Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Anticoagulation; Mechanical Heart Valve Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT01269905

COAG-001

Details and patient eligibility

About

The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• heart valve replacement

Exclusion criteria

• CABG
• Afib

Trial design

0 participants in 3 patient groups

Group A

Description:

Group A patients received mechanical heart valve replacement MHVR (and were educated in INR self-management using the Coagu-Check monitor.

Group B

Description:

Group B patients received MHVR and their anticoagulation was managed by their general practitioners.

Group C

Description:

Group C patients received stentless bioprosthesis, with initial 6 weeks on oral anticoagulation managed by their general practitioners.