motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of
ischemic changes in brain demonstrated by MRI.
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic
stenosis in patients non-eligible for surgical aortic valve replacement. Prosthetic valve
thrombosis is defined as a thrombus that is attached to any part of the prosthesis, and is
not caused by infection. This may result in valve dysfunction and/or thromboembolisation.
Most patients with prosthetic valve thrombosis are asymptomatic, whereas some patients
present with stroke or transient ischemic attack (TIA). Obstructive prosthetic valve
thrombosis may lead to overt congestive heart failure.
Currently, there is no strict guideline recommendation regarding therapeutic anticoagulation
after TAVI. Per institutional protocol dual antiplatelet therapy is used during the first 6
months after THV implantation and single antiplatelet therapy is used after after 6 months.
Diagnosing transcatheter heart valve (THV) thrombosis is of clinical importance even in
asymptomatic patients, because it may lead to thromboembolism and can cause THV dysfunction.
Therefore, early diagnosis and treatment may prevent future TIA or stroke and THV
dysfunction. Current standard clinical practice and guidelines are inconsistent regarding
the antithrombotic treatment of patients who underwent TAVI procedure. Accordingly,
determining the true incidence and potential causative factors of THV thrombosis is of great
importance and would facilitate further investigations and large clinical trials in order to
develop optimal antithrombotic treatment of patients following TAVI procedure.
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence
and independent predictors of reduced leaflet motion and valve thrombosis after TAVI
procedure using multimodality imaging strategy comprising cardiac CT, transesophageal
echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will
assess the incidence of stroke and TIA in those with reduced leaflet motion and thrombosis
when compared with those with normal leaflet function. In addition we will randomise
patients with reduced leaflet motion to unchanged standard therapy versus single
antiplatelet plus oral anticoagulation therapy. The primary outcome of this nested
randomized trial will be the presence of novel ischemic lesions in brain demonstrated by
MRI.
Findings of the RETORIC study may alter current post-TAVI diagnostic work up and treatment
algorithm regarding anticoagulant and antiplatelet therapies.
In total 200 patients who underwent or are undergoing TAVI procedure will be included into
the RETORIC study. The institutional standard of care post-TAVI antithrombotic medication
consists of six months dual antiplatelet treatment with clopidogrel and aspirin followed by
lifelong aspirin therapy.
Currently, the TAVI procedure number at our institution is approximately 80 patients/year.
Therefore, to reach our enrolment goal of 200 patients, subjects will be enrolled from two
cohorts.
Cohort A: Patients who underwent TAVI procedure in the past will be selected from the
Semmelweis TAVI Registry. For this cohort a median TAVI-to-CT time will be calculated.
Cohort B: Patients undergoing TAVI procedure will be enrolled consecutively. In this group
the imaging will be performed 3 months after the prosthesis implantation in every patient.
Four-dimensional cardiac CT, TTE and brain MRI data will be obtained in all patients. In
case the cardiac CT identifies reduced leaflet motion or THV thrombosis TEE exam will be
performed even in asymptomatic patients and patients will enter the randomized control
trial. Patients will be randomized into two groups:
Group 1, standard therapy plus oral anticoagulant therapy; Group 2, standard therapy. After
4 months patients will undergo four-dimensional cardiac CT, TTE and brain MRI.
The primary outcome of the randomized trial will be the presence of reduced leaflet
motion/valve thrombosis, secondary outcome will be the presence of ischemic lesions on brain
MRI images.
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