Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Rigshospitalet, Denmark370 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

370

Conditions

Thromboembolism Bleeding

Interventions

AspirinDRUG

150mg/daily for three months, starting day after surgery

WarfarinDRUG

Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Haemorrhagic complications

Bleeding complications

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

Echocardiographic findings before surgery, before discharge and 3 months after implantation

Time frame: 3 months

Registration of surgical data and postoperative complications

Time frame: 3 months

All cause mortality

Time frame: 3 months

Data from ClinicalTrials.gov

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