Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)

Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC 3 (other complications; Kappetein et al 2012)..

The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups:

1. Mortality (all causes).
2. Cardiovascular mortality.
3. The occurrence of myocardial infarction.
4. The occurrence of stroke.
5. The occurrence of valve thrombosis.
6. The occurrence of major bleeding (BARC ≥ 3).
7. The occurrence of minor bleeding (2 ≤ BARC <3).
8. Treatment compliance.

Inclusion Criteria:

• The patient or his/her representative must have given free and informed consent and signed the consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 12 months of follow-up
• The patient underwent a successful transcutaneous implant procedure for an aortic valve
• The patient required anticoagulant treatment (AVK or DOAC) excepted rivaroxaban the day of inclusion
• The patient is stable on anticoagulant treatment

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient or his/her representative refuses to sign the consent
• It is impossible to correctly inform the patient or his/her representative
• The patient is pregnant or breastfeeding
• The patient has a contraindication (or an incompatible drug association) for a treatment used in this study
• The patient had a coronary stent for less than 12 months
• The patient does not require treatment with aspirin or any other antiplatelet agent
• The patient has a history of aspirin allergy
• High bleeding risk; such as platelets <50,000 / mm3 during screening, Hb <8.5 g / dL, history of intracranial hemorrhage or subdural hematoma, major surgery, parenchymal organ biopsy or severe trauma within 30 days before inclusion, active gastrointestinal ulcer in the last 3 months;
• History of Stroke in the last 3 months;
• Moderate or severe liver affection associated with coagulopathy
• Active infectious endocarditis
• Active tumor treated at the time of inclusion associated with expected survival less than one year
• Not following countraindications specific to the molecules used fo the patients receiving DOAC