Abstract 11378: Preliminary Results of Self-Monitoring of Oral Anticoagulant in French Population Fitted With a Mechanical Heart Valve. The French 4A Study. STIC 2006.
The introduction of portable monitors for the management of patients on oral anticoagulation (OAC) allows self-testing by the patients at home. The effectiveness of self-monitoring of OAC remains controversial. We aimed at comparing clinical outcome and INR stability within therapeutic and target ranges of INR self-monitoring systems (INR self) with standard laboratory method (INR standard) in patients who recently underwent mechanical heart valve replacement in a medico-economical point of vue.
Methods: in this national, multicenter (23), prospective, randomized trial, 871 patients were randomly allocated to either INR standard monitoring at least once a month in the laboratory (n = 293) or INR self-monitoring once a week with either Coaguchek XS (Roche Diagnostics) or INRatio (AAZ-Hemosense) (n = 578). Patients were enrolled after single or multiple mechanical valve replacement, during early postoperative period, and were followed-up at 6 weeks, 6 then 12 months.
Results: overall, 72% were men, mean age 55 years. A total of 474 patients (83.5%) of the INR self group continued on this strategy until month 12. Twenty-six clinical outcomes (9 deaths (2 after haemorrhage), 11 haemorrhages, 6 embolisms) were reported: 10 (3.4%) in the INR standard group, 16 (2.8%) in the INR self group (p=0.30). Based on the description of observed data, time in therapeutic range and target ranges assessed at laboratory did not differ among the 2 groups (therapeutic 86.5 vs 84.9%, target 54.7 vs 54.2%).
Conclusions: compared with monthly laboratory INR testing, self-testing INR monitoring does not significantly modify clinical outcome after mechanical heart valve replacement. The rate of clinical outcome was low in both arms, suggesting improvement of medical survey in the laboratory group in the context of a clinical study. A large proportion of patients remained on self-monitoring system on the long term reflecting a high compliance to this option. INR self-monitoring may represent an interesting alternative when patient access to routine case is limited.
- © 2010 by American Heart Association, Inc.