INR self-management after mechanical heart valve replacement resulted in a higher compliance of therapy. INR self-management with low dose anticoagulation reduces the risk for thromboembolic events without increasing the risk of bleeding. The aim of the present study is to investigate the effects of a very low target range of INR value and to predefine a target value with more reduced complication rates.
ESCAT III is a prospectively controlled randomized multicenter study. All patients received a mechanical heart valve replacement of the company St. Jude Medical GmbH (Eschborn, Germany). The INR home monitoring has been done by CoaguCheck XS (Roche Diagnostics, Mannheim, Germany).
Patients were randomly assigned to a low dose group (n=428) and two very low dose groups (n=591).
The low dose group received low dose anticoagulation with a target INR range of 1.8 - 2.8 for aortic valve replacement and 2.5 - 3.5 for mitral or double valve replacement. Two very low dose groups received a new very-low-dose anticoagulation with a target INR range of 1.6 - 2.1 for aortic valve replacement and 2.0 - 2.5 for mitral or double valve replacement. Under telemedical support one very low dose group (n=293) transferred INR values once a week and the other very low dose group (n= 298) transferred INR values twice a week to the medical service centre. Patients were followed up for 24 months.
In the low dose group and in the two very low dose groups, 89% and 93%, respectively, were within the therapeutic range if in the two very low dose was same wide therapeutic range like the low-dose group. Degree III complications (bleeding and thromboembolic events) occurred 16 times (low dose = 12; very low dose 2 measures/week=3)
Only INR self-management permitted very low dose anticoagulation after mechanical heart valve replacement. This management guaranteed further reduction of “out-of-range” INR values. Besides the variability of INR values decreased. By this method serious complications due to Phenprocoumon were reduced highly significantly. The patients are able to live normally.
H. Koertke, MD, et al. (Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen/ Germany) (Nov. 2009)