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.
Successful TEER procedure, defined as technical success per MVARC criteria.
Indication for long-term OAC.
Ability and willingness to comply with the trial protocol.
Provision of written informed consent.
Severe renal impairment (creatinine clearance < 15 mL/min or requiring dialysis).
Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure.
Platelet count < 50 × 10^9 /L.
Need for reoperation due to complications of the index TEER procedure.
Parallel
Experimental: Rivaroxaban monotherapy
DrugRivaroxaban monotherapy
Active Comparator: Rivaroxaban+Clopidogrel
DrugRivaroxaban+Clopidogrel
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.
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.
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
Composite of ischemic event (2)
Composite of cardiovascular mortality, ischemic stroke, systemic embolic events ,or myocardial infarction at 1 year after TEER.
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.
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