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ePaper created 2014-10-06, 13:17:01 | version 1.33.00
were low (0.78 per patient-year) and showed few differences between monitors. Mortality rates were similar [hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.65–1.70]. Conclusion: Self-testing data from a large cohort of patients in the Netherlands suggest that there is no clinically relevant effect of the choice of coagulation monitor (CoaguChek XS or INRatio2) on the time in therapeutic range (TTR), minor or fatal outcomes of long-term anticoagulation management. Keywords: Anticoagulation; CoaguChek XS; INRatio2; International normalized ratio (INR); Patient self-monitoring (PSM); Patient self- testing (PST); Point of care (POC) test (POCT); Time in therapeutic range (TTR); Time in target range; Vitamin K antagonist (VKA) INTRODUCTION Anticoagulation is a widespread therapeutic intervention as secondary prevention after various venous or arterial thrombotic or thromboembolic events, or as primary prophylaxis, especially of stroke or systemic embolism in patients with atrial fibrillation. More than 6 million people in Europe have atrial fibrillation [1], with prevalence estimated from 1–2% [1] to 2.9% or more in adults [2], and increasing with age. Long-term risk reduction of thrombotic or thromboembolic events can be achieved using vitamin K antagonists (VKA) and in Europe the most commonly used are acenocoumarol, phenprocoumon and warfarin. Treatment with these types of anticoagulants is very effective in reducing the risk of an ischemic stroke while maintaining a low risk of bleeding [3]. The effectiveness of anticoagulant therapy with VKA is however crucially dependent on maintenance of the coagulation status within a specific range. The international normalized ratio (INR) is the established and generally accepted method to guide treatment of patients on long-term anticoagulation treatment with VKA [1]. Time within INR therapeutic range [70% is associated with significantly improved outcomes [4]. Patients whose INR strays too far from the optimal level of anticoagulation are at increased risk of experiencing a hemorrhagic or thromboembolic event [5], with significantly higher incidence of thromboembolism [relative risk 4.5 for INR \2.0, 95% confidence interval (CI) 3.1–6.6, P\0.001] or major bleeding (relative risk 6.4 for INR [5.0, 2.5–16.1, P\0.001) compared with INR 2.0–3.0 [6]. Maintenance of INR within the therapeutic range with VKA is challenging for many patients. More frequent measurement of INR, which improves control of anticoagulant therapy, can be better achieved by the patient using a home-based INR monitoring device compared to outpatient visits to a laboratory or clinic [7, 8]. Two options of self-care are available to the patient: patient self-testing (PST), where the INR test is executed by the patient and the INR value is communicated with the patient’s clinic, which responds with a new dosage schedule; and patient self- management (PSM), where the patients are trained to monitor and interpret the INR themselves, and adjust the anticoagulant dose accordingly. Systematic reviews have shown PST and PSM to be superior to standard monitoring, with fewer thromboembolic events, decreased overall mortality and reduced bleeding events [7, 9–12]. PST/PSM is therefore recommended in anticoagulant guidelines for suitable patients [13, 14]. Effective PST or PSM requires not only able and motivated patients, a user-friendly, Adv Ther