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(Circulation. 2003;108:II-75.)
© 2003 American Heart Association, Inc.

Surgery for Valvular Heart Disease

INR Self-Management Permits Lower Anticoagulation Levels After Mechanical Heart Valve Replacement

H. Koertke, MD; K. Minami, MD; D. Boethig, MD; Th. Breymann, MD; D. Seifert, MD; O. Wagner; N. Atmacha, MD; A. Krian, MD; J. Ennker, MD; U. Taborski, MD; W.P. Klövekorn, MD; R. Moosdorf, MD; W. Saggau, MD; R. Koerfer, MD

From the Heart and Diabetes Center North Rhine-Westphalia Bad Oeynhausen, Germany, Clinic of the Ruhr University of Bochum, Bochum, Germany (H.K., K.M., D.B., T.B., D.S., O.W., K.); Evangelisches und Johanniter Klinikum, Duisburg, Germany (N.A., A.K.); Heart Center Lahr, Lahr, Germany (J.E.); Kerckhoff-Klinik, Bad Nauheim, Germany (U.T., W.P.K.); Heart Center Marburg, Clinic of the Philipps-University Marburg, Marburg, Germany (R.M.); and the Klinikum Ludwigshafen, Clinic for Heart Surgery, Ludwigshafen, Germany (W.S.). Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany, Clinic of the Ruhr University of Bochum, Bochum, Germany Evangelisches und Johanniter Klinikum, Duisburg, Germany Heart Center Lahr, Lahr, Germany Kerckhoff-Klinik, Bad Nauheim, Germany Heart Center Marburg, Clinic of the Philipps-University Marburg, Marburg, Germany Klinikum Ludwigshafen, Clinic for Heart Surgery, Ludwigshafen, Germany

Correspondence to Heinrich Koertke, MD, Herz- und Diabeteszentrum NRW, Georgstrasse 11, 32545 Bad Oeynhausen, Germany. Phone: ++49 5731 97-2319, Fax: ++49 5731 97-1871, E-mail: hkoertke{at}hdz-nrw.de

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 onset INR self-management under oral anticoagulation after mechanical heart valve replacement enables patients to keep within a lower and smaller INR target range. The reduced anticoagulation level resulted in fewer grade III bleeding complications without increasing thromboembolic event rates.

Key Words: anticoagulation • heart valve replacement • INR self-management • low-dose anticoagulation