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[Background]: The relationship between cancer and venous thromboembolic disease (VTD) are complex because the activated coagulation factors are not only involved in thrombosis but also in malignant processes, such as angiogenesis and metastasis., [Objective]: To compare phenotypes of extracellular vesicles (EVs), and levels of D-dimer, soluble P-selectin (sP-selectin) and antigenic tissue factor (TF) between unprovoked VTD patients, who did not develop cancer during one-year follow-up, and those with advanced stage of cancer but not associated with VTD., [Methods]: A prospective study in which we included 138 unprovoked VTD patients and 67 advanced cancer patients, who did not develop thrombosis. Levels of EVs of different cellular origin (platelet, endothelium and leukocyte), EVs positive for tissue factor (TF) and P-selectin glycoprotein ligand 1 were quantified by flow cytometry. D-dimer, soluble P-selectin (sP-selectin) and antigenic TF were determined by ELISA., [Results]: TF-positive EVs, D-dimer, and sP-selectin were markedly elevated in unprovoked VTD patients compared to cancer patients without association with thrombosis., [Conclusions]: Levels of TF-positive EVs, D-dimer and sP-selectin are able to discriminate between unprovoked VTD patients not related to cancer and cancer patients not associated with VTD. These results could lead to the application of EVs as biomarkers of both diseases., This work was supported by research grants from the Plan Nacional de Investigacion Cient ıfica, Desarrollo e Innovacion Tecnologica (Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria [PI11/02308], Red RIC [RD12/0042/ 0029], Junta de Andalucıa [CVI-6654] and by the Fundacion Investigacion Hospital La Fe, Spain.

Anemia is a common condition in cancer patients and is associated with a wide variety of symptoms that impair quality of life (QoL). However, exactly how anemia affects QoL in cancer patients is unclear because of the inconsistencies in its definition in previous reports. We aimed to examine the clinical impact of anemia on the QoL of cancer patients using specific questionnaires. We performed a post-hoc analysis of a multicenter, prospective, case-control study. We included patients with cancer with (cases) or without (controls) anemia. Participants completed the European Organization for Research and Treatment of Cancer Quality of Life questionnaire version 3.0 (EORTC QLQ-C30) and Euro QoL 5-dimension 3-level (EQ−5D−3L) questionnaire. Statistically significant and clinically relevant differences in the global health status were examined. From 2015 to 2018, 365 patients were included (90 cases and 275 controls). We found minimally important differences in global health status according to the EORTC QLQ-C30 questionnaire (case vs. controls: 45.6 vs. 58%, respectively, mean difference: −12.4, p &lt, 0.001). Regarding symptoms, cancer patients with anemia had more pronounced symptoms in six out of nine scales in comparison with those without anemia. In conclusion, cancer patients with anemia had a worse QoL both clinically and statistically.

Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms. Results: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial [CHEST-2]). Conclusion: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified. © 2020 The Authors Eli Lilly and Company; Pfizer; Bayer; GlaxoSmithKline; Merck; Actelion Pharmaceuticals; Meso Scale Diagnostics; United Therapeutics Corporation; Novartis Pharma; Merck Sharp and Dohme; GlaxoSmithKline Australia; Deutsche Forschungsgemeinschaft; Grupo Ferrer Internacional, S.A The EXPERT registry was funded by Bayer AG (Berlin, Germany) and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. The authors acknowledge the database administration by Torsten Tille, Dresden, and the project administration of Mrs Romy Hoppenz and Mrs Linda Kottke at GWT-TUD GmbH, Dresden. Medical writing services provided by Richard Murphy PhD of Adelphi Communications Ltd, Macclesfield, UK were funded by Bayer AG in accordance with Good Publication Practice (GPP3) guidelines. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Prof Marius M. Hoeper reports personal fees from Bayer AG, during the conduct of the study; personal fees from Actelion, personal fees from Acceleron, personal fees from MSD, personal fees from Jansen, personal fees from Pfizer, outside the submitted work. Dr Hans Klose reports speaker and consultancy fees from Actelion, Bayer AG, GSK, Novartis, Pfizer, and United Therapeutics and research support from Actelion, Bayer AG, GSK, Pfizer, and MSD. Dr Michael Halank reports personal fees and non-financial support from Actelion, AstraZeneca, Bayer AG, Berlin-Chemie, GSK, OMT, MSD, and Novartis. Dr George Giannakoulas reports speaker and consultancy fees from Actelion, Bayer, ELPEN Pharmaceuticals, GSK, Pfizer, Lilly, and United Therapeutics, and research support from GSK, ELPEN Pharmaceuticals, and Galenica. Dr Henning Gall has received honoraria and/or other support from Actelion, AstraZeneca, Bayer, BMS, GSK, Janssen-Cilag, Lilly, MSD, Novartis, OMT, Pfizer, and United Therapeutics. Dr Pavel Jansa reports consultancy and speaker fees from MSD, AOP Orphan, and Actelion. Prof Ekkehard Grünig reports research grants and speaker honoraria/consultancy fees from Actelion and Bayer/MSD, research grants from GSK, United Therapeutics, Bellerophon, OMT GmbH, Pfizer, Reata, and Novartis, and speaker honoraria from Bial, Medscape, and OrPha Swiss GmbH. Prof David Pittrow reports personal fees from Actelion, Bayer AG, Aspen, Boehringer Ingelheim, Sanofi, Biogen, Shire, and MSD outside the submitted work. Silvia Ulrich reports research grants and personal fees from Actelion, Bayer, MSD, and Orpha Swiss. Tobias J. Lange has received personal fees from Actelion, MSD, Pfizer, and OMT orphan. Dr Iraklis Tsangaris reports speaker and consultancy fees from Actelion, Bayer AG, ELPEN, GSK, MSD, Pfizer, and United Therapeutics. Stephan Rosenkranz reports remunerations for lectures and/or consultancy from Abbott, Actelion, Arena, Bayer, Ferrer, GSK, MSD, Novartis, Pfizer, and United Therapeutics; and research support to his institution from Actelion, Bayer, Novartis, Pfizer, and United Therapeutics. Repke J. Snijder reports grants from Pfizer and Actelion Pharmaceuticals. Prof Iveta Šimková reports consultancy and speaker fees from MSD, AOP Orphan, and Actelion. Dr Marc Humbert reports grants and personal fees from Bayer and GSK, and personal fees from Actelion, Merck, and United Therapeutics. Marion Delcroix has received investigator, speaker, consultant, and steering committee member fees from Actelion, Bayer AG, Bellerophon, Eli Lilly, GlaxoSmithKline, MSD, Pfizer, and Reata, and research grants from Actelion. Joan A. Barberà reports receipt of honoraria for consultation or speaker fees from Actelion and Merck; and research support through his institution from Actelion, Merck, GlaxoSmithKline, and Ferrer. Joanna Pepke-Zaba reports research grants and speaker honoraria/consultancy fees from Actelion, Bayer/MSD, and GSK. Jean-Luc Vachiéry reports ongoing consultancies to Actelion, Sonnivie, Arena Pharma, Bial Portela, and Respira Therapeutics, past consultancies to AstraZeneca, BayerShering, CardioMEMS, GlaxoSmithKline, Pfizer, Merck, and United Therapeutics, and current membership of an advisory board or similar group for Actelion and GlaxoSmithKline. Jean-Luc Vachiéry's institution receives funding from Actelion Pharmaceuticals for performing clinical studies. Regina Steringer-Mascherbauer, Jens Klotsche, and Miguel-Angel Gomez Sanchez have no conflicts of interest relevant to the EXPERT study. Hossein-Ardeschir Ghofrani reports personal fees for advisory board work, and payment for lectures including service on speaker bureaus, from Actelion, Bayer, GSK, Novartis, and Pfizer; consultancy fees from Actelion, Bayer, Bellerophon Pulse Technologies, GSK, MSD, Novartis, and Pfizer; and grants from Deutsche Forschungsgemeinschaft (DFG). Pilar Escribano Subias reports personal fees from Actelion, Bayer AG, GlaxoSmithKline, and Merck Sharp & Dohme, and grants from Actelion, Bayer AG, GlaxoSmithKline, and Ferrer, outside the submitted work. Gérald Simonneau reports personal fees and non-financial support from Actelion, personal fees and non-financial support from Bayer, personal fees and non-financial support from MSD, outside the submitted work. Douglas S. Helmersen reports industry-sponsored research with Bayer AG, United Therapeutics, and Gilead Sciences, Inc., and advisory board/speaker fees from Bayer AG and Actelion. David Langleben reports honoraria, consultation fees, research support, and/or travel expenses from Actelion, Arena, Bayer AG, Northern Therapeutics, PhaseBio, Acceleron, Janssen, and United Therapeutics. Anco Boonstra reports consultancy fees from Pfizer BV and hospitality from Teva Nederland. Lisa M. Mielniczuk reports speaker fees and honoraria from Bayer AG, and speaker fees, consultancy fees, and travel fees from Actelion. Evgenia Williams and Christian Meier are employees of Bayer AG.

In symptomatic acute pulmonary embolism (PE), the presence of deep vein thrombosis (DVT) is a risk factor for 30- and 90-day mortality. In patients with cancer and incidental PE, the prognostic effect of concomitant incidental DVT is unknown. In this retrospective study, we examined the effect of incidental DVT on all-cause mortality in such patients. Adjusted Cox multivariate regression analysis was used for relevant covariates. From January 2010 to March 2018, we included 200 patients (mean age, 65.3 &plusmn, 12.4 years) who were followed up for 12.5 months (interquartile range 7.4&ndash, 19.4 months). Of these patients, 62% had metastases, 31% had concomitant incidental DVT, and 40.1% (n = 81) died during follow-up. All-cause mortality did not increase in patients with DVT (hazard ratio [HR] 1.01, 95% confidence interval [CI] 0.43&ndash, 2.75, p = 0.855). On multivariate analysis, weight (adjusted HR 0.96, 95% CI 0.92&ndash, 0.99, p = 0.032), and metastasis (adjusted HR 10.26, 95% CI 2.35&ndash, 44.9, p = 0.002) were predictors of all-cause mortality. In conclusion, low weight and presence of metastases were associated with all-cause mortality, while presence of concomitant DVT was unrelated to poorer survival.

• Patients with splanchnic vein thrombosis have a high risk of thrombotic and bleeding events.

Although there is published research on the impact of venous thromboembolism (VTE) on quality of life (QoL), this issue has not been thoroughly investigated in patients with cancer&mdash, particularly using specific questionnaires. We aimed to examine the impact of acute symptomatic VTE on QoL of patients with malignancies. This was a multicenter, prospective, case-control study conducted in patients with cancer either with (cases) or without (controls) acute symptomatic VTE. Participants completed the EORTC QLQ-C30, EQ-5D-3L, PEmb-QoL, and VEINES-QOL/Sym questionnaires. Statistically significant and clinically relevant differences in terms of global health status were examined. Between 2015 and 2018, we enrolled 425 patients (128 cases and 297 controls, mean age: 60.2 &plusmn, 18.4 years). The most common malignancies were gastrointestinal (23.5%) and lung (19.8%) tumors. We found minimally important differences in global health status on the EQ-5D-3L (cases versus controls: 0.55 versus 0.77, mean difference: &minus, 0.22) and EORTC QLQ-C30 (47.7 versus 58.4, 10.3) questionnaires. There were minimally important differences on the PEmb-QoL questionnaire (44.4 versus 23, 21.4) and a significantly worse QoL on the VEINES-QOL/Sym questionnaire (42.7 versus 51.7, 9). In conclusion, we showed that acute symptomatic VTE adversely affects the QoL of patients with malignancies.

Background: The aim of our study was to investigate whether anti-Xa levels assessed in selected groups of LMWH-treated patients with VTE correlate with the risk of developing thromboembolic or bleeding complications. Methods: Retrospective study, in adult patients treated with anti-Xa-adjusted LMWH analysing the association between anti-Xa activity and recurrent VTE or bleeding. Primary outcomes were symptomatic fatal or nonfatal objectively diagnosed VTE and clinically relevant bleeding (ISTH criteria). Results: From 2007-2017, 192 patients were recruited. Mean age was 62 (SD 18) years and 48% were men. Indications for anti-Xa monitoring were: VTE recurrence under anticoagulation (20.8%), prior bleeding (20.3%), renal dysfunction (45.3%), or obesity (9.9%). A total of 33 (17.2%) patients had a recurrent VTE event and 34 (17.7%) experienced clinically relevant bleeding. In the period elapsing between the first (performed after a median of 6 days from index VTE [IQR 1-39]) and the second anti-Xa determination, 9 patients developed a clinical outcome (4 recurrent and 5 bleeding events). An anti-Xa value below reference (versus within + above) correlated with recurrence (relative risk 3.0), whereas an anti-Xa value above (versus within + below) reference correlated with bleeding (relative risk 2.5). Conclusions: In selected subgroups of patients with VTE, anti-Xa levels may represent a marker for the risk of developing recurrent VTE or bleeding events. Whether adjustment of the LMWH dosage would minimize this risk remains to be investigated in management studies.

REHAP investigators., [Introduction] REHAP is a voluntary, observational Spanish registry of patients with pulmonary arterial hypertension. We analyzed the experience (use and effectiveness) with inhaled iloprost (inh-ILO) in real-life conditions during a 3-year period., [Methods] Patients included were those with PAH ≥14 years recruited during 1998–2016 who had received inh-ILO. Variables were collected at the beginning of treatment (0 ± 3 months) and 12 ± 3/36 ± 6 months follow-up. Effectiveness was assessed in the intent-to-treat population as changes in functional class and/or physical performance and transplant-free survival from the beginning of treatment. Stopping inh-ILO-related survival was also assessed. Subanalyses included treatment strategy (first-line therapy –monotherapy or upfront combination- or sequential therapy) and risk of clinical worsening/death., [Results] Inh-ILO was the most frequently used prostanoid in Spain, rendering 267 patients eligible for analysis. Median age was 54 years; 61% were WHO FC III. Sixty (23%) patients started inh-ILO as monotherapy, 27 (10%) as upfront combination and 180 (67%) sequentially. At 3-year follow-up significant clinical improvements were observed; however, transplant-free survival rate was 54%, being poorer in patients at high risk (63% vs. 85% in low risk patients; P, [Conclusion] Data from the REHAP collected during 3 years shows that inh-ILO has low effectiveness independently of the treatment strategy used, with a 3-year survival rate of 54% despite significant clinical improvements, probably due to the use in high-risk patients. Discontinuation rate was as high as 75%., We express our gratitude to Actelion, Ferrer, GlaxoSmithKline (GSK) and Merck Sharp & Dohme (MSD) for supporting the REHAP Registry with an unrestricted educational grant.

[ES] Introducción: Las escalas predictivas de recurrencias de ETV son útiles para decidir la duración del tratamiento anticoagulante. Aunque hay varias escalas, desconocemos la aplicabilidad de las mismas en nuestro medio. Por ello nos planteamos validar el modelo predictivo DASH y el nomograma de Viena a 12 meses.-- Métodos: Estudio retrospectivo de pacientes consecutivos no seleccionados con ETV no provocada desde 2006 hasta 2014. Comparamos la capacidad de predecir recurrencias de ETV de la escala DASH y el nomograma de Viena. La validación se realizó estratificando a los pacientes como de bajo o alto riesgo, según cada escala (discriminación) y comparando las recurrencias observadas frente a las esperadas (calibración).-- Resultados: De 353 pacientes evaluados, se analizaron 195, con una edad media de 53,5+/-19 años. Hubo 21 recurrencias a 1 año (10,8%, IC95%: 6,8-16%). Según la escala DASH, fueron catalogados de bajo riesgo el 42%, observando ETV recurrente en el grupo de bajo fue del 4,9% (IC95%: 1,3-12%) vs. el grupo de alto riesgo en que fue del 15% (IC95%: 9-23%) (p, [EN ] Introduction: Scales for predicting venous thromboembolism (VTE) recurrence are useful for deciding the duration of the anticoagulant treatment. Although there are several scales, the most appropriate for our setting has not been identified. For this reason, we aimed to validate the DASH prediction score and the Vienna nomogram at 12 months.-- Methods: This was a retrospective study of unselected consecutive VTE patients seen between 2006 and 2014. We compared the ability of the DASH score and the Vienna nomogram to predict recurrences of VTE. The validation was performed by stratifying patients as low-risk or high-risk, according to each scale (discrimination) and comparing the observed recurrence with the expected rate (calibration).-- Results: Of 353 patients evaluated, 195 were analyzed, with an average age of 53.5 ± 19 years. There were 21 recurrences in 1 year (10.8%, 95% CI: 6.8%-16%). According to the DASH score, 42% were classified as low risk, and the rate of VTE recurrence in this group was 4.9% (95% CI: 1.3%-12%) vs. the high-risk group that was 15% (95% CI: 9%-23%) (p

Background Optimal duration of anticoagulation for cancer-associated thrombosis (CAT) remains unclear. This study assessed D-dimer (DD) and high-sensitivity C-reactive protein (hs-CRP) levels after the withdrawal of anticoagulation treatment to predict the risk of venous thromboembolism (VTE) recurrence among patients with CAT. Methods Prospective, multicentre study to evaluate CAT with ≥3 months of anticoagulation that was subsequently discontinued. Blood samples were taken when patients stopped the anticoagulation and 21 days later to determine the DD and hs-CRP levels. All patients were followed up for 6 months to detect VTE recurrence. Results Between 2013 and 2015, 325 patients were evaluated and 114 patients were ultimately enrolled in the study. The mean age was 62 ± 14 years and nearly 40% had metastasis. Ten patients developed VTE recurrence within 6 months (8.8%, 95% confidence interval [CI]: 4.3–15.5%). The DD and hs-CRP levels after 21 days were associated with VTE recurrence. The subdistribution hazard ratios were 9.82 for hs-CRP (95% CI: 19–52) and 5.81 for DD (95% CI: 1.1–31.7). Conclusions This study identified that hs-CRP and DD were potential biomarkers of VTE recurrence after discontinuation of anticoagulation in CAT. A risk-adapted strategy could identify low-risk patients who may benefit from discontinuation of anticoagulation.

Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice. Trial registration: Registered in DRKS register, ID number: DRKS00004795

Oncological patients have a higher risk for venous thromboembolism (VTE) (1,2), and also have an elevated risk of VTE recurrence and bleeding (3-5). Actually, guidelines in oncological patients with VTE recommend anticoagulant treatment, although these recommendations are the same, irrespectively of cancer and VTE location (6-9).

Introduction The safety and efficacy of low-molecular-weight heparin (LMWH) treatment in patients with cancer-associated thrombosis (CAT) beyond 6 months are unknown. Our aim was to determine the safety of long-term tinzaparin use in patients with CAT. Methods We performed a prospective, open, single arm, multicentre study in patients with CAT receiving treatment with tinzaparin. We evaluated the rate of clinically relevant bleeding events (major and non-major clinically relevant bleeding) and venous thromboembolism (VTE) recurrence. Results A total of 247 patients were recruited, with a crude incidence of major bleeding of 4.9% (12/247). The rate of clinically relevant bleeding during months 1–6 and 7–12, was 0.9% [95% confidence interval (95% CI) 0.5 to 1.6%] and 0.6% (95% CI 0.2 to 1.4%) (p = 0.5) per patient and month, respectively. Male gender showed greater risk for clinically relevant bleeding with a hazard ratio (HR) of 2.97 (95% CI 1.01 to 8.1; p = 0.02). The incidence of VTE recurrence at months 1–6 and 7–12 was 4.5% (95% CI 2.2 to 7.8%) and 1.1% (95% CI 0.1 to 3.9%), respectively. One patient died due to VTE recurrence and two because of severe bleeding. Conclusions Treatment with tinzaparin beyond 6 months is safe in patients with CAT.

Objective: Determine clinical characteristics, bleedings, thrombotic events and mortality in splanchnic venous thrombosis (SVT) in non-cirrhotic patients. Material and methods: Retrospective cohort (2008-2015) of non-cirrhotic (single center). We evaluated: risk factors; symptoms, location, chronicity, and anticoagulant treatment. During the follow up: evaluated all-causes mortality, thrombotic and bleedings events. Results: 70 patients. Most frequent risk factors: Infectious-inflammatory abdominal conditions (54%) and solid cancer (40%). Affected veins: portal, splenic, mesenteric or multiple. Of all, 54 patients received anticoagulant treatment (average 6.7 months). They were treated with low molecular weight heparin (LMWH) (85%) or vitamin K antagonist (VKA) (15%). Median follow-up was 12 months. Complications: 21 patients (30%) had thrombosis and 18 (26%) major bleeding. The incidence rates were 8.6 per 100 patient-years for major bleeding, 13.9 per 100 patient-years for thrombotic events and 11.9 per 100 patient-years for all-cause mortality. Major bleeding rates were 7.1 per 100 patient-years and 9.6 per 100 patient-years with or without anticoagulant treatment, respectively. Thrombotic events rates were 14.1 per 100 patient-years and 13.9 per 100 patient-years with or without anticoagulant treatment, respectively. Highest rates of major bleeding and thrombotic events were in solid cancer (15.7 per 100 patient-years and 31.4 per 100 patient-years, respectively). Conclusions: SVT has high baseline bleeding risk, although thrombotic events are also high. It9s important balance risk benefit of anticoagulant therapy.

Resumen Antecedentes y objetivo En los algoritmos diagnosticos de pacientes ambulatorios con sospecha de trombosis venosa profunda (TVP), se incluye la determinacion del dimero D (DD). Un valor elevado del DD no es diagnostico de TVP, pero una cifra normal contribuye a excluir una TVP. Desconocemos el mejor metodo para determinar el DD. Hemos analizado la utilidad clinica de 3 metodos cuantitativos para determinar el DD en pacientes ambulatorios con sospecha de TVP. Pacientes y metodos Incluimos a pacientes consecutivos, ambulatorios, con sospecha de TVP que fueron remitidos a la consulta de enfermedad tromboembolica venosa. Aplicamos un algoritmo diagnostico que incluia la determinacion de la probabilidad clinica de padecer una TVP (escala de Wells) y la determinacion del DD mediante 3 metodos cuantitativos (ELISA mini-VIDAS ® , Acute-care DDMR y DD-Plus). El diagnostico de TVP se confirmo mediante ecografia compresiva seriada de miembros inferiores. Analizamos la concordancia entre los 3 metodos analiticos para cuantificar el DD, asi como sus caracteristicas. Resultados Incluimos 306 pacientes (edad media: 60 anos; mujeres: 62%) con sospecha de TVP. La ecografia compresiva confirmo el diagnostico de TVP en el 23,8% de los casos. Los pacientes en los que se descarto TVP no fueron anticoagulados y no se produjo ningun evento tromboembolico en 3 meses de seguimiento. Los metodos de determinacion de DD que mejor se correlacionaron fueron el ELISA mini-VIDAS ® y el Acute-care DDMR. Ambos metodos mostraron una elevada sensibilidad y un valor predictivo negativo. El mejor metodo analitico para el subgrupo de pacientes con probabilidad clinica baja de TVP fue el ELISA mini-VIDAS ® . Conclusiones El metodo ELISA mini-VIDAS ® para la determinacion del DD descarta con seguridad una TVP en pacientes con baja probabilidad clinica.

Introduction An association between pulmonary embolism (PE) and a subsequent diagnosis of cancer has been repeatedly reported. Although screening and early detection might play a pivotal part in reducing mortality from cancer, there are currently no definite data to suggest that cancer screening may improve survival rates in patients with PE. We hereby present the results of a screening program and a two-year follow-up survey for detecting occult cancer in this patient population. Materials and methods A total of 107 patients with PE were consecutively enrolled. All subjects underwent an initial screening program followed by a two-year follow-up survey. We calculated the sensitivity of our screening program, and identified risk factors associated with occult cancer by means of logistic regression. Results The initial screening program yielded positive results in five patients (4.7%), and four additional cases were identified during the 2-year follow-up. The overall sensitivity of our screening program in idiopathic PE was 55.5%. In the entire study cohort, the number necessary for screening was 12.1 (6.1 in idiopathic PE, and 58 in secondary PE). Logistic regression analysis revealed that a shock index ≥ 1 (odds ratio: 5.467; p = 0.007) and idiopathic PE (odds ratio: 12.82; p = 0.03) were independent risk factors for occult cancer in our PE patients. Conclusions A simple and noninvasive screening program yields an acceptable sensitivity for detecting occult cancer in idiopathic PE patients. These results highlight the importance of screening for occult cancer in patients diagnosed with PE, especially in idiopathic forms.

Objetivo Realizamos el estudio con el proposito de conocer, a traves de un cuestionario especifico, el impacto de la enfermedad pulmonar obstructiva cronica (EPOC) sobre las actividades de la vida diaria en un grupo amplio de pacientes en Espana. Asimismo estudiamos su relacion con parametros clinicos, funcionales y socioeconomicos, y con escalas validadas de calidad de vida, para evaluar su utilidad en la practica habitual y determinar que variables pueden definir a los pacientes “fragiles” o que requieren una mayor atencion. Metodos Se ha realizado un estudio observacional, descriptivo, multicentrico y transversal, con la participacion de 227 neumologos de toda Espana, que incluyo a pacientes con el diagnostico de EPOC. A todos estos se les paso un cuestionario especifico con 7 preguntas que median el impacto de la enfermedad sobre aspectos de la vida diaria Las respuestas se valoraron de 0 a 2, segun el grado de afectacion, lo que supone un intervalo entre 0 y 14 unidades. Definimos al paciente como “fragil” si presentaba valores iguales o mayores de 9 en el cuestionario de impacto. Se evaluo la relacion entre la escala de impacto y variables clinicas, situacion socioeconomica, espirometria y calidad de vida medida con el cuestionario especifico St. George's Respiratory Questionnaire (SGRQ). Resultados Estudiamos a 1.057 pacientes (un 95,2% varones), con una edad media (± desviacion estandar) de 67 ± 9 anos y volumen espiratorio forzado en el primer segundo (FEV1), expresado en porcentaje, del 41,8 ± 13,3%. La puntuacion media del cuestionario de impacto fue de 6,3 ± 3,1. Las actividades con mayor afectacion fueron deporte y ocio, actividad fisica habitual y vida sexual (mucha afectacion en el 52,5, el 30,3 y el 20,2% de los pacientes, respectivamente). Encontramos relacion entre la puntuacion del cuestionario y parametros conocidos de gravedad (SGRQ, disnea, numero de agudizaciones y FEV1 expresado en litros). Los pacientes definidos como fragiles tenian mayor edad y menor nivel tanto cultural como economico. Conclusiones El cuestionario de impacto de la EPOC se correlaciona bien con los clasicos parametros clinicos y funcionales de valoracion de la gravedad de la enfermedad (disnea, FEV1 y exacerbaciones) y con el cuestionario de calidad de vida relacionada con la salud SGRQ. Asi pues, podria ser un instrumento util para identificar un perfil de paciente fragil, que presenta, ademas de una peor situacion clinica y funcional, una situacion socioeconomica mas desfavorecida.

Introduction Randomized clinical trials have demonstrated non-inferiority of rivaroxaban compared with vitamin K antagonists (VKAs) in the treatment of venous thromboembolism (VTE). Our objective was to analyze in real life, tolerance, recurrence, bleeding and adverse events of rivaroxaban in patients with acute symptomatic VTE. Material and Methods Open follow-up study of a cohort of patients aged 18 and over diagnosed with deep vein thrombosis (DVT) and/or pulmonary embolism (PE) treated with rivaroxaban from December 2011 to January 2014. Results The total number of patients treated with rivaroxaban was 103. The mean age was 58 +/-17 years. The most frequent co-morbidities were: hypertension (30.0%), dyslipidemia (23.3%) and respiratory disease (25.2%). The type of thromboembolic event treated was: DVT (64.1%), PE (18.4%), DVT + PE (17.5%). Of the rivaroxaban-treated patients, 30% did so from the initial anticoagulant therapy and the other 70% in long-term or extended anticoagulant therapy. The median time of treatment with rivaroxaban was 5 months. There was one recurrence and no deaths occurred. Six patients had bleeding, one of which was severe. Conclusions Rivaroxaban provides a therapeutic alternative in a group of patients with VTE with advantages over VKAs, because of the convenience in dosing, lack of requirements for periodic monitoring and limited interaction with other drugs.

Objectives: To analyse survival rate after 24 months in consecutive patients with a diagnosis of PE as well as associated factors. Methods: Prospective cohort study during a follow-up period of two years in a series of consecutive patients with PE. Results: During the follow-up period, 34 out of 148 patients died (23%). Factors independently associated with reduced survival rate were: creatinine levels > 2 (OR, 8.8; 95% CI, 1.1 - 70.87), previous neoplasm (OR, 8.8; 95% CI, 3.69 - 20.98), dementia (OR, 6.85; 95% CI, 2.1 - 22.33) and dyslipidemia (OR, 5.07; 95% CI, 1.92 - 13.44). Forty four percent of the patients with dyslipidemia died vs. 20.8% of patients without this condition. Conclusions: In our study dyslipidemia shows as a long-term negative prognostic marker for survival in patients with EP. Resumo: Objetivos: Analisar a taxa de sobrevivência após 24 meses, em pacientes consecutivos com diagnóstico de PE, bem como fatores associados. Métodos: Estudo prospectivo durante um período de seguimento de dois anos em uma série consecutiva de pacientes com PE. Resultados: Durante o período de acompanhamento, 34 dos 148 pacientes morreram (23%). Fatores independentemente associados à reduzida taxa de sobrevivência foram: os níveis de creatinina> 2 (OR, 8,8; 95% CI, 1,1-70,87), neoplasia anterior (OR, 8,8; IC 95%, 3,69-20,98), demência (OR, 6,85; 95% CI, 2,1-22,33) e dislipidemia (OR, 5,07; IC 95%, 1,92-13,44). Quarenta e quatro por cento dos pacientes com dislipidemia morreram contra 20,8% dos pacientes sem essa condição. Conclusões: No nosso estudo, a dislipidemia mostra-se um marcador prognóstico negativo de longo prazo na sobrevida de pacientes com EP. Keywords: Dyslipidemia, Lipid metabolic disorders, Pulmonary embolism, Survival analysis, Venous thromboembolism, Palavras-chave: Dislipidemia, Doenças metabólicas lipídicas, Embolia pulmonar, Análise de sobrevivência, Tromboembolismo venoso