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1.
Eur Heart J ; 45(20): 1819-1827, 2024 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-38606837

RESUMO

BACKGROUND AND AIMS: Female sex has been linked with higher risk of ischaemic stroke (IS) in atrial fibrillation (AF), but no prior study has examined temporal trends in the IS risk associated with female sex. METHODS: The registry-linkage Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study included all patients with AF in Finland from 2007 to 2018. Ischaemic stroke rates and rate ratios were computed. RESULTS: Overall, 229 565 patients with new-onset AF were identified (50.0% women; mean age 72.7 years). The crude IS incidence was higher in women than in men across the entire study period (21.1 vs. 14.9 events per 1000 patient-years, P < .001), and the incidence decreased both in men and women. In 2007-08, female sex was independently associated with a 20%-30% higher IS rate in the adjusted analyses, but this association attenuated and became statistically non-significant by the end of the observation period. Similar trends were observed when time with and without oral anticoagulant (OAC) treatment was analysed, as well as when only time without OAC use was considered. The decrease in IS rate was driven by patients with high IS risk, whereas in patients with low or moderate IS risk, female sex was not associated with a higher IS rate. CONCLUSIONS: The association between female sex and IS rate has decreased and become non-significant over the course of the study period from 2007 to 2018, suggesting that female sex could be omitted as a factor when estimating expected IS rates and the need for OAC therapy in patients with AF.


Assuntos
Anticoagulantes , Fibrilação Atrial , AVC Isquêmico , Sistema de Registros , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/tratamento farmacológico , Feminino , Idoso , AVC Isquêmico/epidemiologia , AVC Isquêmico/prevenção & controle , AVC Isquêmico/etiologia , Finlândia/epidemiologia , Masculino , Anticoagulantes/uso terapêutico , Incidência , Fatores Sexuais , Fatores de Risco , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade
2.
Stroke ; 55(1): 122-130, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-38063017

RESUMO

BACKGROUND: Limited data exist on the temporal relationship between new-onset atrial fibrillation (AF) and ischemic stroke and its impact on patients' clinical characteristics and mortality. METHODS: A population-based registry-linkage database includes all patients with new-onset AF in Finland from 2007 to 2018. Ischemic stroke temporally associated with AF (ISTAF) was defined as an ischemic stroke occurring within ±30 days from the first AF diagnosis. Clinical factors associated with ISTAF were studied with logistic regression and 90-day survival with Cox proportional hazards analysis. RESULTS: Among 229 565 patients with new-onset AF (mean age, 72.7 years; 50% female), 204 774 (89.2%) experienced no ischemic stroke, 12 209 (5.3%) had past ischemic stroke >30 days before AF, and 12 582 (5.8%) had ISTAF. The annual proportion of ISTAF among patients with AF decreased from 6.0% to 4.8% from 2007 to 2018. Factors associated positively with ISTAF were higher age, lower education level, and alcohol use disorder, whereas vascular disease, heart failure, chronic kidney disease cancer, and psychiatric disorders were less probable with ISTAF. Compared with patients without ischemic stroke and those with past ischemic stroke, ISTAF was associated with ≈3-fold and 1.5-fold risks of death (adjusted hazard ratios, 2.90 [95% CI, 2.76-3.04] and 1.47 [95% CI, 1.39-1.57], respectively). The 90-day survival probability of patients with ISTAF increased from 0.79 (95% CI, 0.76-0.81) in 2007 to 0.89 (95% CI, 0.87-0.91) in 2018. CONCLUSIONS: ISTAF depicts the prominent temporal clustering of ischemic strokes surrounding AF diagnosis. Despite having fewer comorbidities, patients with ISTAF had worse, albeit improving, survival than patients with a history of or no ischemic stroke. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04645537. URL: https://www.encepp.eu; Unique identifier: EUPAS29845.


Assuntos
Fibrilação Atrial , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Masculino , Acidente Vascular Cerebral/diagnóstico , Fibrilação Atrial/complicações , AVC Isquêmico/complicações , Comorbidade , Sistema de Registros , Fatores de Risco , Anticoagulantes
3.
Eur J Clin Invest ; 54(1): e14107, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37823410

RESUMO

AIMS: To investigate sex-specific temporal trends in the initiation of oral anticoagulant (OAC) therapy among patients diagnosed with atrial fibrillation (AF) in Finland between 2007 and 2018. METHODS: The registry-linkage Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) Study included all patients with incident AF in Finland from 2007 to 2018. The primary outcome was the initiation of any OAC therapy. RESULTS: We identified 229,565 patients with new-onset AF (50.0% women; mean age 72.7 years). The initiation of OAC therapy increased continuously during the observation period. While women were more likely to receive OAC therapy overall, after adjusting for age, stroke risk factors and other confounding factors, female sex was associated with a marginally lower initiation of OACs (unadjusted and adjusted hazard ratios comparing women to men: 1.08 (1.07-1.10) and 0.97 (0.96-0.98), respectively). Importantly, the gender disparities in OAC use attenuated and reached parity by the end of the observation period. Furthermore, when only patients eligible for OAC therapy according to the contemporary guidelines were included in the analyses, the gender inequalities in OAC initiation appeared minimal. Implementation of direct OACs for stroke prevention was slightly slower among women. CONCLUSION: This nationwide retrospective cohort study covering all patients with incident AF in Finland from 2007 to 2018 observed that although female sex was initially associated with a lower initiation of OAC therapy, the sex-related disparities resolved over the course of the study period.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Masculino , Humanos , Feminino , Idoso , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Administração Oral
4.
Europace ; 26(6)2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38829189

RESUMO

AIMS: Elective cardioversion (ECV) is routinely used in atrial fibrillation (AF) to restore sinus rhythm. However, it includes a risk of thromboembolism even during adequate oral anticoagulation treatment. The aim of this study was to evaluate the risk of thromboembolic and bleeding complications after ECV in a real-life setting utilizing data from a large AF population. METHODS AND RESULTS: This nationwide register-based study included all (n = 9625) Finnish AF patients undergoing their first-ever ECV between 2012 and 2018. The thromboembolic and bleeding complications within 30 days after ECV were analysed. The mean age of the patients was 67.7 ± 9.9 years, 61.2% were men, and the mean CHA2DS2-VASc score was 2.6 ± 1.6. Warfarin was used in 6245 (64.9%) and non-vitamin K oral anticoagulants (NOACs) in 3380 (35.1%) cardioversions. Fifty-two (0.5%) thromboembolic complications occurred, of which 62% were ischaemic strokes, 25% transient ischaemic attacks, and 13% other systemic embolisms. Thromboembolic events occurred in 14 (0.4%) NOAC-treated patients and in 38 (0.6%) warfarin-treated patients (odds ratio 0.77; confidence interval: 0.42-1.39). The median time from ECV to the thromboembolic event was 2 days, and 78% of the events occurred within 10 days. Age and alcohol abuse were significant predictors of thromboembolic events. Among warfarin users, thromboembolic complications were more common with international normalized ratio (INR) <2.5 than INR ≥2.5 (0.9% vs. 0.4%, P = 0.026). Overall, 27 (0.3%) bleeding events occurred. CONCLUSION: The rate of thromboembolic and bleeding complications related to ECV was low without significant difference between NOAC- and warfarin-treated patients. With warfarin, INR ≥2.5 at the time of cardioversion reduced the risk of thromboembolic complications.


Assuntos
Anticoagulantes , Fibrilação Atrial , Cardioversão Elétrica , Hemorragia , Sistema de Registros , Tromboembolia , Humanos , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/tratamento farmacológico , Masculino , Cardioversão Elétrica/efeitos adversos , Feminino , Idoso , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Tromboembolia/epidemiologia , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Hemorragia/epidemiologia , Hemorragia/induzido quimicamente , Hemorragia/etiologia , Pessoa de Meia-Idade , Finlândia/epidemiologia , Fatores de Risco , Varfarina/efeitos adversos , Varfarina/uso terapêutico , Medição de Risco , Fatores de Tempo
5.
Europace ; 26(10)2024 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-39383252

RESUMO

AIMS: Atrial fibrillation (AF) patients frequently require active rhythm control therapy to maintain sinus rhythm and reduce symptom burden. Our study assessed whether antiarrhythmic therapies (AATs) are used disproportionately between men and women after new-onset AF. METHODS AND RESULTS: The nationwide Finnish anticoagulation in AF registry-based linkage study covers all patients with new-onset AF in Finland during 2007-2018. Study outcomes included initiation of AATs in the form of antiarrhythmic drugs (AADs), cardioversion, or catheter ablation. The study population constituted of 229 565 patients (50% females). Women were older than men (76.6 ± 11.8 vs. 68.9 ± 13.4 years) and had higher prevalence of hypertension or hyperthyroidism, but lower prevalence of vascular disease, diabetes, renal disease, and cardiomyopathies than men. Overall, 17.6% of women and 25.1% of men were treated with any AAT. Women were treated with AADs more often than men in all age groups [adjusted subdistribution hazard ratio (aSHR) 1.223, 95% confidence interval (CI) 1.187-1.261]. Cardioversions were also performed less often on women than on men aged <65 years (aSHR 0.722, 95% CI 0.695-0.749), more often in patients ≥ 75 years (aSHR 1.166, 95% CI 1.108-1.227), while no difference between the sexes existed in patients aged 65-74 years. Ablations were performed less often in women aged <65 years (aSHR 0.908, 95% CI 0.826-0.998) and ≥75 years (aSHR 0.521, 95% CI 0.354-0.766), whereas there was no difference in patients aged 65-74 years. CONCLUSION: Women used more AAD than men in all age groups but underwent fewer cardioversion and ablation procedures when aged <65 years.


Assuntos
Antiarrítmicos , Fibrilação Atrial , Ablação por Cateter , Sistema de Registros , Humanos , Feminino , Masculino , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Idoso , Antiarrítmicos/uso terapêutico , Finlândia/epidemiologia , Pessoa de Meia-Idade , Fatores Sexuais , Fatores Etários , Ablação por Cateter/estatística & dados numéricos , Idoso de 80 Anos ou mais , Cardioversão Elétrica/estatística & dados numéricos , Disparidades em Assistência à Saúde/tendências , Fatores de Risco , Padrões de Prática Médica/tendências , Padrões de Prática Médica/estatística & dados numéricos
6.
Br J Clin Pharmacol ; 89(1): 351-360, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35986926

RESUMO

AIMS: Socioeconomic disparities have been reported in the outcomes of patients with atrial fibrillation (AF). We assessed the hypothesis that AF patients with higher income or educational level are more frequently initiated with oral anticoagulant (OAC) therapy for stroke prevention. METHODS: The nationwide registry-based Finnish AntiCoagulation in Atrial Fibrillation cohort covers all patients with AF from all levels of care in Finland. Patients were divided into income quartiles according to their highest annual income during 2004-2018 and into three categories based on educational attainment. The outcome was the first redeemed OAC prescription. RESULTS: We identified 239 222 patients (mean age 72.7 ± 13.2 years, 49.8% female) with incident AF during 2007-2018. Higher income was associated with higher OAC initiation rate: compared to the lowest income quartile the adjusted SHRs (95% CI) for OAC initiation were 1.09 (1.07-1.10), 1.13 (1.11-1.14) and 1.13 (1.12-1.15) in the second, third and fourth income quartiles, respectively. Patients in the highest educational category had a slightly lower OAC initiation rate than patients in the lowest educational category (adjusted SHR 0.92 [95% CI 0.90-0.93]). Income-related disparities were larger and education-related disparities only marginal among patients at high risk of ischemic stroke. The socioeconomic disparities in OAC initiation within 1-year follow-up decreased from 2007 to 2018. The adoption of direct OACs as the initial anticoagulant was faster among patients with higher income or educational levels. CONCLUSION: These findings highlight potential missed opportunities in stroke prevention, especially among AF patients with low income, whereas the education-related disparities in OAC initiation appear controversial.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Fibrilação Atrial/tratamento farmacológico , Estudos de Coortes , Finlândia , Acidente Vascular Cerebral/prevenção & controle , Anticoagulantes/efeitos adversos , Escolaridade , Administração Oral , Fatores de Risco
7.
Scand J Public Health ; : 14034948231189918, 2023 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-37571929

RESUMO

AIMS: Rural-urban disparities have been reported in the outcomes of cardiovascular diseases. We assessed whether rural-urban or other geographical disparities exist in the risk of ischemic stroke (IS) and death in patients with atrial fibrillation (AF) in Finland. METHODS: The registry-based FinACAF cohort study covers all patients with AF from all levels of care in Finland from 2007 to 2018. Patients were divided into rural-urban categories and into hospital districts (HDs) based on their municipality of residence. RESULTS: We identified 222,051 patients (50.1% female; mean age 72.8 years; mean follow-up 3.9 years) with new-onset AF, of whom 15,567 (7.0%) patients suffered IS and 72,565 (32.7%) died during follow-up. The crude IS rate was similar between rural and urban areas, whereas the mortality rate was lower in urban areas (incidence rate ratios (IRRs) with 95% confidence intervals (CIs) 0.97 (0.93-1.00) and 0.92 (0.91-0.93), respectively). However, after adjustments, urban residence was associated with slightly higher IS and mortality rates (IRRs with 95% CIs 1.05 (1.01-1.08) and 1.06 (1.04-1.07), respectively). The highest crude IS rate was in the East Savo HD and the lowest in Åland, whereas the highest crude mortality rate was in the Länsi-Pohja HD and the lowest in the North Ostrobothnia HD (IRRs with 95% CIs compared to Helsinki and Uusimaa HD for IS 1.46 (1.28-1.67) and 0.79 (0.62-1.01), and mortality 1.24 (1.16-1.32) and 0.97 (0.93-1.00), respectively. CONCLUSIONS: Rural-urban differences in prognosis of AF in Finland appear minimal, whereas considerable disparities exist between HDs.

8.
Eur J Clin Invest ; 52(9): e13801, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35484936

RESUMO

BACKGROUND: Atrial fibrillation (AF) patients with mental health conditions (MHCs) have higher incidence of ischaemic stroke (IS) than patients without MHC, but whether this results from direct impact of MHCs or relates to higher prevalence of comorbidities and differences in the use of oral anticoagulant (OAC) therapy is unclear. We assessed the hypothesis that MHCs independently increase the risk of IS in patients with incident AF. METHODS: The nationwide FinACAF cohort covered all 203,154 patients diagnosed with incident AF without previous IS or transient ischaemic attack in Finland during 2007-2018. MHCs of interest were depression, bipolar disorder, anxiety disorder, schizophrenia and any MHC. The outcomes were first-ever IS and all-cause death. RESULTS: The patients' (mean age 73.0 ± 13.5 years, 49.0% female) mean follow-up time was 4.3 (SD 3.3) years and 16,272 (8.0%) experienced first-ever IS and 63,420 (31.2%) died during follow-up. After propensity score matching and adjusting for OAC use, no MHC group was associated with increased IS risk (adjusted SHRs (95% CI): depression 0.961 (0.857-1.077), bipolar disorder 1.398 (0.947-2.006), anxiety disorder 0.878 (0.718-1.034), schizophrenia 0.803 (0.594-1.085) and any MHC 1.033 (0.985-1.085)). Lower rate of OAC use partly explained the observed higher crude IS incidence in patients with any MHC. Depression, schizophrenia and any MHC were associated with higher all-cause mortality (adjusted HRs [95% CI]: 1.208 [1.136-1.283], 1.543 [1.352-1.761] and 1.149 [1.116-1.175], respectively). CONCLUSIONS: In this nationwide retrospective cohort study, MHCs were not associated with the incidence of first-ever IS in patients with AF.


Assuntos
Fibrilação Atrial , Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Estudos de Coortes , Feminino , Humanos , Masculino , Saúde Mental , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia
9.
Eur J Epidemiol ; 37(1): 95-102, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34985732

RESUMO

Atrial fibrillation (AF) is a major cause of ischemic stroke and the number of AF patients is increasing. Thus, up-to-date multifaceted data about the characteristics of AF patients, their treatments, and outcomes are urgently needed. The Finnish anticoagulation in atrial fibrillation (FinACAF) study has collected comprehensive data on all Finnish AF patients from 1st January 2004 to 31st December 2018. The aim of this paper is to describe the study rationale, the process of integrating data from the applied resources and to define the study cohort. Using national unique personal identification number, individual patient data is linked from nationwide health care registries (primary, secondary, and tertiary care), drug purchases, education, and socio-economic status as well as places of domicile, incomes, and taxes. Six regional laboratory databases (~ 282,000, 77% of the patients) are also included. The study cohort comprises of a total of 411,000 patients. Since the introduction of the national primary care register in 2012, 9% of all AF patients were identified outside hospital care registers. The prevalence of AF in Finland-4.1% of whole population-is for the first time now established. The FinACAF study allows a unique possibility to investigate the epidemiology and socio-medico-economic impact of AF as well as the cost effectiveness of different AF management strategies in a completely unselected, nationwide population. This article provides the rationale and design of the study together with a summary of the characteristics of the cohort.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Finlândia/epidemiologia , Humanos , Sistema de Registros , Fatores de Risco
10.
Acta Orthop ; 93: 348-354, 2022 02 24.
Artigo em Inglês | MEDLINE | ID: mdl-35224646

RESUMO

BACKGROUND AND PURPOSE: Fast-track total joint replacement (TJR) has become increasingly common. Routine thromboprophylaxis for pulmonary embolism and deep venous thrombosis prevention lasts from 2 to 5 weeks. This retrospective registry study focused on clinically relevant bleeding complications 90 days after fast-track primary TJR. PATIENTS AND METHODS: All primary fast-track total hip (THA) and knee arthroplasties (TKA) performed between 2015 and 2016 were extracted from the Finnish Arthroplasty Register and Finnish Hospital Discharge Register. Type of arthroplasty and indication for the operation were combined with diagnoses of clinically relevant bleeding complications within 90 days of surgery. The incidence of these bleedings was the primary outcome measure. RESULTS: Of the total of 8,511 patients (mean age 67 years (SD 10); 60% female), 45% underwent unilateral THA, 52% unilateral TKA, and 3% bilateral TKA. The incidence of clinically relevant bleeding complications within 90 days was 1% (95% CI 0.8-1.3). No difference was observed in bleeding incidence between the groups. The 87 bleedings comprised 57 operative site bleedings, 17 gastrointestinal bleedings, 6 intracranial non-traumatic bleedings, 5 bleedings from the nose or another undetermined site, and 2 intraocular bleedings. 1 death due to intracranial bleeding was recorded, and hence clinically relevant bleeding-specific 90-day mortality was 0.01%. INTERPRETATION: The incidence of clinically relevant bleeding complications was low. However, they cause patient discomfort, increase the use of healthcare services, and can be life-threatening and even fatal.


Assuntos
Artroplastia de Quadril , Tromboembolia Venosa , Idoso , Anticoagulantes/uso terapêutico , Artroplastia de Quadril/efeitos adversos , Feminino , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Tromboembolia Venosa/prevenção & controle
11.
Eur Respir J ; 57(2)2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32859673

RESUMO

INTRODUCTION: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes. METHODS: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire) and generic (five-level five-dimension EuroQoL (EQ-5D-5L) scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale (ACTS)) after pulmonary embolism. RESULTS: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±sd PEmb-QoL decreased from 28.9±20.6% at 3 weeks to 19.9±15.4% at 3 months, a mean change (improvement) of -9.1% (p<0.0001). Improvement was consistent across all PEmb-QoL dimensions. The EQ-5D-5L was 0.89±0.12 at 3 weeks after enrolment and improved to 0.91±0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age was associated with faster worsening of generic quality of life. The ACTS burden score improved from 40.5±6.6 points at 3 weeks to 42.5±5.9 points at 3 months (p<0.0001). CONCLUSIONS: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.


Assuntos
Embolia Pulmonar , Qualidade de Vida , Idoso , Feminino , Humanos , Alta do Paciente , Estudos Prospectivos , Embolia Pulmonar/tratamento farmacológico , Inquéritos e Questionários
12.
Eur Heart J ; 41(4): 509-518, 2020 01 21.
Artigo em Inglês | MEDLINE | ID: mdl-31120118

RESUMO

AIMS: To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. METHODS AND RESULTS: We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). CONCLUSION: Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.


Assuntos
Pacientes Ambulatoriais , Alta do Paciente/tendências , Embolia Pulmonar/tratamento farmacológico , Rivaroxabana/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Esquema de Medicação , Inibidores do Fator Xa/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Fatores de Risco , Resultado do Tratamento , Adulto Jovem
13.
J Stroke Cerebrovasc Dis ; 28(8): 2242-2249, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31151840

RESUMO

BACKGROUND AND PURPOSE: We studied serum neurofilaments diagnostic value in patients with acute ischemic stroke (AIS) or TIA and evaluated any correlation with symptom severity, cerebral infarction volume, aetiology, and clinical outcome. METHODS: One hundred and thirty-six patients (101 with AIS, and 35 with TIA) were included. Acute-phase serum neurofilament light chain (sNfL) was analyzed with a novel ultrasensitive single molecule array (Simoa). Cerebral infarction volume was measured from brain computed tomography in the subacute phase (>2 days). Stroke aetiology was defined by trial of ORG 10172 in acute stroke treatment classification, severity by National Institute of Health stroke scale (NIHSS) and the degree of disability by the Modified Rankin Scale (mRS) after 90 days. RESULTS: sNfL was markedly higher in patients with AIS (89.5 pg/mL [IQR: 44.7-195.3]) than with TIA (25.2 pg/mL [IQR: 14.6-48.0]), P= <.001), also after adjusting for age, NIHSS, and stroke volume (P= .003). In receiver operating characteristic analysis, sNfL concentration greater than or equal to 49 pg/mL proved to be the best cut-off value to differentiate between patients with stroke and those with TIA (sensitivity of 73% and specificity of 80%). sNfL concentration significantly correlated with cerebral infarction volume (r = .413, P= <.001), this association remained significant after adjusting for established predictors (P= .019). Patients with AIS due to cardioembolism or large artery atherosclerosis had the highest sNfL concentrations. NIHSS on admission (r = .343, P = <.001) and mRS scores after 3 months (r = .306, P = .004) correlated with sNfL concentration, however functional outcome 3 months after stroke was not associated with sNfL after adjusting for potential confounders. CONCLUSIONS: Cases with stroke were distinguishable from those with TIA following the determination of sNfL in the blood samples. The presence and amount of axonal damage estimated by sNfL correlated with the final cerebral infarction volume but was not predictive of degree of disability.


Assuntos
Infarto Encefálico/sangue , Proteínas de Neurofilamentos/sangue , Biomarcadores/sangue , Encéfalo/diagnóstico por imagem , Infarto Encefálico/diagnóstico por imagem , Infarto Encefálico/terapia , Avaliação da Deficiência , Feminino , Finlândia , Humanos , Imageamento por Ressonância Magnética , Masculino , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Tomografia Computadorizada por Raios X , Regulação para Cima
14.
Europace ; 20(4): 565-568, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29016758

RESUMO

Aims: Non-vitamin K antagonist oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF). The aim of this study was to investigate the complications and the use of NOACs in AF patients undergoing elective cardioversion. Methods and results: This nationwide multicentre study included consecutive elective cardioversions in AF patients treated with NOACs between October 2011 and May 2016. Data on patient characteristics, antithrombotic treatment and acute (<30 days) complications were collected. One thousand twenty-one patients (mean age 64 years, 70% men) underwent 1291 elective cardioversions, of which 680 (52.7%) cardioversions were performed in patients using dabigatran, 431 (33.4%) rivaroxaban, and 159 (12.3%) apixaban. Mean CHA2DS2-VASc score was 1.8 (±1.5). A total of 3 thromboembolic events occurred after the cardioversion (0.2%): 1 patient receiving dabigatran experienced an ischaemic stroke on Day 2 and 1 rivaroxaban treated patient on Day 4. One patient receiving dabigatran experienced a transient ischaemic attack on Day 11. All 3 patients had used recommended doses of the NOAC. A total of 6 (0.5%) clinically relevant, but not serious bleeding events occurred. Only short duration of AF was associated with lower rate of AF recurrence. Conclusion: Thrombotic and bleeding complications related to NOACs were uncommon (<0.5%) in real life AF patients undergoing elective cardioversion.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/terapia , Isquemia Encefálica/prevenção & controle , Cardioversão Elétrica , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia/prevenção & controle , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/etiologia , Cardioversão Elétrica/efeitos adversos , Feminino , Finlândia , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Tromboembolia/diagnóstico , Tromboembolia/etiologia , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
15.
J Electrocardiol ; 51(6): 983-989, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30497761

RESUMO

OBJECTIVES: The sensitivity and specificity of the conventional 12-lead ECG to identify carriers of hypertrophic cardiomyopathy (HCM) - causing mutations without left ventricular hypertrophy (LVH) has been limited. We assessed the ability of novel electrocardiographic parameters to improve the detection of HCM mutation carriers. METHODS: We studied 140 carriers (G+) of the TPM1-Asp175Asn or MYBPC3-Gln1061X pathogenic variants for HCM: The G+/LVH+ group (n = 98) consisted of mutation carriers with LVH and the G+/LVH- group (n = 42) without LVH. The control group consisted of 30 subjects. The standard 12-lead ECG was comprehensively analyzed and two novel ECG variables were introduced: RV1RV3 and septal remodeling. A subset of 65 individuals underwent cardiac magnetic resonance imaging and 2D strain echocardiography. RESULTS: Conventional major ECG criteria were sensitive (90%) and specific (97%) in identifying G+/LVH+ subjects. RV1RV3 and septal remodeling were more prevalent in the G+/LVH- subjects compared to the control group (33% vs 3%, p = 0.005 and 45% vs 3%, p < 0.001, respectively). The combination of RV1RV3 and Q waves and repolarization abnormalities (QR) differentiated between the G+/LVH- subjects and the control group with a sensitivity of 52% and specificity of 97%. The combination of septal remodeling and QR differentiated between G+/LVH- subjects and the control group with a sensitivity of 64% and specificity of 97%. CONCLUSIONS: The novel ECG-parameters RV1RV3 and septal remodeling were effective in identifying G+/LVH- subjects and could be useful in the diagnostics of new suspected HCM patients and in the screening and follow-up of HCM families.


Assuntos
Cardiomiopatia Hipertrófica/genética , Cardiomiopatia Hipertrófica/fisiopatologia , Eletrocardiografia/métodos , Mutação/genética , Adulto , Cardiomiopatia Hipertrófica/diagnóstico por imagem , Proteínas de Transporte , Meios de Contraste , Ecocardiografia , Feminino , Finlândia , Heterozigoto , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Tropomiosina
16.
Heart Lung Circ ; 25(6): 592-9, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26809463

RESUMO

BACKGROUND: We investigated the ability of cardiac biomarkers and total pulmonary artery (PA) clot score to predict right ventricular dysfunction (RVD) on admission and at seven-month follow-up in subjects with acute pulmonary embolism (APE). METHODS: Sixty-three normotensive patients with APE were divided into two groups: patients with (n= 32, age 58±19 years) and without (n=31, age 55±16 years) echocardiographic RVD. Transthoracic echocardiography (TTE), N-terminal pro-brain natriuretic peptide (NT-proBNP), and high-sensitivity troponin T (hsTnT) were assessed upon arrival and repeated at seven months. Total PA clot score was determined on admission. RESULTS: The age- and sex dependent NT-proBNP on admission, on day 5, and at seven months exhibited the best sensitivity (admission 94%, day 5 100%, seven months 100%) and negative predictive value (NPV) (89%, 100%, 100%) for detecting RVD. Six patients (10%) had persistent RVD at seven months. Total PA clot score showed only low to moderate sensitivity (77%) and PPV (7%) for detection of RVD at seven months. CONCLUSIONS: Normal age- and sex dependent NT-proBNP on admission or measured five days later seems to be useful in exclusion of RVD at follow up. Total PA clot score shows only to be of modest benefit for predicting persistent RVD.


Assuntos
Ecocardiografia , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Artéria Pulmonar/diagnóstico por imagem , Embolia Pulmonar , Trombose , Troponina/sangue , Disfunção Ventricular Direita , Adulto , Idoso , Biomarcadores/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico por imagem , Trombose/sangue , Trombose/diagnóstico por imagem , Disfunção Ventricular Direita/sangue , Disfunção Ventricular Direita/diagnóstico por imagem
17.
Duodecim ; 132(18): 1625-33, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-29188940

RESUMO

Approximately 15 to 40% of cerebral infarctions and transient ischemic attacks (TIA) are of cardiac origin. Knowledge of a significant cardiac disease arouses the suspicion of cardiogenic embolism, but its diagnosis requires identification of the source of embolism. Atrial fibrillation is the most common cause of cardiogenic embolism, and should be actively sought after an ischemic cerebrovascular attact. The detection of atrial fibrillation or an intracardiac thrombus in these patients requires initiation of permanent anticoagulant therapy. Transesophageal echocardiography (TEE) has proven to be more sensitive than transthoracic echocardiography (TTE) in detecting certain possible cardiogenic sources of embolism.


Assuntos
Cardiopatias/complicações , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/terapia , Anticoagulantes/uso terapêutico , Ecocardiografia Transesofagiana , Humanos
18.
Duodecim ; 131(12): 1177-83, 2015.
Artigo em Finlandês | MEDLINE | ID: mdl-26245048

RESUMO

INTRODUCTION: The recommendation to discharge low-risk pulmonary embolism patients from or after a brief monitoring in the emergency department has not been widely adopted in Finland. METHODS: We explored the practices for examination and treatment of patients with pulmonary embolism in a university hospital and a central hospital. An assessment was made on how these practices followed the risk classifications. RESULTS: A very small proportion (3.9%) of the patients were discharged directly from the emergency department. According to the risk classifications, the proportion of patients suited for home care would have been between 30 and 60%. CONCLUSIONS: A significant proportion of patients with pulmonary embolism can be treated on the outpatient basis.


Assuntos
Serviço Hospitalar de Emergência , Alta do Paciente/estatística & dados numéricos , Embolia Pulmonar/terapia , Finlândia , Hospitais Universitários , Humanos , Medição de Risco
19.
Duodecim ; 130(17): 1709-17, 2014.
Artigo em Finlandês | MEDLINE | ID: mdl-25272782

RESUMO

AF is associated with the risk of stroke, and this risk is exceedingly high in elderly patients (> or = 75 years) and in patients after a stroke. DOACs are appropriate anticoagulants for AF patients without mechanical heart valves or mitral stenosis. Patients on DOACs do not require routine monitoring of coagulation, but need regular follow-up visits including an assessment of therapy adherence, thromboembolic and bleeding events and measurements of hemoglobin and platelets values as well as renal and liver function.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Hemoglobinas/análise , Humanos , Testes de Função Renal , Testes de Função Hepática , Adesão à Medicação , Contagem de Plaquetas , Risco , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
20.
JMIR Mhealth Uhealth ; 12: e51841, 2024 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-38324366

RESUMO

BACKGROUND: Many patients with chronic heart failure (HF) experience a reduced health status, leading to readmission after hospitalization despite receiving conventional care. Telemonitoring approaches aim to improve the early detection of HF decompensations and prevent readmissions. However, knowledge about the impact of telemonitoring on preventing readmissions and related costs remains scarce. OBJECTIVE: This study assessed the effectiveness of adding a telemonitoring solution to the standard of care (SOC) for the prevention of hospitalization and related costs in patients with HF in Finland. METHODS: We performed a nonrandomized pre-post telemonitoring study to estimate health care costs and resource use during 6 months on SOC followed by 6 months on SOC with a novel telemonitoring solution. The telemonitoring solution consisted of a digital platform for patient-reported symptoms and daily weight and blood pressure measurements, automatically generated alerts triggering phone calls with secondary care nurses, and rapid response to alerts by treating physicians. Telemonitoring solution data were linked to patient register data on primary care, secondary care, and hospitalization. The patient register of the Southern Savonia Social and Health Care Authority (Essote) was used. Eligible patients had at least 1 hospital admission within the last 12 months and self-reported New York Heart Association class II-IV from the central hospital in the Southern Savonia region. RESULTS: Out of 50 recruited patients with HF, 43 completed the study and were included in the analysis. The hospitalization-related cost decreased (49%; P=.03) from €2189 (95% CI €1384-€2994; a currency exchange rate of EUR €1=US $1.10589 is applicable) during SOC to €1114 (95% CI €425-€1803) during telemonitoring. The number of patients with at least 1 hospitalization due to HF was reduced by 70% (P=.002) from 20 (47%) out of 43patients during SOC to 6 (14%) out of 43 patients in telemonitoring. The estimated mean total health care cost per patient was €3124 (95% CI €2212-€4036) during SOC and €2104 (95% CI €1313-€2895) during telemonitoring, resulting in a 33% reduction (P=.07) in costs with telemonitoring. CONCLUSIONS: The results suggest that the telemonitoring solution can reduce hospital-related costs for patients with HF with a recent hospital admission.


Assuntos
Insuficiência Cardíaca , Hospitalização , Humanos , Finlândia , Hospitais , Nível de Saúde
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