RESUMO
PURPOSE: To assess the association between acute disease severity and 1-year quality of life in patients discharged after hospitalisation due to coronavirus disease 2019 (COVID-19). METHODS: We conducted a prospective cohort study nested in 5 randomised clinical trials between March 2020 and March 2022 at 84 sites in Brazil. Adult post-hospitalisation COVID-19 patients were followed for 1 year. The primary outcome was the utility score of EuroQol five-dimension three-level (EQ-5D-3L). Secondary outcomes included all-cause mortality, major cardiovascular events, and new disabilities in instrumental activities of daily living. Adjusted generalised estimating equations were used to assess the association between outcomes and acute disease severity according to the highest level on a modified ordinal scale during hospital stay (2: no oxygen therapy; 3: oxygen by mask or nasal prongs; 4: high-flow nasal cannula oxygen therapy or non-invasive ventilation; 5: mechanical ventilation). RESULTS: 1508 COVID-19 survivors were enrolled. Primary outcome data were available for 1156 participants. At 1 year, compared with severity score 2, severity score 5 was associated with lower EQ-5D-3L utility scores (0.7 vs 0.84; adjusted difference, - 0.1 [95% CI - 0.15 to - 0.06]); and worse results for all-cause mortality (7.9% vs 1.2%; adjusted difference, 7.1% [95% CI 2.5%-11.8%]), major cardiovascular events (5.6% vs 2.3%; adjusted difference, 2.6% [95% CI 0.6%-4.6%]), and new disabilities (40.4% vs 23.5%; adjusted difference, 15.5% [95% CI 8.5%-22.5]). Severity scores 3 and 4 did not differ consistently from score 2. CONCLUSIONS: COVID-19 patients who needed mechanical ventilation during hospitalisation have lower 1-year quality of life than COVID-19 patients who did not need mechanical ventilation during hospitalisation.
Assuntos
COVID-19 , Doenças Cardiovasculares , Adulto , Humanos , SARS-CoV-2 , Qualidade de Vida , Atividades Cotidianas , Estudos Prospectivos , Respiração Artificial , Hospitalização , Gravidade do PacienteRESUMO
It was a randomized trial, and 308 patients undergoing revascularization were randomly assigned: 155 to off-pump coronary artery bypass (OPCAB) and 153 to on-pump coronary artery bypass (ONCAB). End points were freedom from death, myocardial infarction, revascularization, and cerebrovascular accidents. The rates for 10-year, event-free survival for ONCAB versus OPCAB were 69.6% and 64%, (hazard ratio [HR]: 0.88; 95% confidence interval [CI] 0.86-1.02; P = .41), respectively. Adjusted Cox proportional hazard ratio was similar (HR: 0.92; 95% CI 0.61-1.38, P = .68). A difference occurred between the duration of OPCAB and ONCAB, respectively (4.9 ± 1.5 vs 6.6 ± 1.1 h, P < .001). Statistical differences occurred between OPCAB and ONCAB in the length of intensive care unit (ICU) stay (20 ± 2.5 vs 48 ± 10 hours, P < .001), time to extubation (5.5 ± 4.2 vs 10.2 ± 3.5 hours, P < .001), hospital stay (6.7 ± 1.4 vs 9.2 ± 1.3 days, P < .001), higher incidence of atrial fibrillation (AF; 33 vs 5 patients, P < .001), and blood requirements (46 vs 64 patients, P < .001). Grafts per patient was higher in ONCAB (3.15 vs 2.55 grafts, P < .001). No difference existed between the groups in primary composite end points at 10-year follow-up. Although OPCAB surgery was related to a lower number of grafts and higher incidence of AF, it had no effects related to long-term outcomes.
Assuntos
Ponte Cardiopulmonar , Ponte de Artéria Coronária sem Circulação Extracorpórea , Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/cirurgia , Idoso , Ponte Cardiopulmonar/efeitos adversos , Ponte Cardiopulmonar/mortalidade , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Ponte de Artéria Coronária sem Circulação Extracorpórea/mortalidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Intervalo Livre de Progressão , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: To assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. METHODS: There were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model. Results Patients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/ systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory. CONCLUSIONS: In anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.
Assuntos
Valva Aórtica , Fibrilação Atrial , Doenças das Valvas Cardíacas , AnticoagulantesRESUMO
BACKGROUND: Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain. METHODS AND RESULTS: We characterized the relationship between sudden cardiac death and metabolic syndrome status among participants of the ARIC (Atherosclerosis Risk in Communities) Study (1987-2012) free of prevalent coronary heart disease or heart failure. Among 13 168 participants, 357 (2.7%) sudden cardiac deaths occurred during a median follow-up of 23.6 years. Participants with the metabolic syndrome (n=4444) had a higher cumulative incidence of sudden cardiac death than those without it (n=8724) (4.1% versus 2.3%, P<0.001). After adjustment for participant demographics and clinical factors other than components of the metabolic syndrome, the metabolic syndrome was independently associated with sudden cardiac death (hazard ratio, 1.70, 95% confidence interval, 1.37-2.12, P<0.001). This relationship was not modified by sex (interaction P=0.10) or race (interaction P=0.62) and was mediated by the metabolic syndrome criteria components. The risk of sudden cardiac death varied according to the number of metabolic syndrome components (hazard ratio 1.31 per additional component of the metabolic syndrome, 95% confidence interval, 1.19-1.44, P<0.001). Of the 5 components, elevated blood pressure, impaired fasting glucose, and low high-density lipoprotein were independently associated with sudden cardiac death. CONCLUSIONS: We observed that the metabolic syndrome was associated with a significantly increased risk of sudden cardiac death irrespective of sex or race. The risk of sudden cardiac death was proportional to the number of metabolic syndrome components.
Assuntos
Aterosclerose/mortalidade , Morte Súbita Cardíaca/epidemiologia , Síndrome Metabólica/mortalidade , Aterosclerose/sangue , Aterosclerose/diagnóstico , Aterosclerose/fisiopatologia , Biomarcadores/sangue , Glicemia/metabolismo , Pressão Sanguínea , Dislipidemias/sangue , Dislipidemias/mortalidade , Feminino , Transtornos do Metabolismo de Glucose/sangue , Transtornos do Metabolismo de Glucose/mortalidade , Humanos , Hipertensão/mortalidade , Hipertensão/fisiopatologia , Incidência , Lipoproteínas LDL/sangue , Masculino , Síndrome Metabólica/sangue , Síndrome Metabólica/diagnóstico , Síndrome Metabólica/fisiopatologia , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Estados UnidosRESUMO
TOPCAT was a multinational clinical trial of 3,445 heart failure with preserved ejection fraction (HFpEF) patients that enrolled in 233 sites in six countries in North America, Eastern Europe and South America. Patients with a heart failure hospitalization in the last 12 months or an elevated B-type natriuretic peptide (BNP) were randomized to the mineralocorticoid receptor antagonist spironolactone vs. placebo. Sites in Russia and the Republic of Georgia provided the majority of early enrollment, primarily based on the hospitalization criterion since BNP levels were initially unavailable there. With the emergence of country-specific aggregate event rate data indicating lower rates in Eastern Europe and differences in patient characteristics there, the DSMB recommended relatively increasing enrollment in North America plus other corrective measures. Although final enrollment reflected the increased contribution from North America, a plurality of the final cohort came from Russia and Georgia (49% vs. 43% in North America). BNP measurements from Russia and Georgia available later in the trial suggested no or a mild level of heart failure consistent with low event rates. The primary results showed no significant spironolactone treatment effect overall (primary endpoint hazard ratio 0.89 (0.77, 1.04)), with a significant hazard ratio in North and South America (0.82 (0.69, 0.98), p =0.026) but not in Russia and Georgia (1.10 (0.79, 1.51), interaction p = 0.12). This report describes the DSMB's detection and management recommendations for regional differences in patient characteristics in TOPCAT, and suggests methods of surveillance and corrective actions that may be useful for future trials.
RESUMO
BACKGROUND: Coronary artery disease (CAD) among patients with diabetes and chronic kidney disease (CKD) is not well studied, and the best treatment for this condition is not established. Our aim was to compare three therapeutic strategies for CAD in diabetic patients stratified by renal function. METHODS: Patients with multivessel CAD that underwent coronary artery bypass graft (CABG), angioplasty (percutaneous coronary intervention [PCI]), or medical therapy alone (MT) were included. Data were analyzed according to glomerular filtration rate in three strata: normal (>90 mL/min), mild CKD (60 to 89 mL/min), and moderate CKD (30 to 59 mL/min). End points comprised overall rate of mortality, acute myocardial infarction, and need for additional revascularization. RESULTS: Among patients with normal renal function (n = 270), 122 underwent CABG, 72 PCI, and 76 MT; among patients with mild CKD (n = 367), 167 underwent CABG, 92 PCI, and 108 MT; and among patients with moderate CKD (n = 126), 46 underwent CABG, 40 PCI, and 40 MT. Event-free survival was 80.4%, 75.7%, 67.5% for strata 1, 2, and 3, respectively (p = 0.037). Survival rates among patients with no, mild, and moderate CKD are 91.1%, 89.6%, and 76.2%, respectively (p = 0.001) (hazard ratio 0.69; 95% confidence interval 0.51 to 0.95; p = 0.024 for stratum 1 versus 3). We found no differences for overall number of deaths or acute myocardial infarctions irrespective of strata. The need of new revascularization was different in all strata, favoring CABG (p < 0.001, p < 0.001, and p = 0.029 for no, mild, and moderate CKD, respectively). CONCLUSIONS: Mortality rates were higher in patients with mild and moderate CKD. Higher event-free survival was observed in the CABG group among patients with no and mild CKD. Besides, CABG was associated with less need for new revascularization compared with PCI and MT in all renal function strata. This trial was registered at http://www.controlled-trials.com as ISRCTN66068876.
Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Diabetes Mellitus Tipo 2/complicações , Intervenção Coronária Percutânea , Insuficiência Renal Crônica/mortalidade , Idoso , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Diabetes Mellitus Tipo 2/fisiopatologia , Feminino , Taxa de Filtração Glomerular , Humanos , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida , Resultado do TratamentoRESUMO
El aumento de la edad se destaca como uno de los factores de riesgo más potentes para la aparición de un accidente cerebrovascular en un paciente con fibrilación auricular (FA). Con el aumento constante de la edad de la población mundial se plantean muchas interrogantes acerca de la estrategia óptima para anticoagular al paciente añoso, y a menudo se presentan dilemas sumamente complejos. Este grupo de pacientes tiene un mayor riesgo de sangrado vinculado a la presencia de múltiples comorbilidades, por la frecuencia de las caídas y la polifarmacia -en especial por los antiplaquetarios-. La mayor sensibilidad del paciente añoso a la warfarina, junto con la mayor frecuencia con la que sufren sangrado intracraneano, hacen que los nuevos anticoagulantes orales constituyan una alternativa atractiva en ciertos subgrupos seleccionados. Esta revisión intenta contextualizar el problema, brindando un enfoque práctico y equilibrado para manejar el ineludible aprieto de sopesar la posibilidad de sangrado contra el accidente cerebrovascular tromboembólico en este grupo de alto riesgo.
Increasing age stands out as one of the most powerful risk factors for stroke in patients with atrial fibrillation. With the steadily increasing age of the global population, questions regarding the optimal anticoagulation strategy in the elderly are pervasive and often present highly complex clinical dilemmas. This group of patients is at increased risk of bleeding related to multiple other comorbidities, higher rates of falling, and polypharmacy -especially the anti-platelet agents. The elderly patient is more sensitive to warfarin, and coupled with higher rates of intracranial bleeding, the newer anticoagulants present an attractive alternative in selected subgroups. This review is aimed at contextualizing the problem, and providing a practical, balanced approach to managing the inescapable predicament of bleeding versus thromboembolic stroke in this high-risk group.
RESUMO
Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrialfibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation(ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients withclinically significant mitral stenosis or mechanical prosthetic heart valves.Methods and ResultsWe compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, majorbleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazardsmodeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heartdisease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolismand bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban overwarfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR],0.70; 95% confidence interval [CI], 0.510.97 and HR, 0.84; 95%, CI 0.671.04; interaction P=0.38), causing less majorbleeding (HR, 0.79; 95% CI, 0.611.04 and HR, 0.65; 95% CI, 0.550.77; interaction P=0.23), and reducing mortality(HR, 1.01; 95% CI, 0.841.22 and HR, 0.84; 95% CI, 0.730.96; interaction P=0.10).ConclusionsMore than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severevalvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke orsystemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.
Assuntos
Acidente Vascular Cerebral , Doenças Cardiovasculares , Fibrilação Atrial , Inibidor de Coagulação do LúpusRESUMO
BACKGROUND: Assuming that coronary interventions, both coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), are directed to preserve left ventricular function, it is not known whether medical therapy alone (MT) can achieve this protection. Thus, we evaluated the evolution of LV ejection fraction (LVEF) in patients with stable coronary artery disease (CAD) treated by CABG, PCI, or MT as a post hoc analysis of a randomized controlled trial with a follow-up of 10 years. METHODS: Left ventricle ejection fraction was assessed with transthoracic echocardiography in patients with multivessel CAD, participants of the MASS II trial before randomization to CABG, PCI, or MT, and re-evaluated after 10 years of follow-up. RESULTS: Of the 611 patients, 422 were alive after 10.32 ± 1.43 years. Three hundred and fifty had LVEF reassessed: 108 patients from MT, 111 from CABG, and 131 from PCI. There was no difference in LVEF at the beginning (0.61 ± 0.07, 0.61 ± 0.08, 0.61 ± 0.09, respectively, for PCI, CABG, and MT, P = 0.675) or at the end of follow-up (0.56 ± 0.11, 0.55 ± 0.11, 0.55 ± 0.12, P = 0.675), or in the decline of LVEF (reduction delta of -7.2 ± 17.13, -9.08 ± 18.77, and -7.54 ± 22.74). Acute myocardial infarction (AMI) during the follow-up was associated with greater reduction in LVEF. The presence of previous AMI (OR: 2.50, 95% CI: 1.40-4.45; P = 0.0007) and during the follow-up (OR: 2.73, 95% CI: 1.25-5.92; P = 0.005) was associated with development of LVEF <45%. CONCLUSION: Regardless of the therapeutic option applied, LVEF remains preserved in the absence of a major adverse cardiac event after 10 years of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Registration number ISRCTN66068876.
Assuntos
Fármacos Cardiovasculares/uso terapêutico , Ponte de Artéria Coronária , Estenose Coronária/terapia , Intervenção Coronária Percutânea , Volume Sistólico/fisiologia , Idoso , Análise de Variância , Estenose Coronária/fisiopatologia , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/fisiopatologia , Revascularização Miocárdica/métodos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento , Disfunção Ventricular Esquerda/etiologia , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
BACKGROUND: The importance of complete revascularization remains unclear and contradictory. This current investigation compares the effect of complete revascularization on 10-year survival of patients with stable multivessel coronary artery disease (CAD) who were randomly assigned to percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). METHODS AND RESULTS: This is a post hoc analysis of the Second Medicine, Angioplasty, or Surgery Study (MASS II), which is a randomized trial comparing treatments in patients with stable multivessel CAD, and preserved systolic ventricular function. We analyzed patients who underwent surgery (CABG) or stent angioplasty (PCI). The survival free of overall mortality of patients who underwent complete (CR) or incomplete revascularization (IR) was compared. Of the 408 patients randomly assigned to mechanical revascularization, 390 patients (95.6%) underwent the assigned treatment; complete revascularization was achieved in 224 patients (57.4%), 63.8% of those in the CABG group and 36.2% in the PCI group (P=0.001). The IR group had more prior myocardial infarction than the CR group (56.2% × 39.2%, P=0.01). During a 10-year follow-up, the survival free of cardiovascular mortality was significantly different among patients in the 2 groups (CR, 90.6% versus IR, 84.4%; P=0.04). This was mainly driven by an increased cardiovascular specific mortality in individuals with incomplete revascularization submitted to PCI (P=0.05). CONCLUSIONS: Our study suggests that in 10-year follow-up, CR compared with IR was associated with reduced cardiovascular mortality, especially due to a higher increase in cardiovascular-specific mortality in individuals submitted to PCI. CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN66068876.