Revisión sistemática de los ensayos clínicos sobre terapia antitrombótica con inhibidores del factor XI / Systematic review of clinical trials on the antithrombotic therapy with factor XI inhibitors

Antecedentes y objetivo La información proveniente de los ensayos clínicos fase 2 sugiere que los inhibidores del factor XI podrían mostrar un perfil de eficacia/seguridad más favorable que las terapias antitrombóticas actuales. El objetivo de esta revisión sistemática es analizar la evidencia disponible derivada de esos estudios. Métodos Se realizó una búsqueda bibliográfica en las bases de datos PubMed, Cochrane Library, Scopus y EMBASE, y en las plataformas de registro de ensayos clínicos Clinical Trials y Cochrane Central Register of Controlled Trials. Los resultados se publicaron según la declaración PRISMA. Resultados Se identificaron un total de 18 ensayos clínicos concluidos o en curso abordando múltiples escenarios, incluyendo fibrilación auricular, ictus, infarto de miocardio y tromboembolismo venoso. Se analizó la evidencia procedente de 8 estudios con resultados disponibles. En general, los estudios fase 2 con inhibidores del factor XI mostraron un perfil adecuado de eficacia y seguridad. El balance beneficio/riesgo fue más favorable en términos de reducción de tromboembolismo venoso en pacientes sometidos a artroplastia total de rodilla. Para esta indicación, los inhibidores del factor XI mostraron una reducción global del 50% en la tasa de complicaciones trombóticas y del 60% en la tasa de hemorragias comparado con enoxaparina. En los estudios de pacientes con fibrilación auricular, ictus e infarto de miocardio se observaron resultados más modestos. Conclusión Los inhibidores del Factor XI abren nuevas perspectivas en el tratamiento y la profilaxis antitrombótica. Los estudios fase 3 en curso permitirán definir los fármacos e indicaciones más idóneas. (AU)

Background and objective Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favourable efficacy/safety profile than current antithrombotic therapies. This systematic review aims to analyze the available evidence derived from these studies. Methods A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. The results were reported in accordance with the PRISMA statement. Results A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Overall, phase 2 studies with factor XI inhibitors demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favourable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed. Conclusions Factor XI inhibitors offer new prospects in antithrombotic treatment and prevention. Ongoing phase 3 studies will help define the most suitable drugs and indications. (AU)

Systematic review of clinical trials on antithrombotic therapy with factor XI inhibitors.

INTRODUCTION AND OBJECTIVE: Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favorable efficacy/safety profile compared to current antithrombotic therapies. The aim of this systematic review is to analyze the available evidence derived from these studies. METHODS: A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. In accordance with the PRISMA statement, results were reported. RESULTS: A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Phase 2 studies with factor XI inhibitors, overall, demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favorable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in the rate of bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed. CONCLUSIONS: Factor XI inhibitors offer new prospects in antithrombotic treatment and prophylaxis. Ongoing phase 3 studies will help define the most suitable drugs and indications.

On-site testing and treatment of sexually transmitted infections among female sex workers using molecular point-of-care testing integrated into harm reduction services in Madrid, Spain.

INTRODUCTION: This study aimed to evaluate the feasibility of molecular point-of-care testing for STIs, the prevalence of STIs and associated factors, and testing and treatment uptake among street-based female sex workers (FSWs) attending a mobile harm reduction unit in Madrid, Spain. METHODS: This was a prospective, longitudinal study. From August 15th to December 6th, 2022, participants were screened for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using molecular testing (Xpert) on self-collected urine samples at a mobile harm reduction unit. Additionally, rapid tests were used to screen participants for HIV, hepatitis C virus (HCV), and syphilis. On-site same-day results and treatment for those infected were offered. RESULTS: Among 77 FSWs included the median age was 40 (range, 33-48), 64 % were homeless, and 84 % reported drug use in the past six months. Four participants self-reported having HIV, of whom all were on antiretroviral therapy, and 14 (18 %) had HCV antibodies, including three with current infection. The prevalence of at least one STI was 66 %. When categorized by type of STI, the prevalences were as follows: 15 % for CT, 15 % for NG, 51 % for TV, and 21 % for syphilis. Notably, the prevalence of STIs was higher among FSW with recent drug use, with no cases of CT or NG detected among FSWs who did not recently use drugs. In adjusted analysis, drug use was associated an increased odds of having an STI (adjusted odds ratio, 10.47; 95 % CI: 1.67-65.42). All participants consented to screening, and all but one received on-site result-based linkage to treatment. CONCLUSIONS: This study demonstrates the feasibility, high STI prevalence, and high linkage to testing and treatment following point-of-care molecular testing among street-based FSWs who have recently used drugs in Madrid, Spain.

Principales aplicaciones de la ecografía clínica en cuidados paliativos / Main applications of point-of care ultrasound in palliative care

El uso de la ecografía clínica, entendida como una extensión de la exploración física que ayuda a la toma de decisiones clínicas en tiempo real, se ha generalizado en diversas especialidades médicas y quirúrgicas. En los últimos años, los avances tecnológicos han permitido disponer de ecógrafos de bolsillo, económicamente asequibles, que pueden ser utilizados en el propio domicilio del paciente. En esta revisión se describen las principales aplicaciones de la ecografía clínica en cuidados paliativos, un escenario de potencial utilidad tanto para mejorar la certeza en el diagnóstico de procesos agudos intercurrentes, que producen un impacto en la calidad de vida del paciente, como para guiar la realización de procedimientos invasivos sin necesidad de desplazamientos al medio hospitalario. Para la implantación de la ecografía clínica en cuidados paliativos son necesarios programas formativos con objetivos concretos, definiendo curvas de aprendizaje y estableciendo alianzas con sociedades científicas de reconocida trayectoria docente, asistencial e investigadora para la acreditación de competencias (AU)

Combined with a physical examination, clinical ultrasound offers a valuable complement that can help guide clinical decision-making. In various medical and surgical specialties, it is increasingly used for diagnostic and therapeutic purposes. Due to recent technological advances, smaller and more affordable ultrasound machines are now being developed for use in home hospice care. The purpose of this paper is to describe how clinical ultrasound may be applied in Palliative Care, where it can be a valuable tool to assist the clinician in making better clinical decisions and to assist in accurately guiding palliative procedures. Furthermore, it can be used to identify unnecessary hospitalizations and prevent them from occurring. Training programs with specific objectives are necessary to implement clinical ultrasound in Palliative Care, as well as defining learning curves and promoting alliances with scientific societies that recognize the teaching, care and research trajectory for accreditation of competencies (AU)

Acute phase characteristics and long-term complications of pulmonary embolism in COVID-19 compared to non-COVID-19 cohort: a large single-centre study.

BACKGROUND: To compare the severity of pulmonary embolism (PE) and the long-term complications between patients with and without COVID-19, and to investigate whether the tools for risk stratification of death are valid in this population. METHODS: We retrospectively included hospitalized patients with PE from 1 January 2016 to 31 December 2022. Comparisons for acute episode characteristics, risk stratification of the PE, outcomes, and long-term complications were made between COVID and non-COVID patients. RESULTS: We analyzed 116 (27.5%) COVID patients and 305 (72.4%) non-COVID patients. In patients with COVID-19, the traditional risk factors for PE were absent, and the incidence of deep vein thrombosis was lower. COVID patients showed significantly higher lymphocyte count, lactate dehydrogenase, lactic acid, and D-dimer levels. COVID patients had PE of smaller size (12.3% vs. 25.5% main pulmonary artery, 29.8% vs. 37.1% lobar, 44.7% vs. 29.5% segmental and 13.2% vs. 7.9% subsegmental, respectively; p < 0.001), less right ventricular dysfunction (7.7% vs. 17.7%; p = 0.007) and higher sPESI score (1.66 vs. 1.11; p < 0.001). The need for mechanical ventilation was significantly higher in COVID patients (8.6% vs. 1.3%; p < 0.001); However, the in-hospital death was less (5.2% vs. 10.8%; p = 0.074). The incidence of long-term complications was lower in COVID cohort (p < 0.001). PE severity assessed by high sPESI and intermediate and high-risk categories were independently associated with in-hospital mortality in COVID patients. CONCLUSION: The risk of in-hospital mortality and the incidence of long-term complications were lower in COVID-19. The usual tools for risk stratification of PE are valid in COVID patients.

Utilidad de las escalas de predicción diagnósticas de embolia de pulmón en pacientes con infección por SARS-CoV-2: una revisión sistemática / Utility of probability scores for the diagnosis of pulmonary embolism in patients with SARS-CoV-2 infection: A systematic review

Antecedentes y objetivo Las escalas de predicción clínica para embolia de pulmón (EP) determinan la probabilidad pretest y valoran la necesidad de las pruebas para estos pacientes. La infección por coronavirus se asocia a un mayor riesgo de EP, aumentando su gravedad y confiriendo un peor pronóstico. La patogénesis de la EP parece ser diferente en pacientes con y sin infección por SARS-CoV-2. Esta revisión sistemática pretende conocer, revisando la bibliografía disponible, la utilidad de los modelos predictivos desarrollados para EP en pacientes con COVID-19. Métodos Se realizó una búsqueda bibliográfica en las bases de datos de PubMed, Scopus y EMBASE, incluyendo todos los estudios que comunican datos relacionados con la aplicación de escalas de predicción clínica para EP en pacientes con COVID-19. La calidad de los estudios se evaluó con la escala Newcastle-Ottawa para estudios no aleatorizados. Resultados Se incluyeron 13 estudios de cohortes que evaluaron cinco modelos predictivos (escala de Wells, puntuación de Ginebra, algoritmo YEARS y las reglas de decisión clínica PERC y PEGeD). Las diversas escalas se aplicaron en 1.187 pacientes con COVID-19. En general, los modelos tuvieron una capacidad predictiva limitada. La escala de Wells de dos categorías con probabilidad clínica baja (o improbable) en combinación con un dímero D<3.000ng/mL o con una ecografía pulmonar a pie de cama normal mostraron una adecuada correlación para excluir la EP. Conclusión Nuestra revisión sistemática sugiere que las escalas de predicción disponibles para EP desarrolladas en población general no son aplicables a los pacientes con COVID-19, por lo que, de momento, no se recomienda su uso en la práctica clínica como única herramienta de cribado diagnóstico. Se necesitan nuevas escalas de probabilidad clínica para EP validadas en estos pacientes (AU)

Background and objective Clinical prediction models determine the pre-test probability of pulmonary embolism (PE) and assess the need for tests for these patients. Coronavirus infection is associated with a greater risk of PE, increasing its severity and conferring a worse prognosis. The pathogenesis of PE appears to be different in patients with and without SARS-CoV-2 infection. This systematic review aims to discover the utility of probability models developed for PE in patients with COVID-19 by reviewing the available literature. Method A literature search on the PubMed, Scopus, and EMBASE databases was carried out. All studies that reported data on the use of clinical prediction models for PE in patients with COVID-19 were included. Study quality was assessed using the Newcastle-Ottawa scale for non-randomized studies. Results Thirteen studies that evaluated five prediction models (Wells score, Geneva score, YEARS algorithm, and PERC and PEGeD clinical decision rules) were included. The different scales were used in 1,187 patients with COVID-19. Overall, the models showed limited predictive ability. The two-level Wells score with low (or unlikely) clinical probability in combination with a D-dimer level <3000ng/mL or a normal bedside lung ultrasound showed an adequate correlation for ruling out PE. Conclusions Our systematic review suggests that the clinical prediction models available for PE that were developed in the general population are not applicable to patients with COVID-19. Therefore, their use is in clinical practice as the only diagnostic screening tool is not recommended. New clinical probability models for PE that are validated in these patients are needed (AU)

Utility of probability scores for the diagnosis of pulmonary embolism in patients with SARS-CoV-2 infection: A systematic review.

BACKGROUND AND OBJECTIVE: Clinical prediction models determine the pre-test probability of pulmonary embolism (PE) and assess the need for tests for these patients. Coronavirus infection is associated with a greater risk of PE, increasing its severity and conferring a worse prognosis. The pathogenesis of PE appears to be different in patients with and without SARS-CoV-2 infection. This systematic review aims to discover the utility of probability models developed for PE in patients with COVID-19 by reviewing the available literature. METHODS: A literature search on the PubMed, Scopus, and EMBASE databases was carried out. All studies that reported data on the use of clinical prediction models for PE in patients with COVID-19 were included. Study quality was assessed using the Newcastle-Ottawa scale for non-randomized studies. RESULTS: Thirteen studies that evaluated five prediction models (Wells score, Geneva score, YEARS algorithm, and PERC and PEGeD clinical decision rules) were included. The different scales were used in 1,187 patients with COVID-19. Overall, the models showed limited predictive ability. The two-level Wells score with low (or unlikely) clinical probability in combination with a D-dimer level <3000ng/mL or a normal bedside lung ultrasound showed an adequate correlation for ruling out PE. CONCLUSIONS: Our systematic review suggests that the clinical prediction models available for PE that were developed in the general population are not applicable to patients with COVID-19. Therefore, their use is in clinical practice as the only diagnostic screening tool is not recommended. New clinical probability models for PE that are validated in these patients are needed.

[Utility of probability scores for the diagnosis of pulmonary embolism in patients with SARS-CoV-2 infection: A systematic review]. / Utilidad de las escalas de predicción diagnósticas de embolia de pulmón en pacientes con infección por SARS-CoV-2: una revisión sistemática.

Background and objective: Clinical prediction models determine the pre-test probability of pulmonary embolism (PE) and assess the need for tests for these patients. Coronavirus infection is associated with a greater risk of PE, increasing its severity and conferring a worse prognosis. The pathogenesis of PE appears to be different in patients with and without SARS-CoV-2 infection. This systematic review aims to discover the utility of probability models developed for PE in patients with COVID-19 by reviewing the available literature. Methods: A literature search on the PubMed, Scopus, and EMBASE databases was carried out. All studies that reported data on the use of clinical prediction models for PE in patients with COVID-19 were included. Study quality was assessed using the Newcastle-Ottawa scale for non-randomized studies. Results: Thirteen studies that evaluated five prediction models (Wells score, Geneva score, YEARS algorithm, and PERC and PEGeD clinical decision rules) were included. The different scales were used in 1,187 patients with COVID-19. Overall, the models showed limited predictive ability. The two-level Wells score with low (or unlikely) clinical probability in combination with a D-dimer level < 3000 ng/mL or a normal bedside lung ultrasound showed an adequate correlation for ruling out PE. Conclusions: Our systematic review suggests that the clinical prediction models available for PE that were developed in the general population are not applicable to patients with COVID-19. Therefore, their use is in clinical practice as the only diagnostic screening tool is not recommended. New clinical probability models for PE that are validated in these patients are needed.

Incidence of pulmonary embolism in non-critically ill COVID-19 patients. Predicting factors for a challenging diagnosis.

Recent studies suggest that thrombotic complications are a common phenomenon in the novel SARS-CoV-2 infection. The main objective of our study is to assess cumulative incidence of pulmonary embolism (PE) in non critically ill COVID-19 patients and to identify its predicting factors associated to the diagnosis of pulmonary embolism. We retrospectevely reviewed 452 electronic medical records of patients admitted to Internal Medicine Department of a secondary hospital in Madrid during Covid 19 pandemic outbreak. We included 91 patients who underwent a multidetector Computed Tomography pulmonary angiography(CTPA) during conventional hospitalization. The cumulative incidence of PE was assessed ant the clinical, analytical and radiological characteristics were compared between patients with and without PE. PE incidence was 6.4% (29/452 patients). Most patients with a confirmed diagnosed with PE recieved low molecular weight heparin (LMWH): 79.3% (23/29). D-dimer peak was significatly elevated in PE vs non PE patients (14,480 vs 7230 mcg/dL, p = 0.03). In multivariate analysis of patients who underwent a CTPA we found that plasma D-dimer peak was an independen predictor of PE with a best cut off point of > 5000 µg/dl (OR 3.77; IC95% (1.18-12.16), p = 0.03). We found ninefold increased risk of PE patients not suffering from dyslipidemia (OR 9.06; IC95% (1.88-43.60). Predictive value of AUC for ROC is 75.5%. We found a high incidence of PE in non critically ill hospitalized COVID 19 patients despite standard thromboprophylaxis. An increase in D-dimer levels is an independent predictor for PE, with a best cut-off point of > 5000 µg/ dl.

Tromboembolismo pulmonar y COVID-19: un cambio de paradigma / Pulmonary embolism and COVID-19: a paradigm change

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Ecografía clínica en la enfermedad pulmonar obstructiva crónica / Clinical ultrasonography in chronic obstructive pulmonary disease

La EPOC es una enfermedad con una elevada prevalencia y representa uno de los motivos más frecuentes de ingreso en los servicios de Medicina Interna. Además, presenta una importante morbimortalidad asociada. En los últimos años la ecografía clínica multiórgano (pulmonar, cardiaca y vascular) ha surgido como una herramienta de gran utilidad en el manejo de estos pacientes en múltiples situaciones. Entre ellas podemos destacar el diagnóstico diferencial de la disnea de origen incierto, la evaluación de la etiología en los episodios de exacerbación, la detección de insuficiencia cardiaca concomitante o de hipertensión pulmonar asociada y como apoyo en el manejo de algunos factores de riesgo cardiovascular, como la ateroesclerosis subclínica. En este trabajo se resumen las evidencias más importantes al respecto y se plantean escenarios futuros en el uso de los ultrasonidos que permitan mejorar el diagnóstico, la estimación pronóstica y la selección del tratamiento óptimo en este tipo de pacientes

COPD is a highly prevalent disease and one of the most common reasons for hospitalization in Internal Medicine departments. COPD also has significant associated morbidity and mortality. In recent years, multiorgan clinical ultrasonography (pulmonary, cardiac and vascular) has emerged as a tool of considerable usefulness in managing patients with COPD in numerous situations, including the differential diagnosis of dyspnoea of uncertain origin, the assessment of the aetiology in episodes of exacerbation, detecting concomitant heart failure or associated pulmonary hypertension and as support in managing cardiovascular risk factors such as subclinical atherosclerosis. This study summarises the most important evidence regarding this approach and proposes future scenarios for the use of ultrasonography that will help improve the diagnosis, prognostic estimations and the selection of the optimal treatment for this type of patient

Ecografía clínica en el proceso de toma de decisiones en medicina / Clinical ultrasonography in the decision-making process in medicine point-of-care ultrasound in clinical decision making

La ecografía clínica ha experimentado un importante desarrollo en los últimos años debido a su gran utilidad y a la miniaturización de los equipos que han permitido llegar a la cabecera del enfermo. Se trata de una herramienta que complementa la anamnesis y la exploración física tradicional aumentando la potencia diagnóstica del profesional que la emplea en numerosos escenarios clínicos y que puede ser aplicada en todos los pasos de la toma de decisiones sobre el paciente. En manos de los generalistas, la aplicación de los ultrasonidos en diferentes áreas del cuerpo (ecografía multiórgano) permite optimizar no solo la capacidad diagnóstica, sino la estratificación pronóstica y el seguimiento evolutivo tras la aplicación de un tratamiento. De la misma forma que existe una sistemática de exploración física convencional, se debe plantear el establecimiento de un protocolo de exploración ecográfica que complemente a la primera y de esta forma poder redefinir y potenciar la exploración clásica

Clinical ultrasonography has undergone significant development in recent years due to its considerable usefulness and equipment miniaturisation, which have enabled its use at the point of care. Clinical ultrasonography is a tool that supplements the classical anamnesis and physical examination, thereby increasing the practitioner's diagnostic power. This tool can be employed in numerous clinical scenarios and can be applied at all steps when making decisions about the patient. In the hands of the general practitioner, ultrasonography of the various areas of the body (multiorgan ultrasonography) optimises not only the diagnostic capacity but also the prognostic stratification and monitoring of progress after treatment has been applied. As with the systematic nature of conventional physical examinations, we need to establish an ultrasound examination protocol that supplements the physical examination, thereby redefining and boosting the classic examination