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Application of an adjusted patient blood management protocol in patients undergoing elective total hip arthroplasty: towards a zero-percent transfusion rate in renal patients-results from an observational cohort study.
Hourlier, H, Fennema, P
Journal of orthopaedic surgery and research. 2021;(1):697
Abstract
BACKGROUND Renal patients are at high risk of blood transfusion following major orthopaedic surgery. A variety of patient blood management (PBM) policies have been proposed to reduce the rate of transfusions. The aim of this observational study was to assess the performance of an adjusted PBM protocol in patients with chronic kidney disease (CKD) undergoing elective total hip arthroplasty (THA). METHODS A total of 1191 consecutive patients underwent elective unilateral THA and took part in an adjusted PBM protocol. The PBM protocol consisted of epoetin (EPO) alfa therapy prescribed by the surgeon, routine administration of tranexamic acid (TXA), an avascular approach to the hip and postoperative prophylaxis of thromboembolism. The performance of this PBM protocol was analysed in patients with a glomerular filtration rate (GFR) below or above 60 ml/min/1.73 m2 at baseline. Haemoglobin levels were controlled at admission, on postoperative day (POD) 1 and on POD 7 ± 1. A bleeding index (BI) was used as a proxy for blood loss. RESULTS In total, 153 patients (12.9%) presented with a modification of diet in renal disease value below 60 at baseline. Of these, 20 (13.1%) received EPO therapy and 120 (78.4%) received TXA. None of the patients received allogenic blood transfusions during the first perioperative week. The mean BI for the entire study population was 2.7 (95% CI 2.6, 2.8). CKD did not exert a significant impact on the BI (p = 0.287). However, it was found that both TXA and EPO therapy significantly lowered the BI (difference, - 0.3, p < 0.001). There were no thromboembolic complications in renal patients who received TXA and/or EPO therapy. CONCLUSIONS A zero-percent transfusion rate during the first perioperative week is attainable in patients with stage 3 or stage 4 CKD undergoing contemporary elective THA. With the use of a pragmatic blood-sparing protocol, patients with renal dysfunction did not have an increased risk of bleeding and did not have an increased incidence in the rate of perioperative blood transfusions.
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Effectiveness and Safety of Off-label Dosing of Non-vitamin K Antagonist Anticoagulant for Atrial Fibrillation in Asian Patients.
Lee, KN, Choi, JI, Boo, KY, Kim, DY, Kim, YG, Oh, SK, Baek, YS, Lee, DI, Roh, SY, Shim, J, et al
Scientific reports. 2020;(1):1801
Abstract
Non-vitamin K antagonist anticoagulants (NOACs) have been used to prevent thromboembolism in patients with atrial fibrillation (AF) and shown favorable clinical outcomes compared with warfarin. However, off-label use of NOACs is frequent in practice, and its clinical results are inconsistent. Furthermore, the quality of anticoagulation available with warfarin is often suboptimal and even inaccurate in real-world data. We have therefore compared the effectiveness and safety of off-label use of NOACs with those of warfarin whose anticoagulant intensity was accurately estimated. We retrospectively analyzed data from 2,659 and 3,733 AF patients at a tertiary referral center who were prescribed warfarin and NOACs, respectively, between 2013 and 2018. NOACs were used at off-label doses in 27% of the NOAC patients. After adjusting for significant covariates, underdosed NOAC (off-label use of the reduced dose) was associated with a 2.5-times increased risk of thromboembolism compared with warfarin, and overdosed NOAC (off-label use of the standard dose) showed no significant difference in either thromboembolism or major bleeding compared with warfarin. Well-controlled warfarin (TTR ≥ 60%) reduced both thromboembolism and bleeding events. In conclusion, the effectiveness of NOACs was decreased by off-label use of the reduced dose.
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Management of therapeutic anticoagulation in patients with intracerebral haemorrhage and mechanical heart valves.
Kuramatsu, JB, Sembill, JA, Gerner, ST, Sprügel, MI, Hagen, M, Roeder, SS, Endres, M, Haeusler, KG, Sobesky, J, Schurig, J, et al
European heart journal. 2018;(19):1709-1723
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AIMS: Evidence is lacking regarding acute anticoagulation management in patients after intracerebral haemorrhage (ICH) with implanted mechanical heart valves (MHVs). Our objective was to investigate anticoagulation reversal and resumption strategies by evaluating incidences of haemorrhagic and thromboembolic complications, thereby defining an optimal time-window when to restart therapeutic anticoagulation (TA) in patients with MHV and ICH. METHODS AND RESULTS We pooled individual patient-data (n = 2504) from a nationwide multicentre cohort-study (RETRACE, conducted at 22 German centres) and eventually identified MHV-patients (n = 137) with anticoagulation-associated ICH for outcome analyses. The primary outcome consisted of major haemorrhagic complications analysed during hospital stay according to treatment exposure (restarted TA vs. no-TA). Secondary outcomes comprised thromboembolic complications, the composite outcome (haemorrhagic and thromboembolic complications), timing of TA, and mortality. Adjusted analyses involved propensity-score matching and multivariable cox-regressions to identify optimal timing of TA. In 66/137 (48%) of patients TA was restarted, being associated with increased haemorrhagic (TA = 17/66 (26%) vs. no-TA = 4/71 (6%); P < 0.01) and a trend to decreased thromboembolic complications (TA = 1/66 (2%) vs. no-TA = 7/71 (10%); P = 0.06). Controlling treatment crossovers provided an incidence rate-ratio [hazard ratio (HR) 10.31, 95% confidence interval (CI) 3.67-35.70; P < 0.01] in disadvantage of TA for haemorrhagic complications. Analyses of TA-timing displayed significant harm until Day 13 after ICH (HR 7.06, 95% CI 2.33-21.37; P < 0.01). The hazard for the composite-balancing both complications, was increased for restarted TA until Day 6 (HR 2.51, 95% CI 1.10-5.70; P = 0.03). CONCLUSION Restarting TA within less than 2 weeks after ICH in patients with MHV was associated with increased haemorrhagic complications. Optimal weighing-between least risks for thromboembolic and haemorrhagic complications-provided an earliest starting point of TA at Day 6, reserved only for patients at high thromboembolic risk.
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Anticoagulation in atrial fibrillation: NOAC prescribing in primary health care.
Bastida, C, Corominas, N, Sotoca, JM, Rovira, M
International journal of clinical pharmacy. 2017;(2):478-482
Abstract
Background Few studies assess the use of non-vitamin K antagonist oral anticoagulants (NOACs) in daily practice for the prevention of thromboembolic complications associated to nonvalvular atrial fibrillation (AF). Objectives Describe NOACs' use and analyze its prescribing pattern. Evaluate possible factors associated to adverse events (AEs) and the applicability of prescription support forms. Methods We included patients with AF treated with a NOAC during 2014 in three primary healthcare centers in Barcelona, Spain. Demographic and clinical data was collected, as well as embolic and bleeding risk and reported AEs. Results A total of 101 patients were included, with a median age of 75 years. The NOACs most frequently prescribed were dabigatran and rivaroxaban. An 87.2% of the patients were receiving the recommended dosage. A potential bleeding risk was present in 47% of the subjects. Ten AEs were reported, of which eight hemorrhages. Patients who presented an AE were >65 years and had a higher proportion of concomitant treatment and/or co-morbidities that could prompt to bleeding (p < 0.001). Conclusions Current treatment practice is according to regulatory agencies' recommendations. Close monitoring is especially needed in patients >65 years and at higher risk of bleeding. Prescription support forms help good prescribing and identifying potential individuals at high risk of AEs.
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e-Health-based management of patients receiving oral anticoagulation therapy: results from the observational thrombEVAL study.
Prochaska, JH, Göbel, S, Keller, K, Coldewey, M, Ullmann, A, Lamparter, H, Schulz, A, Schinzel, H, Bickel, C, Lauterbach, M, et al
Journal of thrombosis and haemostasis : JTH. 2017;(7):1375-1385
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UNLABELLED Essentials e-Health based health care by an expert centre may advance management of oral anticoagulation. Outcome of patients was compared between an e-health based coagulation service and regular care. Patients in the coagulation service cohort experienced a significantly better clinical outcome. Lower risk for adverse events was related to anticoagulation-specific and non-specific outcome. SUMMARY Background Management of oral anticoagulation (OAC) therapy is essential to minimize adverse events in patients receiving vitamin K-antagonists (VKAs). Data on the effect of e-health-based anticoagulation management systems on the clinical outcome of OAC patients are limited. Objectives To compare the clinical outcome of OAC patients managed by an e-health-based coagulation service (CS) with that of patients receiving regular medical care (RMC). Methods The prospective multicenter cohort study thrombEVAL (NCT01809015) comprised 1558 individuals receiving RMC and 760 individuals managed by a CS. Independent study monitoring and adjudication of endpoints by an independent review panel were implemented. Results The primary study endpoint (composite of thromboembolism, clinically relevant bleeding and death) occurred in 15.7 per 100 patient-years (py) with RMC and in 7.0 per 100 py with the CS (rate ratio [RR], 2.3; 95% confidence interval [CI], 1.7-3.1). Rates for major and clinically relevant bleeding were higher with RMC than with the CS: 6.8 vs. 2.6 and 10.1 vs. 3.6 per 100 py, respectively. Thromboembolic events showed an RR of 1.5 (95% CI, 0.8-2.6) comparing RMC with the CS. Hospitalization (RR, 2.6; 95% CI, 2.3-3.0) and all-cause mortality (RR, 4.6; 95% CI, 2.8-7.7) were markedly more frequent with RMC. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, treatment characteristics and sociodemographic status, hazard ratios (HR) for the primary endpoint (HR, 2.2; 95% CI, 1.5-3.4), clinically relevant bleeding (HR, 3.1; 95% CI, 1.7-5.5), hospitalization (HR, 2.2; 95% CI, 1.8-2.8) and all-cause mortality (HR, 5.6; 95% CI, 2.9-11.0) favored CS treatment. Conclusions In this study, e-health-based management of OAC therapy was associated with a lower frequency of OAC-specific and non-specific adverse events.
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Effectiveness, safety and costs of thromboembolic prevention in patients with non-valvular atrial fibrillation: phase I ESC-FA protocol study and baseline characteristics of a cohort from a primary care electronic database.
Giner-Soriano, M, Vedia Urgell, C, Roso-Llorach, A, Morros, R, Capellà, D, Castells, X, Ferreira-González, I, Troncoso Mariño, A, Diògene, E, Elorza, JM, et al
BMJ open. 2016;(1):e010144
Abstract
PURPOSE Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain. PARTICIPANTS The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007-2012. FINDINGS TO DATE A total of 22,585 patients with non-valvular atrial fibrillation were included in the baseline description. Their mean age was 72.8 years and 51.6% were men. The most commonly prescribed antithrombotics were vitamin K antagonists (40.1% of patients) and platelet aggregation inhibitors (32.9%); 25.3% had not been prescribed antithrombotic treatment. Age, gender, comorbidities and co-medication at baseline were similar to those reported for previous studies. FUTURE PLANS The next phase in the ESC-FA study will involve assessing the effectiveness and safety of antithrombotic treatments, analysing stroke events and bleeding episodes' rates in our patients (rest of phase I), describing the current management of the disease and its costs in our setting, and assessing how the introduction of new oral anticoagulants changes the stroke prevention in non-valvular atrial fibrillation.
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Evaluation of oral anticoagulation therapy: rationale and design of the thrombEVAL study programme.
Prochaska, JH, Coldewey, M, Göbel, S, Keller, K, Hendelmeier, M, Konstantinides, S, Münzel, T, Wild, PS, ,
European journal of preventive cardiology. 2015;(5):622-8
Abstract
BACKGROUND Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine. Increasing life expectancy, demographic changes, and novel oral anticoagulants have led to an increasing complexity of medical therapy. However, data on quality and management of VKA therapy with phenprocoumon in current medical care are limited. Our aim is to investigate the quality of OAC with VKA in current health care and to evaluate the potential for improvements. STUDY DESIGN The investigator-initiated thrombEVAL study programme comprises two cohorts of patients treated with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a multicentre cohort of patients in regular medical care and a multilocal, single-centre cohort of patients in a telemedicine-based coagulation service. The study programme is expected to enrol a total number of approximately 2000 to 2500 patients. Both cohorts will build on a detailed clinical assessment of participants and anticoagulation therapy at study enrolment. Subsequently active and passive follow-up investigations are carried out to document and validate complications of the treatment. The primary short-term outcome is the distribution of time in therapeutic range; the primary long-term outcome comprises the composite of stroke, systemic embolism, myocardial infarction, major and clinically relevant bleeding, and death. CONCLUSIONS The thrombEVAL project will provide a large prospective observational cohort of patients predominantly treated with phenprocoumon. It will evaluate the quality of oral anticoagulation in regular medical care and a telemedicine-based coagulation service.