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INTRODUCTION: Direct oral anticoagulants (DOACs) have overtaken warfarin in the treatment of nonvalvular atrial fibrillation (AF) and venous thromboembolism (VTE). Limited data explore the safety of DOACs in obesity. METHODS: This multicenter retrospective study between June 2015 and September 2019 uses the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry to compare DOACs and warfarin across weight classes (not obese: body mass index (BMI) ⩾ 18.5 and < 30; obese: BMI ⩾ 30 and < 40; severely obese: BMI ⩾ 40). Primary outcomes include major, clinically relevant nonmajor (CRNM), and minor bleeding events per 100 patient-years. Secondary outcomes include stroke, recurrent VTE, and all-cause mortality. RESULTS: DOACs were prescribed to 49% of the 4089 patients with AF and 46% of the 3162 patients with VTE. Compared to patients treated with warfarin, those treated with DOACs had a higher estimated glomerular filtration rate across BMI categories regardless of indication. In the AF population, severely obese patients treated with DOACs had more major (3.4 vs 1.8, p = 0.004), CRNM (8.6 vs 5.9, p = 0.019), and minor bleeding (11.4 vs 9.9, p = 0.001). There was no difference in stroke or all-cause mortality. In the VTE population, both CRNM (7.5 vs 6.7, p = 0.042) and minor bleeding (19.3 vs 10.5, p < 0.001) events occurred at higher rates in patients treated with DOACs. There was no difference in recurrent pulmonary embolism, stroke, or all-cause mortality. CONCLUSION: There is a higher rate of bleeding in severely obese patients with VTE and AF treated with DOACs compared to warfarin, without a difference in secondary outcomes. Further studies to compare the anticoagulant classes and understand bleeding drivers in this population are needed.
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Safety and efficacy of direct oral anticoagulants (DOAC) in low weight patients with atrial fibrillation (AF) is unclear due to few low body weight patients enrolled in clinical trials. To assess bleeding and thrombotic event rates for patients with AF that are prescribed apixaban and have a low versus normal body weight. We analyzed patients with AF prescribed apixaban from 2017 to 2020 with at least 12 months of follow-up. Patients were divided into low [< 60 kg (kg)] and normal (60-100 kg) weight cohorts. Bleeding and thrombotic event rates were compared. Poisson regression and Cox proportional hazard models were used to estimate adjusted adverse event rates. A total of 545 patients met inclusion criteria. In the unadjusted analysis, there was an increase in non-major bleeding events requiring an Emergency Department visit more often in the low versus normal weight cohort (10.8 versus 7.4 per 100 patient-years, p = 0.15). Thrombotic event rates also occurred more often in the lower versus normal weight cohort (2.4 versus 0.9 per 100 patient-years, p = 0.09). However, adjusted analysis found no statistically significant difference in bleeding or thrombotic events between low and normal weight cohorts. The adjusted hazard ratio for bleeding was similar between the two weight cohorts. The use of apixaban in low body weight patients was not associated with higher rates of bleeding or thrombotic events, compared to those with normal body weight, after adjusting for potential confounding covariates. Larger studies may offer further insight into the overall safety and efficacy of DOAC therapy in these patients.
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Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Varfarina/uso terapêutico , Anticoagulantes/efeitos adversos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Peso Corporal Ideal , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Piridonas/efeitos adversos , Magreza/tratamento farmacológico , Administração OralRESUMO
A lack in patient knowledge of warfarin therapy is associated with poor adherence. This knowledge gap may result in a lower INR Time in Therapeutic Range (TTR). To investigate association between patient anticoagulation knowledge and warfarin control. Michigan Anticoagulation Quality Improvement Initiative (MAQI2) is a Blue Cross Blue Shield of Michigan sponsored consortium of six anticoagulation management services. Patients prescribed warfarin at two MAQI2 sites completed a voluntary Oral Anticoagulation Knowledge (OAK) questionnaire at warfarin initiation and 6-month follow-up. The results of 20 OAK questions and TTRs (excluding 1st month post-initiation) were compared using chi-square tests, t-tests and multivariate analysis adjusting for SAMe-TT2R2 and days on warfarin. Of 1836 surveys distributed at warfarin initiation, 481 (26.2%) patients completed the baseline questionnaire (within 1 month post-initiation): mean OAK score: 14.6 ± 3.4. Of those, 147 (30.6%) completed 6-month follow-up surveys (OAK: 12.7 ± 5.8). Patients with TTR ≥ 70% at baseline scored higher on OAK tests than patients with TTR < 70% in unadjusted analyses (15.1 ± 3.2 v. 14.2 ± 3.5, p = 0.003) and adjusted analysis (p = 0.020). There was no unadjusted or adjusted difference in OAK scores at 6-month follow-up between patients with TTR ≥ 70% and TTR < 70%. For patients who completed baseline and follow-up surveys, there was a decrease of 2.4 points in OAK score between baseline and 6-month follow up (p < 0.001). Higher baseline, but not follow-up, OAK score is associated with better warfarin control and average OAK scores decreased between baseline and follow-up. Further studies are needed to determine what type of patient education may improve patient knowledge retention and warfarin control.
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Fibrilação Atrial , Varfarina , Humanos , Varfarina/uso terapêutico , Varfarina/farmacologia , Fibrilação Atrial/tratamento farmacológico , Anticoagulantes/uso terapêutico , Anticoagulantes/farmacologia , Coagulação Sanguínea , Fatores de Tempo , Coeficiente Internacional NormatizadoRESUMO
Clinical trials comparing direct oral anticoagulants (DOAC) to warfarin excluded patients with a history of bariatric surgery. The anatomic changes from bariatric procedures have several effects on drug absorption which can have serious consequences for these patients. We sought to describe real-world use of DOACs among adults that had a history of bariatric surgery or underwent a bariatric surgery while receiving a DOAC. We conducted a retrospective case series of adult patients, at a large academic medical center, who initiated any DOAC in 2016 thru 2019 and had a history of bariatric surgery or underwent a bariatric surgery while receiving a DOAC. Thrombotic and bleeding events were described using summary statistics and bleeding severity was described using the International Society on Thrombosis and Haemostasis criteria. Twenty-eight patients met the inclusion criteria of having bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or gastric band) and receiving a DOAC. Twenty (71.4%) were prescribed apixaban and eight (28.6%) were prescribed rivaroxaban. Seven patients (25%) experienced at least one clinically relevant non-major bleeding event, including one patient (3.6%) that had a major bleeding event. Two patients (7.1%) had a thromboembolic event. Coagulation laboratory studies were infrequently performed at the time of the bleeding or clotting events. Among patients with a history of bariatric surgery, use of DOACs were commonly associated with clinically relevant non-major bleeding events and less commonly associated with major bleeding and thromboembolic events. Larger studies may offer further insight into the overall safety and efficacy of DOAC therapy in patients that have undergone bariatric surgery. The specific role of coagulation laboratory studies warrants further evaluation.
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Fibrilação Atrial , Cirurgia Bariátrica , Tromboembolia , Trombose , Administração Oral , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Cirurgia Bariátrica/efeitos adversos , Dabigatrana/uso terapêutico , Hemorragia/induzido quimicamente , Humanos , Pirazóis , Piridonas/efeitos adversos , Estudos Retrospectivos , Rivaroxabana/efeitos adversos , Tromboembolia/tratamento farmacológico , Trombose/tratamento farmacológicoRESUMO
To understand how physicians from various specialties perceive coordination of care when managing peri-procedural anticoagulation. Cross-sectional survey of cardiologists, gastroenterologists, and primary care physicians (PCPs) in an integrated health system (N = 251). The survey began with a vignette of a patient with atrial fibrillation co-managed by his PCP, cardiologist, and an anticoagulation clinic who must hold warfarin for a colonoscopy. Respondents' experiences and opinions around responsibilities and institutional support for managing peri-procedural anticoagulation were elicited using multiple choice questions. We examined differences in responses across specialties using Chi square analysis. The response rate was 51% (n = 127). 52% were PCPs, 28% cardiologists, and 21% gastroenterologists. Nearly half (47.2%) of respondents believed that the cardiologist should be primarily responsible for managing peri-procedural anticoagulation, while fewer identified the PCP (25.2%), anticoagulation clinic (21.3%), or gastroenterologist (6.3%; p = 0.09). Respondents across specialties had significantly different approaches to deciding how to manage the clinical case presented (p < 0.001). Most cardiologists (60.0%) would decide whether to offer bridging without consulting with other providers or clinical resources, while most PCPs would decide after consulting clinical resources (57.6%). Gastroenterologists would most often (46.2%) defer the decision to another provider. A majority of all three specialties agreed that their institution could do more to help manage peri-procedural anticoagulation, and there was broad support (88.1%) for anticoagulation clinics' managing all aspects of peri-procedural anticoagulation. Providers across specialties agree that their institution could do more to help manage peri-procedural anticoagulation, and overwhelmingly support anticoagulation clinics' taking responsibility.
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Anticoagulantes/uso terapêutico , Comunicação Interdisciplinar , Assistência Perioperatória/métodos , Padrões de Prática Médica/estatística & dados numéricos , Estudos Transversais , Humanos , Inquéritos e QuestionáriosRESUMO
Randomized controlled trials (RCTs) examining warfarin use for stroke prevention in atrial fibrillation (AF) may not accurately reflect real-world populations. We aimed to determine the representativeness of the RCT populations to real-world patients and to describe differences in the characteristics of trial populations from trial eligible patients in a real-world setting. We hypothesized that a significant fraction of real-world patients would not qualify for the RE-LY, ROCKET-AF, and ARISTOTLE trials and that real-world patients qualifying for the studies may have more strokes and bleeding events. We compared the inclusion and exclusion criteria, patient characteristics, and clinical outcomes from RE-LY, ROCKET-AF, and ARISTOTLE against data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI2), a regional network of six community- and academic-based anticoagulation clinics. Of the 1446 non-valvular AF patients in the MAQI2 registry taking warfarin, approximately 40-60% would meet the selection criteria used in RE-LY (788, 54.5%), ROCKET-AF (566, 39.1%), and ARISTOTLE (866, 59.9%). The most common reasons for exclusion from one or more trial were anemia (15.1%), other concurrent medications (11.2%), and chronic kidney disease (9.4%). Trial-eligible MAQI2 patients were older, more frequently female, with a higher rate of paroxysmal AF, and lower rates of congestive heart failure, previous stroke, and previous myocardial infarction than the trial populations. MAQI2 patients eligible for each trial had a lower rate of stroke and similar rate of major bleeding than was observed in the trials. A sizable proportion of real-world AF patients managed in anticoagulation clinics would not have been eligible for the RE-LY, ROCKET-AF, and ARISOTLE trials. The expected stroke risk reduction and bleeding risk among real-world AF patients on warfarin may not be congruent with published clinical trial data.
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Fibrilação Atrial/tratamento farmacológico , Tromboembolia/prevenção & controle , Varfarina/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Feminino , Humanos , Masculino , Michigan , Seleção de Pacientes , Melhoria de Qualidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Resultado do TratamentoRESUMO
A high SAMe-TT2R2 score predicted poor warfarin control and adverse events among atrial fibrillation patients. However, the SAMe-TT2R2 score has not been well validated in venous thromboembolism (VTE) patients. A cohort of 1943 warfarin-treated patients with acute VTE was analyzed to correlate the SAMe-TT2R2 score with time in therapeutic range (TTR) and clinical adverse events. A TTR <60% was more frequent among patients with a high (>2) versus low (0-1) SAMe-TT2R2 score (63.4% vs 52.3%, p<0.0001). A high SAMe-TT2R2 score (>2) correlated with increased overall adverse events (7.9 vs 4.5 overall adverse events/100 patient years, p=0.002), driven primarily by increased recurrent VTE rates (4.2 vs 1.5 recurrent VTE/100 patient years, p=0.0003). The SAMe-TT2R2 score had a modest predictive ability for international normalized ratio (INR) quality and adverse clinical events among warfarin-treated VTE patients. The utility of the SAMe-TT2R2 score to guide clinical decision-making remains to be investigated.
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Anticoagulantes/uso terapêutico , Coagulação Sanguínea/efeitos dos fármacos , Técnicas de Apoio para a Decisão , Tromboembolia Venosa/sangue , Tromboembolia Venosa/tratamento farmacológico , Varfarina/uso terapêutico , Adulto , Fatores Etários , Idoso , Anticoagulantes/efeitos adversos , Monitoramento de Medicamentos/métodos , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Grupos Raciais , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Fumar , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiologia , Varfarina/efeitos adversosRESUMO
Direct oral anticoagulant (DOAC) agents offer several lifestyle and therapeutic advantages for patients relative to warfarin in the treatment of atrial fibrillation (AF). These alternative agents are increasingly used in the treatment of AF, however the adoption practices, patient profiles, and reasons for switching to a DOAC from warfarin have not been well studied. Through the Michigan Anticoagulation Quality Improvement Initiative, abstracted data from 3873 AF patients, enrolled between 2010 and 2015, were collected on demographics and comorbid conditions, stroke and bleeding risk scores, and reasons for anticoagulant switching. Over the study period, patients who switched from warfarin to a DOAC had similar baseline characteristics, risk scores, and insurance status but differed in baseline CrCl. The most common reasons for switching were patient related ease of use concerns (37.5%) as opposed to clinical reasons (16.5% of patients). Only 13% of patients that switched to a DOAC switched back to warfarin by the end of the study period.
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Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Substituição de Medicamentos/tendências , Varfarina/uso terapêutico , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Substituição de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Cobertura do Seguro , Masculino , Fatores de Risco , Varfarina/administração & dosagemRESUMO
BACKGROUND: A number of factors can lead to adverse events (AEs) in patients taking warfarin. Performing a root cause analysis (RCA) of serious AEs is one systematic way of determining the causes of these events. METHODS: Multidisciplinary teams were formed at Michigan Anticoagulation Quality Improvement Initiative (MAQI2) sites with organized anticoagulation management services (AMS). Medical records from patients who suffered serious AEs (major bleed, embolic stroke, venous thromboembolism) were reviewed, and AMS staff were interviewed to determine the root cause using the "5 Whys" technique. More than 600 patients had an AE and underwent screening by trained RNs. Of these, 79 required full review by a multidisciplinary panel. All potential contributing factors (comorbidities, concurrent medications, current protocols) were assessed to determine the main factor that caused the AE. RESULTS: Full RCA was completed in 79 cases. The main contributing factor was identified in 69/79 (87%) cases. Most identified AEs, 55/69 (80%), were due to patient-specific factors such as comorbidities. Patient-to-provider and provider-to-provider communication accounted for 16/69 (23%) of events and was the second most common cause. Other causes included protocol non-adherence and technology/equipment issues. After each detailed review, the multidisciplinary panel recommended system changes that addressed the primary cause. CONCLUSION: The majority of severe AEs for patients taking warfarin were related to nonmodifiable patient-related issues. The remaining AEs were primarily due to patient-to-provider and provider-to-provider communication issues. Methods for improving communication need to be addressed, and methods for more effective patient education should be investigated.
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Anticoagulantes/efeitos adversos , Pacientes Ambulatoriais , Melhoria de Qualidade/organização & administração , Análise de Causa Fundamental , Varfarina/efeitos adversos , Protocolos Clínicos , Comunicação , Comorbidade , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Segurança do Paciente , Relações Profissional-Paciente , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia Venosa/prevenção & controleRESUMO
All available direct oral anticoagulants (DOACs) are at least partially eliminated by the kidneys. These agents are increasingly being used as alternatives to warfarin for stroke prevention in patients with atrial fibrillation. The aim of this study was to identify changes in renal function and associated DOAC dosing implications in a multicenter cohort of atrial fibrillation patients switched from warfarin to DOAC treatment. We included all patients in the Michigan Anticoagulation Quality Improvement Initiative cohort who switched from warfarin to a DOAC with atrial fibrillation as their anticoagulant indication between 2009 and 2014, and who had at least two creatinine values. Compliance with FDA-recommended dosing based on renal function was assessed. Of the 189 patients switched from warfarin to a DOAC, 34 (18.0 %) had a baseline creatinine clearance <50 mL/min and 23 (12.2 %) experienced important fluctuations in renal function. Of these 23 patients, 6 (26.1 %) should have impacted the DOAC dosing, but only 1 patient actually received an appropriate dose adjustment. Additionally, 15 (7.9 %) of patients on DOACs had a dose change performed, but only one patient demonstrated a change in renal function to justify the dose adjustment. Most atrial fibrillation patients who switched from warfarin to a DOAC had stable renal function. However, the majority of patients who had a change in renal function did not receive the indicated dose change. As the use of DOACs expands, monitoring of renal function and appropriate dose adjustments are critical.
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Anticoagulantes/administração & dosagem , Fibrilação Atrial , Substituição de Medicamentos , Rim , Varfarina/administração & dosagem , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/sangue , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/fisiopatologia , Creatinina/sangue , Feminino , Humanos , Rim/metabolismo , Rim/fisiopatologia , Testes de Função Renal , Masculino , Pessoa de Meia-IdadeRESUMO
It has been suggested that direct oral anticoagulants are being preferentially used in low risk atrial fibrillation (AF) patients. Understanding the changing risk profile of new AF patients treated with warfarin is important for interpreting the quality of warfarin delivery through an anticoagulation clinic. Six anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative enrolled 1293 AF patients between 2010 and 2014 as an inception cohort. Abstracted data included demographics, comorbidities, medication use and all INR values. Risk scores including CHADS2, CHA2DS2-VASc, HAS-BLED, SAMe-TT2R2, and Charlson comorbidity index (CCI) were calculated for each patient at the time of warfarin initiation. The quality of anticoagulation was assessed using the Rosendaal time in the therapeutic range (TTR) during the first 6 months of treatment. Between 2010 and 2014, patients initiating warfarin therapy for AF had an increasing mean CHADS2 (2.0 ± 1.1 to 2.2 ± 1.4, p = 0.02) and CCI (4.7 ± 1.8 to 5.1 ± 2.0, p = 0.03), and a trend towards increasing mean CHA2DS2-VASc, HAS-BLED, and SAMe-TT2R2 scores. The actual TTR remained unchanged over the study period (62.6 ± 18.2 to 62.7 ± 17.0, p = 0.98), and the number of INR checks did not change (18.9 ± 5.2 to 18.5 ± 5.1, p = 0.06). Between 2010 and 2014, AF patients newly starting warfarin had mild increases in risk for stroke and death with sustained quality of warfarin therapy.
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Fibrilação Atrial/tratamento farmacológico , Varfarina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo , Varfarina/efeitos adversosAssuntos
Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Hemorragia Gastrointestinal/prevenção & controle , Inibidores da Bomba de Prótons/uso terapêutico , Melhoria de Qualidade , Indicadores de Qualidade em Assistência à Saúde , Varfarina/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Monitoramento de Medicamentos , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/diagnóstico , Humanos , Masculino , Michigan , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Resultado do Tratamento , Varfarina/administração & dosagemRESUMO
To more accurately quantify the proportion of anticoagulated patients with atrial fibrillation (AF) that may be inappropriately treated with warfarin for stroke prevention. Patients with AF have an increased risk of stroke, which is lowered by the use of warfarin. However there is likely more potential harm than benefit in patients that do not have additional stroke risk factors. Studies have described overuse of warfarin for stroke prophylaxis in lowest risk patients. However, many of those studies did not assess for electrical cardioversion (ECV) or radiofrequency ablation (RFA) as indications for warfarin therapy. Data from 1852 non-valvular AF patients treated with warfarin between October 2009 and October 2011 at seven anticoagulation centers participating in the Michigan Anticoagulation Quality Improvement Initiative registry were analyzed. Low risk AF patients were risk stratified using the CHADS2 scoring systems, with a score of zero representing lowest risk. 193 (10.4 %) of AF patients receiving warfarin were identified as having the lowest risk of stroke by the CHADS2 score. Of the patients with CHADS2 = 0, 130 (67.4 %) had undergone a recent ECV and/or RFA. Of all AF patients, only 63 (3.4 %) had a CHADS2 score of 0 and no recent ECV or RFA. The vast majority of AF patients receiving anticoagulation in this multi-center registry are doing so in accordance with national and international guidelines. In contrast to prior population-based studies, very few low risk patients are receiving inappropriate warfarin therapy for stroke prophylaxis in AF, when procedure-based indications are also considered.
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Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/administração & dosagem , Idoso , Anticoagulantes/efeitos adversos , Fibrilação Atrial/epidemiologia , Feminino , Humanos , Masculino , Michigan/epidemiologia , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Varfarina/efeitos adversosRESUMO
BACKGROUND: For patients on warfarin for mechanical heart valve replacement, the 2020 American College of Cardiology and American Heart Association Guidelines recommend only adding aspirin in patients with a specific indication for antiplatelet therapy. This contrasts with prior guidelines, which recommended concomitant aspirin therapy. We sought to assess the prevalence of guideline-discordant aspirin use among patients on warfarin for mechanical heart valve replacement and to compare adverse event rates among patients with and without concomitant aspirin. METHODS: Patients on warfarin for mechanical heart valve replacement were identified from the Michigan Anticoagulation Quality Improvement Initiative registry. Patients with myocardial infarction, percutaneous coronary intervention, or coronary artery bypass within the past 12 months were excluded. Patients were divided into 2 groups based on aspirin use. Patient characteristics and bleeding and thromboembolic outcomes were compared. RESULTS: Four hundred forty-four patients met the inclusion criteria, with 341 (76.8%) on concomitant aspirin. The aspirin group was older (50.6 vs 46.3 years, P = .028) and had more hypertension (57.8% vs 46.6%, P = .046) but other patient characteristics were similar. The aspirin group had a higher rate of bleeding events (28.3 vs 13.3 per 100 patient-years, P < .001) and bleed-related emergency department visits (11.8 vs 2.9 per 100 patient-years, P = .001) compared with the non-aspirin group. There was no observed difference in rates of ischemic stroke (0.56 vs 0.48 per 100 patient-years, P = .89). CONCLUSIONS: A significant proportion of patients on warfarin for mechanical heart valve replacement are on guideline-discordant aspirin. Aspirin deprescribing in select patients may safely reduce bleeding events.
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Anticoagulantes , Aspirina , Implante de Prótese de Valva Cardíaca , Hemorragia , Inibidores da Agregação Plaquetária , Varfarina , Humanos , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Aspirina/administração & dosagem , Varfarina/efeitos adversos , Varfarina/uso terapêutico , Masculino , Feminino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Guias de Prática Clínica como Assunto , Tromboembolia/prevenção & controle , Tromboembolia/epidemiologia , Sistema de Registros , Adulto , Próteses Valvulares Cardíacas , Idoso , Prevalência , Fidelidade a Diretrizes/estatística & dados numéricosRESUMO
BACKGROUND: While direct oral anticoagulants (DOACs) may be viewed as simpler to manage then warfarin, they present their own unique management challenges resulting in frequent off-label dosing. It is unknown to what extent off-label dosing occurs when a patient is started on a DOAC versus later in their treatment. OBJECTIVES: We aimed to better characterize when off-label DOAC dosing is occurring and to evaluate the effectiveness of prescribing oversight using a registry-based intervention. METHODS: We evaluated data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry, a retrospective quality-improvement process using data abstractors, from 2018 to 2022 on the number of "alerts" that are generated in response to dosing deviating from the U.S. Food and Drug Administration instructions for atrial fibrillation (AF) and venous thromboembolism (VTE). RESULTS: Among a sample of 789 to 1,022 annual AF patients and 381 to 484 annual VTE patients prescribed a DOAC in the MAQI2 registry, off-label dosing was relatively common. Over the 5-year period (2018-2022), there were 569 alerts for AF patients and 162 alerts for VTE patients. Alerts occurred more frequently during follow-up than at the time of initial prescribing in AF patients (78.2 vs. 21.8%), but more commonly at initial prescribing in VTE patients (59.9 vs. 40.1%). After initial review by quality-improvement abstractors, 19.3% of AF alerts and 14.8% of VTE alerts resulted in contact to the prescriber. When the prescriber was contacted, it led to an intervention about 75% of the time for both populations. The most common intervention was a change in DOAC dosing. CONCLUSION: This study demonstrates the benefit of DOAC prescribing oversight using a registry-based intervention to monitor for off-label dosing for the entirety of the time period a patient is prescribed DOAC, particularly for patients with AF, as off-label prescribing occurs frequently during the follow-up period.
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Background: For patients anticoagulated with direct oral anticoagulants (DOACs) or warfarin and on aspirin (ASA) for nonvalvular atrial fibrillation and/or venous thromboembolism, it is unclear if bleeding outcomes differ. Objectives: To assess bleeding rates for ASA with DOACs vs warfarin and one another. Methods: Registry-based cohort study of patients followed by a 6-center quality improvement collaborative in Michigan using data from 2009 to 2022. The study included adults on ASA with warfarin or DOACs for atrial fibrillation and/or venous thromboembolism without a recent myocardial infarction or heart valve replacement. Results: After propensity matching by anticoagulant class, we compared 2 groups of 1467 patients followed for a median of 18.0 months. Any bleeding and nonmajor bleeding was increased with DOACs + ASA compared with warfarin + ASA (32.2 vs 27.8 and 27.1 vs 22.9 events/100 patient-years; relative risks [RRs], 1.1 and 1.2; 95% CIs, 1.1-1.2 and 1.1-1.3, respectively). After matching by drug, patients on apixaban + ASA vs warfarin + ASA had more bleeding (31.2 vs 27.8 events/100 patient-years; RR, 1.1; 95% CI, 1.0-1.2) and nonmajor bleeding but less major bleeding (3.8 vs 4.7 events/100 patient-years; RR, 0.8; 95% CI, 0.6-1.0) and emergency room visits for bleeding. Patients on rivaroxaban + ASA vs warfarin + ASA had more bleeding (39.3 vs 26.3 events/100 patient-years, RR, 1.5; 95% CI, 1.3-1.6), nonmajor bleeding, and thrombosis. Patients on apixaban + ASA vs rivaroxaban + ASA had significantly less bleeding (22.5 vs 39.3/100 patient-years; RR, 0.6; 95% CI, 0.5-0.7), nonmajor bleeding, major bleeding (2.1 vs 5.5 events/100 patient-years; RR, 0.4; 95% CI, 0.2-0.6), emergency room visits for bleeding, and thrombotic events. Conclusion: Patients on DOAC + ASA without a recent myocardial infarction or heart valve replacement had more nonmajor bleeding but otherwise similar outcomes compared with warfarin + ASA. Patients treated with rivaroxaban + ASA experienced more adverse clinical events compared with warfarin + ASA or apixaban + ASA.
RESUMO
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are associated with high rates of venous thromboembolism (VTE). Anticoagulants, such as warfarin, are commonly used to prevent VTE in such patients. The practice and effectiveness of warfarin in real world populations is not well documented. 595 TKA and THA patients treated with warfarin were followed by two anticoagulation clinics in the Michigan Anticoagulation Quality Improvement Initiative. Length of prescribed anticoagulation, percent time in therapeutic range (%TTR) and time to first therapeutic INR were calculated for each surgical group. For THA, all 300 patients received at least ten days with a 28-day median length of anticoagulation therapy. For TKA, all 295 patients received at least 10 days with a 28-day median length of anticoagulation therapy. For THA patients, time to first therapeutic INR was on average 12.0 ± 8.0 days with a mean %TTR of 36.6 ± 26.8% for goal INR 2.0-3.0. For THA patients, 39 (13%) never reached target INR. For TKA patients, time to first therapeutic INR was on average 12.8 ± 10.3 days with a mean %TTR of 36.0 ± 28.3% for goal INR 2.0-3.0. For TKA patients, 44 (14.9%) never reached target INR. Many orthopaedic surgeons who use warfarin for post-arthroplasty VTE prophylaxis do so in accordance with national guidelines. The time to first therapeutic INR is strikingly long and %TTR markedly low for these patients, raising questions about the efficacy of warfarin therapy in the first 1-2 post-operative weeks. Further studies to investigate the best target INR for warfarin prophylaxis, as well as the composite rates of VTE and clinically relevant bleeding from treatment with warfarin, LMWH and newer anticoagulants are needed.
Assuntos
Anticoagulantes/administração & dosagem , Artroplastia de Quadril , Artroplastia do Joelho , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Varfarina/administração & dosagem , Feminino , Humanos , Coeficiente Internacional Normatizado/métodos , Masculino , Michigan , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Fatores de Tempo , Tromboembolia Venosa/etiologiaRESUMO
Background: Bleeding events are common complications of oral anticoagulant drugs, including both warfarin and the direct oral anticoagulants (DOACs). Some patients have their anticoagulant changed or discontinued after experiencing a bleeding event, while others continue the same treatment. Differences in anticoagulation management between warfarin- and DOAC-treated patients following a bleeding event are unknown. Methods: Patients with non-valvular atrial fibrillation from six anticoagulation clinics taking warfarin or DOAC therapy who experienced an International Society of Thrombosis and Haemostasis (ISTH)-defined major or clinically relevant non-major (CRNM) bleeding event were identified between 2016 and 2020. The primary outcome was management of the anticoagulant following bleeding (discontinuation, change in drug class, and restarting of same drug class). DOAC- and warfarin-treated patients were propensity matched based on the individual elements of the CHA2DS2-VASc and HAS-BLED scores as well as the severity of the bleeding event. Results: Of the 509 patients on warfarin therapy and 246 on DOAC therapy who experienced a major or CRNM bleeding event, the majority of patients continued anticoagulation therapy. The majority of warfarin (231, 62.6%) and DOAC patients (201, 81.7%) restarted their previous anticoagulation. Conclusion: Following a bleeding event, most patients restarted anticoagulation therapy, most often with the same type of anticoagulant that they previously had been taking.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Varfarina/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/induzido quimicamente , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Anticoagulantes , Coagulação Sanguínea , Administração Oral , Acidente Vascular Cerebral/tratamento farmacológicoRESUMO
BACKGROUND: Differences in clinical outcomes following a temporary interruption of warfarin or a direct oral anticoagulant (DOAC) for a surgical procedure are not well described. Differences in patient characteristics from practice-based cohorts have not typically been accounted for in prior analyses. AIM: To describe risk-adjusted differences in postoperative outcomes following an interruption of warfarin vs DOACs. METHODS: Patients receiving care at six anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative were included if they had at least one oral anticoagulant interruption for a procedure. Inverse probability of treatment weighting (IPTW) was used to balance baseline differences between the warfarin cohort and DOAC cohort. Bleeding and thromboembolic events within 30 days following the procedure were compared between the IPTW cohorts using the Poisson distribution test. RESULTS: A total of 525 DOAC patients were matched with 1323 warfarin patients, of which 923 were nonbridged warfarin patients and 400 were bridged warfarin patients. The occurrence of postoperative minor bleeding (10.8% vs. 4.7%, p < .001), major bleeding (2.9% vs. 1.1%, p = .01) and clinically relevant nonmajor bleeding (CRNMB) (6.5% vs. 3.0%, p = .002) was greater in the DOAC cohort compared with the nonbridged warfarin cohort. The rates of postoperative bleeding outcomes were similar between the DOAC and the bridged warfarin cohorts. CONCLUSION: Perioperative interruption of DOACs, compared with warfarin without bridging, is associated with a higher incidence of 30-day minor bleeds, major bleeds, and CRNMBs. Further research investigating the perioperative outcomes of these two classes of anticoagulants is warranted.