Rationale/context:~Long term management of anticoagulant treatment is not straightforward, especially in patients bearing mechanical heart valves due to the requirement of maintaining a high INR over a narrow range.~Due to the narrow therapeutic window of AVK, undesirable events (hemorrhages, thromboembolic accidents) tend to be both serious and common leading to frequent admissions to hospital The self-monitoring of AVK, in addition to conventional monitoring of INR in the laboratory, is now being introduced in several countries (USA and Europe).~Main objective To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.~Secondary objectives~To compare over one year the effect of self-monitoring of coagulation with conventional follow-up of anticoagulation on:~the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death~the proportion of monthly values of INR within the target range,~the inherent cost of each strategy of monitoring of anticoagulation,~the incidence of death, bleeding and thromboembolic episodes (each studied separately)~The quality of life and the satisfaction of the patient To evaluate the patients' learning to be autonomous Diagram of the study Progress of the trial~A national, multicenter, randomized, blind trial, designed to examine the type of strategy used for monitoring anticoagulation in two parallel groups:~a conventional follow-up of anticoagulation (monthly checks and adjustment of INR by the family doctor (GP))~a self-measurement of anticoagulation by the patient at home using a Roche Diagnostics Laboratories test CoaguChek XS® or the Hemosense laboratories test INRatio® (weekly measurements and adjustment of INR by the family doctor) + a monthly laboratory check of INR~Inclusion criteria:~adults (age ≥ 18 years), either sex~patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization~oral anticoagulant treatment~patients with social security cover~written informed consent signed by both patient and investigator Exclusion criteria~women pregnant or liable to become pregnant during the study~nursing women~patients unable to master the self-monitoring procedures~individuals under judicial control or enquiry~patients consuming excessive amounts of alcohol ((>40g/j for men et >30g/j for women femmes ; 1 glass = 10g)~patients on dialysis~patients with incomplete understanding of instructions~blind patients and those unable to read~presence of circulating anticoagulant~Treatments/Strategies/Procedures:~1.1. Strategies of anticoagulation monitoring~After signature of informed consent and verification of criteria of eligibility, patients are randomly allocated into the following groups:~1.1.1. Conventional follow-up of anticoagulation In this group, the patients are instructed in the use of oral anticoagulants. INR is measured once a month in the laboratory. INR must lie in the therapeutic range designated by the investigative center as a function of the type and the location of the valve and any associated risk factors. If necessary, the family doctor adjusts INR on the day of the blood test and a new measurement is taken 48 hours later if dosage has been changed.~This algorithm is applied until the INR comes into the designated range.~1.1.2. Self-measurement of anticoagulation In this group, the patients are instructed in the use and monitoring of oral anticoagulants. They are further trained in the use of the self-monitoring test system.~Reference INR will be INR labo during first post operatives weeks up to the return at home because the self-measurement of anticoagulation maybe for lack of the fact of the anaemia, the inflammatory syndrome and the residues of heparin.~When the patients return at home, they take a measurement every week and if the result is abnormal, inform their family doctor. The INR must lie within the therapeutic range designated by the investigative center as a function of the type and the location of the valve and any associated risk factors. If necessary, the family doctor adjusts the INR on the same day as the self-measurement. A measurement is taken 48 hours later if the dosage has been changed.~This algorithm is applied until the INR comes into the designated range. INR is measured in the laboratory every month.~Main evaluation criteria:~Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.~Main secondary evaluation criteria:~the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death) within a population recently fitted with a mechanical hear valve.~the proportion of monthly measurements of INR within the designated range,~the inherent cost of each strategy of anticoagulation monitoring,~the impact of death, bleeding and thromboembolic episodes (each studied separately),~Evaluation of patients' learning of monitoring procedures.~Planned population size: 1050 patients, i.e.~350 in the group Conventional follow-up of anticoagulation~700 in the group Self-measurement of anticoagulation :~350 using the Roche Diagnostics laboratories test CoaguChek XS®~350 using the Hemosense laboratories test INRatio®~Time-line:~Period of inclusion: 12-18 months~Duration of participation by patients: 12 months~Duration of trial: 30 months
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.