ABSTRACT
BACKGROUND: Home INR testing (patient self-testing) is feasible and effective for warfarin patients but little is known about real-world differences in outcomes for patients using PST versus laboratory-based INR monitoring. OBJECTIVE: To compare the safety/efficacy of patient self-testing of real-world warfarin therapy versus office/lab-based monitoring of therapy. DESIGN/SETTING/PARTICIPANTS/EXPOSURE: A retrospective claims-based analysis of warfarin patients enrolled in the MarketScan® Commercial Claims and Encounters and Medicare databases between January 1, 2013, and March 30, 2020. Stratification was based on INR testing method: patient self-testing versus testing at physicians' offices/local laboratory. The probability of adverse events in each cohort was determined after adjusting for demographic and baseline clinical characteristics using a repeated measures analysis. MAIN MEASURES: Rates of all adverse events: deep venous thrombosis, pulmonary embolism, bleeding, and stroke. A secondary outcome of interest was emergency department visits. KEY RESULTS: A total of 37,837 patients were included in the analysis: 1592 patients in the patient self-testing group and 36,245 in the office-based therapy group. After adjusting for demographic and baseline clinical characteristics, patients in the office-based group had statistically significantly higher rates of all adverse events (incidence rate ratio [IRR]=2.07, 95% CI [1.82, 2.36]), and specific adverse events including thromboembolism (IRR=4.38, 95% CI [3.29, 5.84]), major bleed (IRR=1.45, 95% CI [1.28, 1.64]), and stroke (IRR=1.30, 95% CI [1.05, 1.61]) than patients in the patient self-testing group. Office-based patients also had a statistically significant higher rate of emergency department visits than patient self-testing patients (IRR = 1.65, 95% CI [1.47, 1.84]). CONCLUSIONS/RELEVANCE: This analysis of real-world claims data shows lower rates of stroke, thromboembolism, and major bleeding, as well as fewer emergency department visits, with patient self-testing compared to office-based/lab INR monitoring. Our finding that PST is safe and effective among current users suggests that more patients may benefit from its use.
Subject(s)
Anticoagulants , Drug Monitoring , International Normalized Ratio , Warfarin , Humans , Warfarin/adverse effects , Warfarin/administration & dosage , Warfarin/therapeutic use , Retrospective Studies , Male , International Normalized Ratio/methods , Female , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Aged , Middle Aged , Drug Monitoring/methods , Adult , Self-Testing , United States/epidemiology , Insurance Claim Review , Aged, 80 and over , Office Visits/statistics & numerical data , Hemorrhage/chemically induced , Hemorrhage/epidemiologyABSTRACT
OBJETIVO: Comparar parâmetros clínicos relacionados aos pacientes em uso de varfarina sódica. MÉTODOS: Estudo retrospectivo, cujos dados foram buscados em prontuários e, em seguida, os pacientes foram categorizados em dois grupos: Grupo 1, composto por indivíduos que passaram por consultas nas quais apresentaram ao menos um episódio de valor de Coeficiente Internacional Normatizado (INR) abaixo do limite de normalidade, e Grupo 2, com ao menos uma dosagem de valor de INR acima do limite de normalidade. RESULTADOS: Foram incluídos 73 pacientes que totalizaram 363 consultas em uso de anticoagulante oral, sendo 42 pacientes homens. O intervalo médio entre as consultas foi de 36 dias. Quanto à etnia, a mais prevalente foi a branca, com 56,16%, e a escolaridade mais prevalente foi o primeiro grau completo (72,6%). As doses semanais de varfarina 5mg não diferiram entre as indicações de uso (F=0,218; p=0,953). CONCLUSÃO: Mais da metade das consultas estava fora da faixa terapêutica, demonstrando que a estratégia atual no atendimento clínico-ambulatorial tem suas limitações como o grande intervalo interconsultas e a dificuldade de comunicação com o paciente, seja pelo baixo grau de instrução ou pelo alto fluxo de pacientes. As interações medicamentosas e a interferência do sexo e de comorbidades nos valores de INR devem ser melhores avaliadas em estudos controlados
OBJECTIVE: To compare some clinical parameters related to patients taking warfarin sodium. METHODS: This is a retrospective study, the data of which was collected in medical records, with patients then being categorized into two groups: Group 1, consisting of individuals presenting for consultation who had at least one episode of an International Normalized Ratio (INR) value below the normal range, and Group 2, with at least one dose of INR values above the normal range. RESULTS: The study included 73 patients with a total of 363 visits, on oral anticoagulant therapy, with 42 patients b eing males. The average interval between visits was 36 days. As for ethnicity, the most prevalent was the white one with 56,16%, and the most prevalent educational level was primary school (72.6%). The weekly doses of warfarin 5mg did not differ within the indications of use (F=0.218, p=0.953). CONCLUSION: More than half of the visits were outside therapeutic range, demonstrating that the current strategy in clinical and ambulatory care has its limitations, such as the large interval between consultations, and the difficulty of communication with the patient, either because of the low educational level or the high flow of patients. Drug interactions, the interference of gender, and comorbidities
Subject(s)
Humans , Male , Female , Ambulatory Care , Anticoagulants/pharmacokinetics , Vitamin K/administration & dosage , Vitamin K/antagonists & inhibitors , Warfarin/administration & dosage , International Normalized Ratio/methods , Retrospective Studies , Vitamin K/administration & dosageABSTRACT
ABSTRACT Purpose: To analyze the safety of warfarin therapy during cataract surgery under topical anesthesia. Methods: This was a prospective nonrandomized comparative study of 60 eyes of 60 patients treated with or without concurrent oral warfarin anticoagulant therapy, referred for cataract surgery under topical anesthesia. The sample included a treatment (n=30) and a control (n=30) group. Results: There were no records of intraoperative or postoperative intracameral bleeding complications in both the groups. At 1-month postoperative follow-up, 90.0% of patients presented spectacle-corrected visual acuity of at least 20/40. Conclusion: Cataract surgery by phacoemulsification with topical anesthesia can be successfully conducted without discontinuing warfarin. .
RESUMO Objetivo: Avaliar a segurança da cirurgia de catarata com anestesia tópica em pacientes em uso de varfarina. Métodos: Estudo comparativo não aleatorizado, prospectivo de 30 olhos de 30 indivíduos sob terapia anticoagulante por via oral com Varfarina que se submeteram à cirurgia de catarata com anestesia tópica. O grupo controle foi composto por 30 olhos de 30 pacientes, com indicação de cirurgia de catarata, que não faziam uso de terapia anticoagulante. Resultados: Não houve registro de complicações hemorrágicas intracamerais transoperatórias ou pós-operatórias em ambos os grupos. Na visita pós-operatória de 30 dias, 90,0% dos pacientes apresentavam acuidade visual corrigida por óculos de pelo menos 20/40. Conclusão: A cirurgia de catarata por facoemulsificação com anestesia tópica pode ser realizada com sucesso sem interrupção da terapia com varfarina. .
Subject(s)
Humans , Anticoagulants/administration & dosage , Cataract Extraction/methods , Warfarin/administration & dosage , Administration, Oral , Anesthesia, Local , Anesthetics, Local/administration & dosage , Cataract Extraction/adverse effects , Eye Hemorrhage/chemically induced , Follow-Up Studies , Intraoperative Period , International Normalized Ratio/methods , Lens Implantation, Intraocular , Prospective Studies , Postoperative Hemorrhage/chemically induced , Visual AcuityABSTRACT
The use of oral anticoagulation treatment (OAT) in patients with an international normalized ratio (INR) higher than 1.7 is a contraindication to thrombolysis in acute ischemic stroke. The aim of the present study is to compare the use of point-of-care (POC) coagulometers to the standard coagulation analysis (SCA) procedure of the INR as a decision-making test for use with patients taking OAT. Method: Eighty patients on chronic OAT underwent a POC and an SCA during a regular outpatient evaluation. Results: When comparing the abilities of the POC test and the SCA test to identify adequate levels for thrombolysis (≤1.7), the POC had a sensitivity of 96.6% (95%CI 88.4-99.1) and a specificity of 60.0% (95%CI 38.6-78). POC overestimated INR levels by 0.51 points compared to the SCA test. Conclusion: POC has a high sensitivity compared to the SCA test for the identification of patients within the cut-off point for thrombolysis. .
Valores acima de 1.7 no RNI de pacientes em uso de terapia anticoagulante (ACO) é uma contraindicação para a trombólise no AVC isquêmico. O Objetivo do presente estudo é comparar o teste capilar rápido (TCR) com o exame tradicional de RNI como método de decisão para indicação de terapia trombolítica em pacientes em uso de ACO. Método: Oitenta pacientes em uso crônico de ACO foram submetidos ao TCR e ao exame tradicional durante consulta ambulatorial. Resultados: Ao serem comparados os resultados do TCR com o exame tradicional com o ponto de corte de 1,7 de RNI, o teste rápido teve sensibilidade de 96,6% (IC95% 88,4-99,1) e especificidade de 60,0% (IC95% 38,6-78). O TCR superestimou os níveis de RNI em 0,51 pontos comparado ao exame tradicional. Conclusão: O TCR apresentou elevada sensibilidade, comparado ao exame tradicional para a identificação de pacientes em uso de ACO com indicação de trombólise. .
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Anticoagulants/therapeutic use , International Normalized Ratio/standards , Point-of-Care Systems/standards , Thrombolytic Therapy , Brain Ischemia/drug therapy , International Normalized Ratio/methods , Reference Values , Reproducibility of Results , Sensitivity and Specificity , Statistics, Nonparametric , Stroke/drug therapyABSTRACT
OBJETIVO: Comparar os resultados do índice de Normalização Internacional (INR) obtidos pelo teste rápido com os do método convencional nos pacientes em terapia de anticoagulação oral com varfarina sódica. MÉTODOS: Para 383 pacientes tratados com varfarina (idade média: 56,5 anos; 207 mulheres), o INR foi determinado em sangue capilar pelo equipamento Hemochron Jr. e comparado com os resultados de amostras de plasma venoso analisadas pelo teste convencional realizado em equipamento Coag-A-Mate. Foram avaliados os resultados do desempenho global das amostras e dos seguintes subgrupos: INR < 2,0, entre 2,0 a 3,5 e > 3,5. RESULTADOS: A comparação entre os valores de INR dos dois métodos resultou em um coeficiente de correlação (r) de 0,86. Entretanto, a análise das diferenças médias entre os resultados dos dois testes, considerando os três subgrupos, apresentou diferenças estatisticamente significativas (p < 0,001): 0,14 ± 0,21 (INR < 2,0); 0,54 ± 0,31 (2,0 < INR < 3,5) e 1,64 ± 1,10 (INR> 3,5). O cálculo do teste t-pareado de Student resultou em um p < 0,001 para os três subgrupos analisados. CONCLUSÃO: A adoção do teste rápido para monitoramento da anticoagulação oral apresenta restrições. Esse método subestimou a intensidade da anticoagulação nos três subgrupos estudados.
OBJECTIVE: to compare the international normalized ratio (INR) measured by a point-of-care (POC) testing device with that measured by the conventional method in patients undergoing anticoagulation therapy with warfarin sodium. METHODS: The INR of 383 warfarin-treated patients (mean age: 56.5 years; 207 female) was measured in capillary blood using the Hemochron Jr. device and compared with that of venous plasma samples determined by the conventional method performed in a Coag-A-Mate analyzer. Results were evaluated globally and for the following subgroups: INR < 2.0, from 2.0 to 3.5, and > 3.5. RESULTS: Using both methods, the comparison between INR values yielded a correlation coefficient (r) of 0.86. However, mean differences in INR in both tests, considering the three subgroups, proved to be statistically significant (p <0.001): 0.14 ± 0.21 (INR< 2.0); 0.54 ± 0.31 (2.0 < INR < 3.5), and 1.64 ± 1.10 (INR> 3.5). Paired StudentÆs t-test analysis revealed a p value < 0.001 for the three subgroups studied. CONCLUSION: The use of point-of-care testing for monitoring oral anticoagulation has some limitations. Anticoagulation intensity was underestimated by this method in the three subgroups studied.