Self-reported adherence to direct oral anticoagulants versus warfarin therapy in a specialized thrombosis service-a cross-sectional study of patients in a Canadian Health Region.

PURPOSE: Direct oral anticoagulants (DOACs) have a better safety and efficacy profile than warfarin and are currently recommended for stroke prevention in non-valvular atrial fibrillation (AF) and treatment of venous thromboembolism (VTE). Given that DOACs do not require regular laboratory monitoring compared to warfarin, patients' interactions with the health care system is reduced. Adequate adherence to DOACs is important and reported adherence to anticoagulation is unclear in clinical practice. This study aims to assess self-reported adherence to oral anticoagulants in a specialized Adult Outpatient Thrombosis Service (TS).  METHODS: This cross-sectional study included patients aged ≥ 18 years who were prescribed an oral anticoagulant and had attended at least one appointment with an Adult Outpatient Thrombosis Service (TS) between October 10, 2017, and May 31, 2019. Adherence to oral anticoagulant therapy was assessed using the 12-item validated Adherence to Refills and Medications Scale (ARMS) score. Logistic regression analyses were used to evaluate association between patient characteristics and medication adherence. Adherence rates in DOACs and warfarin were compared. RESULTS: Three hundred and ninety-nine patients completed and returned the survey. Of the 399 who completed the survey, 74% were prescribed DOACs and 26% received warfarin. Most of the patients (89.3%) were ≥ 50 years of age and half (57.3%) were male. About two-thirds (67%) had at least post-secondary education. The duration of anticoagulation use differed between patients on DOAC and warfarin; a greater proportion of those who had used anticoagulants for less than 1 year was on DOACs compared to warfarin (20.9% vs 4.9%, p = 0.001). For patients who had been on anticoagulation for > 5 years, the proportion of warfarin patients was greater than DOAC (57.8% vs 20.5%, p = 0.001). Self-reported adherence to oral anticoagulant therapy using the 12-item ARMS scale for warfarin and DOACs were 87.3% and 90.9%, respectively. Among the warfarin users, patient satisfaction with TS was associated with medication adherence (OR = 0.22; 95% CI: 0.05-0.89). CONCLUSIONS: Self-reported medication adherence was similar between warfarin and DOACs. Since suboptimal adherence is associated with poor clinical outcomes and increased costs, various stakeholders should emphasize the importance of medication adherence to oral anticoagulants at each patient encounter.

Adherence to Antithrombotic Therapy for Patients Attending a Multidisciplinary Thrombosis Service in Canada - A Cross-Sectional Survey.

Background: Poor medication adherence puts patients who require antithrombotic therapy at greater risk of complications. We started a multidisciplinary Adult Outpatient Thrombosis Service in 2017 in a Canadian health authority and were interested in the level of medication adherence in the population attending. AimS: The aim of this study is to assess adherence to antithrombotic medications for patients attending a multidisciplinary Thrombosis Service. Methods: We conducted a cross-sectional survey of outpatients seen at the Thrombosis Service between 2017 and 2019 using the 12-item validated Adherence to Refills and Medications Scale (ARMS) to assess adherence to antithrombotic (anticoagulants and antiplatelet) therapy. Linear regression analysis examined the factors associated with adherence to antithrombotic therapy. Results: Of 1058 eligible patients, 53.2% responded to the survey. Seventeen were excluded from the analysis for missing more than 6 responses to the 12 items on the ARMS. About 55% (n = 297) were on direct oral anticoagulants (DOACs), 19% (n = 102) on warfarin, 5.0% (n = 27) on low molecular weight heparin, 3.3% (n = 18) on antiplatelet therapy and 18% (n = 96) were no longer on antithrombotic therapy. Nearly half (47%, n = 253) had taken antithrombotic therapy for 1-5 years while 28% (n = 150) and 25% (n = 137) had taken antithrombotic treatments for <1 and >5 years, respectively. Most patients (87%, n = 475) were ≥50 years and half (51%, n = 277) were male. The mean adherence score was 13.9 (SD±2.2) and 88% (n = 481) of participants were adherent to antithrombotic treatment (ARMS = 12-16). Multivariable linear regression showed that patients with post-graduate education had 0.4% lower adherence to antithrombotic therapy as compared with elementary education (ß = 0.0039, p = 0.048). Patients with prior antithrombotic agent use >5 years had 0.5% lower adherence to antithrombotic treatment compared to patients with <1 year (ß = 0.0047, p = 0.0244). Conclusion: Self-reported adherence to antithrombotic therapy was high (88%) within a multidisciplinary Thrombosis Service. Patients with advanced education and prolong duration of antithrombotic therapy were more likely to have lower self-reported adherence to antithrombotic treatment.

Patient satisfaction with quality of care of a multidisciplinary thrombosis service - a cross sectional survey.

BACKGROUND: In October 2017 we opened a multidisciplinary Adult Outpatient Thrombosis Service (Thrombosis Service) in a regional health authority servicing over 300 000 people. The Thrombosis Service is a comprehensive thrombosis and anticoagulation management program with unique, interrelated clinics providing a broad spectrum of care for this patient group. Evaluation of patient satisfaction with this new model of patient care is an important quality measurement. METHODS: We conducted a cross-sectional survey of patients who attended the Thrombosis Service between October 2017 and May 2019. We measured patient satisfaction with the seven-item Short Assessment of Patient Satisfaction (SAPS) which uses a 5 point scale (0-4) for responses. The continuous score range for SAPS is 0 to 28. Categorical responses for SAPS are defined as 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied. We used linear regression analysis to examine the associations between patients' characteristics and their satisfaction with the Thrombosis Service. RESULTS: Of the 1058 surveys distributed, 563 were returned. The mean score for the SAPS was 22.1 (SD 4.1, range 8 to 28). For the categorical response, 85% were satisfied or very satisfied with the Thrombosis Service. The multivariate analysis showed patients with post-secondary education were more satisfied with the Thrombosis Service (ß-coefficient 1.6153, p = 0.024), and patients taking warfarin were less likely to be satisfied with the Thrombosis Service (ß-coefficient -1.5832, p = 0.0390). CONCLUSIONS: The majority of survey participants (85%) who attended an appointment in one of the Thrombosis Service clinics were satisfied or very satisfied with the care they received. This information may benefit other centres who are interested in developing a program to manage thrombosis and anticoagulation.

Assessment of a Pharmacist-Led Direct Oral Anticoagulant Monitoring Clinic.

BACKGROUND: Direct oral anticoagulants (DOACs) are recommended as first-line therapy for treatment and prevention of venous thromboembolism (VTE) and prevention of stroke related to nonvalvular atrial fibrillation. Recent publications have suggested incorporating DOAC monitoring into anticoagulant management clinics. The Eastern Health Adult Outpatient Thrombosis Service (Newfoundland and Labrador) includes a pharmacist-led DOAC monitoring clinic that uses standardized evidence-based care processes. OBJECTIVES: To describe a new pharmacist-led DOAC monitoring clinic and to assess patients' adherence to medication therapy, adherence to guideline-recommended frequencies for blood work, and adverse and non-adverse events. METHODS: This retrospective chart review involved patients who attended their first visit to the DOAC clinic between October 10, 2017, and May 31, 2018. Patients were followed until November 30, 2018. Data were abstracted from electronic hospital records and the provincial pharmacy network. Descriptive statistics were used to analyze the data: categorical variables were presented as frequencies and percentages; continuous variables were analyzed and presented as means with standard deviations and, where applicable, as medians with interquartile ranges. RESULTS: Forty-seven patients, who attended a total of 74 clinic visits, were included. Twenty-eight patients (60%) were adherent to their DOAC therapy. All patients had blood work completed before each clinic appointment. The mean time between the first and second sets of blood tests was 6.2 (standard deviation [SD] 1.4) months and between the second and third sets of blood tests was 5.1 (SD 1.0) months. There were no episodes of VTE or major bleeding. There was 1 cerebrovascular accident (3.2 events per 100 person-years, 95% confidence interval [CI] 0.2-15.7) and 5 episodes of clinically relevant non-major bleeding (12.8 events per 100 person-years, 95% CI 4.1-30.1). Pharmacists identified 51 issues at the clinic appointments, of which 48 were medication-related. Referral to the Thrombosis Service physician was required to resolve 8 (16%) of the issues identified. A brief discussion between the Thrombosis Service physician and pharmacist was required to resolve 30 (59%) of the issues, with 13 (25%) resolved by the pharmacist alone. CONCLUSIONS: This study described the implementation and outcomes of a novel pharmacist-led DOAC clinic. Clinic patients underwent blood work at recommended intervals and received guidance on adherence and adverse events; as such, patients had follow-up that aligned with guideline recommendations.

CONTEXTE: Les anticoagulants oraux directs (AOD) sont recommandés comme thérapie de première ligne pour le traitement et la prévention de la thromboembolie veineuse (TEV) et la prévention des AVC liés à la fibrillation auriculaire non valvulaire. Des publications récentes ont proposé d'incorporer le contrôle des AOD dans les cliniques des anticoagulants. L'Eastern Health Adult Outpatient Thrombosis Service (St John's, Terre-Neuve-et-Labrador) comprend une clinique de surveillance des AOD, dirigée par des pharmaciens qui utilisent des processus de soins standardisés basés sur des éléments de preuve. OBJECTIFS: Décrire une nouvelle clinique de surveillance des AOD dirigée par des pharmaciens et évaluer l'adhésion des patients à la pharmacothérapie, le respect de la fréquence des analyses sanguines recommandées dans les lignes directrices ainsi que les effets indésirables et ceux qui ne le sont pas. MÉTHODES: Cet examen rétrospectif des dossiers impliquait des patients ayant effectué leur première visite à la clinique AOD entre le 10 octobre 2017 et le 31 mai 2018. Les patients étaient suivis jusqu'au 30 novembre 2018. Les données analysées provenaient de dossiers d'hospitalisation électroniques et du réseau des pharmacies provinciales. Des statistiques descriptives ont servi à analyser les données : les variables catégorielles ont été présentées sous forme de fréquences et de pourcentages; les variables continues ont été analysées et présentées sous forme de moyennes avec les écarts-types et, le cas échéant, sous forme de moyennes avec les écarts interquartiles. RÉSULTATS: Quarante-sept patients, ayant effectué 74 visites en clinique, ont participé à l'étude. Vingt-huit patients (60 %) se conformaient à leur thérapie AOD. Les analyses sanguines de tous les patients ont été effectuées avant chaque rendez-vous en clinique. Le temps moyen entre le premier et le deuxième ensemble de tests sanguins était de 6,2 mois (écart-type standard [ET] 1,4), et de 5,1 mois (ET 1) entre le deuxième et le troisième. Aucun épisode de TEV ou d'hémorragie importante n'a eu lieu. Il y a eu un accident cérébrovasculaire (3,2 événements par 100 années-personnes; intervalle de confiance [IC] à 95 % 0,2­15,7) et 5 épisodes de saignements non majeurs et cliniquement pertinents (12,8 événements par 100 années-personnes, IC 95 % 4,1­30,1). Les pharmaciens ont décelé 51 problèmes lors des rendez-vous en clinique; parmi ceux-ci, 48 étaient liés aux médicaments. Il a fallu faire appel au médecin du service des thromboses pour résoudre 8 (16 %) problèmes. Une brève discussion entre ce médecin et le pharmacien a été nécessaire pour résoudre 30 (59 %) problèmes et 13 (25 %) ont été réglés uniquement par le pharmacien. CONCLUSIONS: Cette étude décrivait la mise en place et les résultats d'une nouvelle clinique AOD dirigée par les pharmaciens. Les patients de la clinique ont subi une analyse sanguine aux intervalles recommandés et ont reçu des conseils sur l'adhésion et les effets indésirables; les patients ont donc bénéficié d'un suivi conforme aux lignes directrices.

Recommendations for the anticoagulation of pregnant patients with mechanical heart valves.

BACKGROUND: The management of pregnant patients with mechanical heart valves remains challenging because there are no large randomised studies to provide guidelines for effective anticoagulant therapy. Both vitamin K antagonists and heparins may be associated with maternal and foetal adverse events. METHOD: The Southern African Society of Thrombosis and Haemostasis reviewed available literature and comprehensive evidence-based guidelines for the anticoagulation of pregnant patients with mechanical heart valves. A draft document was produced and revised by consensus agreement. The guidelines were adjudicated by independent international experts to avoid local bias. RESULTS AND CONCLUSION: We present concise, practical guidelines for the clinical management of pregnant patients with mechanical heart valves. Recommendations reflect current best practice which will hopefully lead to improved anticoagulation practice in this select group of high risk patients.

A prospective trial showing the safety of adjusted-dose enoxaparin for thromboprophylaxis of pregnant women with mechanical prosthetic heart valves.

OBJECTIVE: To determine whether dosage adjustment of enoxaparin during pregnancy, to maintain a peak anti-Xa of 1.0 to 1.2 U/mL, is safe for women with mechanical prosthetic heart valves (MPHV). DESIGN: A prospective observational study. SETTING: This study was performed at Charlotte Maxeke Johannesburg Academic Hospital from 2007 to 2009. POPULATION: Fifteen women with MPHVs. METHODS: Women were treated with enoxaparin with dosage adjustment to achieve a peak anti-Xa of 1.0 to 1.2 U/ mL. MAIN OUTCOME MEASURES: Main outcomes measured were prosthetic valve thrombosis, bleeding, and maternal mortality. RESULTS: There was no maternal mortality. None of the women developed valvular thrombosis during pregnancy. In all, 2 women developed epistaxis and another developed spotting per vaginum. CONCLUSION: Our data show that enoxaparin may be administered safely during pregnancy to pregnant women with MPHV when there is dosage adjustment throughout pregnancy to maintain an anti-Xa of 1.0 to 1.2 U/mL.