Bleeding, Thromboembolism
Conditions
Keywords
Thromboembolic complications, Bleeding complications, Haemorrhagic complications, Anticoagulant therapy, Aspirin, biological Aorta Valve
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.
Interventions
DRUGAspirin
150mg/daily for three months, starting day after surgery
DRUGWarfarin
Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemorrhagic complications | 3 months | Bleeding complications |
| Thromboembolic complications | 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
| Measure | 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 |
Outcome results
None listed