Accuracy of the 6-Minute Walk Test for Assessing Functional Capacity in Patients With Heart Failure With Preserved Ejection Fraction and Other Chronic Cardiac Pathologies: Results of the ExIC-FEp Trial and a Meta-Analysis.

BACKGROUND: Heart diseases, particularly heart failure, significantly impact patient quality of life and mortality rates. Functional capacity assessment is vital for predicting prognosis and risk in these patients. While the cardiopulmonary exercise test is considered the gold standard, the 6-minute walk test has emerged as a more accessible alternative. However, the screening accuracy and optimal cut-off points of the 6-minute walk test for detecting severely reduced functional capacity in cardiac pathologies, including heart failure with preserved ejection fraction, are unclear. The study aimed to analyse the diagnostic accuracy of the 6-minute walk test for detecting reduced functional capacity, defined as VO2max < 14 ml/kg/min, compared with the cardiopulmonary exercise test in participants with heart failure with preserved ejection fraction using data from the "Ejercicio en Insuficiencia Cardiaca con Fracción de Eyección Preservada" (ExIC-FEp) trial; and to compare these results with previous studies investigating the screening accuracy for assessing functional capacity of the 6-minute walk test in participants with other chronic cardiac pathologies through a meta-analysis. RESULTS: The ExIC-FEp trial involved 22 participants with heart failure with preserved ejection fraction, who were not treated with beta-blockers, using the cardiopulmonary exercise test, specifically VO2max, as the reference test. The 6-minute walk test had a sensitivity of 70%, a specificity of 80%, and an area under the curve of 76% in the ExIC-FEp trial. Five studies were included in the meta-analysis showing a sensitivity of 79%, a specificity of 78%, and an area under the curve of 85%. CONCLUSION: In conclusion, the 6-minute walk test holds promise as a screening tool for assessing functional capacity in heart failure with preserved ejection fraction and chronic heart diseases, with a VO2max < 14 ml/kg/min as a reference point. It demonstrates moderate to good screening accuracy. However, the screening accuracy and optimal cut-off points of the 6-minute walk test for detecting severely reduced functional capacity, regardless of aetiology, are unclear. TRIAL REGISTRATION: NCT05726474. Registered 16 February 2023, https://clinicaltrials.gov/study/NCT05726474 .

Clinical implications of diabetes mellitus in patients with acute coronary syndrome: Prognostic role and use of new P2Y12 receptor inhibitors.

AIMS: We investigated the impact of diabetes mellitus (DM) in acute coronary syndrome (ACS) patients, and the 2-year prognosis based on antiplatelet therapy. METHODS: This is a prospective and multicenter registry including hospitalized ACS patients. Clinical management and antiplatelet therapy at discharge were recorded. Bleeding events, all-cause mortality and major adverse cardiovascular events (MACEs) were recorded during 2-years and compared according to DM and the P2Y12 receptor inhibitor. RESULTS: From 1717 ACS patients, 653 (38%) had DM. Diabetic patients were older, more commonly females, with higher prevalence of comorbidities and more conservative management. After excluding antiplatelet monotherapy or oral anticoagulation, clopidogrel was prescribed in 59.6% of DM patients. Cox regression analysis showed that DM was an independent risk factor for MACE (aHR 1.39, 95% CI 1.05-1.83). The use of clopidogrel instead of ticagrelor/prasugrel was also independently associated with MACE (aHR 1.71, 95% CI 1.11-2.63), and all-cause mortality (aHR 2.47, 95% CI 1.23-4.96) in diabetic patients (log-rank p-values < 0.001). CONCLUSIONS: In ACS patients, DM was associated with higher risk of MACE. In such patients, the use of ticagrelor/prasugrel reduced MACE and mortality compared to clopidogrel. Novel P2Y12 receptor inhibitors might be used as the first therapeutic choice in these high-risk patients.

Impact of anemia as risk factor for major bleeding and mortality in patients with acute coronary syndrome.

BACKGROUND: Anemia is frequent in acute coronary syndrome (ACS) patients and is associated with worse clinical outcomes. We aimed to investigate the therapeutic strategies, the use of novel P2Y12 inhibitors, and the prognostic implication of anemia in a "real world" cohort of ACS patients. METHODS: This is an observational and prospective registry including 1717 ACS patients from three tertiary hospitals. During hospitalization we recorded the clinical management and the antiplatelet therapy at discharge. Patients were divided into 2 groups according to the baseline hemoglobin level, i.e. anemic (hemoglobin < 13 g/dL in men and <12 g/dL in women) and non-anemic patients. Bleeding events, mortality and major adverse cardiovascular events (MACEs) were recorded during 1-year of follow-up. RESULTS: Anemia was present in 445 (25.9%) patients. Cardiac catheterization (83.8% vs. 94.5%, p < .001), and revascularization by percutaneous coronary intervention (53.5% vs. 70.5%, p < .001) were less frequent in these patients. Excluding anticoagulated patients, novel P2Y12 inhibitors were less prescribed in anemic patients (OR 2.80 [95% CI 2.13-3.67], p < .001). Anemia was independently associated with major bleeding (HR 2.26 [95% CI 1.07-4.78], p = .033) and all-cause mortality (HR 1.62 [95% CI 1.03-2.56], p = .038), but not with MACE. At 1-year of follow-up, the risk of mortality in anemic patients taking clopidogrel was higher (HR 2.38 [95% CI 1.01-5.67]; p = .049). CONCLUSIONS: In this registry involving ACS patients, anemia had influence on clinical management and antiplatelet therapy. Patients suffering from anemia had higher risk for major bleeding and mortality. In particular, anemic patients treated with clopidogrel had even more mortality events.

Disparities in the Estimation of Glomerular Filtration Rate According to Cockcroft-Gault, Modification of Diet in Renal Disease-4, and Chronic Kidney Disease Epidemiology Collaboration Equations and Relation With Outcomes in Patients With Acute Coronary Syndrome.

BACKGROUND: A simple method to assess renal function is the estimated glomerular filtration rate, and it shows prognostic implications. However, it remains unknown which equation should be used in patients with acute coronary syndrome. We compared the ability and correlation of the Cockcroft-Gault, Modification of Diet in Renal Disease-4 (MDRD-4), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations and their predictive performance for major adverse cardiovascular events, all-cause mortality, and major bleeding in a cohort of patients with acute coronary syndrome. METHODS AND RESULTS: Multicenter prospective registry involving 1699 consecutive patients with acute coronary syndrome from 3 tertiary institutions. At entry, renal function was assessed using the Cockcroft-Gault, MDRD-4, and CKD-EPI-creatinine equations. During 12 months of follow-up, we recorded all major adverse cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke), bleeding events (Bleeding Academic Research Consortium classification), and all-cause mortality. Receiver operating characteristic curve comparisons demonstrated that Cockcroft-Gault equation had higher predictive ability compared with MDRD-4 equation for major adverse cardiovascular events (0.651 versus 0.616; P=0.023), major bleeding (0.600 versus 0.551; P=0.005), and all-cause mortality (0.754 versus 0.717; P=0.033), as well as higher predictive ability compared with CKD-EPI equation for major bleeding (0.600 versus 0.564; P=0.018). Integrated discrimination improvement and net reclassification improvement analyses showed superior discrimination and reclassification of Cockcroft-Gault equation. Decision curve analyses graphically demonstrated higher net benefit and clinical usefulness of the Cockcroft-Gault equation in comparison with MDRD-4 and CKD-EPI equations. CONCLUSIONS: In patients with acute coronary syndrome, the Cockcroft-Gault equation presented superior predictive ability for major adverse cardiovascular events, major bleeding, and all-cause mortality compared with MDRD-4 equation, and superior predictive ability for major bleeding compared with CKD-EPI equation. The Cockcroft-Gault equation also showed higher net benefit and clinical usefulness.