Patient Self-management Of Oral Anticoagulation Research Articles

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up

BackgroundPatient self-management (PSM) of vitamin K antagonists (VKA) seems a very promising model of care for oral anticoagulation in terms of efficacy and safety. In comparison with other management models of VKA therapy, the number of scientific publications supporting the advantages of PSM is more limited. Currently, most of the scarce information comes from randomized clinical trials. Moreover, a small number of studies have assessed PSM of VKA therapy in real life conditions.MethodsWe analyzed clinical outcomes of 927 patients in a single center (6018.6 patient-years of follow-up). Recruitment took place between 2002 and 2017. All patients followed a structured training program, conducted by specialized nurses.ResultsFifty percent of individuals had a mechanical heart valve (MHV), 23% suffered from recurrent venous thromboembolism (VTE) or high-risk thrombophilia, and 13% received VKA therapy because of atrial fibrillation (AF). Median follow-up was 6.5 years (range 0.1–15.97 years), median age was 58.1 years (IQR 48–65.9) and 46.5% were women. The incidence of major complications (either hemorrhagic or thromboembolic) was 1.87% patient-years (pt-ys) with a 95% CI of 1.54–2.27. The incidence of major thromboembolic events was 0.86% pt-ys (95% CI 0.64–1.13) and that of major hemorrhagic events was 1.01% pt-ys (95% CI 0.77–1.31). The incidence of intracranial bleeding was 0.22% pt-ys (95% CI 0.12–0.38). In terms of clinical indication for VKA therapy, the incidence of total major complications was 2.4% pt-ys, 2.0% pt-ys, 0.9% pt-ys and 1.34% pt-ys for MHV, AF, VTE and other (including valvulopathies and myocardiopathies), respectively. Clinical outcomes were worse in patients with multiple comorbidities, previous major complications during conventional VKA therapy, and in older individuals. The percentage of time in therapeutic range (TTR) was available in 861 (93%) patients. Overall, the mean (SD) of TTR was 63.6 ± 13.4%, being higher in men (66.2 ± 13.1%) than women (60.6 ± 13.2%), p < 0.05.ConclusionsIn terms of clinically relevant outcomes (incidence of major complications and mortality), PSM in real life setting seems to be a very good alternative in properly trained patients.

Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: efficacy and safety in a nationwide long-term prospective cohort study.

Patient self-management (PSM) of oral anticoagulation is under discussion, because evidence from real-life settings is missing. Using data from a nationwide, prospective cohort study in Switzerland, we assessed overall long-term efficacy and safety of PSM and examined subgroups. Data of 1140 patients (5818.9 patient-years) were analysed and no patient were lost to follow-up. Median follow-up was 4.3 years (range 0.2–12.8 years). Median age at the time of training was 54.2 years (range 18.2–85.2) and 34.6% were women. All-cause mortality was 1.4 per 100 patient-years (95% CI 1.1–1.7) with a higher rate in patients with atrial fibrillation (2.5; 1.6–3.7; p<0.001), patients>50 years of age (2.0; 1.6–2.6; p<0.001), and men (1.6; 1.2–2.1; p = 0.036). The rate of thromboembolic events was 0.4 (0.2–0.6) and independent from indications, sex and age. Major bleeding were observed in 1.1 (0.9–1.5) per 100 patient-years. Efficacy was comparable to standard care and new oral anticoagulants in a network meta-analysis. PSM of properly trained patients is effective and safe in a long-term real-life setting and robust across clinical subgroups. Adoption in various clinical settings, including those with limited access to medical care or rural areas is warranted.

External Quality Assessment Schemes in Coagulation in Germany: Between Regulatory Bodies and Patient Outcome

In the early 1980s, the first external quality assessment schemes (EQAS) regarding parameters of the coagulation laboratory were established in the daily routine of German laboratories. At present, the EQAS performed by INSTAND offers a wide range of global and single parameters of thrombosis and hemostasis. Only the participation in prothrombin time and activated partial thromboplastin time exercises is mandatory. However, devices applied for patient self-management of oral anticoagulation are not included. This article provides an overview of the EQA activities of INSTAND regarding different coagulation parameters. Problems in acquiring adequate sample material and strategies in establishing acceptability ranges are also discussed.

Patient Self-Management of Oral Anticoagulation

Letters21 June 2005Patient Self-Management of Oral AnticoagulationBenton M. Wheeler III, MDBenton M. Wheeler III, MDFrom The West Clinic, Memphis, TN 38120.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-142-12_Part_1-200506210-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The design of the study by Menéndez-Jándula and colleagues on patient self-management of oral anticoagulant therapy (1) has some important limitations. The authors compared monthly conventional management of anticoagulant therapy with weekly self-management and reported no significant difference in unadjusted percentages of end-range international normalized ratios (INRs). However, this is an unfair comparison.In my office, prothrombin times are checked every 2 weeks and then weekly if the dose has to be adjusted. Patients who do not require frequent dose adjustments can have this interval increased to 3 or 4 weeks. It would seem more reasonable for ...Reference1. Menendez-Jandula B, Souto JC, Oliver A, Montserrat I, Quintana M, Gich I, et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med. 2005;142:1-10. [PMID: 15630104] LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From The West Clinic, Memphis, TN 38120.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoComparing Self-Management of Oral Anticoagulant Therapy with Clinic Management Bárbara Menéndez-Jándula , Juan Carlos Souto , Arturo Oliver , Isabel Montserrat , Mireia Quintana , Ignasi Gich , Xavier Bonfill , and Jordi Fontcuberta Patient Self-Management of Oral Anticoagulation Juan Carlos Souto , Bárbara Menéndez-Jándula , and Jordi Fontcuberta Patient Self-Management of Oral Anticoagulation Juan Carlos Souto , Bárbara Menéndez-Jándula , and Jordi Fontcuberta Metrics 21 June 2005Volume 142, Issue 12_Part_1Page: 1023KeywordsAnticoagulant therapyAnticoagulantsConflicts of interestResearch laboratoriesThrombin ePublished: 21 June 2005 Issue Published: 21 June 2005 CopyrightCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...

Patient Self-Management of Oral Anticoagulation

Patient Self-Management of Oral Anticoagulation

Guidelines for implementation of patient self-testing and patient self-management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation

Aims: This document provides health care professionals involved in initiating and monitoring oral anticoagulation therapy with guidelines for the provision of safe and effective patient self-testing/patient self-management of oral anticoagulation. Methods and results: The consensus group has critically reviewed the literature and compared the results of usual care (UC) vs. anticoagulation clinic and patient self-management/patient self-testing (PSM/PST). The education and training of patients for self-monitoring are described, together with the suitability of patients, the effect on quality of life and cost-effectiveness. The consensus agrees that patient self-testing and patient self-management are effective methods of monitoring oral anticoagulation therapy, providing outcomes at least as good as, and possibly better than, those achieved with an anticoagulation clinic. All patients must be appropriately selected and trained. Currently available self-testing/self-management devices give INR results which are comparable with those obtained in laboratory testing. The most frequent testing frequency is weekly but lower frequency of testing can be justified based on institutional or patient conditions. Conclusions: The consensus agrees that there are several points in favour of PST/PSM, for example, a higher degree of medical safety, increased patient education, improved response to changes in lifestyle, increased independence for the patient and improved quality of life.

Patient self-management of oral anticoagulation and external quality assessment procedures.

The role of external quality assessment (EQA) is a contentious issue for patient self-management (PSM) of oral anticoagulation. Patients from general practices in the West Midlands undertaking PSM were recruited to compare efficacy of patients' and health professionals' EQA procedure using the UK National External Quality Assessment Scheme (NEQAS). Patients using Coaguchek (Roche Diagnostics) were trained to perform EQA as part of their PSM training. They undertook PSM for 26 weeks and were asked to perform EQA using material provided by the UK NEQAS twice at home without supervision and twice at the practice with supervision. Patients' results were compared with health care professional users of Coaguchek S. Twenty-three PSM patients were compared with 75 health care professional users of the NEQAS scheme. The PSM group international normalized ratio (INR) percentage time in range was 74%. There was no significant difference in the median results on NEQAS samples obtained by the patients and those obtained by professionals. Three patients were outwith consensus (results > 15% from the median INR) on more than one occasion. Patients were able to perform the EQA tests competently. The data show that good agreement can be achieved between patients analysing the same EQA samples, with coefficients of variation ranging from 22.3% to as low as 5.4%. Further study is required to determine how precision within these EQA schemes relates to the stability of treatment in patients' management of their own anticoagulation.

Patient self-management of oral anticoagulation

More than six million patients worldwide are being treated with an oral anticoagulant. Dosing of the anticoagulant is usually managed by a primary care physician, cardiologist, or a specialized anticoagulation clinic. With the introduction of point-of-care testing devices, it is possible for patients to monitor their coagulation time, the international normalized ratio, at home. Selected patients, when properly trained, are capable of managing their oral anticoagulation treatment from home, so-called patient self-management (PSM). PSM has been practiced for many years in Europe, where training centers and reimbursement are well established. Because the US Center for Medicare and Medicaid Services recently decided to cover PSM, the practice will likely become more common in the United States. This article reviews the evidence behind the efficacy, safety, and cost effectiveness of PSM.

Patient self-management of oral anticoagulation.

Patient self-management of oral anticoagulation is now widely practised in Germany and the USA. There are three different home-testing monitors available in the UK which are all reliable in terms of accuracy and reproducibility of results. Selected patients can be trained to perform their own International Normalized Ratio (INR) testing and dosing, with outcomes as good if not better than those from specialized anticoagulant clinics. Consensus on the frequency of testing and what quality control should be deployed is lacking. The cost-effectiveness in the UK is unproven.

Advances in Therapy and the Management of Antithrombotic Drugs for Venous Thromboembolism.

This review focuses on antithrombotic therapy for venous thromboembolism and covers a diverse range of topics including a discussion of emerging anticoagulant drugs, a renewed focus on thrombolytic agents for selected patients, and an analysis of the factors leading to adverse events in patients on warfarin, and how to optimize therapy. In Section I Dr. Weitz discusses new anticoagulant drugs focusing on those that are in the advanced stages of development. These will include drugs that (a) target factor VIIa/tissue factor, including tissue factor pathway inhibitor and NAPc2; (b) block factor Xa, including the synthetic pentasaccharide and DX9065a; (c) inhibit factors Va and VIIIa, i.e., activated protein C; and (d) block thrombin, including hirudin, argatroban, bivalirudin and H376/95. Oral formulations of heparin will also be reviewed. In Section II, Dr. Comerota will discuss the use of thrombolysis for selected patients with venous thromboembolism. Fibrinolytic therapy, which has suffered from a high risk/benefit ratio for routine deep venous thrombosis, may have an important role to play in patients with iliofemoral venous thrombosis. Dr. Comerota presents his own results with catheter-directed thrombolytic therapy and the results from a large national registry showing long-term outcomes and the impact on quality of life. In Section III, Dr. Ansell presents a critical analysis of the factors responsible for adverse events with oral anticoagulants and the optimum means of improving outcomes. The poor status of present day anticoagulant management is reviewed and the importance of achieving a high rate of "time in therapeutic range," is emphasized. Models of care to optimize outcomes are described, with an emphasis on models that utilize patient self-testing and patient self-management of oral anticoagulation which are considered to be the ultimate in anticoagulation care. The treatment of venous and arterial thromboembolism is undergoing rapid change with respect to the development of new antithrombotic agents, an expanding list of new indications, and new methods of drug delivery and management. In spite of these changes, many of the traditional therapeutics are still with us and continue to play a vital role in the treatment of thromboembolic disease. The following discussion touches on a wide range of therapeutic interventions, from old to new, exploring the status of anticoagulant drug development, describing a new intervention for iliofemoral venous thrombosis, and analyzing the critical factors for safe and effective therapy with oral anticoagulants.

Advances in Therapy and the Management of Antithrombotic Drugs for Venous Thromboembolism

AbstractThis review focuses on antithrombotic therapy for venous thromboembolism and covers a diverse range of topics including a discussion of emerging anticoagulant drugs, a renewed focus on thrombolytic agents for selected patients, and an analysis of the factors leading to adverse events in patients on warfarin, and how to optimize therapy. In Section I Dr. Weitz discusses new anticoagulant drugs focusing on those that are in the advanced stages of development. These will include drugs that (a) target factor VIIa/tissue factor, including tissue factor pathway inhibitor and NAPc2; (b) block factor Xa, including the synthetic pentasaccharide and DX9065a; (c) inhibit factors Va and VIIIa, i.e., activated protein C; and (d) block thrombin, including hirudin, argatroban, bivalirudin and H376/95. Oral formulations of heparin will also be reviewed.In Section II, Dr. Comerota will discuss the use of thrombolysis for selected patients with venous thromboembolism. Fibrinolytic therapy, which has suffered from a high risk/benefit ratio for routine deep venous thrombosis, may have an important role to play in patients with iliofemoral venous thrombosis. Dr. Comerota presents his own results with catheter-directed thrombolytic therapy and the results from a large national registry showing long-term outcomes and the impact on quality of life.In Section III, Dr. Ansell presents a critical analysis of the factors responsible for adverse events with oral anticoagulants and the optimum means of improving outcomes. The poor status of present day anticoagulant management is reviewed and the importance of achieving a high rate of “time in therapeutic range,” is emphasized. Models of care to optimize outcomes are described, with an emphasis on models that utilize patient self-testing and patient self-management of oral anticoagulation which are considered to be the ultimate in anticoagulation care. The treatment of venous and arterial thromboembolism is undergoing rapid change with respect to the development of new antithrombotic agents, an expanding list of new indications, and new methods of drug delivery and management. In spite of these changes, many of the traditional therapeutics are still with us and continue to play a vital role in the treatment of thromboembolic disease. The following discussion touches on a wide range of therapeutic interventions, from old to new, exploring the status of anticoagulant drug development, describing a new intervention for iliofemoral venous thrombosis, and analyzing the critical factors for safe and effective therapy with oral anticoagulants.

Advances in Therapy and the Management of Antithrombotic Drugs for Venous Thromboembolism

This review focuses on antithrombotic therapy for venous thromboembolism and covers a diverse range of topics including a discussion of emerging anticoagulant drugs, a renewed focus on thrombolytic agents for selected patients, and an analysis of the factors leading to adverse events in patients on warfarin, and how to optimize therapy. In Section I Dr. Weitz discusses new anticoagulant drugs focusing on those that are in the advanced stages of development. These will include drugs that (a) target factor VIIa/tissue factor, including tissue factor pathway inhibitor and NAPc2; (b) block factor Xa, including the synthetic pentasaccharide and DX9065a; (c) inhibit factors Va and VIIIa, i.e., activated protein C; and (d) block thrombin, including hirudin, argatroban, bivalirudin and H376/95. Oral formulations of heparin will also be reviewed.In Section II, Dr. Comerota will discuss the use of thrombolysis for selected patients with venous thromboembolism. Fibrinolytic therapy, which has suffered from a high risk/benefit ratio for routine deep venous thrombosis, may have an important role to play in patients with iliofemoral venous thrombosis. Dr. Comerota presents his own results with catheter-directed thrombolytic therapy and the results from a large national registry showing long-term outcomes and the impact on quality of life.In Section III, Dr. Ansell presents a critical analysis of the factors responsible for adverse events with oral anticoagulants and the optimum means of improving outcomes. The poor status of present day anticoagulant management is reviewed and the importance of achieving a high rate of “time in therapeutic range,” is emphasized. Models of care to optimize outcomes are described, with an emphasis on models that utilize patient self-testing and patient self-management of oral anticoagulation which are considered to be the ultimate in anticoagulation care. The treatment of venous and arterial thromboembolism is undergoing rapid change with respect to the development of new antithrombotic agents, an expanding list of new indications, and new methods of drug delivery and management. In spite of these changes, many of the traditional therapeutics are still with us and continue to play a vital role in the treatment of thromboembolic disease. The following discussion touches on a wide range of therapeutic interventions, from old to new, exploring the status of anticoagulant drug development, describing a new intervention for iliofemoral venous thrombosis, and analyzing the critical factors for safe and effective therapy with oral anticoagulants.

Post-conference session: Experience with patient self-management of oral anticoagulation

Long-term oral anticoagulation requires careful patient monitoring in order to optimize results and to limit hemorrhagic or thromboembolic complications of treatment. For this reason, any improvement in anticoagulant control and management can be expected to have far-reaching consequences in extending longevity and decreasing complications in anticoagulated patients after heart valve surgery. Because one attractive means of improving anticoagulant management is to give patients a share of the responsibility, a program was designed to encourage patients to take an active role in monitoring their own prothrombin time (PT) and managing their own oral anticoagulation. During the period from August 1986 to February 1992, 600 patients requiring long-term anticoagulation, mainly after heart valve replacement, were trained to measure their own PT at the Cardiac Rehabilitation Center (Herz-Krauslauf-Klinik, Bad Berleburg, Germany) and to manage their own therapy: 216 patients could be followed with regard to their self-determined prothrombin times. The results were within the target range in 83.1% of the PT determinations (n=12,306 measurements) taken by the patients themselves. Neither major bleeding nor thromboembolic complications were observed in 205 patient-years of self-monitoring of PT and self-management of oral anticoagulation.

Long-term Patient Self-management of Oral Anticoagulation

The management of oral anticoagulation is fraught with difficulties. This study assessed a new model of anticoagulation management regarding the ability, safety, and efficacy of patients to self-monitor and self-adjust the dose of their oral anticoagulants guided by a capillary whole-blood prothrombin time (PT) monitor. This investigation is a retrospective cohort study of 20 patients compared with 20 matched control patients receiving oral anticoagulation at a tertiary medical institution. Study patients monitored their PTs 2153 times during a mean interval of 44.7 months compared with 1608 PTs in matched control patients during a mean interval of 42.5 months. Study patients made an average of 11.5 dosage changes per patient, contrasted with 22.7 changes per control patient (P < .001). The PTs in study patients were within the recommended therapeutic range in 88.6% (95% confidence interval, 87.2 to 89.9) of the determinations compared with 68.0% (95% confidence interval, 65.7 to 70.3; P < .001) of the determinations made by the matched control patients. In response to the 2153 PTs, study patients made 67 (3.1%) dosage decisions that were considered incorrect based on physician guidelines. None of these changes led to adverse outcomes. There was no significant difference in complication rates between the two groups. Results from what is the first long-term study of patient self-monitoring of PTs and self-adjustment of the warfarin sodium dosage for oral anticoagulation suggest that patients can successfully measure their own PTs, adjust their own warfarin dosage, and achieve a degree of therapeutic effectiveness at least as good, if not better than patients managed in an anti-coagulation clinic. Larger, prospective, randomized trials are needed to confirm the efficacy and safety of this new approach to therapy and to assess its cost-effectiveness.

Long-term patient self-management of oral anticoagulation

Background : The management of oral anticoagulation is fraught with difficulties. This study assessed a new model of anticoagulation management regarding the ability, safety, and efficacy of patients to self-monitor and self-adjust the dose of their oral anticoagulants guided by a capillary whole-blood prothrombin time (PT) monitor. Methods : This investigation is a retrospective cohort study of 20 patients compared with 20 matched control patients receiving oral anticoagulation at a tertiary medical institution. Results : Study patients monitored their PTs 2153 times during a mean interval of 44.7 months compared with 1608 PTs in matched control patients during a mean interval of 42.5 months. Study patients made an average of 11.5 dosage changes per patient, contrasted with 22.7 changes per control patient (P<.001). The PTs in study patients were within the recommended therapeutic range in 88.6% (95% confidence interval, 87.2 to 89.9) of the determinations compared with 68.0% (95% confidence interval, 65.7 to 70.3 ; P<.001) of the determinations made by the matched control patients. In response to the 2153 PTs, study patients made 67 (3.1%) dosage decisions that were considered incorrect based on physician guidelines. None of these changes led to adverse outcomes. There was no significant difference in complication rates between the two groups. Conclusions : Results from what is the first long-term study of patient self-monitoring of PTs and self-adjustment of the warfarin sodium dosage for oral anticoagulation suggest that patients can successfully measure their own PTs, adjust their own warfarin dosage, and achieve a degree of therapeutic effectiveness at least as good, if not better than patients managed in an anti- coagulation clinic. Larger, prospective, randomized trials are needed to confirm the efficacy and safety of this new approach to therapy and to assess its cost-effectiveness.

Patient Self-Management of Oral Anticoagulation Guided by Capillary (Fingerstick) Whole Blood Prothrombin Times

Physician management of long-term oral anticoagulation is labor-intensive and costly. Moreover, errors of communication may lead to complications. We assessed the ability of patients to regulate their own therapy based on fingerstick prothrombin times (PTs) in order to avoid these problems. Such management was made possible by the availability of a device capable of measuring a PT from a capillary sample of whole blood. Sixteen patients adjusted their warfarin therapy based on specially developed guidelines for a mean duration of 43 weeks (range, 8 to 92 weeks). Four hundred fifty-eight PTs were measured by patients at home during the entire study. Three hundred ninety-three were in therapeutic range and patients correctly continued their dosages. Of the 65 nontherapeutic PTs, patients made correct dose adjustments in 49 and incorrect adjustments in 16. These incorrect adjustments were minor and judged to be clinically insignificant. They often resulted from a misunderstanding of the dosage guidelines. Given the slow onset of warfarin's effect, the assessment of the PT on a weekly or biweekly basis, and the ability to refine dosage guidelines, these errors were not felt to represent a serious drawback to the concept of warfarin self-management. No complications of therapy occurred during the study. Although this mode of therapy needs further evaluation, this pilot study suggests that patient self-management is feasible and that this model of anticoagulant care offers the potential for improved care at reduced cost.

Patient self-management of oral anticoagulation guided by capillary (fingerstick) whole blood prothrombin times

Patient self-management of oral anticoagulation guided by capillary (fingerstick) whole blood prothrombin times