BACKGROUND: A significant number of patients depend on the intake of vitamin K antagonists for prevention and treatment of thromboembolic events. The development of portable anticoagulation monitors has enabled self-testing and self-adjustment of anticoagulation therapy. OBJECTIVE: To describe the principles of a training course to learn INR self-management and to illustrate reliability of our concept. DESCRIPTION: The training is divided into an early postoperative training, an ambulatory training six months later, and a 24 hours care and consultation. According to our concept, each patient who depends on long-term anticoagulation therapy is able to learn INR self-management. Reliability of our concept has been proved in two prospective, randomized clinical trials. STUDY RESULTS: A study with 1,155 patients has demonstrated that INR values lie more often in the predetermined target range in the INR self-management group if compared to the conventional group (79.2% vs. 64.9%; P < 0.001). Moreover, this study has demonstrated that self-management can lead to a reduction of thromboembolism (1.5% vs. 2.8%; P < 0.05), and to a lower lethality if compared to conventional INR management (3.5% vs 6.0%; P < 0.025). A second study with 1,816 patients has confirmed that INR self-management results in a high percentage of INR values in the target range (76%), even though target INR-range is reduced and narrowed. Thus, low dose INR self-management did not increase the risk of thromboembolism while avoiding the zone of higher risk for bleeding, beginning from INR > 3.5. CONCLUSIONS: The Bad Oeynhausen concept of INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. It can thus be successfully applied to patients with an indication for permanent anticoagulation therapy.
RCT Entities:
BACKGROUND: A significant number of patients depend on the intake of vitamin K antagonists for prevention and treatment of thromboembolic events. The development of portable anticoagulation monitors has enabled self-testing and self-adjustment of anticoagulation therapy. OBJECTIVE: To describe the principles of a training course to learn INR self-management and to illustrate reliability of our concept. DESCRIPTION: The training is divided into an early postoperative training, an ambulatory training six months later, and a 24 hours care and consultation. According to our concept, each patient who depends on long-term anticoagulation therapy is able to learn INR self-management. Reliability of our concept has been proved in two prospective, randomized clinical trials. STUDY RESULTS: A study with 1,155 patients has demonstrated that INR values lie more often in the predetermined target range in the INR self-management group if compared to the conventional group (79.2% vs. 64.9%; P < 0.001). Moreover, this study has demonstrated that self-management can lead to a reduction of thromboembolism (1.5% vs. 2.8%; P < 0.05), and to a lower lethality if compared to conventional INR management (3.5% vs 6.0%; P < 0.025). A second study with 1,816 patients has confirmed that INR self-management results in a high percentage of INR values in the target range (76%), even though target INR-range is reduced and narrowed. Thus, low dose INR self-management did not increase the risk of thromboembolism while avoiding the zone of higher risk for bleeding, beginning from INR > 3.5. CONCLUSIONS: The Bad Oeynhausen concept of INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. It can thus be successfully applied to patients with an indication for permanent anticoagulation therapy.
Authors: S Mörsdorf; W Erdlenbruch; U Taborski; J F Schenk; K Erdlenbruch; G Novotny-Reichert; B Krischek; E Wenzel Journal: Semin Thromb Hemost Date: 1999 Impact factor: 4.180
Authors: M E Cromheecke; M Levi; L P Colly; B J de Mol; M H Prins; B A Hutten; R Mak; K C Keyzers; H R Büller Journal: Lancet Date: 2000-07-08 Impact factor: 79.321