This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
650
Vitamin-K antagonists (warfarin)
Aspirin
Fuwai hospital
Beijing, Beijing Municipality, China
RECRUITINGA composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Time frame: 1 year
Rates of bioprosthetic valve thrombosis detected by 4D-CT
Time frame: 1 year
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
Time frame: 1 year
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Time frame: 1 year
Cardiac death
Cardiac death
Time frame: 1 year
Minor bleeding (BRAC 2)
Minor bleeding (BRAC 2)
Time frame: 1 year
Bleeding (BRAC 1, 2, 3a-c, 5)
Bleeding (BRAC 1, 2, 3a-c, 5)
Time frame: 1 year
All-cause mortality
All-cause mortality
Time frame: 1 year
Myocardial infarction
Myocardial infarction
Time frame: 1 year
Stroke
Stroke
Time frame: 1 year
TIA
TIA
Time frame: 1 year
Peripheral artery thrombosis
Peripheral artery thrombosis
Time frame: 1 year
Intracardiac thrombosis
Intracardiac thrombosis
Time frame: 1 year
Major bleeding (BARC 3a)
Major bleeding (BARC 3a)
Time frame: 1 year
Disabling/life-threatening bleeding (BARC 3b,3c,5)
Disabling/life-threatening bleeding (BARC 3b,3c,5)
Time frame: 1 year
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