Diagnosis and treatment of deep vein thrombosis of the lower and upper limbs. 2024 recommendations of the thromboembolic disease group of the Spanish Society of Internal Medicine.

Deep vein thrombosis (DVT) of the limbs is a common disease and causes significant morbidity and mortality. It is frequently the prelude to pulmonary embolism (PE), it can recur in 30% of patients and in 25-40% of cases they can develop post-thrombotic syndrome (PTS), with a significant impact in functional status and quality of life. This document contains the recommendations on the diagnosis and treatment of acute DVT from the Thromboembolic Disease group of the Spanish Society of Internal Medicine (SEMI). PE and thrombosis of unusual venous territories (cerebral, renal, mesenteric, superficial, etc.) are outside its scope, as well as thrombosis associated with catheter and thrombosis associated with cancer, which due to their peculiarities will be the subject of other positioning documents of the Thromboembolic Disease group of the Spanish Society of Internal Medicine (SEMI).

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.

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 tromboembólica venosa / Clinical ultrasonography in venous thromboembolism disease

La ecografía clínica se ha desarrollado exponencialmente en la última década en distintos ámbitos de la medicina. De igual manera que ha ocurrido en otros campos de actuación de la medicina interna, su uso se ha implantado en la enfermedad tromboembólica venosa, tanto en la trombosis venosa profunda como en la embolia pulmonar. En esta revisión se repasan las técnicas para el diagnóstico, tanto de la trombosis venosa profunda a través de la ultrasonografía por compresión, como de la ecografía multiórgano que incluye la ultrasonografía por compresión, la ecografía pulmonar en busca de infartos pulmonares y la ecocardioscopia para la detección de dilatación y/o disfunción del ventrículo derecho, para el diagnóstico de la embolia pulmonar. Además, se plantean los escenarios clínicos más frecuentes en los que puede ser de ayuda la ecografía clínica en la vida real, así como sus limitaciones y la evidencia existente

The use of clinical ultrasonography has grown exponentially in the past decade in various medical settings. As with other areas of activity in the field of internal medicine, clinical ultrasonography has been implemented in venous thromboembolism disease, both in deep vein thrombosis and pulmonary embolism. In this review, we cover the diagnostic techniques, both for deep vein thrombosis through compression ultrasonography and for multiorgan ultrasonography, which include compression ultrasonography, pulmonary ultrasonography in the search for pulmonary infarctions and echocardiography for detecting dilation and right ventricular dysfunction for the diagnosis of pulmonary embolism. We also establish the most common clinical scenarios in which clinical ultrasonography can be of assistance in actual clinical practice, as well as its limitations and current evidence

Clinical ultrasonography in venous thromboembolism disease. / Ecografía clínica en la enfermedad tromboembólica venosa.

The use of clinical ultrasonography has grown exponentially in the past decade in various medical settings. As with other areas of activity in the field of internal medicine, clinical ultrasonography has been implemented in venous thromboembolism disease, both in deep vein thrombosis and pulmonary embolism. In this review, we cover the diagnostic techniques, both for deep vein thrombosis through compression ultrasonography and for multiorgan ultrasonography, which include compression ultrasonography, pulmonary ultrasonography in the search for pulmonary infarctions and echocardiography for detecting dilation and right ventricular dysfunction for the diagnosis of pulmonary embolism. We also establish the most common clinical scenarios in which clinical ultrasonography can be of assistance in actual clinical practice, as well as its limitations and current evidence.