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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
The Vitamin K antagonist or direct oral anticoagulant treatment will be administered to obtain an International Normalized Ratio between 2 and 3 as recommended if the treatment is AVK. The Direct oral anticoagulant treatment : Apixaban 5 mg x2 or 2.5 mg X2, Edoxaban 30 ou 60 mg
Daily dose is between 75 mg and 100 mg. Allergic reactions to aspirin may be observed in rare cases. In case of suspicion of allergy, treatment with aspirin is stopped.
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
Clinique du Millénaire
Montpellier, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Hôpital Privé les Franciscaines
Nîmes, France
Composite outcome of the following events: death from any cause, myocardial infarction, stroke all causes, valve thrombosis and hemorrhage ≥ 2 as defined by the VARC 3 (Valve Academic Research Consortium scale).
Time frame: Month 12
All cause death according to the VARC 3 criteria
Time frame: month 1
All cause death according to the VARC 3 criteria
Time frame: month 3
All cause death according to the VARC 3 criteria
Time frame: month 6
All cause death according to the VARC 3 criteria
Time frame: month 12
Death due to cardio-vascular causes according to the VARC 2 criteria
Time frame: month 1
Death due to cardio-vascular causes according to the VARC 3 criteria
Time frame: month 3
Death due to cardio-vascular causes according to the VARC 3 criteria
Time frame: month 6
Death due to cardio-vascular causes according to the VARC 3 criteria
Time frame: month 12
Myocardial infarction according to VARC 3 criteria
Time frame: month 1
Myocardial infarction according to VARC 3 criteria
Time frame: month 3
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Clinique Saint-Pierre
Perpignan, France
CH de Perpignan - Hôpital Saint Jean
Perpignan, France
Myocardial infarction according to VARC 2 criteria
Time frame: month 6
Myocardial infarction according to VARC 3 criteria
Time frame: month 12
Stroke (all cause) according to the VARC 3 criteria
Time frame: month 1
Stroke (all cause) according to the VARC 3 criteria
Time frame: month 3
Stroke (all cause) according to the VARC 3 criteria
Time frame: month 6
Stroke (all cause) according to the VARC 3 criteria
Time frame: month 12
Valve thrombosis according to the VARC 3 criteria
Time frame: Month 1
Valve thrombosis according to the VARC 3 criteria
Time frame: Month 3
Valve thrombosis according to the VARC 3 criteria
Time frame: Month 6
Valve thrombosis according to the VARC 3 criteria
Time frame: Month 12
Major hemorrhage (BARC ≥ 3)
Time frame: Month 1
Major hemorrhage (BARC ≥ 3)
Time frame: Month 3
Major hemorrhage (BARC ≥ 3)
Time frame: Month 6
Major hemorrhage (BARC ≥ 3)
Time frame: Month 12
Minor hemorrhage (2 ≤ BARC < 3)
Time frame: Month 1
Minor hemorrhage (2 ≤ BARC < 3)
Time frame: Month 3
Minor hemorrhage (2 ≤ BARC < 3)
Time frame: Month 6
Minor hemorrhage (2 ≤ BARC < 3)
Time frame: Month 12
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time frame: Month 1
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time frame: Month 3
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time frame: Month 6
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time frame: Month 12