RESUMO
BACKGROUND: Apixaban, rivaroxaban, and warfarin have shown benefit for preventing major ischemic events, albeit with increased bleeding risk, among patients in the general population with atrial fibrillation (AF). However, data are scarce in patients with cirrhosis and AF. OBJECTIVE: To compare the effectiveness and safety of apixaban versus rivaroxaban and versus warfarin in patients with cirrhosis and AF. DESIGN: Population-based cohort study. SETTING: Two U.S. claims data sets (Medicare and Optum's de-identified Clinformatics Data Mart Database [2013 to 2022]). PARTICIPANTS: 1:1 propensity score (PS)-matched patients with cirrhosis and nonvalvular AF initiating use of apixaban, rivaroxaban, or warfarin. MEASUREMENTS: Primary outcomes included ischemic stroke or systemic embolism and major hemorrhage (intracranial hemorrhage or major gastrointestinal bleeding). Database-specific and pooled PS-matched rate differences (RDs) per 1000 person-years (PY) and Cox proportional hazard ratios (HRs) with 95% CIs were estimated, controlling for 104 preexposure covariates. RESULTS: Rivaroxaban initiators had significantly higher rates of major hemorrhagic events than apixaban initiators (RD, 33.1 per 1000 PY [95% CI, 12.9 to 53.2 per 1000 PY]; HR, 1.47 [CI, 1.11 to 1.94]) but no significant differences in rates of ischemic events or death. Consistently higher rates of major hemorrhage were found with rivaroxaban across subgroup and sensitivity analyses. Warfarin initiators also had significantly higher rates of major hemorrhage than apixaban initiators (RD, 26.1 per 1000 PY [CI, 6.8 to 45.3 per 1000 PY]; HR, 1.38 [CI, 1.03 to 1.84]), particularly hemorrhagic stroke (RD, 9.7 per 1000 PY [CI, 2.2 to 17.2 per 1000 PY]; HR, 2.85 [CI, 1.24 to 6.59]). LIMITATION: Nonrandomized treatment selection. CONCLUSION: Among patients with cirrhosis and nonvalvular AF, initiators of rivaroxaban versus apixaban had significantly higher rates of major hemorrhage and similar rates of ischemic events and death. Initiation of warfarin versus apixaban also contributed to significantly higher rates of major hemorrhagic events, including hemorrhagic stroke. PRIMARY FUNDING SOURCE: National Institutes of Health.
Assuntos
Anticoagulantes , Fibrilação Atrial , Inibidores do Fator Xa , Hemorragia , Cirrose Hepática , Pirazóis , Piridonas , Rivaroxabana , Varfarina , Humanos , Varfarina/efeitos adversos , Varfarina/uso terapêutico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Pirazóis/uso terapêutico , Pirazóis/efeitos adversos , Masculino , Feminino , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Idoso , Cirrose Hepática/complicações , Inibidores do Fator Xa/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Estados Unidos/epidemiologia , Pontuação de Propensão , Pessoa de Meia-Idade , AVC Isquêmico/prevenção & controle , AVC Isquêmico/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/epidemiologia , Estudos de Coortes , Embolia/prevenção & controle , Embolia/etiologia , Embolia/epidemiologiaRESUMO
INTRODUCTION: There is a paucity of real-world studies examining the risks of stroke/systemic embolism (SE) and major bleeding (MB) among non-valvular atrial fibrillation (NVAF) patients switching from warfarin to a direct oral anticoagulant (DOAC). This retrospective study was conducted to compare the stroke/SE and MB risks between patients switched from warfarin to apixaban, dabigatran, or rivaroxaban in real-world clinical practice. MATERIALS AND METHODS: This study used data from four United States commercial claims databases from January 1, 2012 to June 30, 2019. The study population included NVAF patients initially treated with warfarin and switched to apixaban, dabigatran, or rivaroxaban within 90 days of their warfarin prescription ending. Patients were matched 1:1 between the DOACs in each database using propensity scores and then pooled for the final analysis. Cox proportional hazards models were used to calculate the risk of stroke/SE and MB. RESULTS AND CONCLUSIONS: The final population consisted of 2,611 apixaban-dabigatran, 12,165 apixaban-rivaroxaban, and 2,672 dabigatran-rivaroxaban pairs. Apixaban vs. dabigatran was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.39-0.96) and MB (HR: 0.67; 95% CI: 0.50-0.91). Apixaban vs. rivaroxaban was associated with a similar risk of stroke/SE (HR: 0.88; 95% CI: 0.73-1.07) and a lower risk of MB (HR: 0.60; 95% CI: 0.52-0.68). There was no significant difference in either risk between dabigatran and rivaroxaban. These results provide important insights into how the risks of stroke/SE and MB for NVAF patients vary when switching from warfarin to different DOACs.
Assuntos
Anticoagulantes , Fibrilação Atrial , Dabigatrana , Hemorragia , Pirazóis , Piridonas , Rivaroxabana , Acidente Vascular Cerebral , Varfarina , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Varfarina/efeitos adversos , Varfarina/uso terapêutico , Varfarina/administração & dosagem , Masculino , Feminino , Idoso , Estudos Retrospectivos , Estados Unidos/epidemiologia , Rivaroxabana/uso terapêutico , Rivaroxabana/efeitos adversos , Rivaroxabana/administração & dosagem , Dabigatrana/efeitos adversos , Dabigatrana/uso terapêutico , Dabigatrana/administração & dosagem , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Pirazóis/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/epidemiologia , Pessoa de Meia-Idade , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Piridonas/administração & dosagem , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Anticoagulantes/administração & dosagem , Hemorragia/induzido quimicamente , Administração Oral , Substituição de Medicamentos , Embolia/prevenção & controle , Embolia/etiologia , Embolia/epidemiologia , Resultado do TratamentoRESUMO
PURPOSE: We sought to estimate the prevalence of incidental retinal emboli and identify associated factors using a nationally representative sample of the U.S. DESIGN: Cross-sectional study. METHODS: We included adult (age ≥40 years) participants of the 2005-2008 National Health and Nutrition Examination Survey (NHANES). Incidental retinal emboli were identified through retinal fundus photography. Multivariable logistic regression was used to determine the association between the presence of retinal emboli and sociodemographic, lifestyle, and clinical factors (age, sex, race/ethnicity, education, income, smoking, alcohol use, body mass index [BMI], hypertension, diabetes, hypercholesterolemia, and history of cardiovascular disease). RESULTS: This study included 5,764 adults (53% female). Incidental retinal emboli were identified in 0.7% (39/5764) of individuals. The survey-weighted prevalence of retinal emboli increased with age, from 0.1% in participants 40-49 years of age to 1.4% in participants≥70 years of age. The prevalence did not differ by sex or race/ethnicity. Factors associated with retinal emboli after adjusting for age and sex included underweight BMI (odds ratio [OR] 7.24 [95% confidence interval {CI} 1.06-49.3]), current smoking (OR 6.16 [95% CI 1.49-25.5]), low household income (OR 4.41 [95% CI 1.3-15.0]), and hypertension (OR 2.67 [95% CI 1.31-5.44]). CONCLUSIONS: In a cohort representative of the U.S. adult population, the prevalence of incidental retinal emboli increased with age but did not differ by sex, race, or ethnicity. Further investigation into the potential association of socioeconomic and nutritional status with retinal emboli may enable opportunities to identify individuals with underlying cardiovascular risk.
Assuntos
Embolia , Hipertensão , Doenças Retinianas , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Lactente , Masculino , Inquéritos Nutricionais , Estudos Transversais , Fatores de Risco , Embolia/complicações , Embolia/epidemiologia , Doenças Retinianas/epidemiologia , Hipertensão/epidemiologia , PrevalênciaRESUMO
The presence of symptoms plays an important role in determining whether to focus on rhythm control or rate control when treating atrial fibrillation (AF). Previous comparative studies on the clinical outcomes of symptomatic and asymptomatic AF have yielded inconsistent results, and a link between AF symptoms and left atrial (LA) remodeling is not established. Patients selected from the COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, which is a prospective, multicenter study consisting of patients with non-valvular AF, were grouped into 2 groups: symptomatic and asymptomatic. The primary outcome was a composite of the following cardiovascular outcomes: all-cause death, ischemic stroke, transient ischemic attack, systemic embolism, myocardial infarction, and heart failure hospitalization. Of 10,210 patients with AF, 4,327 (42%) had symptomatic AF. The asymptomatic group had an older mean age, more men, and more patients with hypertension and diabetes mellitus than the symptomatic group. The asymptomatic group had a larger left atrium (LA) diameter (43.6 vs 42.2 mm, p <0.001) than the symptomatic group. During a median follow-up of 32.9 (29.5 to 36.4) months, the asymptomatic and symptomatic groups showed similar incidences of the primary outcome (1.44 vs 1.45 per 100 person-years; log-rank, p = 0.8). In conclusion, the absence of AF symptoms is associated with increased LA. However, symptomatic and asymptomatic patients with AF have a similar risk of cardiovascular outcomes. This suggests that beneficial treatment for AF may be considered regardless of whether patients have symptomatic or asymptomatic AF.
Assuntos
Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Masculino , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/diagnóstico , Estudos Prospectivos , Átrios do Coração , Embolia/epidemiologia , Embolia/etiologia , Embolia/prevenção & controle , Sistema de Registros , Acidente Vascular Cerebral/epidemiologia , Fatores de RiscoRESUMO
BACKGROUND: The ELDERCARE-AF trial showed that low-dose edoxaban benefits elderly patients with nonvalvular atrial fibrillation considered ineligible for standard oral anticoagulants due to high bleeding risk, but whether this applied to patients with extremely low body weight was unclear. METHODS AND RESULTS: This was a prespecified subanalysis by body weight (≤45, >45 kg) of the phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven ELDERCARE-AF trial, which compared low-dose edoxaban (15 mg once daily) with placebo in Japanese patients considered ineligible for oral anticoagulants at the recommended therapeutic strength or the approved doses. The primary efficacy and safety end points were stroke or systemic embolism and major bleeding (International Society on Thrombosis and Hemostasis definition), respectively. The ≤45-kg weight group included 374/984 patients (38.0%), and the >45-kg group included 610/984 patients (62.0%). The stroke or systemic embolism rate was lower with edoxaban than placebo in both weight groups (≤45 kg: hazard ratio [HR], 0.36 [95% CI, 0.16-0.80]; >45 kg: HR, 0.31 [95% CI, 0.13-0.73]; interaction P=0.82). Major bleeding incidence was numerically higher with edoxaban than placebo (≤45 kg: HR, 3.05 [95% CI, 0.84-11.11]; >45 kg: HR, 1.40 [95% CI, 0.56-3.48), with no interaction with body weight (interaction P=0.33). All-cause mortality was higher in the ≤45-kg group, with no significant difference between treatment groups. CONCLUSIONS: The benefit of edoxaban 15 mg was consistent in elderly patients with atrial fibrillation and extremely low body weight, though clinicians must remain vigilant about the risk of major bleeding, especially gastrointestinal bleeding. REGISTRATION INFORMATION: ClinicalTrials.gov. Identifier: NCT02801669.
Assuntos
Fibrilação Atrial , Embolia , Piridinas , Acidente Vascular Cerebral , Tiazóis , Humanos , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Varfarina , Inibidores do Fator Xa , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Anticoagulantes/uso terapêutico , Embolia/epidemiologia , Embolia/etiologia , Embolia/prevenção & controle , Peso CorporalRESUMO
Real-world data on coronary events (CE) in elderly patients with atrial fibrillation (AF) are lacking in the direct oral anticoagulant era. This prespecified sub-analysis of the ANAFIE Registry, a prospective observational study in > 30,000 Japanese patients aged ≥ 75 years with non-valvular AF (NVAF), investigated CE incidence and risk factors. The incidence and risk factors for new-onset CE (a composite of myocardial infarction [MI] and cardiac intervention for coronary heart diseases other than MI), MI, and cardiac intervention for coronary heart diseases other than MI during the 2-year follow-up were assessed. Bleeding events in CE patients were also examined. Among 32,275 patients, the incidence rate per 100 patient-years was 0.48 (95% confidence interval (CI): 0.42-0.53) for CE during the 2-year follow-up, 0.20 (0.16-0.23) for MI, and 0.29 (0.25-0.33) for cardiac intervention for coronary heart diseases other than MI; that of stroke/systemic embolism was 1.62 (1.52-1.73). Patients with CE (n = 287) likely had lower creatinine clearance (CrCL) and higher CHADS2 and HAS-BLED scores than patients without CE (n = 31,988). Significant risk factors associated with new-onset CE were male sex, systolic blood pressure of ≥ 130 mmHg, diabetes mellitus (glycated hemoglobin ≥ 6.0%), CE history, antiplatelet agent use, and CrCL < 50 mL/min. Major bleeding incidence was significantly higher in patients with new-onset CE vs without CE (odds ratio [95% CI], 3.35 [2.06-5.43]). In elderly patients with NVAF, CE incidence was lower than stroke/systemic embolism incidence. New-onset CE (vs no CE) was associated with a higher incidence of major bleeding.Trial registration: UMIN000024006.
Assuntos
Fibrilação Atrial , Doença das Coronárias , Embolia , Infarto do Miocárdio , Acidente Vascular Cerebral , Idoso , Humanos , Masculino , Feminino , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Fatores de Risco , Embolia/epidemiologia , Embolia/etiologia , Infarto do Miocárdio/complicações , Sistema de Registros , Doença das Coronárias/complicações , Anticoagulantes/uso terapêuticoRESUMO
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) have largely supplanted vitamin K antagonists (VKAs) for oral anticoagulation in non-valvular atrial fibrillation (NVAF). However, data on the real-world effectiveness of NOACs vs. phenprocoumon, a VKA widely used in Germany, are limited. The RELOADED study aimed to compare effectiveness of factor Xa NOACs and phenprocoumon in NVAF in clinical practice. METHODS: Patients who started on a factor Xa NOAC or phenprocoumon for NVAF during the study period were enrolled from the Institute for Applied Healthcare Research Berlin. Patients were followed from first prescription until the end of exposure or available data. Primary outcomes were analyzed by Cox proportional hazard regression models and included ischemic stroke and systemic embolism for effectiveness, and intracranial hemorrhage (ICH) for safety. Subgroups of interest were patients with diabetes and patients with renal impairment. RESULTS: The total study population was 64,920; 36.3% of patients initiated phenprocoumon, 34.4% initiated rivaroxaban, 25.0% apixaban, and 4.4% edoxaban. Treatment with phenprocoumon is associated with a similar risk of ischemic stroke/systemic embolism as treatment with rivaroxaban or apixaban; while rivaroxaban (adjusted hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.43-0.75) and apixaban (adjusted HR 0.43, 95% CI 0.31-0.6) were associated with a lower risk of ICH compared to phenprocoumon in NVAF patients. The use of rivaroxaban and apixaban was associated with a lower risk of developing kidney failure in patients with diabetes or renal impairment in comparison to those treated with phenprocoumon. CONCLUSION: The factor Xa NOACs rivaroxaban and apixaban demonstrated similar effectiveness and lower rates of ICH compared with phenprocoumon in this study.
Assuntos
Fibrilação Atrial , Diabetes Mellitus , Embolia , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Anticoagulantes/efeitos adversos , Femprocumona/efeitos adversos , Rivaroxabana/uso terapêutico , Fator Xa/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Hemorragias Intracranianas , Piridonas/efeitos adversos , Diabetes Mellitus/tratamento farmacológico , Embolia/epidemiologia , Dabigatrana/uso terapêuticoRESUMO
BACKGROUND: Left ventricular (LV) thrombus is not common but poses significant risks of embolic stroke or systemic embolism. However, the distinction in embolic risk between nonischemic cardiomyopathy (NICM) and ischemic cardiomyopathy (ICM) remains unclear. METHODS AND RESULTS: In total, 2738 LV thrombus patients from the JROAD-DPC (Japanese Registry of All Cardiac and Vascular Diseases Diagnosis Procedure Combination) database were included. Among these patients, 1037 patients were analyzed, with 826 (79.7%) having ICM and 211 with NICM (20.3%). Within the NICM group, the distribution was as follows: dilated cardiomyopathy (DCM; 41.2%), takotsubo cardiomyopathy (27.0%), hypertrophic cardiomyopathy (18.0%), and other causes (13.8%). The primary outcome was a composite of embolic stroke or systemic embolism (SSE) during hospitalization. The ICM and NICM groups showed no significant difference in the primary outcome (5.8% vs. 7.6%, p = 0.34). Among NICM, SSE occurred in 12.6% of patients with DCM, 7.0% with takotsubo cardiomyopathy, and 2.6% with hypertrophic cardiomyopathy. Multivariate logistic regression analysis for SSE revealed an odds ratio of 1.4 (95% confidence interval [CI], 0.7-2.7, p = 0.37) for NICM compared to ICM. However, DCM exhibited a higher adjusted odds ratio for SSE compared to ICM (2.6, 95% CI 1.2-6.0, p = 0.022). CONCLUSIONS: This nationwide shows comparable rates of embolic events between ICM and NICM in LV thrombus patients, with DCM posing a greater risk of SSE than ICM. The findings emphasize the importance of assessing the specific cause of heart disease in NICM, within LV thrombus management strategies.
Assuntos
Bases de Dados Factuais , Isquemia Miocárdica , Sistema de Registros , Trombose , Humanos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Trombose/epidemiologia , Isquemia Miocárdica/epidemiologia , Isquemia Miocárdica/diagnóstico , Japão/epidemiologia , Fatores de Risco , Embolia/epidemiologia , Embolia/complicações , Ventrículos do Coração/diagnóstico por imagem , Cardiomiopatias/epidemiologia , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: The prevalence and impact of coronary emboli (CE) in patients with ST-segment-elevation myocardial infarction (STEMI) and atrial fibrillation (AF) have not been specifically studied. The objective was to describe the clinical characteristics and outcomes of patients with AF and CE in a large series of patients with STEMI. METHODS AND RESULTS: We investigated 2292 consecutive patients with STEMI and among them 225 patients with AF: 46 patients with a STEMI related to CE (group A) and 179 patients with a STEMI related to an atherosclerotic cause (group B). Compared with the 2067 patients without AF and CE (group C), patients with AF and CE were older (73 versus 59 years, P<0.05), more likely to be female (43% versus 22%, P<0.05), and presented more frequently with cardiogenic shock at admission (26% versus 9%, P<0.05). The baseline characteristics of patients with AF (group A versus B) did not differ significantly according to STEMI pathogenesis. In the unadjusted analysis, the 45-day mortality was higher in patients with CE and AF (group A versus group C: 20% versus 4%; P<0.05 and group A versus group B: 20% versus 8%, P=not significant); this trend persisted at 2-year follow-up (group A versus group C: 24% versus 6%; P<0.05 and group A versus group B: 24% versus 17%, P=not significant). After stabilized inverse exposure probability weighting adjustment, a higher 45-day mortality rate was confirmed in patients with CE and AF (group A versus group C: 18% versus 5%, P<0.05). CONCLUSIONS: In patients presenting with STEMI and AF, CE was associated with excess early mortality. REGISTRATION: URL: clinicaltrials.gov. Identifier: NCT05679843.
Assuntos
Fibrilação Atrial , Embolia , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Fibrilação Atrial/epidemiologia , Feminino , Masculino , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Pessoa de Meia-Idade , Idoso , Embolia/mortalidade , Embolia/epidemiologia , Embolia/diagnóstico , Embolia/etiologia , Prevalência , Fatores de Risco , Idoso de 80 Anos ou mais , Fatores de TempoRESUMO
There is insufficient data on systemic embolic events (SSEs) in patients with ischemic left ventricular aneurysm (LVA) concerning the impact of anticoagulation therapy. In this retrospective cohort study with 1043 patients with ischemic LVA, SSEs occurred in 7.2% over 2.4 years. After adjusting for relevant factors, the use of anticoagulants was independently associated with a lower incidence of SSE (3.1% vs. 9.0%, P < 0.001; subdistribution hazard ratios (SHR) 0.21, 95% confidence intervals (CI) 0.10-0.44, P < 0.001), with no significant difference in net adverse clinical events (NACEs) (10.6% vs. 13.3%, P = 0.225). Specifically, anticoagulation in patients with apical segment akinesis significantly reduced SSEs (3.9% vs. 13.6%, P = 0.002) and NACE rates (7.8% vs. 19.4%, P = 0.002). Major bleeding rates did not significantly differ between groups (5.6% vs. 3.5%, P = 0.111). These findings highlight the SSE risk in ischemic LVA and suggest potential benefits of anticoagulation, particularly in those with apical segment akinesis. These findings need to be validated in independent datasets.
Assuntos
Anticoagulantes , Aneurisma Cardíaco , Humanos , Estudos Retrospectivos , Anticoagulantes/uso terapêutico , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Prognóstico , Aneurisma Cardíaco/tratamento farmacológico , Aneurisma Cardíaco/epidemiologia , Ventrículos do Coração/patologia , Ventrículos do Coração/efeitos dos fármacos , Ventrículos do Coração/fisiopatologia , Isquemia Miocárdica/tratamento farmacológico , Isquemia Miocárdica/epidemiologia , Fatores de Risco , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Embolia/epidemiologia , Embolia/tratamento farmacológicoRESUMO
BACKGROUND: There are limited data on the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation with significant tricuspid regurgitation (TR), which can lead to hepatic dysfunction and intestinal malabsorption. We aimed to compare the efficacy and safety of DOACs and warfarin for patients with atrial fibrillation with significant (moderate to severe) TR. METHODS AND RESULTS: A total of 1215 patients with significant TR and atrial fibrillation who were treated with warfarin (N=491) or DOACs (N=724) were retrospectively analyzed. The primary outcomes were ischemic stroke, systemic embolic events, and hospitalization for major bleeding. The secondary outcomes were intracranial hemorrhage, hospitalization for gastrointestinal bleeding, all-cause mortality, and a composite outcome. The median follow-up duration was 2.4 years. In the inverse probability treatment weighting-adjusted cohort, DOACs and warfarin had a similar risk for ischemic stroke and systemic embolic events (adjusted hazard ratio [aHR], 0.95 [95% CI, 0.67-1.36]; P=0.79) and major bleeding (aHR, 0.78 [95% CI, 0.57-1.06]; P=0.11). For the secondary outcomes, relative to warfarin, DOACs had a lower risk of intracranial hemorrhage and the composite outcome, and a comparable risk for gastrointestinal bleeding and all-cause mortality. In the subgroup analysis, the effects of DOACs on ischemic stroke and systemic embolic events were comparable to the effects of warfarin, even in patients with inferior vena cava plethora (increased right atrial pressure) or severe TR. CONCLUSIONS: In this study, relative to warfarin, DOACs demonstrated comparable efficacy for ischemic stroke and systemic embolic events and major bleeding, with a lower intracranial hemorrhage risk in patients with significant TR and atrial fibrillation, indicating their effectiveness and safety.
Assuntos
Fibrilação Atrial , Embolia , AVC Isquêmico , Acidente Vascular Cerebral , Insuficiência da Valva Tricúspide , Humanos , Varfarina/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Estudos Retrospectivos , Insuficiência da Valva Tricúspide/complicações , Embolia/epidemiologia , Embolia/etiologia , Embolia/prevenção & controle , AVC Isquêmico/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Administração OralRESUMO
BACKGROUND: Patients with atrial fibrillation and severe chronic kidney disease have higher risks of bleeding, thromboembolism, and mortality. However, optimal anticoagulant choice in these high-risk patients remains unclear. METHODS AND RESULTS: Using deidentified electronic health records from the Optum Labs Data Warehouse, adults with atrial fibrillation and severe chronic kidney disease (estimated glomerular filtration rate <30 mL/min per 1.73 m2) initiating warfarin, apixaban, or rivaroxaban between 2011 and 2021 were included. Using inverse probability of treatment weighting, adjusted risks of major bleeding, stroke/systemic embolism, and death were compared among agents. A total of 6794 patients were included (mean age, 78.5 years; mean estimated glomerular filtration rate, 24.7 mL/min per 1.73 m2; 51% women). Apixaban versus warfarin was associated with a lower risk of major bleeding (incidence rate, 1.5 versus 2.9 per 100 person-years; subdistribution hazard ratio [sub-HR], 0.53 [95% CI, 0.39-0.70]), and similar risks for stroke/systemic embolism (incidence rate, 1.9 versus 2.4 per 100 person-years; sub-HR, 0.80 [95% CI, 0.59-1.09]) and death (incidence rate, 4.6 versus 4.5 per 100 person-years; HR, 1.03 [95% CI, 0.82-1.29]). Rivaroxaban versus warfarin was associated with a higher risk of major bleeding (incidence rate, 4.9 versus 2.9 per 100 person-years; sub-HR, 1.65 [95% CI, 1.10-2.48]), with no difference in risks for stroke/systemic embolism and death. Apixaban versus rivaroxaban was associated with a lower risk of major bleeding (sub-HR, 0.53 [95% CI, 0.36-0.78]). CONCLUSIONS: These real-world findings are consistent with potential safety advantages of apixaban over warfarin and rivaroxaban for patients with atrial fibrillation and severe chronic kidney disease. Further randomized trials comparing individual oral anticoagulants are warranted.
Assuntos
Anticoagulantes , Fibrilação Atrial , Embolia , Hemorragia , Pirazóis , Piridonas , Insuficiência Renal Crônica , Rivaroxabana , Acidente Vascular Cerebral , Varfarina , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Fibrilação Atrial/mortalidade , Feminino , Masculino , Idoso , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/mortalidade , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem , Varfarina/efeitos adversos , Varfarina/uso terapêutico , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Rivaroxabana/administração & dosagem , Embolia/prevenção & controle , Embolia/epidemiologia , Embolia/etiologia , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Piridonas/administração & dosagem , Administração Oral , Medição de Risco , Idoso de 80 Anos ou mais , Fatores de Risco , Estudos Retrospectivos , Índice de Gravidade de Doença , Incidência , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Inibidores do Fator Xa/administração & dosagemRESUMO
JUSTIFICATIVA E OBJETIVOS: Os aquecedores de sangue e de líquidos que aquecem em linha são amplamente usados por causa do baixo custo, do uso prático e porque não dependem de equipamentos. Nosso objetivo foi investigar a formação de bolhas em dois aquecedores tipo linha com duas formas de aquecimento diferentes. MATERIAIS E MÉTODOS: Dois grupos foram designados às marcas de aquecedores de sangue e líquidos: S-line e Astoflo®. Com o uso de 10 conjuntos de soro para cada grupo (n = 20), 1.000 mL de solução NaCl a 9% foram infundidos a 350 mL.hora-1 durante uma hora na sala de operação. As seguintes temperaturas foram mensuradas: das partes proximal, intermediária e distal das linhas; do ambiente de ensaio; do líquido usado e do líquido ao atingir a cânula após o aquecimento. O tempo para a formação visível de bolhas foi registrado. Os achados foram estatisticamente comparados com o uso do teste-U de Mann-Whitney. RESULTADOS: Não houve diferença entre os grupos em relação às temperaturas proximal, intermediária e distal das partes das linhas; do ambiente do estudo; do líquido usado e do líquido ao atingir a cânula (p > 0,05). Bolhas foram observadas nos dois aquecedores e o tempo para a formação de bolhas foi semelhante nos dois grupos de estudo (p = 0,143). CONCLUSÕES: No cenário experimental, criamos condições semelhantes ao nosso ambiente clínico. Ambos os tipos de aquecedores forneceram níveis de aquecimento semelhantes e formaram bolhas visíveis. Considerando que uma pequena quantidade de êmbolos pode ser fatal em bebês e crianças, a formação de bolhas deve ser seriamente considerada em caso de êmbolos e estudos adicionais devem ser feitos para determinar a quantidade, as razões e os conteúdos da formação de bolhas.
INTRODUCTION: Line type blood-liquid warmers are used widely due to their low expense, practical use and nondependence on sets. We aimed to investigate the relationship of bubbles in line type warmers with two different warming properties. MATERIALS AND METHODS: Two groups were designed with S-line and Astoflo® brand blood-liquid warmers. By using 10 medisets for each group (n = 20), we infused 1,000 mL 0.9% NaCl solutions at 350 mL.hour-1 speed for one hour in the operating room. Temperatures at the proximal, midway and distal parts of lines, temperature of experiment environment, temperature of liquid used and temperature of liquid reaching the cannula after warming were measured. Time to visually observable bubble formation was recorded. We compared findings statistically using the Mann-Whitney U test. RESULTS: There were no differences between the groups with respect to temperatures at the proximal, midway and distal parts of lines, temperature of experiment environment, temperature of liquid used and temperature of liquid reaching the cannula (p > 0.05). Bubbles were observed with both warmers and time to bubble formation was similar in the two study groups (p = 0.143). CONCLUSIONS: In the experimental setting, we have designed conditions similar to our clinical environment. Both types of warmers provided similar warming levels and formed visible bubbles. Considering that low amounts of emboli can be fatal in infants and children, bubble formation should be taken seriously into account for emboli and further studies should be carried out to determine the amount, the reasons and the contents of bubble formation.
JUSTIFICATIVA Y OBJETIVOS: Los calentadores que poseen un calentamiento en línea de sangre y de líquidos son extensamente usados a causa de su bajo coste, del uso práctico y también porque no dependen de equipos. Nuestro objetivo fue investigar la formación de burbujas en dos calentadores de tipo línea con dos formas de calentamiento diferentes. MATERIALES Y M&EACUTE;TODOS: Dos grupos fueron designados a las marcas de calentadores de sangre y líquidos: S-line y Astoflo®. Con el uso de 10 conjuntos de suero para cada grupo (n = 20), 1.000 mL de solución NaCl al 9% se infundieron a 350 mL.hora-1 durante una hora en quirófano. Las siguientes temperaturas fueron mensuradas: de las partes proximal, intermedia y distal de las líneas; del ambiente de ensayo; del líquido usado y del líquido al alcanzar la bránula después del calentamiento. El tiempo para la formación visible de burbujas fue registrado. Los hallazgos fueron estadísticamente comparados con el uso del test-U de Mann-Whitney. RESULTADOS: No hubo diferencias entre los grupos con relación a las temperaturas proximal, intermedia y distal de las partes de las líneas; del ambiente del estudio; del líquido usado y del líquido al alcanzar la bránula (p > 0,05). Burbujas se observaron en los dos calentadores y el tiempo para la formación de burbujas fue similar en los dos grupos de estudio (p = 0,143). CONCLUSIONES: Dentro del escenario experimental, creamos condiciones parecidas a nuestro ambiente clínico. Ambos tipos de calentadores suministraron niveles de calentamiento parecidos y formaron burbujas visibles. Considerando que una pequeña cantidad de émbolos puede ser fatal en bebés y en niños, la formación de burbujas debe ser seriamente considerada en caso de émbolos y estudios adicionales deben ser realizados para determinar la cantidad, las razones y los contenidos de la formación de burbujas.
Assuntos
Humanos , Embolia/etiologia , Reaquecimento/efeitos adversos , Sangue , Embolia Aérea/etiologia , Embolia Aérea/prevenção & controle , Embolia/epidemiologia , Reaquecimento/instrumentação , Reaquecimento/métodos , TemperaturaRESUMO
OBJECTIVE: We analyzed the frequency of peripheral embolisms, the underlying heart disease,triggering factors, the sites of the emboli, and evolution of the patients. METHODS: We analyzed 29 cases of peripheral arterial embolism out of a total of 20,211 hospitalizations in a cardiology center in the city of São Paulo. The age was 51.89ñ18.66 years, and 15 were males. RESULTS: Embolism in the right lower limb occurred in 18 patients (62.0 percent),in the left lower 11(37.9 percent) and right upper 3 (10.3 percent) limbs, and in the left arm (1). Four patients had embolism in two limbs. The heart disease, mitral valvar heart disease (9 patients - 31.0 percent); infective endocarditis (7-24.1 percent); dilated cardiomyopathy (6 - 20.6 percent); ischemic coronary heart disease (6 patients - 20.6 percent); and one patient with cor pulmonale. Atrial fibrillation was observed in 20 patients (68.9 percent), chronic in 12 patients (41.3 percent ) and acute in 8 (27.5 percent). All patients with mitral valvar heart disease had atrial fibrillation, chronic in 8 patients (88.8percent); patients with cardiomyopathy and coronary heart disease, 4 in each group had atrial fibrillation, acute in 60 percent of the patients.Patients with infective endocarditis, 3 had staphylococcus and 2 Gram-negative bacteria. In the follow-up, 2 patients (6.8percent) required limbs amputation, and 5 (17.2 percent) died due to embolism. CONCLUSION: Most of the time, embolism does not cause permanent complications. Our data highlight the importance of anticoagulation for patients acute atrial fibrillation in myocardial dysfunction and for patients with chronic atrial fibrillation in cases of mitral valvar heart disease to prevent peripheral embolism.