Background-The Early Self Controlled Anticoagulation Trial (ESCAT I) showed that anticoagulation self-management after mechanical heart valve replacement decreased complication rates by maintaining INR levels closer to the target range than International Normalized Ratio (INR) home doctor management. The therapeutic range for the INR in that study was between 2.5 and 4.5 for all positions of prosthetic valves. ESCAT II should find out whether lowering the target range for INR self-management would further reduce complication rates. Methods-ESCAT II is a prospective controlled randomized (valves: St. Jude Medical Standard or Medtronic Hall, treatment: conventional/low-dose) multicenter study with 3 300 patients. We present interim results of 1 818 patients. 908 were categorized as having a low-dose target range, which was INR 1.8 to 2.8 for prostheses in aortic position and 2.5 to 3.5 for prostheses in mitral position or in combined valve replacement. The control group (conventional group) with 910 patients aimed at an INR of 2.5 to 4.5 for all valve positions. Results-In the conventional group, 74% of INR values measured were within the therapeutic range. In the low-dose group, 72% of the values were within that range. The linearized thromboembolism rate (% per patient year) was 0.21% for both groups. The bleeding complication rate was 0.56% in the low-dose regimen group versus 0.91% in the conventional group. Conclusions-Early

Patients (94.2%) with mechanical heart valve replacement have no persistent complaints about the valve noise. The grade of annoyance by valve noise is paralleled by lower average quality of life. Age under 60 years or being female increases the probability of severe disturbance due to mechanical valve sounds. It remains unclear whether the disturbing noise is reason or consequence of lower quality of life.

Severe thromboembolic and hemorrhagic complications following mechanical heart valve replacement essentially occur due to intense oral anticoagulation and fluctuating individual INR values around the target range. INR self-management can help to minimize these fluctuations. Beginning this therapeutic control immediately after mechanical heart valve replacement further reduces anticoagulant-induced complications. Included in the study were 1200 patients. The quality of oral anticoagulation also improved through INR self-management. Over an observation period of two years, nearly 80 % of INR values recorded by the patients themselves were within the target therapeutic range of 2.5-4.5. This corresponds to a high significance of p < = 0.001 in favor of INR self-management. Only 64.9 % of INR values monitored by family practitioners were within the desired range. The results differed slightly in quality between patient groups with different levels of training (comprehensive, secondary modern, grammar with or without university). Of patients trained in INR self-management following mechanical heart valve replacement, 91.7 % maintained their competence in this technique throughout the entire follow-up period. Only 8.3 % of those trained immediately after surgery were unable to continue with INR self-management.

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