Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients who have an indication for OAC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
880
Rivaroxaban monotherapy
Rivaroxaban+Aspirin
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China
All bleeding complications at 1 year after TEER
For the classification of bleeding complications, the Mitral Valve Academic Research Consortium (MVARC) Primary Bleeding Scale is used. All bleeding can be categorized into five types: minor bleeding, major bleeding, extensive bleeding, life-threatening bleeding, and fatal bleeding.
Time frame: 1 year
Non-procedure-related bleeding complications at 1 year after TEER(key secondary outcome 1)
Non-procedure-related bleeding is consisted of all MVARC bleeding, excluding Bleeding Academic Research Consortium (BARC ) type 4 severe bleeding.BARC type 4 severe bleeding is defined by any of the following: perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy for the purpose of controlling bleeding, transfusion of 5 or more units of whole blood or packed red cells within a 48-hour period, chest-tube output of 2 or more liters within a 24-hour period.
Time frame: 1 year
Composite of ischemic event (1)(key secondary outcome 2)
composite of all-cause mortality, stroke, systemic embolic events , or myocardial infarction at 1 year after TEER
Time frame: 1 year
Composite of ischemic event (2)
Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER.
Time frame: 1 year
Composite of ischemic and bleeding events(1)
Composite of all bleeding, all-cause mortality, stroke, systemic embolic events or myocardial infarction at 1 year after TEER.
Time frame: 1 year
Composite of ischemic and bleeding events(2)
Composite of non-procedure-related bleeding events, cardiovascular mortality, ischemic stroke, systemic embolic events or myocardial infarction at 1 year after TEER.
Time frame: 1 year
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