Predictors of use of direct oral anticoagulants in patients with venous thromboembolism: Findings from the Registro Informatizado Enfermedad Tromboembólica registry.

Background: Current guidelines recommend the use of direct oral anticoagulants (DOACs) for patients with venous thromboembolism (VTE). However little is known about the use of DOACs in daily practice. Methods: We used the RIETE registry to identify predictors of use of DOACs for initial and/or long-term therapy of VTE based on patient-related factors, institution-related factors or over time. Results: Among 41,678 patients from March 2013 to September 2021, 12,286 (29%) used DOACs: for initial therapy 6,456; for long-term therapy 12,046. On multivariable analysis, independent predictors were: age < 65 years (odds ratio [OR]: 1.30; 95% CI: 1.23-1.38), body weight <50 kg (OR: 0.54; 95% CI: 0.45-0.65) or >120 kg (OR: 0.64; 95% CI: 0.53-0.77), initial VTE presentation as pulmonary embolism (OR: 1.18; 95% CI: 1.13-1.25), recent bleeding (OR: 0.53; 95% CI: 0.45-0.63), renal insufficiency (OR: 0.44; 95% CI: 0.38-0.51), liver cirrhosis (OR: 0.32; 95% CI: 0.20-0.52), thrombocytopenia (OR: 0.40; 95% CI: 0.34-0.49), atrial fibrillation (OR: 1.58; 95% CI: 1.42-1.75) and prior VTE (OR: 1.14; 95% CI: 1.06-1.22). The DOACs were more likely used in other European countries (OR: 8.97; 95% CI: 8.49-9.49), America (OR: 6.35; 95% CI: 5.67-7.11) or in other countries of the world (OR: 2.99; 95% CI: 2.70-3.31) than in Spain, and progressively increased from 2013-2015 to 2016-2018 (OR: 2.78; 95% CI: 2.62-2.95) and 2019-2021 (OR: 6.36; 95% CI: 5.95-6.80). Conclusion: In this large multinational VTE registry, variations were observed in the use of DOACs according to patient or country factors, and over time. The safety, costs, and influence of the DOACs on VTE-related outcomes in daily practice warrant further investigation.

Caracterización y eventos adversos relacionados con la asistencia sanitaria en pacientes infectados por el SARS-CoV-2 fallecidos en un hospital de tercer nivel / Patient characterization and adverse health care-related events in SARS-CoV-2 infected patients who died in a tertiary hospital

Objetivo: Caracterizar los episodios adversos relacionados con la asistencia sanitaria en pacientes infectados por SARS-CoV-2 fallecidos en un hospital de tercer nivel.MétodosEstudio observacional retrospectivo en el que se incluyeron los pacientes fallecidos en el centro entre el 16 de marzo y el 10 de abril de 2020. La información fue extraída desde la historia clínica electrónica.ResultadosLa mediana de edad de los 164 pacientes analizados fue de 77,5 años. Más de 9 de cada 10 pacientes fallecidos presentaban al menos una comorbilidad. El 40,2% de los pacientes presentó al menos un episodio adverso (EA) asociado a la atención sanitaria. Un 23,8% de los pacientes presentó alguna reacción adversa a medicamentos, constituyendo la primera causa de EA entre los pacientes fallecidos. Entre los pacientes que fallecieron en unidades de cuidados intensivos, los problemas relacionados con la ventilación mecánica han aparecido con una frecuencia del 8,8%.ConclusionesA pesar de que la letalidad asociada a los EA detectados fue muy reducida, es fundamental establecer una vigilancia estrecha de los posibles EA asociados a la asistencia sanitaria, especialmente los farmacológicos, dado que se trata de una enfermedad con un tratamiento terapéutico incierto. (AU)

Objective: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital.MethodsThis is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record.ResultsThe median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and> 90% of patients had ≥ 1 comorbidity. Forty point two percent of patients had at least ≥ 1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%.ConclusionsAlthough the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear. (AU)

Patient characterization and adverse health care-related events in SARS-CoV-2 infected patients who died in a tertiary hospital.

OBJECTIVE: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital. METHODS: This is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record. RESULTS: The median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and >90% of patients had ≥1 comorbidity. Forty point two percent of patients had at least ≥1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%. CONCLUSIONS: Although the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear.

OBJETIVO: Caracterizar los eventos adversos relacionados con la asistencia sanitaria en pacientes infectados por SARS-CoV-2 fallecidos en un hospital de tercer nivel. MÉTODOS: Estudio observacional retrospectivo en el que se incluyeron los pacientes fallecidos en el centro entre el 16 de marzo y el 10 de abril de 2020. La información fue extraída desde la historia clínica electrónica. RESULTADOS: La mediana de edad de los 164 pacientes analizados fue de 77,5 años. Más de 9 de cada 10 pacientes fallecidos presentaban al menos una comorbilidad. El 40,2% de los pacientes presentó al menos un evento adverso (EA) asociado a la atención sanitaria. Un 23,8% de los pacientes presentó alguna reacción adversa a medicamentos, constituyendo la primera causa de EA entre los pacientes fallecidos. Entre los pacientes que fallecieron en unidades de cuidados intensivos, los problemas relacionados con la ventilación mecánica han aparecido con una frecuencia del 8,8%. CONCLUSIONES: A pesar de que la letalidad asociada a los EA detectados fue muy reducida, es fundamental establecer una vigilancia estrecha de los posibles EA asociados a la asistencia sanitaria, especialmente los farmacológicos, dado que se trata de una enfermedad con un manejo terapéutico incierto.

[Patient characterization and adverse health care-related events in SARS-CoV-2 infected patients who died in a tertiary hospital]. / Caracterización y eventos adversos relacionados con la asistencia sanitaria en pacientes infectados por el SARS-CoV-2 fallecidos en un hospital de tercer nivel.

OBJECTIVE: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital. METHODS: This is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record. RESULTS: The median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and> 90% of patients had ≥ 1 comorbidity. Forty point two percent of patients had at least ≥ 1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%. CONCLUSIONS: Although the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear.

Rivaroxaban or apixaban in fragile patients with acute venous thromboembolism.

INTRODUCTION: The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients (age ≥ 75 years and/or creatinine clearance [CrCl] levels ≤50 mL/min and/or body weight ≤50kg) with venous thromboembolism (VTE) have not been consistently compared. MATERIAL AND METHODS: We used the RIETE database to compare the rates of the composite of VTE recurrences or major bleeding during anticoagulation in fragile patients with VTE, according to the use of rivaroxaban or apixaban for initial and long-term therapy. RESULTS: From January 2013 to October 2019, 36,889 patients were recruited, of whom 14,831 (40%) were fragile. Overall, 999 fragile patients (15%) received DOACs starting within the first 48 h: rivaroxaban 711 and apixaban 288. Median duration of therapy was: 113 vs. 111 days. A substantial amount of patients in both subgroups (25% vs. 40%) received non-recommended doses of DOACs. During anticoagulation, 13 patients developed VTE recurrences, 18 had major bleeding and 36 died. When only considering patients receiving recommended doses (n = 705), there were no differences between drugs in the rate of the composite outcome (rate ratio [RR]: 1.08; 95%CI: 0.35-3.30) or all-cause death (RR: 0.99; 95%CI: 0.32-3.08). On multivariable analysis, patients receiving rivaroxaban or apixaban at recommended doses had a similar risk for the composite outcome (hazard ratio: 1.34; 95%CI: 0.35-5.06). CONCLUSION: The use of rivaroxaban or apixaban at recommended doses in fragile patients with VTE was associated with a similar risk for VTE recurrences or major bleeding.