Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)

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).

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.

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