This study compares the efficacy and safety of two different antithrombotic drugs, warfarin and aspirin, in early application after mitral valve repair (MVRep). The objective is to verify whether the type of antithrombotic therapy affects clinical outcomes and the incidence of thromboembolic and bleeding complications within 3 months after MVRep, and to provide safe and effective antithrombotic treatment options for patients undergoing MVRep.
Patients were randomly assigned in a 1:1 ratio to two groups: the Warfarin Group and the Aspirin Group. Warfarin Group: Anticoagulation therapy was initiated on the second day after surgery, starting at 4.5 mg once nightly, with adjustments made based on changes in the INR value. Aspirin Group: Antiplatelet therapy was initiated on the second day after surgery with oral administration of Aspirin Enteric-coated Tablets (Bayer Aspirin) at a dose of 100 mg once daily. For all patients, antithrombotic therapy was continued for at least 3 months post-surgery. Patients were scheduled for outpatient visits at 1, 4, 8, and 12 weeks following the surgical intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
384
Antiplatelet therapy was initiated on the second day after surgery with oral administration of Aspirin Enteric-coated Tablets (Bayer Aspirin) at a dose of 100 mg once daily.
Anticoagulation therapy was initiated on the second day after surgery, starting at 4.5 mg once nightly, with adjustments made based on changes in the INR value.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGClinical thromboembolic events
Clinical thromboembolic events are defined as stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep venous thrombosis, or pulmonary embolism.
Time frame: From enrollment to the end of treatment at 12 weeks
Asymptomatic intracardiac thrombosis
Asymptomatic intracardiac thrombosis is defined as subclinical leaflet thrombosis or intracavitary thrombus detected by cardiac computed tomography (CT) or echocardiography within 12 weeks postoperatively. Subclinical leaflet thrombosis is defined as leaflet thickening with reduced leaflet motion and at least moderate (reduction \>50%) valve area obstruction, demonstrated by cardiac CT, with a lesser degree of leaflet thinning.
Time frame: From enrollment to the end of treatment at 12 weeks
Death due to cardiovascular causes or thromboembolic events
Time frame: From enrollment to the end of treatment at 12 weeks
Major bleeding
Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial or intramuscular bleeding with compartment syndrome; and/or bleeding resulting in a decrease in hemoglobin level by 3.0 g/dL。
Time frame: From enrollment to the end of treatment at 12 weeks
postoperative length of hospital stay
from the day of surgery to the first discharge
Time frame: From enrollment to the end of treatment at 12 weeks
International normalized ratio at the time of thromboembolic or bleeding events
Time frame: From enrollment to the end of treatment at 12 weeks
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CHA2DS2-VASc scores
The CHA2DS2-VASC score is a risk stratification tool for assessing the likelihood of stroke in patients with non-valvular atrial fibrillation. The maximum score is 9, and the minimum score is 0.A lower CHA2DS2-VASC score is generally considered better.
Time frame: From enrollment to the end of treatment at 12 weeks
HAS-BLED scores
The HAS-BLED score is a scoring system used to predict the risk of bleeding in patients with atrial fibrillation undergoing anticoagulant therapy. Its full name is the "Hemorrhagic risk in Atrial fibrillation patients on anti-coagulation therapy using European League Against Rheumatism (EULAR) criteria, Bleeding Academic Research Consortium (BARC) definitions" score system, often abbreviated as HAS-BLED.The maximum score is 9, and the minimum score is 0.A lower HAS-BLED score is generally considered better.
Time frame: From enrollment to the end of treatment at 12 weeks