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BACKGROUND: In 2010, we published our stroke prevention clinic's performance as compared to Canadian stroke prevention guidelines. We now compare our clinic's adherence with guidelines to our previous results, following the implementation of an electronic documentation form. METHODS: All new patients referred to our clinic (McGill University Health Center) for recent transient ischemic attack (TIA) or ischemic stroke between 2014 and 2017 were included. We compared adherence to guidelines to our previous report (N=408 patients for period 2008-2010) regarding vascular risk management and treatment. RESULTS: Three hundred and ninety-two patients were included, of which 36% had a TIA and 64% had an ischemic stroke, with a mean age of 70 years and 43% female. Although the more recent cohort has shown a higher proportion of cardioembolic stroke compared to previous (19.1% vs. 14.7%) following new guidelines regarding prolonged cardiac monitoring, increased popularity in CT angiography has not translated into greater proportion of large-artery stroke subtype (26.3% vs. 26.2%). Blood pressure (BP) targets were achieved in 83% compared with 70% in our previous report (p<0.01). Attainment of low-density lipoprotein cholesterol target was also improved in our recent study (66% vs. 46%, p<0.01). No significant difference was found in the consistency of antithrombotic use (97.7% vs. 99.8%, p=0.08). However, there was a decline in smoking cessation (35% vs. 73%, p=0.02). Overall, optimal therapy status was better attained in the present cohort compared to the previous one (52% vs. 22%, p<0.01). The male sex was associated with better attainment of optimal therapy status (odds ratio, 1.61; 95% confidence interval, 1.04-2.51). The number of follow-up visits and the length of follow-up were not associated with attainment of stroke prevention targets. CONCLUSIONS: Our study shows improvement in attainment of therapeutic goals as recommended by Canadian stroke prevention guidelines, possibly attributed in part to the implementation of electronic medical recording in our clinic. Areas for improvement include smoking cessation counseling and diabetes screening.
CONTEXTE: En 2010, nous avons rendu publics les résultats de notre clinique de prévention des AVC en ce qui regarde les lignes directrices canadiennes de prévention des AVC. Suite à la mise en place d'un formulaire d'information électronique, nous voulons maintenant comparer l'adhésion actuelle de notre clinique à ces lignes directrices à celle mesurée en 2010. MÉTHODES: Tous les nouveaux patients adressés à notre clinique (Centre universitaire de santé McGill) pour des cas récents d'ischémie cérébrale transitoire (ICT) ou d'AVC ischémique survenus entre 2014 et 2017 ont été inclus dans cette étude. Nous avons ainsi comparé l'adhésion actuelle aux lignes directrices évoquées ci-haut à celle du précédent rapport (N = 408 patients pour la période allant de 2008 à 2010), et ce, en ce qui concerne la prise en charge du risque vasculaire et les traitements nécessaires. RÉSULTATS: Au total, 392 patients ont été inclus; de ce nombre, 36 % d'entre eux avaient été victimes d'ICT tandis que 64 % avaient été victimes d'un AVC ischémique. Leur âge moyen était de 70 ans et 43 % d'entre eux étaient de sexe féminin. Bien que la cohorte la plus récente, à la suite de l'introduction de nouvelles lignes directrices portant sur la surveillance cardiaque prolongée, ait donné à voir une proportion plus élevée d'AVC d'origine cardio-embolique comparativement à la précédente (19,1 % par opposition à 14,7 %), la popularité croissante de l'angiographie par tomodensitométrie ne s'est pas traduite par une proportion plus grande de sous-types d'AVC affectant de grandes artères (26,3 % de 2014 à 2017 par opposition à 26,2 % de 2008 à 2010). Les valeurs cibles fixées en matière de pression artérielle ont été atteintes dans 83 % des cas comparativement à 70 % des cas dans notre rapport précédent (p < 0,01). L'atteinte de la valeur cible en ce qui concerne le taux de LDL-cholestérol (lipoprotéines de faible intensité) a également été améliorée dans notre plus récent rapport (66 % par opposition à 46 %; p < 0,01). Ajoutons aussi qu'aucune différence notable n'a été observée quant à une utilisation constante d'anti-thrombotiques (97,7 % par opposition à 99,8 %; p = 0,08). Fait à souligner, un déclin dans l'abandon du tabagisme a été noté (35 % par opposition à 73%; p = 0,02). Dans l'ensemble, les conditions d'une guérison optimale (optimal therapy status) ont été davantage atteintes dans la cohorte la plus récente comparativement à celle de 2008 à 2010 (52 % par opposition à 22 %; p < 0,01). Le fait d'être de sexe masculin a été associé à de meilleures conditions de guérison optimale (rapport des cotes: 1,61; IC 95 %, 1,04 2,51). Enfin, mentionnons que le nombre de consultations de suivi et la durée des suivis n'ont pas été associés à l'atteinte de valeurs cibles en matière de prévention des AVC. CONCLUSIONS: Notre étude montre une série d'améliorations dans l'atteinte des objectifs thérapeutiques recommandés par les lignes directrices canadiennes de prévention des AVC. Cela pourrait être en partie attribuable à la mise en place de dossiers médicaux informatisés au sein de notre clinique. Parmi les aspects qui méritent une amélioration, citons l'établissement d'un programme de counseling en ce qui regarde l'abandon du tabagisme et le dépistage du diabète.
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Ataque Isquêmico Transitório/prevenção & controle , Cooperação do Paciente , Guias de Prática Clínica como Assunto/normas , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/psicologia , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea , LDL-Colesterol/metabolismo , Estudos de Coortes , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Atrial fibrillation is a leading preventable cause of recurrent stroke for which early detection and treatment are critical. However, paroxysmal atrial fibrillation is often asymptomatic and likely to go undetected and untreated in the routine care of patients with ischemic stroke or transient ischemic attack (TIA). METHODS: We randomly assigned 572 patients 55 years of age or older, without known atrial fibrillation, who had had a cryptogenic ischemic stroke or TIA within the previous 6 months (cause undetermined after standard tests, including 24-hour electrocardiography [ECG]), to undergo additional noninvasive ambulatory ECG monitoring with either a 30-day event-triggered recorder (intervention group) or a conventional 24-hour monitor (control group). The primary outcome was newly detected atrial fibrillation lasting 30 seconds or longer within 90 days after randomization. Secondary outcomes included episodes of atrial fibrillation lasting 2.5 minutes or longer and anticoagulation status at 90 days. RESULTS: Atrial fibrillation lasting 30 seconds or longer was detected in 45 of 280 patients (16.1%) in the intervention group, as compared with 9 of 277 (3.2%) in the control group (absolute difference, 12.9 percentage points; 95% confidence interval [CI], 8.0 to 17.6; P<0.001; number needed to screen, 8). Atrial fibrillation lasting 2.5 minutes or longer was present in 28 of 284 patients (9.9%) in the intervention group, as compared with 7 of 277 (2.5%) in the control group (absolute difference, 7.4 percentage points; 95% CI, 3.4 to 11.3; P<0.001). By 90 days, oral anticoagulant therapy had been prescribed for more patients in the intervention group than in the control group (52 of 280 patients [18.6%] vs. 31 of 279 [11.1%]; absolute difference, 7.5 percentage points; 95% CI, 1.6 to 13.3; P=0.01). CONCLUSIONS: Among patients with a recent cryptogenic stroke or TIA who were 55 years of age or older, paroxysmal atrial fibrillation was common. Noninvasive ambulatory ECG monitoring for a target of 30 days significantly improved the detection of atrial fibrillation by a factor of more than five and nearly doubled the rate of anticoagulant treatment, as compared with the standard practice of short-duration ECG monitoring. (Funded by the Canadian Stroke Network and others; EMBRACE ClinicalTrials.gov number, NCT00846924.).
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Fibrilação Atrial/diagnóstico , Eletrocardiografia Ambulatorial , Ataque Isquêmico Transitório/etiologia , Acidente Vascular Cerebral/etiologia , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Feminino , Humanos , Ataque Isquêmico Transitório/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/uso terapêutico , Fatores de Risco , Acidente Vascular Cerebral/tratamento farmacológicoRESUMO
BACKGROUND: We analyzed a 10-year stroke administrative dataset to examine trends in admissions, mortality, and discharge destination in Canada. METHODS: We conducted an analysis of hospital administrative data from April 1st 2003 to March 31st 2013 from the Canadian Institute of Health Information's Discharge Abstract Database. Ten-year trends for population-based age- and sex-standardized admission rates were calculated. We reviewed 10-year trends in absolute stroke admissions for differences between provinces and age groups. Stroke 30-day in-hospital mortality rates were calculated and adjusted for sex, age, stroke type and comorbidities. We documented changes in discharge location for ischemic and hemorrhagic stroke patients discharged from acute care. RESULTS: The rate of hospital admissions has declined from 140.2 to 117.5 (per 100,000 people). The number of absolute stroke admissions within provinces increased in Alberta and British Columbia (21.7% and 16.2% respectively). The proportion of stroke patients aged 40-69 years old increased by 4.8% (p<0.0001) over the 10 years, whereas the proportion aged over 70 decreased by 4.9% (p<0.0001). Risk-adjusted 30-day in-hospital mortality decreased from: 18.5% to 14.9% for all strokes; 15.2% to 12.1% for ischemic strokes; 35.6% to 29.7% for intracerebral hemorrhage; and 25.1% to 18.0% for subarachnoid hemorrhage. The absolute increase in patients requiring inpatient and outpatient support increased by 4% (p<0.0001). CONCLUSION: The rate of admissions for stroke is decreasing but there is an increase in stroke admissions for younger patients. In-hospital mortality is decreasing; fewer patients are going directly home without services and more are requiring support services.
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Admissão do Paciente/estatística & dados numéricos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/terapia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial/estatística & dados numéricos , Isquemia Encefálica/epidemiologia , Isquemia Encefálica/mortalidade , Canadá/epidemiologia , Criança , Pré-Escolar , Comorbidade , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar/tendências , Hospitalização/estatística & dados numéricos , Humanos , Lactente , Recém-Nascido , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/mortalidade , Masculino , Pessoa de Meia-Idade , Alta do Paciente/estatística & dados numéricos , Risco Ajustado , Fatores Sexuais , Acidente Vascular Cerebral/mortalidade , Hemorragia Subaracnóidea/epidemiologia , Hemorragia Subaracnóidea/mortalidade , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Few studies have assessed the performance of stroke prevention clinics. In particular, limited information exists on patient compliance, achievement of therapeutic targets, and related occurrence of vascular events. METHODS: We compared our clinical practice to recommendations from published guidelines in newly referred patients for transient ischemic attack (TIA) or ischemic stroke between 2008 and 2010. We monitored our cohort for at least 1 year and assessed for adequacy of vascular risk factor management, drug adherence, and occurrence of nonlethal vascular outcomes. RESULTS: Of 408 patients, 57.8% had a stroke and 42.2% a TIA. The mean age was 68±13 years, and 52% male. Average follow-up was 15.8 months. During follow-up, 253 patients (70.3%) completely achieved their blood pressure target, 151 (45.5%) achieved their low-density lipoprotein (LDL) cholesterol target, and 407 (99.8%) were on antithrombotics. Eighty-nine patients (21.8%) attained optimal therapy status, defined as reaching targets for LDL cholesterol, blood pressure, and antithrombotic use. Adherence to drug therapy was associated with attainment of optimal therapy status (p=0.01). Diabetes was associated with lower probability of attaining optimal therapy status (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.20-0.66) and blood pressure targets (OR, 0.09; 95% CI, 0.05-0.17). During follow-up, 52 (12.7%) patients had a nonlethal vascular event. CONCLUSION: Our study shows good attainment of therapeutic goals associated with adherence to drug therapy. However, optimal therapy status and blood pressure targets were more difficult to attain in patients with diabetes; therefore, more intensive preventive efforts may be required for these individuals.
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Cooperação do Paciente , Guias de Prática Clínica como Assunto/normas , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Canadá/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnósticoRESUMO
BACKGROUND AND PURPOSE: Evidence-based stroke care has been shown to improve patient outcomes and may reduce health system costs. Cost savings, however, are poorly quantified. This study assesses 4 aspects of stroke management (rapid assessment and treatment services, thrombolytic therapy, organized stroke units, and early home-supported discharge) and estimates the potential for cost avoidance in Canada if these services were provided in a comprehensive fashion. METHODS: Several independent data sources, including the Canadian Institute of Health Information Discharge Abstract Database, the 2008-2009 National Stroke Audit, and the Acute Cerebrovascular Syndrome Registry in the province of British Columbia, were used to assess the current status of stroke care in Canada. Evidence from the literature was used to estimate the effect of providing optimal stroke care on rates of acute care hospitalization, length of stay in hospital, discharge disposition (including death), changes in quality of life, and costs avoided. RESULTS: Comprehensive and optimal stroke care in Canada would decrease the number of annual hospital episodes by 1062 (3.3%), the number of acute care days by 166 000 (25.9%), and the number of residential care days by 573 000 (12.8%). The number of deaths in the hospital would be reduced by 1061 (14.9%). Total avoidance of costs was estimated at $682 million annually ($307.4 million in direct costs, $374.3 million in indirect costs). CONCLUSIONS: The costs of stroke care in Canada can be substantially reduced, at the same time as improving patient outcomes, with the greater use of known effective treatment modalities.
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Controle de Custos/métodos , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/terapia , Idoso , Isquemia Encefálica/complicações , Isquemia Encefálica/economia , Isquemia Encefálica/epidemiologia , Canadá , Hemorragia Cerebral/complicações , Hemorragia Cerebral/economia , Hemorragia Cerebral/epidemiologia , Custos e Análise de Custo , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Modelos Estatísticos , Anos de Vida Ajustados por Qualidade de Vida , Sistema de Registros , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Longitudinal, patient-level data on resource use and costs after an ischemic stroke are lacking in Canada. The objectives of this analysis were to calculate costs for the first year post-stroke and determine the impact of disability on costs. METHODOLOGY: The Economic Burden of Ischemic Stroke (BURST) Study was a one-year prospective study with a cohort of ischemic stroke patients recruited at 12 Canadian stroke centres. Clinical history, disability, health preference and resource utilization information was collected at discharge, three months, six months and one year. Resources included direct medical costs (2009 CAN$) such as emergency services, hospitalizations, rehabilitation, physician services, diagnostics, medications, allied health professional services, homecare, medical/assistive devices, changes to residence and paid caregivers, as well as indirect costs. Results were stratified by disability measured at discharge using the modified Rankin Score (mRS): non-disabling stroke (mRS 0-2) and disabling stroke (mRS 3-5). RESULTS: We enrolled 232 ischemic stroke patients (age 69.4 ± 15.4 years; 51.3% male) and 113 (48.7%) were disabled at hospital discharge. The average annual cost was $74,353; $107,883 for disabling strokes and $48,339 for non-disabling strokes. CONCLUSIONS: An average annual cost for ischemic stroke was calculated in which a disabling stroke was associated with a two-fold increase in costs compared to NDS. Costs during the hospitalization to three months phase were the highest contributor to the annual cost. A "back of the envelope" calculation using 38,000 stroke admissions and the average annual cost yields $2.8 billion as the burden of ischemic stroke.
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Isquemia Encefálica/complicações , Pessoas com Deficiência , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/fisiopatologia , Isquemia Encefálica/epidemiologia , Canadá/epidemiologia , Avaliação da Deficiência , Feminino , Custos de Cuidados de Saúde , Hospitalização , Humanos , Masculino , Estudos Retrospectivos , Índice de Gravidade de Doença , Acidente Vascular Cerebral/epidemiologia , Fatores de TempoRESUMO
BACKGROUND: Low-dose direct oral anticoagulant (DOAC) use is quite prevalent in clinical practice, but evidence of its effectiveness and safety compared with high-dose DOAC in patients with atrial fibrillation (AF) remains limited. We aimed to assess the effectiveness and safety of low-dose and high-dose DOACs in patients with AF with similar baseline characteristics. METHODS: We used a cohort of hospitalized patients with a primary or secondary diagnosis of AF after discharge to the community, whose data were stored in the Quebec administrative databases, from 2011 to 2017. Older adults with AF newly prescribed with rivaroxaban (15 or 20 mg) or apixaban (2.5 mg or 5 mg) were classified as under treatment (UT) and intent to treat (ITT). We used an inverse probability treatment weighting study of new users of rivaroxaban and apixaban to address confounding by indication. The primary effectiveness outcome was ischemic stroke/systemic embolism (SE), while the primary safety outcome was major bleeding (MB). We used Cox proportional models to estimate the marginal hazard ratios (HRs). FINDINGS: A total of 1,722 and 4,639 patients used low-dose and standard-dose rivaroxaban, respectively, while 3,833 and 6,773 patients used low-dose and standard-dose apixaban, respectively. No significant difference was observed in the incidence of comparative stroke/SE and MB between low-dose and standard-dose rivaroxaban, except for the risk of acute myocardial infarction (AMI), which was increased with the low dose in the UT analysis. For apixaban, no difference was found in the bleeding rates, but the risk of stroke/SE (HR: 1.95; 95% confidence interval (CI): 1.38-2.76) and death (HR: 1.99; 95% CI: 1.46-2.70) were greater in the low-dose group than in the standard-dose group in the UT analysis. Similar results were observed for the ITT analysis. CONCLUSION: No significant differences were observed in the effectiveness or safety outcome between low-dose and standard-dose rivaroxaban, except for AMI. However, low-dose apixaban was associated with a greater risk of stroke/SE and death without a reduction in the bleeding rates.
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Fibrilação Atrial , Infarto do Miocárdio , Acidente Vascular Cerebral , Humanos , Idoso , Rivaroxabana/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Piridonas/efeitos adversos , Anticoagulantes , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controleRESUMO
INTRODUCTION: Previous analysis of registered clinical trials has found a number of protocols result in changes in the registered primary outcome measures. This investigation determined if reported primary outcomes in chiropractic-related clinical trials registered in clinicaltrials.gov match their published results. Additionally, we assessed secondary outcomes, publication status and whether raw data were posted to the registry. METHODS: Clinicaltrials.gov was searched for chiropractic-related trials and having a completed status. If the study was published, outcome measures were compared between the clinicaltrials.gov entry and the published paper to assess for consistency. RESULTS: Within clinicaltrials.gov 171 chiropracticrelated protocols were identified with 102 of those published (59.6% publication rate). Ninety-two of the published papers (90.2%) had agreement between their primary outcome and the entry on clinicaltrials.gov and 82 (80.4%) agreed with the secondary outcomes. CONCLUSION: A modest rate of agreement between clinicaltrials.gov entries and the published papers was found. While chiropractic-related clinical trials are fewer compared to medical trials, chiropractic-related research has a substantially better rate of primary and secondary outcome concordance with registered protocols.
INTRODUCTION: En examinant des essais cliniques enregistrés, on s'est rendu compte qu'un certain nombre de protocoles faisaient varier les résultats principaux. On a mené une étude pour savoir si les résultats primaires d'essais cliniques sur la chiropratique enregistrés sur clinicaltrials.gov correspondaient à ceux publiés. On a aussi examiné les résultats secondaires, l'état de publication et cherché à savoir si les données brutes étaient publiées dans le registre. MÉTHODOLOGIE: Dans la base de données Clinicaltrials.gov, on a repéré des essais cliniques sur la chiropratique qui étaient terminés. Lorsque l'essai clinique avait été publié, on a comparé les résultats au moment de son enregistrement sur clinicaltrials.gov à ceux parus dans des publications pour savoir s'ils concordaient. RÉSULTATS: Sur le site clinicaltrials.gov, on a trouvé 171 études sur la chiropratique, dont 102 avaient été publiés (taux de publication:59,6 %). Pour quatrevingt-douze publications (90,2 %), on a observé une concordance entre les résultats primaires au moment de l'enregistrement sur clinicaltrials.gov et 82 (80,4 %) et les résultats secondaires. CONCLUSION: On a observé un taux modeste de concordance entre les données à l'enregistrement sur clinicaltrails.gov et les données publiées. Les essais cliniques sur la chiropratique sont moins nombreux que des essais cliniques de médicaments. Mais le taux de concordance entre les résultats primaires et les résultats secondaires était considérablement plus élevé lorsque les protocoles de recherches sur la chiropratique sont enregistrés.
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AIM: Real-world predictors of major bleeding (MB) have been well-studied among warfarin users, but not among all direct oral anticoagulant (DOAC) users diagnosed with atrial fibrillation (AF). Thus, our goal was to build a predictive model of MB for new users of all oral anticoagulants (OAC) with AF. METHODS: We identified patients hospitalized for any cause and discharged alive in the community from 2011 to 2017 with a primary or secondary diagnosis of AF in Quebec's RAMQ and Med-Echo administrative databases. Cohort entry occurred at the first OAC claim. Patients were categorized according to OAC type. Outcomes were incident MB, gastrointestinal bleeding (GIB), non-GI extracranial bleeding (NGIB) and intracranial bleeding within 1 year of follow-up. Covariates included age, sex, co-morbidities (within 3 years before cohort entry) and medication use (within 2 weeks before cohort entry). We used logistic-LASSO and adaptive logistic-LASSO regressions to identify MB predictors among OAC users. Discrimination and calibration were assessed for each model and a global model was selected. Subgroup analyses were performed for MB subtypes and OAC types. RESULTS: Our cohort consisted of 14,741 warfarin, 3,722 dabigatran, 6,722 rivaroxaban and 11,196 apixaban users aged 70-86 years old. The important MB predictors were age, prior MB and liver disease with ORs ranging from 1.37-1.64. The final model had a c-statistic of 0.63 (95% CI 0.60-0.65) with adequate calibration. The GIB and NGIB models had similar c-statistics of 0.65 (95% CI 0.63-0.66) and 0.67 (95% CI 0.64-0.70), respectively. CONCLUSIONS: MB and MB subtype predictors were similar among DOAC and warfarin users. The predictors selected by our models and their discriminative potential are concordant with published data. Thus, these models can be useful tools for future pharmacoepidemiologic studies involving older oral anticoagulant users with AF.
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Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Hemorragia/classificação , Hemorragia/epidemiologia , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Dabigatrana/administração & dosagem , Dabigatrana/efeitos adversos , Bases de Dados Factuais , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia/induzido quimicamente , Hospitalização , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Masculino , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Análise de Regressão , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Varfarina/administração & dosagem , Varfarina/efeitos adversosRESUMO
Aims: Observational studies of various dose levels of direct oral anticoagulants (DOACs) for patients with atrial fibrillation (AF) found that a high proportion of patients received a dose lower than the target dose tested in randomized controlled trials. There is a need to compare low-dose DOACs with warfarin or other DOACs on effectiveness and safety. Methods: Using administrative data from Quebec province, Canada, we built a cohort of new warfarin or DOAC users discharged from hospital between 2011 and 2017. We determined CHA2DS2-VASc and HAS-BLED scores, and comorbidities for 3-year prior cohort entry. The primary effectiveness endpoint was a composite of ischemic stroke/systemic embolism (SE), and secondary outcomes included a safety composite of major bleeding (MB) events and effectiveness composite (stroke/SE, death) at 1-year follow-up. We contrasted each low-dose DOAC with warfarin or other DOACs as references using inverse probability of treatment weighting to estimate marginal Cox hazard ratios (HRs). Results: The cohort comprised 22,969 patients (mean age: 80-86). We did not find a significant risk reduction for the stroke/SE primary effectiveness endpoint for DOACs vs. warfarin; however, we observed a significantly lower risk for low-dose dabigatran vs. warfarin (HR [95%CI]: 0.59 [0.42-0.81]) for effectiveness composite, mainly due to a lower death rate. The differences in effectiveness and safety composites between low-dose rivaroxaban vs. warfarin were not significant. However, low-dose apixaban had a better safety composite (HR: 0.68 [0.53-0.88]) vs. warfarin. Comparisons of dabigatran vs. apixaban showed a lower risk of stroke/SE (HR: 0.53 [0.30-0.93]) and a 2-fold higher risk of MB. The MB risk was higher for rivaroxaban than for apixaban (HR: 1.58 [1.09-2.29]). Conclusions: The results of this population-based study suggest that low-dose dabigatran has a better effective composite than warfarin. Compared with apixaban, low-dose dabigatran had a better effectiveness composite but a worse safety profile. Low-dose apixaban had a better safety composite than warfarin and other low-dose DOACs. Given that the comparative effectiveness and safety seem to vary from one DOAC to another, pharmacokinetic data for specific populations are now warranted.
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STUDY OBJECTIVE: Observational studies assessing direct oral anticoagulant (DOACs) dosage in atrial fibrillation (AF) reported that a lower proportion of patients received high-dose DOACs compared to those in randomized controlled trials (RCTs). Effectiveness and safety of high-dose DOACs relative to apixaban in a real-world AF population need to be addressed. The aim is to assess comparative effectiveness and safety of high-dose rivaroxaban relative to apixaban. DESIGN: We conducted a cohort study. Setting We built a cohort of patients hospitalized and discharged in community with a primary or secondary AF diagnosis from 2011-2017 using Quebec administrative databases (Med-Echo and RAMQ). Patients Cohort entry was defined as the first OAC claim in new users of high-dose rivaroxaban and apixaban, with no OAC claims in the prior year. Intervention To compare effectiveness and safety of high-dose rivaroxaban to apixaban. Measurement We ascertained patient demographics, comorbidities, CHA2DS2-VASc and HASBLED scores and Charlson score within 3 years prior to cohort entry. Primary effectiveness and safety were a composite of ischemic stroke/systemic thrombosis, death, myocardial infarction, and of intracranial bleeding (ICH), extracranial major bleeding, in the first year following drug initiation. We conducted propensity score matching and estimated hazard ratios (HRs) for outcomes using Cox proportional hazard models. All the analyses were conducted to account for competing risks. Main results The cohort consisted of 4,632 and 6,771 patients received high-dose rivaroxaban and apixaban, respectively. High-dose rivaroxaban users were younger with a mean age of 73.2 years, presented less associated comorbidities and had lower CHA2DS2-VASc scores compared to apixaban. High-dose rivaroxaban at the intention to treat was associated with a higher risk of stroke/SE/death (HR 1.21, 95% CI 1.04-1.40) and worse composite effectiveness (HR 1.21: 1.05-1.40); under treatment exposure, those values were at HR (1.66: 1.21-2.29) and HR (1.58:1.19-2.10), respectively. And, rivaroxaban presented a less favorable safety profile relative to apixaban. Conclusion In this study, composite effectiveness and safety varied between rivaroxaban and apixaban. High-dose apixaban was observed to have a better effectiveness and safety.
Assuntos
Fibrilação Atrial , Pirazóis , Piridonas , Rivaroxabana , Idoso , Fibrilação Atrial/tratamento farmacológico , Estudos de Coortes , Relação Dose-Resposta a Droga , Humanos , Pontuação de Propensão , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Rivaroxabana/administração & dosagem , Rivaroxabana/efeitos adversos , Resultado do TratamentoAssuntos
Serviço Hospitalar de Emergência , Ataque Isquêmico Transitório/diagnóstico , Ataque Isquêmico Transitório/terapia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Canadá , Diagnóstico Precoce , Intervenção Médica Precoce , Humanos , Índice de Gravidade de Doença , Fatores de TempoRESUMO
BACKGROUND: Cardiovascular diseases (CVD) represent a heavy economic burden on individuals, health services, and society. Low adherence to antihypertensive (AH) agents is acknowledged as a major contributor to the lack of blood pressure control, and may have a significant impact on clinical outcomes and healthcare costs. OBJECTIVES: To evaluate the impact of low adherence to AH agents on cardiovascular outcomes and hospitalization costs. METHODS: A cohort of 59,647 patients with essential hypertension was reconstructed from the Régie de l'assurance maladie du Québec and Med-Echo databases. Subjects included were between 45 and 85 years of age, without any evidence for symptomatic CVD, newly treated with AH agents between 1999 and 2002 and followed-up for a 3-year period. Adherence to AH agents was categorized as >or=80% or <80%. The adjusted odds ratio (OR) for CVD events between the 2 adherence groups was estimated using a polytomous logistic analysis. A 2-part model was applied for hospitalization costs. RESULTS: Patients with low adherence were more likely to have coronary disease (OR, 1.07; 95% confidence interval [CI], 1.00-1.13), cerebrovascular disease (OR, 1.13; 95% CI, 1.03-1.25), and chronic heart failure (OR, 1.42; 95% CI, 1.27-1.58) within the 3-year follow-up period. Among hospitalized patients, low adherence to AH therapy was associated with increased costs by approximately $3574 (95% CI, $2897-$4249) per person within a 3-year period. CONCLUSIONS: Low adherence to AH agents is correlated with a higher risk of vascular events, hospitalization, and greater healthcare costs. An increased level of adherence to AH agents should provide a better health status for individuals and a net economic gain.
Assuntos
Anti-Hipertensivos/uso terapêutico , Doenças Cardiovasculares/economia , Preços Hospitalares/estatística & dados numéricos , Hipertensão/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/economia , Doenças Cardiovasculares/etiologia , Transtornos Cerebrovasculares/economia , Transtornos Cerebrovasculares/etiologia , Estudos de Coortes , Doença da Artéria Coronariana/economia , Doença da Artéria Coronariana/etiologia , Quimioterapia Combinada , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/etiologia , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Hipertensão/complicações , Hipertensão/economia , Revisão da Utilização de Seguros/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Resultado do TratamentoRESUMO
BACKGROUND: The Canadian Neurological Scale (CNS) and the National Institutes of Health Stroke Scale (NIHSS) are among the most reliable stroke severity assessment scales. The CNS requires less extensive neurological evaluation and is quicker and simpler to administer. OBJECTIVE: Our aim was to develop and validate a simple conversion model from the CNS to the NIHSS. METHODS: A conversion model was developed using data from a consecutive series of acute-stroke patients who were scored using both scales. The model was then validated in an external dataset in which all patients were prospectively assessed for stroke severity using both scales by different observers which consisted of neurology residents or stroke fellows. RESULTS: In all, 168 patients were included in the model development, with a median age of 73 years (20-94). Men constituted 51.8%. The median NIHSS score was 6 (0-31). The median CNS score was 8.5 (1.5-11.5). The relationship between CNS and NIHSS could be expressed as the formula: NIHSS = 23 - 2 x CNS. A cohort of 350 acute-stroke patients with similar characteristics was used for model validation. There was a highly significant positive correlation between the observed and predicted NIHSS score (r = 0.87, p < 0.001). The predicted NIHSS score was on average 0.61 higher than the observed NIHSS score (95% CI = 0.31-0.91). CONCLUSIONS: The CNS can be reliably converted to the NIHSS using a simple conversion formula: NIHSS = 23 - 2 x CNS. This finding may have a practical impact by permitting reliable comparisons with NIHSS-based evaluations and simplifying the routine assessment of acute-stroke patients in more diverse settings.
Assuntos
Indicadores Básicos de Saúde , Modelos Estatísticos , Acidente Vascular Cerebral/diagnóstico , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , National Institutes of Health (U.S.) , Variações Dependentes do Observador , Ontário , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Índice de Gravidade de Doença , Acidente Vascular Cerebral/fisiopatologia , Acidente Vascular Cerebral/psicologia , Tailândia , Estados Unidos , Adulto JovemRESUMO
OBJECTIVE: Statins have been shown to reduce the risk of major cardiovascular disease. We recognize that there is a major gap between the use of statins in actual practice and treatment guidelines for dyslipidemia. Low adherence to statins may have a significant impact on clinical issues and health-care costs. The objective is to evaluate the impact of low adherence to statins on clinical issues and direct health-care costs. METHODS: A cohort of 55,134 patients newly treated with statins was reconstructed from the Régie de l'Assurance Maladie du Québec and Med-Echo databases. Subjects included were aged between 45 and 85, initially free of cardiovascular disease, newly treated with statins between 1999 and 2002, and followed-up for a minimum of 3 years. Adherence to statins was measured in terms of the proportion of days' supply of medication dispensed over a defined period, and categorized as >or=80% or <80%. The adjusted odds ratio (OR) of cardiovascular events between the two adherence groups was estimated using a polytomous logistic analysis. The mean costs of direct health-care services were evaluated. A two-part model was applied for hospitalization costs. RESULTS: The mean high adherence level to statins was around to 96% during follow-up; and this value was at 42% for the low adherence level. The patients with low adherence to statins were more likely to have coronary artery disease (OR 1.07; 95% confidence interval [CI], 1.01-1.13), cerebrovascular disease (OR 1.13; 95% CI 1.03-1.25), and chronic heart failure within 3-year period of follow-up (OR 1.13; 95% CI 1.01-1.26). Low adherence to statins was also associated with an increased risk of hospitalization by 4% (OR 1.04; 95% CI 1.01-1.09). Among patients who were hospitalized, low adherence to statins was significantly associated with increase of hospitalization costs by approximately $1060/patient for a 3-year period. CONCLUSION: Low adherence to statins was correlated with a higher risk of cardiovascular disease, hospitalization rate, and hospitalization costs. An increased level of adherence to statins agents should provide a better health status for individuals and a net economic gain.
Assuntos
Doenças Cardiovasculares/prevenção & controle , Dislipidemias/tratamento farmacológico , Custos de Cuidados de Saúde/estatística & dados numéricos , Inibidores de Hidroximetilglutaril-CoA Redutases/economia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Análise Custo-Benefício , Bases de Dados Factuais , Dislipidemias/economia , Dislipidemias/epidemiologia , Feminino , Fidelidade a Diretrizes/economia , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Masculino , Registro Médico Coordenado , Pessoa de Meia-Idade , Programas Nacionais de Saúde/economia , Programas Nacionais de Saúde/estatística & dados numéricos , Quebeque/epidemiologiaRESUMO
BACKGROUND: More than 60% of new strokes each year are "mild" in severity and this proportion is expected to rise in the years to come. Within our current health care system those with "mild" stroke are typically discharged home within days, without further referral to health or rehabilitation services other than advice to see their family physician. Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention, community reintegration, medication counselling and problem solving with regard to specific concerns that arise. Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization.The purpose of this study is to assess the effectiveness, for individuals who experience a first "mild" stroke, of a sustainable, low cost, multimodal support intervention (comprising information, education and telephone support)--"WE CALL" compared to a passive intervention (providing the name and phone number of a resource person available if they feel the need to)--"YOU CALL", on two primary outcomes: unplanned-use of health services for negative events and quality of life. METHOD/DESIGN: We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites. Baseline measures will be taken within the first month after stroke onset. Participants will be stratified according to comorbidity level and randomised to one of two groups: YOU CALL or WE CALL. Both interventions will be offered over a six months period. Primary outcomes include unplanned use of heath services for negative event (frequency calendar) and quality of life (EQ-5D and Quality of Life Index). Secondary outcomes include participation level (LIFE-H), depression (Beck Depression Inventory II) and use of health services for health promotion or prevention (frequency calendar). Blind assessors will gather data at mid-intervention, end of intervention and one year follow up. DISCUSSION: If effective, this multimodal intervention could be delivered in both urban and rural environments. For example, existing infrastructure such as regional stroke centers and existing secondary stroke prevention clinics, make this intervention, if effective, deliverable and sustainable. TRIAL REGISTRATION: ISRCTN95662526.
Assuntos
Reabilitação do Acidente Vascular Cerebral , Telemedicina/métodos , Canadá , Protocolos Clínicos , Comorbidade , Depressão/epidemiologia , Depressão/terapia , Seguimentos , Humanos , Aceitação pelo Paciente de Cuidados de Saúde , Educação de Pacientes como Assunto , Escalas de Graduação Psiquiátrica , Qualidade de Vida , Projetos de Pesquisa , Acidente Vascular Cerebral/epidemiologia , Telefone , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND AND PURPOSE: Data on oral anticoagulant (OAC) uptake and pattern of use are limited. Real-life data in patients with atrial fibrillation (AF) are important for understanding patient exposure. A cohort study of new OAC users was built to assess trends of drug use from 2011 to 2017, persistence rate, switching rate, adherence level, and predictors of adherence. METHODS: We built a cohort using the Régie d'Assurance Maladie du Québec (RAMQ) and Med-Echo administrative databases of new adult OAC users within 1 year following hospitalization with a diagnosis of AF. New users of OAC were defined as having no OAC claims in the year before cohort entry. We assessed trends of OAC use; persistence rate, defined as a gap between refills of no longer than two times the duration of the previous prescriptions; and adherence level, defined as the proportion of days covered (PDC) over a 1-year period following initiation. Predictors of nonadherence (PDC less than 80%) were analyzed using logistic regression models. RESULTS: The cohort consisted of 33,311 incident OAC users. Of total OAC claims, the proportions of warfarin claims decreased from 77.9% in 2011 to 12.7% in 2017, with direct oral anticoagulants (DOACs) accounting for 87.3% of claims, of which apixaban and rivaroxaban accounted for 60.1% and 23.4%, respectively, by the end of 2017. One year after OAC initiation, persistence rates ranged from 53% with warfarin to 77% with a high dose of apixaban. Approximately 75% of incident OAC users were considered "adherent" (PDC 80% or more), with a mean PDC of 95.6-98.1%, compared with "nonadherent," with a mean PDC varying between 43.1% and 50.7%. Older age, female sex, higher CHA2 DS2 -VASc score (to predict thromboembolic risk in AF), prior stroke, and treatment with chronic cardiovascular disease drugs were associated with high adherence levels. CONCLUSION: The clinical uptake of DOACs increased over time, accounting for 87.3% of prescriptions in 2017. In our study, 25% of new OAC users presented a low adherence level. Adherence to OACs remains a significant challenge in patients with AF.
Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Padrões de Prática Médica/tendências , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/sangue , Estudos de Coortes , Feminino , Humanos , Revisão da Utilização de Seguros , Masculino , Quebeque , Estudos Retrospectivos , Varfarina/uso terapêuticoRESUMO
BACKGROUND AND PURPOSE: The benefits of antihypertensive (AH) drugs on the risks of major cardiovascular outcomes have been demonstrated in clinical trials. However, approximately half of hypertensive patients do not adhere well to their prescribed AH therapy in actual practice. The purpose of this study was to assess the impact of adherence to AH agents on the incidence of cerebrovascular disease (CD) in real-world practice. METHODS: A cohort of 83 267 hypertensive patients was reconstructed from the Régie de l'assurance maladie du Québec databases. Subjects included were between 45 and 85 years old, initially free of cardiovascular disease, and newly treated for hypertension with AH agents between 1999 and 2004. A nested case-control design was conducted to study CD occurrence. Every case was matched for age and duration of follow-up with up to 15 randomly selected control subjects. The adherence to AH drugs was measured by calculating the medication possession ratio. Conditional logistic regression models were performed to assess the association between adherence to AH agents and CD adjusting for various potential confounders. RESULTS: At cohort entry, the mean patient age was 65 years, 37.3% were male, 8.6% had diabetes, and 19.5% had dyslipidemia. High adherence (>/=80%) to AH drugs significantly decreased the risk of CD by 22% (rate ratio, 0.78; 95% CI, 0.70 to 0.87) compared with lower adherence. Male gender, occurrence of cardiovascular disease during follow-up, and dyslipidemia were risk factors for CD. CONCLUSIONS: High adherence to AH therapy is associated with a reduced risk of CD outside the context of clinical trials in primary prevention.
Assuntos
Anti-Hipertensivos/uso terapêutico , Transtornos Cerebrovasculares/epidemiologia , Transtornos Cerebrovasculares/prevenção & controle , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Cooperação do Paciente/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/epidemiologia , Estudos de Casos e Controles , Comorbidade , Dislipidemias/epidemiologia , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Fatores de Risco , Comportamento de Redução do Risco , Distribuição por SexoRESUMO
BACKGROUND: The effect of pre-stroke use of antihypertensives, antiplatelets, and statins on initial severity and early outcome of ischemic stroke is uncertain. METHODS: We performed a retrospective chart review of 553 consecutive acute ischemic stroke patients presenting to the Montreal General Hospital between April 1st 2002 and October 15th 2005. We defined a severe stroke as a Canadian Neurological Scale score of < or =7 and a poor early outcome as a modified Rankin Scale score of >3 at 10 days post-stroke. RESULTS: In total, 339 patients were included. Superior early functional outcome was associated with the premorbid use of statins (OR = 0.50, 95% CI: 0.25-1.00) and the combination of all 3 medications (OR = 0.37, 95% CI: 0.16-0.87). Angiotensin-II-decreasing agents were associated with an increased risk of severe strokes (OR = 2.13, 95% CI: 1.00-4.52). CONCLUSIONS: Pre-stroke use of statins and the combination of antihypertensives, antiplatelets, and statins were both associated with a favorable functional outcome at 10 days post-stroke. Angiotensin-II-decreasing agents were associated with increased initial stroke severity.