Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
Overview
- Phase
- Phase 4
- Intervention
- Aspirin
- Conditions
- Thromboembolism
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 370
- Primary Endpoint
- Haemorrhagic complications
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.
The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.
Investigators
Nikolaj B. Lilleoer
Clinical Project Coordinator
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients planned for double valve surgery
- •Patients with active endocarditis
- •Patients with atrial fibrillation/flutter
- •Patients in anticoagulation treatment of other reason.
- •Patients with previous cerebrovascular accidents or insults.
- •Patients with TCI
- •Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable
- •Patients with pacemaker
- •Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer
- •Patients that is HIV-positive or have active AIDS
Arms & Interventions
Aspirin
Aspirin 150mg daily, starting day 1 after surgery, for three months.
Intervention: Aspirin
Warfarin
Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
Intervention: Warfarin
Outcomes
Primary Outcomes
Haemorrhagic complications
Time Frame: 3 months
Bleeding complications
Thromboembolic complications
Time Frame: 3 months
TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.
Secondary Outcomes
- Registration of surgical data and postoperative complications(3 months)
- All cause mortality(3 months)
- Echocardiographic findings before surgery, before discharge and 3 months after implantation(3 months)