Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial.
ABSTRACT Although many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N = 99) or routine care group (RCG) (N = 96). The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 +/- 1.2 and 3.0 +/- 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p = 0.049). The post-hoc analysis on OAC treatment sensitivity supported the benefit of self-management (HR 0.27; 95% CI: 0.13 to 0.71; p = 0.006). Fifteen patients in the SMG died during the study, but none of the deaths was directly associated with anticoagulation therapy. In the RCG, 11 patients died; of those, three deaths were directly associated with anticoagulation therapy and there was one death of unknown cause. During follow-up, the quality of OAC control was significantly better in the SMG than in the RCG. In elderly patients, long-term self-management of oral anticoagulation is superior for the prevention of major thromboembolic and bleeding complications and for the quality of oral anticoagulation control compared to routine care for a mean follow-up period of three years.
Article: Self-management of oral anticoagulation in elderly patients - effects on treatment-related quality of life.[show abstract] [hide abstract]
ABSTRACT: BACKGROUND - RATIONALE FOR STUDY: In elderly patients, long-term self-management of oral anticoagulation has been shown to reduce the number of major thromboembolic and bleeding complications and improve the quality of oral anticoagulation (OAC) control compared to routine care for a mean follow-up period of three years. This article presents the results of the predefined secondary endpoint treatment-related quality of life (QoL). METHODS AND RESULTS: The effect of self-management on five aspects of QoL was evaluated in comparison with routine care. A validated questionnaire specifically designed for patients receiving OAC was used. The evaluation was possible for 141 patients, comprising 90% of surviving patients on OAC. At baseline, all patients had high scores for the following QoL-aspects: general treatment satisfaction, self-efficacy, daily hassles and strained social network. A high proportion of patients in both groups explicitly reported high distress, indicating that general psychological distress seems to be of particular concern in this population. After about 3 years of follow-up, patients performing self-management showed a significantly greater improvement in general treatment satisfaction than controls (median score increase [25th percentile, 75th percentile]: 0.9 [0.0, 1.6] vs. 0.0 [-0.2, 0.6], p=0.002; scale 1-6). Changes in general psychological distress, self-efficacy, daily hassles and strained social network were not significant. CONCLUSION: Treatment related quality of life in elderly patients performing self-management of OAC was similar as for patients in routine care setting, with a tendency of higher general treatment satisfaction, after three years of follow up.Thrombosis Research 06/2012; 130(3):e60-6. · 2.44 Impact Factor
Article: Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes.[show abstract] [hide abstract]
ABSTRACT: Anticoagulation with vitamin K antagonists reduces major thromboembolic complications in at-risk patients. With portable monitoring devices, patients can conduct their own international normalized ratio testing and dose adjustment at home. To determine whether patient self-testing (PST), alone or in combination with self-adjustment of doses (patient self-management [PSM]), is associated with a reduction in thromboembolic complications and all-cause mortality without an increase in major bleeding events compared with usual care. MEDLINE and the Cochrane Central Register of Controlled Trials. Studies published in English from 1966 to October 2010 that enrolled outpatient adults receiving long-term (>3 months) oral anticoagulant therapy and that compared PST or PSM with care in a physician's office or an anticoagulation clinic were included. Two investigators reviewed each article. Three investigators extracted data from articles that met inclusion criteria by using standardized data abstraction forms. Studies were assessed for quality, and the overall strength of evidence was rated for each clinical outcome. Twenty-two trials, with a total of 8413 patients, were included. In one half of the trials, fewer than 50% of potentially eligible persons successfully completed the training and agreed to be randomly assigned. Patients randomly assigned to PST or PSM had lower total mortality (Peto odds ratio [OR], 0.74 [95% CI, 0.63 to 0.87]), lower risk for major thromboembolism (Peto OR, 0.58 [CI, 0.45 to 0.75]), and no increased risk for a major bleeding event (Peto OR, 0.89 [CI, 0.75 to 1.05]). The strength of evidence was moderate for the bleeding and thromboembolism outcomes but low for mortality. Eight of 11 trials reported that patient satisfaction, quality of life, or both was better with PST or PSM than with usual care. In one half of the trials, fewer than 50% of the potentially eligible patients were randomly assigned. Only 5 trials were considered high quality, and only 2 were conducted in the United States. No studies addressed whether PST or PSM is safe during the high-risk initiation phase. Compared with usual care, PST with or without PSM is associated with significantly fewer deaths and thromboembolic events, without increased risk for a serious bleeding event, for a highly selected group of motivated adult patients requiring long-term anticoagulation with vitamin K antagonists. Whether this care model is cost-effective and can be implemented successfully in typical U.S. health care settings requires further study. U.S. Department of Veterans Affairs Health Services Research and Development Service.Annals of internal medicine 04/2011; 154(7):472-82. · 16.73 Impact Factor
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ABSTRACT: Oral anticoagulation therapy (OAT) with coumarins (vitamin K-antagonists) is prescribed for both prophylactic and therapeutic use to patients at increased risk of thromboembolism. OAT has a narrow therapeutic index, and monitoring is based on the International Normalized Ratio (INR) conventionally determined on citrated plasma obtained by venepuncture. Based on the INR measurements, health care providers determine the appropriate dose of coumarins (e.g. warfarin (Marevan). Optimised management of OAT improves the quality of treatment. Patient self-management (PSM) is a new concept where the patient takes an active part in his or her own treatment. PSM in OAT implies that the patient analyses a drop of blood using a portable coagulometer (INR-monitor). The coagulometer displays the INR, which the patient uses for coumarins dosage. It is still not clarified which subset of patients (in terms of indication for OAT, age, co-morbidity etc.) that potentially will benefit from PSM, and how large this potential effect is. A precondition for a correct dosage of coumarins is a correct estimation of the INR, and the method and apparatus used for providing the INR measurements is in this context essential. The coagulometers used for PSM have not been investigated adequately in terms of precision and agreement, so this is warranted. INR has proven adequate for adjusting dosages. It is doubtful that the level of INR reflects the overall haemostatic capacity or thrombotic potential of individual patients. Measurement of continuous calibrated automated thrombin generation (CAT) and coagulation factors activities may serve as a more sensitive and global haemostatic parameter and potentially with better performance in predicting risk of complications in patients on OAT. We found that the clotting activity of coagulation factors II, VII, IX, and X and CAT exhibited no variability over a 6-week period. The activity of the coagulation factors and CAT was significantly associated with the INR, so these two tests can be used concomitantly and/or interchangeably with the INR. Approximately 50% of the total variability of the coagulation factor activities and CAT was reflected by the INR, whereas the remaining variability was within the subject (patient). Coagulation factor activities and CAT can therefore potentially be used to provide further information to the risk of bleeding and thromboembolism, since almost 50% of the variability within the subject is not displayed in the INR value. Yet it remains uncertain if this method can predict complications in individual patients on OAT. Larger clinical trials with a longer follow-up period, preferably using clinical endpoints, are needed in order to draw any firm conclusions regarding the clinical consequences. However, measurement of coagulation factor activities and CAT may improve measurement of coagulation activity in patients prescribed OAT beyond the parameters currently clinically available. The CoaguChek S and XS coagulometers used for PSM were found to have an adequate precision. Regarding the accuracy, the INR measurements tended to be lower on the coagulometers, compared with the laboratory. A large proportion of the measurements on the coagulometers deviated more than 15% from the laboratory measurements. However, only one laboratory was used for comparison and the original WHO method (gold standard) for estimating INR was not used. Furthermore, the inherent limitations of the INR have to be taken into consideration, and the results have to be viewed in this context. The accuracy of the coagulometers seems in this respect acceptable and they can be used in a clinical setting. However, external quality control is essential. In the observational studies, it was found that PSM was feasible and provides satisfactory treatment quality for various indications and in a wide range of patient age. In a randomised controlled trial, using a documented blinded composite endpoint, PSM was found to provide a treatment quality that was at least as good as that provided by conventional management. Additionally it was found, that training and implementation of PSM lead to a smaller variance in INR measurements, a higher median INR and a higher dose of coumarins compared to that obtained for conventionally managed patients. Further evidence was provided in a systematic review and meta-analysis, where it was documented, that PSM appears at least as good as and possibly better than conventional management in highly selected patients.Danish medical bulletin 05/2011; 58(5):B4284. · 0.75 Impact Factor