Association of the KDIGO Risk Classification with the Prevalence of Heart Failure in Patients with Type 2 Diabetes

[Abstract] The objectives of this study were to determine the main characteristics associated with the presence of heart failure (HF) in patients with type 2 diabetes (T2DM), and specifically to assess the association of the risk classification proposed by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines with HF. The DIABET-IC study is a multicentre, observational, prospective and analytical study in T2DM patients recruited in Spanish hospitals. This work, which features a cross-sectional design, has been conducted with the data obtained at the inclusion visit. The main dependent variable analysed was the presence of HF. The predictive variables evaluated were the demography, clinic, laboratory testing (including natriuretic peptides) and echocardiography. Patients were classified according to the number of vascular territories with atherosclerotic involvement and the KDIGO risk category. Multivariate logistic regression models were performed to determine the risk posed by the various baseline variables to present HF at the time of study inclusion. The study included 1517 patients from 58 hospitals, with a mean age of 67.3 (standard deviation (SD): 10) years, out of which 33% were women. The mean DM duration was 14 (SD: 11) years. The prevalence of HF was 37%. In a multivariate analysis, the independent predictors of HF were increased age (odds ratio (OR) per 1 year = 1.02; p = 0.006), decreased systolic blood pressure (OR per 1 mmHg = 0.98; p 1 territory = 2.39; p = 0.02 and p < 0.001 respectively) and the KDIGO risk classification (high-risk OR = 2.46 and very high-risk OR = 3.39; p < 0.001 for both). The KDIGO risk classification is useful to screen for the presence of HF in T2DM patients. Therefore, we believe that it is necessary to carry out a systematic screening for HF in the high- and very high-risk KDIGO categories.This research was funded by the Spanish Society of Diabetes (SED) and the Spanish Society of Cardiology (SEC

Impact of heart failure on the clinical profile and outcomes in patients with atrial fibrillation treated with rivaroxaban. Data from the EMIR study

Background: The aim of this study was to analyze the impact of the presence of heart failure (HF) on the clinical profile and outcomes in patients with atrial fibrillation (AF) anticoagulated with rivaroxaban. Methods: Observational and non-interventional study that included AF adults recruited from 79 Spanish centers, anticoagulated with rivaroxaban ≥ 6 months before inclusion. Data were analyzed according to baseline HF status. Results: Out of 1,433 patients, 326 (22.7%) had HF at baseline. Compared to patients without HF, HF patients were older (75.3 ± 9.9 vs. 73.8 ± 9.6 years; p = 0.01), had more diabetes (36.5% vs. 24.3%; p < 0.01), coronary artery disease (28.2% vs. 12.9%; p < 0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA2DS2-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p < 0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p < 0.01). After a median follow-up of 2.5 years, among HF patients, annual rates of stroke/ /systemic embolism/transient ischemic attack, major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, revascularization and cardiovascular death), cardiovascular death, and major bleeding were 1.2%, 3.0%, 2.0%, and 1.4%, respectively. Compared to those patients without HF, HF patients had greater annual rates of MACE (3.0% vs. 0.5%; p < 0.01) and cardiovascular death (2.0% vs. 0.2%; p < 0.01), without significant differences regarding other outcomes, including thromboembolic or bleeding events. Previous HF was an independent predictor of MACE (odds ratio 3.4; 95% confidence interval 1.6–7.3; p = 0.002) but not for thromboembolic events or major bleeding. Conclusions: Among AF patients anticoagulated with rivaroxaban, HF patients had a worse clinical profile and a higher MACE risk and cardiovascular mortality. HF was independently associated with the development of MACE, but not with thromboembolic events or major bleeding. (Cardiol J 2022; 29, 6: 936–947)

Outcomes and predictive value of the 2MACE score in patients with atrial fibrillation treated with rivaroxaban in a prospective, multicenter observational study: The EMIR study

atrial fibrillation (AF) treated with rivaroxaban and to improve the accuracy of 2MACE. Methods: This was a post-authorization and observational study of AF adults treated with rivaroxaban for ≥ 6 months. The primary endpoint was any of the major adverse cardiac events (MACE), namely, cardiovas cular death, non-fatal myocardial infarction, and myocardial revascularization. The area under the curve (AUC) was calculated to evaluate the performance of 2MACE, and a new score, 2MACER to predict MACE. Results: A total of 1433 patients were included (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.5, 26.9% 2MACE ≥ 3). The annual event rates (follow-up 2.5 years) were 1.07% for MACE, 0.66% for throm boembolic events and 1.04% for major bleeding. Patients with 2MACE ≥ 3 (vs. < 3) had higher risk of stroke/systemic embolism/transient ischemic attack (odds ratio [OR] 5.270; 95% confidence interval [CI] 2.216–12.532), major bleeding (OR 4.624; 95% CI 2.163–9.882), MACE (OR 3.202; 95% CI 1.548–6.626) and cardiovascular death (OR 3.395; 95% CI 1.396–8.259). 2MACE was recalcu lated giving 1 more point to patients with baseline a glomerular filtration rate < 50 mL/min/1.73 m2 (2MACER); (2MACER vs. 2MACE: IDI 0.1%, p = 0.126; NRI 23.9%, p = 0.125; AUC: 0.651 [95% CI 0.547–0.755] vs. 0.638 [95% CI 0.534–0.742], respectively; p = 0.361). Conclusions: In clinical practice, AF patients anticoagulated with rivaroxaban exhibit a low risk of events. 2MACE score acts as a modest predictor of a higher risk of adverse outcomes in this population. 2MACER did not significantly increase the ability of 2MACE to predict MACE. (Cardiol J 2022; 29, 4: 601–609

Major Adverse Cardiovascular Events in Coronary Type 2 Diabetic Patients: Identification of Associated Factors Using Electronic Health Records and Natural Language Processing

Diabetes mellitus; Natural language processing; Risk factorsDiabetis mellitus; Processament del llenguatge natural; Factors de riscDiabetes mellitus; Procesamiento del lenguaje natural; Factores de riesgoPatients with Type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD) are at high risk of developing major adverse cardiovascular events (MACE). This is a multicenter, retrospective, and observational study performed in Spain aimed to characterize these patients in a real-world setting. Unstructured data from the Electronic Health Records were extracted by EHRead®, a technology based on Natural Language Processing and machine learning. The association between new MACE and the variables of interest were investigated by univariable and multivariable analyses. From a source population of 2,184,662 patients, we identified 4072 adults diagnosed with T2DM and CAD (62.2% male, mean age 70 ± 11). The main comorbidities observed included arterial hypertension, hyperlipidemia, and obesity, with metformin and statins being the treatments most frequently prescribed. MACE development was associated with multivessel (Hazard Ratio (HR) = 2.49) and single coronary vessel disease (HR = 1.71), transient ischemic attack (HR = 2.01), heart failure (HR = 1.32), insulin treatment (HR = 1.40), and percutaneous coronary intervention (PCI) (HR = 2.27), whilst statins (HR = 0.73) were associated with a lower risk of MACE occurrence. In conclusion, we found six risk factors associated with the development of MACE which were related with cardiovascular diseases and T2DM severity, and treatment with statins was identified as a protective factor for new MACE in this study.This study was funded by AstraZeneca Spain (Externally Sponsored Scientific Research, ESR-18-13815) and sponsored by the Spanish Society of Cardiology

Impact of Advanced Age on the Incidence of Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes Mellitus and Stable Coronary Artery Disease in a Real-World Setting in Spain

Coronary artery disease; Type 2 diabetes mellitusArteriopatía coronaria; Diabetes mellitus tipo 2Arteriopatia coronària; Diabetis mellitus tipus 2Patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD) without myocardial infarction (MI) or stroke are at high risk for major cardiovascular events (MACEs). We aimed to provide real-world data on age-related clinical characteristics, treatment management, and incidence of major cardiovascular outcomes in T2DM-CAD patients in Spain from 2014 to 2018. We used EHRead® technology, which is based on natural language processing and machine learning, to extract unstructured clinical information from electronic health records (EHRs) from 12 hospitals. Of the 4072 included patients, 30.9% were younger than 65 years (66.3% male), 34.2% were aged 65–75 years (66.4% male), and 34.8% were older than 75 years (54.3% male). These older patients were more likely to have hypertension (OR 2.85), angina (OR 1.64), heart valve disease (OR 2.13), or peripheral vascular disease (OR 2.38) than those aged <65 years (p < 0.001 for all comparisons). In general, they were also more likely to receive pharmacological and interventional treatments. Moreover, these patients had a significantly higher risk of MACEs (HR 1.29; p = 0.003) and ischemic stroke (HR 2.39; p < 0.001). In summary, patients with T2DM-CAD in routine clinical practice tend to be older, have more comorbidities, are more heavily treated, and have a higher risk of developing MACE than is commonly assumed from clinical trial data.This study was funded and sponsored by the Spanish Society of Cardiology

Assessment of medical management in Coronary Type 2 Diabetic patients with previous percutaneous coronary intervention in Spain: A retrospective analysis of electronic health records using Natural Language Processing

Coronary heart disease; Type 2 diabetes; Electronic medical recordsEnfermedad coronaria; Diabetes tipo 2; Registros médicos electrónicosMalaltia coronària; Diabetis tipus 2; Registres mèdics electrònicsIntroduction and objectives Patients with type 2 diabetes (T2D) and stable coronary artery disease (CAD) previously revascularized with percutaneous coronary intervention (PCI) are at high risk of recurrent ischemic events. We aimed to provide real-world insights into the clinical characteristics and management of this clinical population, excluding patients with a history of myocardial infarction (MI) or stroke, using Natural Language Processing (NLP) technology. Methods This is a multicenter, retrospective study based on the secondary use of 2014–2018 real-world data captured in the Electronic Health Records (EHRs) of 1,579 patients (0.72% of the T2D population analyzed; n = 217,632 patients) from 12 representative hospitals in Spain. To access the unstructured clinical information in EHRs, we used the EHRead® technology, based on NLP and machine learning. Major adverse cardiovascular events (MACE) were considered: MI, ischemic stroke, urgent coronary revascularization, and hospitalization due to unstable angina. The association between MACE rates and the variables included in this study was evaluated following univariate and multivariate approaches. Results Most patients were male (72.13%), with a mean age of 70.5±10 years. Regarding T2D, most patients were non-insulin-dependent T2D (61.75%) with high prevalence of comorbidities. The median (Q1-Q3) duration of follow-up was 1.2 (0.3–4.5) years. Overall, 35.66% of patients suffered from at least one MACE during follow up. Using a Cox Proportional Hazards regression model analysis, several independent factors were associated with MACE during follow up: CAD duration (p < 0.001), COPD/Asthma (p = 0.021), heart valve disease (p = 0.031), multivessel disease (p = 0.005), insulin treatment (p < 0.001), statins treatment (p < 0.001), and clopidogrel treatment (p = 0.039). Conclusions Our results showed high rates of MACE in a large real-world series of PCI-revascularized patients with T2D and CAD with no history of MI or stroke. These data represent a potential opportunity to improve the clinical management of these patients.This study was funded by AstraZeneca Spain and sponsored by the Spanish Society of Cardiology

Anticoagulantes orales directos frente a antagonistas de la vitamina K en pacientes del «mundo real» con fibrilación auricular no valvular: estudio FANTASIIA

Observational study[Abstract] Introduction and objectives: To compare the long-term results of direct oral anticoagulants (DOAC) vs vitamin K antagonists (VKA) in real-world-patients with nonvalvular atrial fibrillation (NVAF) in a nationwide, prospective study. Methods: The FANTASIIA registry prospectively included outpatients with AF anticoagulated with DOAC or VKA (per protocol, proportion of VKA and DOAC 4:1), consecutively recruited from June 2013 to October 2014 in Spain. The incidence of major events was analyzed and compared according to the anticoagulant treatment received. Results: A total of 2178 patients were included in the study (mean age 73.8±9.4 years), and 43.8% were women. Of these, 533 (24.5%) received DOAC and 1645 (75.5%) VKA. After a median follow up of 32.4 months, patients receiving DOAC vs those receiving VKA had lower rates of stroke-0.40 (95%CI, 0.17-0.97) vs 1.07 (95%CI,0.79-1.46) patients/y, P=.032-, severe bleedings-2.13 (95%CI, 1.45-3.13) vs 3.28 (95%CI, 2.75-3.93) patients/y; P = .044-, cardiovascular death-1.20 (95%CI, 0.72-1.99) vs 2.45 (95%CI, 2.00-3.00) patients/y; P = .009-, and all-cause death-3.77 (95%CI, 2.83-5.01) vs 5.54 (95%CI, 4.83-6.34) patients/y; P = .016-. In a modified Cox regression model by the Andersen-Gill method for multiple events, hazard ratios for patients receiving DOAC were: 0.42 (0.16-1.07) for stroke; 0.47 (0.20-1.16) for total embolisms; 0.76 (0.50-1.15) for severe bleedings; 0.67 (0.39-1.18) for cardiovascular death; 0.86 (0.62-1.19) for all-cause death, and 0.82 (0.64-1.05) for the combined event consisting of stroke, embolism, severe bleeding, and all-cause death. Conclusions: Compared with VKA, DOAC is associated with a trend to a lower incidence of all major events, including death, in patients with NVAF in Spain.[Resumen] Introducción y objetivos. Comparar los resultados a largo plazo de los anticoagulantes orales directos (ACOD) frente a los antagonistas de la vitamina K (AVK) en pacientes del mundo real con fibrilación auricular no valvular (FANV) en un estudio nacional prospectivo. Métodos. El estudio FANTASIIA incluyó consecutivamente a pacientes ambulatorios con FANV anticoagulados con ACOD o AVK desde junio de 2013 hasta octubre de 2014. Se compararon las tasas de eventos según el anticoagulante administrado. Resultados. Se incluyó a 2.178 pacientes (edad, 73,8 ± 9,4 años; el 43,8% mujeres); de ellos, 533 (24,5%) recibían ACOD y 1.645 (75,5%), AVK. Tras una mediana de seguimiento de 32,4 meses, los pacientes con ACOD tuvieron tasas más bajas de ictus —0,40 (IC95%, 0,17-0,97) frente a 1,07 (IC95%, 0,79-1,46) pacientes/año; p = 0,032—, hemorragias mayores —2,13 (IC95%, 1,45-3,13) frente a 3,28 (IC95%, 2,75-3,93) pacientes/año; p = 0,044—, muerte cardiovascular —1,20 (IC95%, 0,72-1,99) frente a 2,45 (IC95%, 2,00-3,00) pacientes/año; p = 0,009— y muerte total —3,77 (IC95%, 2,83-5,01) frente a 5,54 (IC95%, 4,83-6,34) pacientes/año; p = 0,016—. En el análisis de Cox modificado según el método de Andersen-Gill para datos con múltiples eventos, las razones de riesgos instantáneos para los pacientes con ACOD fueron 0,42 (0,16-1,07) para el ictus; 0,47 (0,20-1,16) para la embolia sistémica en general; 0,76 (0,50-1,15) para las hemorragias mayores; 0,67 (0,39-1,18) para la muerte cardiovascular; 0,86 (0,62-1,19) para la mortalidad total y 0,82 (0,64-1,05) para el combinado de ictus, embolias, hemorragias mayores y muerte. Conclusiones. El tratamiento con ACOD se asocia con una tendencia a una menor tasa de todos los eventos graves, incluida la mortalidad, en relación con los AVK en pacientes con FANV en España

Characteristics of women with type 2 diabetes and heart failure in Spain. The DIABET-IC study

Background: Heart failure (HF) is the second most common initial presentation of cardiovascular disease in people with type 2 diabetes mellitus (T2DM). T2DM carries an increased risk of HF in women. The aim of this study is to analyze the clinical characteristics and the treatment received by women with HF and T2DM in Spain. Methods: The DIABET-IC study included 1517 patients with T2DM in 2018–2019 in Spain, in 30 centers, which included the first 20 patients with T2DM seen in cardiology and endocrinology clinics. They underwent clinical evaluation, echocardiography, and analysis, with a 3-year follow-up. Baseline data are presented in this study. Results: 1517 patients were included (501 women; aged 67.28 ± 10.06 years). Women were older (68.81 ± 9.90 vs. 66.53 ± 10.06 years; p &lt; 0.001) and had a lower frequency of a history of coronary disease. There was a history of HF in 554 patients, which was more frequent in women (38.04% vs. 32.86%; p &lt; 0.001), and preserved ejection fraction being more frequent in them (16.12% vs. 9.00%; p &lt; 0.001). There were 240 patients with reduced ejection fraction. Women less frequently received treatment with angiotensin converting enzyme inhibitors (26.20% vs. 36.79%), neprilysin inhibitors (6.00% vs. 13.51%), mineralocorticoid receptor antagonists (17.40% vs. 23.08%), beta-blockers (52.40% vs. 61.44%), and ivabradine (3.60% vs. 7.10%) (p &lt; 0.001 for all), and 58% received guideline-directed medical therapy. Conclusions: A selected cohort with HF and T2DM attending cardiology and endocrinology clinics did not receive optimal treatment, and this finding was more pronounced in women

INR during stroke and bleeding in patients with atrial fibrillation and on vitamin K antagonists

[Resumen] Introducción y objetivos. La fibrilación auricular tiene un mal pronóstico asociado fundamentalmente al desarrollo de ictus. A pesar del uso de anticoagulantes, algunos pacientes pueden sufrir ictus y también hemorragias graves. El tratamiento con antagonistas de la vitamina K (AVK) se controla mediante la razón internacional normalizada (INR). Nuestro objetivo fue estudiar la incidencia de ictus y hemorragias mayores, e investigar los valores de la INR y el tiempo en rango terapéutico en los 6 meses previos durante dichos episodios en pacientes con fibrilación auricular tratados con AVK. Métodos. Se incluyeron 1.483 pacientes con fibrilación auricular tratados con AVK durante al menos los 6 meses previos, incluidos consecutivamente desde junio de 2013 hasta octubre de 2014, con una mediana de seguimiento de 32,4 meses. Se identificaron aquellos pacientes que ingresaron por ictus o hemorragia mayor y se determinó la INR en cada episodio. Resultados. Se registraron 40 ictus (1,07/100 pacientes/año) y 120 hemorragias mayores (3,28/100 pacientes/año). La INR durante los ictus fue 2,33 ± 0,59, y durante las hemorragias 3,17 ± 1,48. El 57,5% de los pacientes tenían una INR de 2-3 durante los ictus y el 48,3% durante las hemorragias. Los pacientes que sufrieron un ictus con una INR fuera de rango durante el episodio presentaron un tiempo en rango terapéutico más bajo que aquellos con la INR en rango (49,2 ± 20,8% frente a 68,8 ± 19,4%; p = 0,043). Conclusiones. La mitad de los ictus y hemorragias mayores se producen con valores de la INR «adecuados» (2 a 3). Cambios en la estrategia de anticoagulación pueden ser necesarios para disminuir esta elevada tasa de eventos.[Abstract] Introduction and objectives. Atrial fibrillation has a poor prognosis, mainly due to the occurrence of cardioembolic stroke. Despite the use of anticoagulants some patients can develop stroke as well as severe bleeding. Treatment with vitamin K antagonists is usually controlled by means of the international normalized ratio (INR). The aim of this study was to investigate the incidence of stroke and major bleedings, as well the values of INR and the time in therapeutic range within the previous 6 months during these events. Methods. The study included 1483 patients with atrial fibrillation treated with vitamin K antagonists for at least 6 months prior to inclusion, consecutively recruited from June 2013 to October 2014, with a median follow-up of 32.4 months. Those patients admitted due to an episode of stroke or severe bleeding were identified, and an analysis was performed on the INR values obtained for each episode. Results. There was a total of 40 strokes (1.07/100 patients/year) and 120 severe bleedings (3.28/100 patients/year) during the study period. The mean INR value during stroke episodes was 2.33 ± 0.59, and during severe bleeding 3.17 ± 1.48, with 57.5% of patients having had an INR of 2-3 during strokes, and 48.3% during bleedings. Patients with an INR out of range during the stroke had a time in therapeutic range lower than those with an INR between 2 and 3 during the event (49.2 ± 20.8% vs. 68.8 ± 19.4%; P = .043). Conclusions. More than 50% of strokes and almost 50% of severe bleedings occur with ‘adequate’ (2 to 3) INR values. Changes in the anticoagulation strategy seem to be necessary to decrease this high rate of severe events

Dos estructuras del Bronce Final destinadas a trabajos de producción, próximas al asentamiento prerromano de la Colina de los Quemados de Córdoba

Las estructuras documentadas evidencian una actividad, desarrollada con fuego a baja temperatura, en la zona periférica del yacimiento prerromano de Colina de los Quemados. Realizado un estudio comparativo con otras estructuras similares, se podría deducir que estaban destinadas a la producción, siendo la hipótesis más factible que se trate de dos hornos de pan del Bronce Final, desconociéndose aún si tenían un uso familiar o comunitarioThe documented structures demonstrate an activity in the peripheral zone of the preroman Colina de los Quemados site based on low temperature firing. After doing a comparative study with other similar structures, it is possible to deduce that they were destined for production, being the more feasible hypothesis that they are two bread ovens of the Late Bronze Age. The question whether they had a family or community use or not remains to be answered at presen