Transcatheter Aortic Valve Replacement
Conditions
Keywords
antivitamins K, direct oral anti-coagulant
Brief summary
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)..
Detailed description
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.
Interventions
DRUGVitamin K antagonist or direct oral anticoagulant treatment
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
DRUGAspirin
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.
Sponsors
Medtronic
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial infarction according to VARC 3 criteria | month 1 |
| Myocardial infarction according to VARC 2 criteria | month 6 |
| Stroke (all cause) according to the VARC 3 criteria | month 1 |
| All cause death according to the VARC 3 criteria | month 1 |
| Death due to cardio-vascular causes according to the VARC 3 criteria | month 3 |
| Valve thrombosis according to the VARC 3 criteria | Month 1 |
| Major hemorrhage (BARC ≥ 3) | Month 1 |
| Minor hemorrhage (2 ≤ BARC < 3) | Month 1 |
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) | Month 1 |
| Death due to cardio-vascular causes according to the VARC 2 criteria | month 1 |
Countries
France
Outcome results
None listed