Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial.

Area of Science:

• Cardiovascular Surgery
• Infectious Diseases
• Clinical Trials

Background:

• Prosthetic heart valve endocarditis (PVE) is a serious complication after valve replacement surgery.
• The SilzoneTM coating is a novel technology designed to reduce the risk of PVE.
• Current data on the efficacy of coated mechanical heart valves in preventing PVE is limited.

Purpose of the Study:

• To evaluate the efficacy of SilzoneTM-coated St. Jude Medical Masters Series mechanical heart valves in preventing PVE.
• To compare the incidence of PVE in patients receiving Silzone-coated valves versus conventional valves.
• To gather data on practice patterns and outcomes associated with mechanical heart valve replacement.

Main Methods:

• A multicenter, international randomized trial (AVERT) involving 4,400 patients undergoing mechanical heart valve replacement.
• Patients will be randomized to receive either Silzone-coated or conventional St. Jude mechanical valves in the mitral and/or aortic position.
• Follow-up will include regular surveys to identify potential endocarditis events, with adjudication by infectious disease specialists.

Main Results:

• Primary endpoint is freedom from PVE, determined by a published algorithm and expert review.
• Intention-to-treat analysis will compare PVE rates between the Silzone and conventional cuff groups.
• Data Safety Monitoring Board will periodically review study data.

Conclusions:

• The AVERT trial is expected to provide critical evidence on the effectiveness of Silzone coating in reducing PVE.
• Findings will inform clinical decision-making regarding the use of coated mechanical heart valves.
• The study will also contribute to understanding broader outcomes in valve replacement surgery.