Aortic Valve Stenosis, Intracranial Embolism, Transcatheter Aortic Valve Replacement
Conditions
Brief summary
TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen. The study evaluates the effect of dual antiplatelet pretreatment on periinterventional embolic cerebral lesions and bleeding complications in patients undergoing transfemoral aortic valve implantation (TF-TAVI).
Detailed description
Patients undergoing TAVI bear a high risk of ischaemic stroke, which is an independent predictor of mortality1. Dual antiplatelet therapy (DAPT) is recommended by current guidelines without clear specifications on the time of initiation of treatment due to a lack of data. While some centers initiate DAPT with aspirin and clopidogrel prior to TAVI to reduce the rate of periinterventional embolic events, others start these medications after the procedure.Data on antithrombotic therapy during TAVI are scarce and no randomized evaluation has been performed to demonstrate what the best strategy is during the procedure. Therefore, the objective of this clinical trial is to assess the efficacy of pre- versus postoperative dual antiplatelet loading with Aspirin and Clopidogrel on volume of periinterventional cerebral ischemic lesions as quantified by diffusion weight MRI (DW-MRI) and neurocognitive function in patients undergoing transfemoral aortic valve replacement. The statistical trial design assumes superiority of preloading with DAPT regarding the primary endpoint.
Interventions
DRUGPreloading before TAVI
Preloading with Aspirin and Clopidogrel before TAVI
DRUGPostloading after TAVI
Postloading with Aspirin and Clopidogrel after TAVI
Sponsors
Prof. Dr. Jochen Fiebach, Center for Stroke Research Berlin (CSB), Charité - Universitaetsmedizin Berlin
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years and \<90 years * Patients undergoing TF-TAVI for severe aortic stenosis (combined with aortic regurgitation) * Informed consent
Exclusion criteria
* TIA/Stroke within last 90 days * Aortic valve-in-valve procedures * TAVI for treatment of isolated aortic regurgitation * known significant carotid stenosis (\>70%) * Prior myocardial infarction or revascularization with PCI or CABG within past 3 months * Clopidogrel and/ or Aspirin within past 7 days * any other indication for (dual) antiplatelet therapy * Contraindication to MRI (MRI conditional pacemakers accepted!) * participation in another interventional trial * cardiogenic shock (positive shock index OR need for catecholamine support OR systolic bloodpressure \< 90 mmHg) or need for pre-hospital intubation * cardiac arrest \<90 days prior to randomization * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total volume of new cerebral lesions on MRI after TAVI versus Baseline | Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| location of new cerebral lesions early AFTER TAVI | 24-72h after TAVI | To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan |
| extent of new cerebral lesions early AFTER TAVI | 24-72h after TAVI | To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan |
| Assessment of different neurocognitive tests before and after TAVI procedure | 24-72 h after TAVI | To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans |
| New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI | 24-72h post TAVI versus baseline | Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images). |
| localization of clinically apparent non-cerebral emboli after TAVI | 24-72 h after TAVI | To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...) |
| Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. | 24-72 h after TAVI | — |
| Extent of clinically apparent non-cerebral emboli after TAVI | 24-72 h after TAVI | To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...) |
Outcome results
None listed