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.

Long-term effectiveness and safety of self-management of oral anticoagulants in real-world settings

BackgroundThe patient self-management (PSM) is an effective approach for controlling the international normalized ratio, INR, within the therapeutic range. Nevertheless, most of the literature derives from randomized clinical trials, and no from routine clinical practice. The main objective of the present study was to evaluate long-term effectiveness and safety of PSM of oral anticoagulants (OACs) in real-world settings.MethodsThis prospective cohort study involved 808 patients who were trained for PSM between July 2009 and March 2012, and followed-up for a maximum observational period of 5 years. The follow-up consisted of a visit to the physician every 6 months. All patients used the same type of portable coagulometer, able to store digitally up to 100 INR measurements. Effectiveness outcomes included the percentage of patients within the therapeutic range, the time within therapeutic range (TTR), and the evolution of the TTR over 365 days of follow-up. Long-term safety profile of PSM included the incidence of all-cause deaths and complications (thromboembolic or hemorrhagic) reported between July 2009 and June 2014, and the time to event.ResultsThe median follow-up was 3.3 years. The percentage of patients within therapeutic INR target range was 67.5%. The median TTR was 71.5%. The TTR increased over the follow-up period, either overall and regarding target INR. All-cause mortality was 2.4 per 100 patient-years (59 cases). The thromboembolic event rate was 0.9 per 100 patient-years (24 cases). The rate of major hemorrhages was 0.45 per 100 patient-years. Patients who drop out the PSM to perform the conventional management had greater rates of complications: 2.4, 1.8, and 3.4 per 100 patient-years for thromboembolic complications, major hemorrhagic events, and mortality, respectively.ConclusionsThe PSM of OACs is effective for maintaining patients within the INR therapeutic range for a long period of time in routine clinical practice. Results of the present study suggest that its effectiveness is at least comparable to the conventional management. Moreover, it seems safe in real-world settings, by preventing all-cause mortality, and thromboembolic and major hemorrhagic complications.Trial registrationThis study was not a trial, thus registration was not required.

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Patient self-testing and self-management of oral anticoagulation with vitamin K antagonists: guidance from the British Committee for Standards in Haematology.

Ian Jennings, Dianne Kitchen, David Keeling, David Fitzmaurice and Carl Heneghan on behalf of the BCSH Committee UK NEQAS (Blood Coagulation), Sheffield, Oxford University Hospitals, Oxford Haemophilia and Thrombosis Centre, Churchill Hospital, Oxford, The University of Birmingham, Primary Care Clinical Sciences, Edgbaston, Birmingham, and Department of Primary Care Health Sciences, Oxford University, Oxford, UK

Self-management of oral anticoagulation.

Properly dosed oral anticoagulation effectively prevents thromboembolic events. It is unclear whether adult patients with an indication for long-term oral anticoagulation can benefit from self-management in terms of patient-oriented endpoints and improved coagulation values. We selectively searched the Medline database for high-quality systematic reviews based on randomized controlled trials of self-measurement or self-management of oral anticoagulation, compared to standard treatment. We identified eight review articles based on overlapping sets of ran - domized clinical trials. In all of these systematic reviews, patients who performed self-measurement or self-management had a 40% to 50% lower rate of thromboembolic events; in six of them, the mortality was also significantly lower, by 30% to 50%. Subgroup analysis revealed that these effects were present exclusively in patients who performed self-management, and not in those who only performed self-measurement. None of the review articles revealed any difference in the frequency of severe hemorrhagic events. Quality of life and patient satisfaction were rated in five reviews, which, however, used different instruments, with the result that no clear conclusions could be drawn. All of the review articles documented an improvement in coagulation values, but information on statistical significance was mostly lacking. Adults with an indication for long-term oral anticoagulation benefit from self-management, as compared to standard treatment with management of dosing by a physician. A limitation of this study is that the multiple review articles on which it is based were largely analyses of the same group of clinical trials.

Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions

In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions. One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6±2.1 years, representing 3612 patient-years. During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P=0.213) and 15.4% thromboembolic events (P=0.064) in the Conv-T group. Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P=0.03); grade III thromboembolic events: 0.6 versus 5.0% (P=0.011)]. Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P<0.001). Actuarial survival after 1, 5 and 10 years was 100, 99 and 97 with Self-M and 100, 95 and 81% with Conv-T, respectively (P<0.001). Univariate risk factors for mortality were age (P=0.008), type of operation (P=0.021) and conventional OA (P<0.001). In multivariate analysis, only conventional OA reached significance (P<0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.

Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data

Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

Self-monitoring and self-management of oral anticoagulation

Self-monitoring and self-management of oral anticoagulation

Weekly INR self-testing did not reduce stroke, major bleeding, or death more than monthly clinic testing

ACP Journal Club18 January 2011Weekly INR self-testing did not reduce stroke, major bleeding, or death more than monthly clinic testingDaniel M. Witt, PharmD, FCCP, BCPS, CACPDaniel M. Witt, PharmD, FCCP, BCPS, CACPKaiser Permanente Colorado, Aurora, Colorado, USA (D.M.W.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-154-2-201101180-02004 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Source CitationMatchar DB, Jacobson A, Dolor R, et al. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010;363:1608-20. https://pubmed.ncbi.nlm.nih.gov/20961244Clinical Impact RatingsGIM/FP/GP: Cardiology: Hematology: References1 Garcia-Alamino JM, Ward AM, Alonso-Coello P, et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev. 2010;(4):CD003839. [PMID: 20393937] Google Scholar2 Cundiff DK. Clinical evidence for rebound hypercoagulability after discontinuing oral anticoagulants for venous thromboembolism. Medscape J Med. 2008;10:258. [PMID: 19099008] Google Scholar3 Rodger MA, Kahn SR, Wells PS, et al. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008;179:417-26. [PMID: 18725614] Google Scholar Author, Article, and Disclosure InformationAffiliations: Kaiser Permanente Colorado, Aurora, Colorado, USA (D.M.W.)This article was published at Annals.org on 4 January 2011. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoReview: Positive D-dimer results predict recurrence after first unprovoked VTE regardless of test timing or cutpoint, or patient age Daniel M. Witt Metrics 18 January 2011Volume 154, Issue 2Page: JC1-4KeywordsAnticoagulantsHemorrhageObesityPatientsQuality of lifeStroke ePublished: 18 January 2011 Issue Published: 18 January 2011 CopyrightCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...

Self-monitoring and self-management of oral anticoagulation

Self-monitoring and self-management of oral anticoagulation

Self-management program improves anticoagulation control and quality of life: a prospective randomized study

Previous retrospective studies suggest that patients' self management of oral anticoagulants leads to improved control. In this prospective randomized study, we investigated the effects of self management on the control of anticoagulant therapy and quality of life. Comparison with the conventional management through the Dutch Thrombosis Service is addressed. Between January 2005 and June 2007, 62 consecutive patients who underwent elective mechanical aortic valve replacement were included in this study. Patients were randomized into two groups: (1) conventional group controlled by the Local Thrombosis Service, and (2) self management group using CoaguChek. Primary endpoints were the total number of international normalized ratio (INR) values within the target range as well as the quality of life measurements (SF-36v2) one year postoperatively. The number of INR values within the target range (2.5-4.5) was significantly higher in the self management group (mean=72.9+/-11%) than in the conventional group (53.9+/-14%; p=0.01). Both groups showed an improvement in the quality of life scores one year postoperatively. However, postoperative improvement was statistically significant in the self management group regarding the physical component summary only (p=0.001). Despite the well-organized INR control by the Thrombosis Service in The Netherlands, self management program after adequate training improves the INR control. Postoperative improvement in the quality of life scores was significant in the self management group with regards to the physical component summary only. Further studies are needed to describe whether self management program will reduce the risk of bleeding and/or thrombo-embolism.

Patient self-testing and self-management of oral anticoagulation

The development of portable instruments for measuring the prothrombin time (PT) in capillary whole blood has made it possible for patients on lifelong coumarin therapy to monitor the effect of the anticoagulant themselves (patient self-testing) and to adjust the dosage if necessary on their own (patient self-management). Dosage variations between individual patients and the narrow therapeutic range of the anticoagulant account for the need to monitor its effect, in order to minimize the risk of thromboembolism resulting from inadequate anticoagulation as well as the risk of bleeding due to overanticoagulation. This review focuses on the prerequisites for the successful implementation of patient self-testing and self-management, such as the selection of eligible patients, appropriate training and the reliability of available instruments. The outcomes of relevant clinical studies involving patient self-testing and self-management are also discussed.

Self-management of oral anticoagulation with low- or conventional-intensity INR did not differ for thromboembolism prevention

Source Citation Koertke H, Zittermann A, Tenderich G, et al. Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagul...

Self-management of oral anticoagulation reduces major outcomes in the elderly

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.

Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II

In mechanical heart valve recipients, low-dose international normalized ratio (INR) self-management of oral anticoagulants can reduce the risk of developing thrombo-embolic events and improve long-term survival compared with INR control by a general practitioner. Here, we present data on the safety of low-dose INR self-management. In a prospective, randomized multi-centre trial, 1346 patients with a target INR range of 2.5-4.5 and 1327 patients with a target INR range of 1.8-2.8 for aortic valve recipients and an INR range of 2.5-3.5 for mitral or double valve recipients were followed up for 24 months. The incidence of thrombo-embolic events that required hospital admission was 0.37 and 0.19% per patient year in the conventional and low-dose groups, respectively (P = 0.79). No thrombo-embolic events occurred in the subgroups of patients with mitral or double valve replacement. The incidence of bleeding events that required hospital admission was 1.52 and 1.42%, respectively (P = 0.69). In the majority of patients with bleeding events, INR values were < 3.0. Mortality rate did not differ between the study groups. Data demonstrate that low-dose INR self-management does not increase the risk of thrombo-embolic events compared with conventional dose INR self-management. Even in patients with low INR target range, the risk of bleeding events is still higher than the risk of thrombo-embolism.

Patient self management of oral anticoagulation in routine care in the UK

Background:Self management of anticoagulation: a randomised trial (SMART) was the first large scale UK trial to assess clinical and cost effectiveness of patient self management (PSM) of oral anticoagulation therapy...

Self-management of oral anticoagulation in the elderly: Rationale, design, baselines and oral anticoagulation control after one year of follow-up

Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.

Long-term anticoagulation self-testing after mechanical heart valve replacement

Objectives: Management of oral anticoagulation (OA) is a key determent to prevent thromboembolic or hemorrhagic complications after mechanical heart valve (MHV) replacement. We report a single center experience with self-management of OA.

INR comparison between the CoaguChek® S and a standard laboratory method among patients with self-management of oral anticoagulation

Introduction Portable coagulation monitors have been developed to measure International Normalised Ratio (INR) in orally anticoagulated patients using capillary whole blood from a finger stick. Because of unsatisfactory precision of some of the monitors in comparison with laboratory methods new devices are being developed. In the present study we compared INR determination with the CoaguChek S device with a standard laboratory method among patients with self-management of oral anticoagulation (OAC). Methods Two hundred and forty-two patients performing self-management of OAC were enrolled into this study. Parallel INR measurements were performed within one hour. Capillary INR measurements (INRcap) were done by the patients with the CoaguChek S and venous INR (INRven) by qualified medical staff using a standard laboratory method. Results We found a correlation coefficient ( r S) of 0.85 (95% CI: 0.81–0.88) among the 242 patients between INRven and INRcap. In 84.4% of the INR parallel measurements the difference between the two values was below 0.5 INR units. In only 2 of 242 cases the difference was > 1 INR unit (1.1 and 1.3). The slope of the Passing Bablok regression line was 0.91 (95% CI: 0.83–1.0) and the y-intercept 0.06 (95% CI: − 0.20–0.25). Agreement between both methods was 90.5% (95% CI: 86.8–94.2) and standard-agreement even 97.1% (95% CI: 95–99.2). Conclusions INR measurement with CoaguChek S device by trained patients revealed reliable results in comparison to the values obtained with a standard laboratory method.

A meta-analysis of self-management of oral anticoagulation

A meta-analysis of self-management of oral anticoagulation