Spirituality, Functional Gain, and Quality of Life in Cardiovascular Rehabilitation. / Espiritualidade, Ganho Funcional e Qualidade de Vida em Reabilitação Cardiovascular.

BACKGROUND: Religiosity and spirituality have been associated with higher recovery rates, greater adherence to treatments, and better levels of quality of life in patients with heart disease. OBJECTIVES: To evaluate the association between spirituality, functional gain, and improved quality of life in patients in a cardiovascular rehabilitation program. METHODS: This prospective cohort study evaluated the association between functional and quality of life gains during a cardiovascular rehabilitation program and a religiosity/spirituality index based on a validated scale. Depression, anxiety, and stress symptoms were screened for control purposes. P values < 0.05 were considered significant for all analyses. RESULTS: The study followed 57 patients (66 ± 12 years old; 71.7% male; 76% with coronary artery disease). The Spearman correlation coefficient did not show any associations between increases in functional capacity and organizational (rs = 0.110; p = 0.421), non-organizational (rs = -0.007; p = 0.421), or intrinsic (rs = -0.083; p = 0.543) religiosity. Furthermore, no associations were detected between the results of a quality of life score and organizational (rs = 0.22; p = 0.871), non-organizational (rs = 0.191; p = 0.159), or intrinsic (rs = 0.108; p = 0.429) religiosity. CONCLUSION: No association was detected between functional and quality of life gains and organizational, non-organizational, or intrinsic religiosity in this sample of patients undergoing cardiovascular rehabilitation.

FUNDAMENTO: Religiosidade e espiritualidade têm sido associadas a maiores taxas de recuperação, maior adesão a tratamentos e melhores níveis de qualidade de vida em pacientes cardiopatas. OBJETIVOS: Avaliar a associação entre espiritualidade, ganho funcional e melhoria de qualidade de vida em pacientes de um programa de reabilitação cardiovascular. MÉTODOS: Estudo de coorte prospectiva, no qual foi avaliada a associação entre os ganhos funcional e em qualidade de vida obtidos durante um programa de reabilitação cardiovascular e o índice de religiosidade/espiritualidade a partir de escala validada. Sintomas de depressão, ansiedade e estresse foram rastreados, para fins de controle. Um p < 0,05 foi adotado como padrão significante para todas as análises. RESULTADOS: Foram acompanhados 57 pacientes (66 ± 12 anos; 71,7% masculinos, 76% com doença arterial coronariana). O cálculo do coeficiente de correlação de Spearman não evidenciou associações entre incrementos na capacidade funcional e religiosidade organizacional (rs = 0,110; p = 0,421), não organizacional (rs = −0,007; p = 0,421) ou intrínseca (rs = −0,083; p = 0,543). Também não foram detectadas associações entre os resultados de um escore de qualidade de vida e religiosidade organizacional (rs = 0,22; p = 0,871), não organizacional (rs = 0,191; p = 0,159) ou intrínseca (rs = 0,108; p = 0,429). CONCLUSÃO: Não foi detectada associação entre ganho funcional ou em qualidade de vida e religiosidade organizacional, não organizacional ou intrínseca, nesta amostra de pacientes em reabilitação cardiovascular.

Espiritualidade, Ganho Funcional e Qualidade de Vida em Reabilitação Cardiovascular / Spirituality, Functional Gain, and Quality of Life in Cardiovascular Rehabilitation

Resumo Fundamento Religiosidade e espiritualidade têm sido associadas a maiores taxas de recuperação, maior adesão a tratamentos e melhores níveis de qualidade de vida em pacientes cardiopatas. Objetivos Avaliar a associação entre espiritualidade, ganho funcional e melhoria de qualidade de vida em pacientes de um programa de reabilitação cardiovascular. Métodos Estudo de coorte prospectiva, no qual foi avaliada a associação entre os ganhos funcional e em qualidade de vida obtidos durante um programa de reabilitação cardiovascular e o índice de religiosidade/espiritualidade a partir de escala validada. Sintomas de depressão, ansiedade e estresse foram rastreados, para fins de controle. Um p < 0,05 foi adotado como padrão significante para todas as análises. Resultados Foram acompanhados 57 pacientes (66 ± 12 anos; 71,7% masculinos, 76% com doença arterial coronariana). O cálculo do coeficiente de correlação de Spearman não evidenciou associações entre incrementos na capacidade funcional e religiosidade organizacional (rs = 0,110; p = 0,421), não organizacional (rs = −0,007; p = 0,421) ou intrínseca (rs = −0,083; p = 0,543). Também não foram detectadas associações entre os resultados de um escore de qualidade de vida e religiosidade organizacional (rs = 0,22; p = 0,871), não organizacional (rs = 0,191; p = 0,159) ou intrínseca (rs = 0,108; p = 0,429). Conclusão Não foi detectada associação entre ganho funcional ou em qualidade de vida e religiosidade organizacional, não organizacional ou intrínseca, nesta amostra de pacientes em reabilitação cardiovascular.

Abstract Background Religiosity and spirituality have been associated with higher recovery rates, greater adherence to treatments, and better levels of quality of life in patients with heart disease. Objectives To evaluate the association between spirituality, functional gain, and improved quality of life in patients in a cardiovascular rehabilitation program. Methods This prospective cohort study evaluated the association between functional and quality of life gains during a cardiovascular rehabilitation program and a religiosity/spirituality index based on a validated scale. Depression, anxiety, and stress symptoms were screened for control purposes. P values < 0.05 were considered significant for all analyses. Results The study followed 57 patients (66 ± 12 years old; 71.7% male; 76% with coronary artery disease). The Spearman correlation coefficient did not show any associations between increases in functional capacity and organizational (rs = 0.110; p = 0.421), non-organizational (rs = −0.007; p = 0.421), or intrinsic (rs = −0.083; p = 0.543) religiosity. Furthermore, no associations were detected between the results of a quality of life score and organizational (rs = 0.22; p = 0.871), non-organizational (rs = 0.191; p = 0.159), or intrinsic (rs = 0.108; p = 0.429) religiosity. Conclusion No association was detected between functional and quality of life gains and organizational, non-organizational, or intrinsic religiosity in this sample of patients undergoing cardiovascular rehabilitation.

Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial.

BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3-0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59-1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61-8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. FUNDING: Coalition COVID-19 Brazil, Bayer SA.

Randomized clinical trial to evaluate a routine full anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV2) admitted to hospital: Rationale and design of the ACTION (AntiCoagulaTlon cOroNavirus)-Coalition IV trial.

BACKGROUND: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation. DESIGN: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria. SUMMARY: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels.