Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Study Overview
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Brief Summary
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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.

Official Title
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Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin

Conditions
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Thromboembolism, Bleeding

Intervention / Treatment
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* Drug: Aspirin
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery. Age 60 years Sinus rhythm 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 Patients that are known drug abuser Patients in chronic haemodialysis or other types of dialysis

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Aspirin 150mg daily, starting day 1 after surgery, for three months. | Drug: Aspirin<br>* 150mg/daily for three months, starting day after surgery<br>* Other names: Magnyl, Acetyl salicylic acid;|
| Active Comparator: Warfarin<br>Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0. | Drug: Warfarin<br>* Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.<br>* Other names: marevan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemorrhagic complications | Bleeding complications | 3 months | 
| Thromboembolic complications | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic findings before surgery, before discharge and 3 months after implantation |  | 3 months | 
| Registration of surgical data and postoperative complications |  | 3 months | 
| All cause mortality |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboembolic complications, Bleeding complications, Haemorrhagic complications, Anticoagulant therapy, Aspirin, biological Aorta Valve