Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

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

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 Overview

• Status: Completed
• Conditions: Bleeding; Thromboembolism
• Intervention / Treatment: Drug: Aspirin; Drug: Warfarin

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aspirin; Aspirin 150mg daily, starting day 1 after surgery, for three months.	Drug: Aspirin; 150mg/daily for three months, starting day after surgery; Other Names: Magnyl, Acetyl salicylic acid
ACTIVE_COMPARATOR: Warfarin; Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.	Drug: Warfarin; Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.; Other Names: marevan

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Peter S Olsen, MD, DMSc, Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen; Principal Investigator: Nikolaj B Lilleør, Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen; Study Chair: Sulman Rafiq, Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: October 14, 2011
• First Posted (ESTIMATE): October 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Aspirin; Bleeding complications; Haemorrhagic complications; Anticoagulant therapy; Thromboembolic complications; biological Aorta Valve
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Hemorrhage; Thromboembolism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Anticoagulants; Aspirin; Salicylic Acid; Warfarin; Salicylates
• Other Study ID Numbers: 01-080/04; (KF) 01-080/04 (OTHER: Science Ethics Committee Copenhagen)