Document Detail

Efficacy and safety of very low-dose self-management of oral anticoagulation in patients with mechanical heart valve replacement.
MedLine Citation:
PMID:  20971245     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Self-management improves oral anticoagulation control. Here we provide data of a preplanned interim analysis of very low-dose early self-controlled anticoagulation. METHODS: In a prospective, randomized, multicenter trial, 1,137 patients performed low-dose international normalized ratio (INR) self-management with a target INR range of 1.8. to 2.8 for aortic valve replacement recipients and 2.5 to 3.5 for mitral or double valve replacement recipients for the first six postoperative months. Thereafter, 379 patients continued to achieve the aforementioned INR target range (LOW group), whereas the INR target value was set at 2.0 (range, 1.6 to 2.1) for the remaining patients with aortic valve replacement and 2.3 (range, 2.0 to 2.5) for the remaining patients with mitral valve or double valve replacement. One half of this latter group had to check their INR values once a week (VL1 group) the other half twice a week (VL2 group). Patients were followed up for 24 months. RESULTS: Beyond study month six, the incidence of thromboembolic events that required hospital admission was 0.58%, 0.0%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.368). The incidence of bleeding events per patient-year was 1.16%, 1.07%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.665). Mortality rate did not differ among study groups. CONCLUSIONS: Data demonstrate the efficacy and safety of very low-dose INR self-management.
Heinrich Koertke; Armin Zittermann; Otto Wagner; Juergen Ennker; Werner Saggau; Falk-Udo Sack; Jochen Cremer; Christof Huth; Maurizio Braccio; Francesco Musumeci; Reiner Koerfer
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  The Annals of thoracic surgery     Volume:  90     ISSN:  1552-6259     ISO Abbreviation:  Ann. Thorac. Surg.     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-25     Completed Date:  2010-11-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  15030100R     Medline TA:  Ann Thorac Surg     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  1487-93     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Clinic for Thoracic and Cardiovascular Surgery, Heart Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
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MeSH Terms
Administration, Oral
Aged, 80 and over
Anticoagulants / adverse effects,  therapeutic use*
Heart Valve Prosthesis Implantation* / adverse effects
International Normalized Ratio
Longitudinal Studies
Middle Aged
Prospective Studies
Self Care
Reg. No./Substance:
Comment In:
Ann Thorac Surg. 2010 Nov;90(5):1493-4   [PMID:  20971246 ]

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