Revistas
Autores:
Beddar-Chaib, F.; Jiménez Hernández, S.; Pedrajas-Navas, J. M.; et al.
Revista:
EMERGENCIAS
ISSN:
1137-6821
Año:
2023
Vol.:
35
N°:
2
Págs.:
109 -116
Objetivo: Describir el manejo terapéutico de los pacientes con trombosis venosa superficial (TVS) aislada de miembros inferiores en servicios de urgencias hospitalarios (SUH) españoles. Evaluar el impacto del tratamiento instaurado en urgencias en la evolución, en términos de complicaciones de enfermedad tromboembólica venosa (ETV), y conocer las características de los pacientes que sufren complicaciones.
Metodo: El estudio multicentrico (18 SUH) ALTAMIRA (fActores de riesgo, compLicaciones y evaluación del manejo de la TVS de Miembros Inferiores en hospitales españoles atendidos en los seRvicios de urgenciAs) creó un cohorte retrospectivo de pacientes consecutivos con diagnóstico objetivo de TVS aislada. Se recogieron las complicaciones de ETV sintomáticas (trombosis venosa profunda, tromboembolia pulmonar y extensión o recurrencia de TVS), sangrados clínicamente relevantes y defunciones a 180 días. Se evaluaron las variables asociadas a las complicaciones mediante una regresión de Cox.
Resultados: Se incluyeron 703 pacientes. El 84,1% recibieron anticoagulación durante 30 días (rango intercuartil 15-42), 81,3% con heparina de bajo peso molecular (48% dosis profilácticas, 52% intermedias-terapéuticas). En 180 días, 64 pacientes (9,1%) tuvieron complicación de ETV, 12 (1,7%) tuvieron sangrado clínicamente relevante, y 4 fallecieron (0,6%). Los pacientes en que se instauró anticoagulación en urgencias tardaron más tiempo en desarrollar complicaciones (66 vs 11 días, p = 0,009). El 76,6% de los que se complicaron no estaban anticoagulados en ese momento. La ETV previa se asoció de forma independiente con el desarrollo de complicaciones (hazard ratio ajustada 2,20; intervalo de confianza del 95%: 1,34-3,62).
Conclusiones: El tratamiento en urgencias de la TVS aislada es heterogéneo y con frecuencia subóptimo. La incidencia de complicaciones de ETV es elevada. El tratamiento anticoagulante iniciado en urgencias supone un retraso en el desarrollo de complicaciones. Los pacientes con ETV previa tienen más riesgo de complicaciones.
Revista:
CANCERS
ISSN:
2072-6694
Año:
2022
Vol.:
14
N°:
17
Págs.:
4127
Simple Summary Cancer is a widely heterogeneous disease, and the natural history of patients with cancer-associated thrombosis may differ according to the cancer site. Lung cancer is the most common malignancy, and a leading cause of death. A number of studies in the literature suggest that patients with adenocarcinoma may have a worse outcome than those with squamous or other types of lung cancer. The aim of the current study was to assess the potential impact of lung cancer histology on the incidence rates of VTE recurrences, major bleeding, or death appearing during the course of anticoagulation, in patients with lung cancer and VTE. Our findings, obtained from a large series of consecutive patients with lung cancer and VTE (482 patients), reveal important differences between patients with adenocarcinoma vs. other histologies in their outcomes during anticoagulation. This might likely help to design better therapeutic strategies for patients with lung cancer. Background: In patients with lung cancer and venous thromboembolism (VTE), the influence of cancer histology on outcome has not been consistently evaluated. Methods: We used the RIETE registry (Registro Informatizado Enfermedad TromboEmbolica) to compare the clinical characteristics and outcomes during anticoagulation in patients with lung cancer and VTE, according to the histology of lung cancer. Results: As of April 2022, there were 482 patients with lung cancer and VTE: adenocarcinoma 293 (61%), squamous 98 (20%), small-cell 44 (9.1%), other 47 (9.8%). The index VTE was diagnosed later in patients with squamous cancer than in those with adenocarcinoma (median, 5 vs. 2 months). In 50% of patients with adenocarcinoma, the VTE appeared within the first 90 days since cancer diagnosis. During anticoagulation (median 106 days, IQR: 45-214), 14 patients developed VTE recurrences, 15 suffered major bleeding, and 218 died: fatal pulmonary embolism 10, fatal bleeding 2. The rate of VTE recurrences was higher than the rate of major bleeding in patients with adenocarcinoma (11 vs. 6 events), and lower in those with other cancer types (3 vs. 9 events). On multivariable analysis, patients with adenocarcinoma had a non-significantly higher risk for VTE recurrences (hazard ratio [HR]: 3.79; 95%CI: 0.76-18.8), a lower risk of major bleeding (HR: 0.29; 95%CI: 0.09-0.95), and a similar risk of mortality (HR: 1.02; 95%CI: 0.76-1.36) than patients with other types of lung cancer. Conclusions: In patients with lung adenocarcinoma, the rate of VTE recurrences outweighed the rate of major bleeding. In patients with other lung cancers, it was the opposite.
Autores:
Lobo, J. L.; Alonso, S.; Arenas, J.; et al.
Revista:
ARCHIVOS DE BRONCONEUMOLOGIA
ISSN:
0300-2896
Año:
2022
Vol.:
58
N°:
3
Págs.:
246 - 254
El objetivo del presente documento es actualizar el consenso previo publicado en 2013, en relación con 12 áreas controvertidas en el manejo de la tromboembolia de pulmón (TEP). Para cada área se realizó una exhaustiva revisión bibliográfica y una propuesta de recomendación, sometida a un proceso de debate interno en dos teleconferencias sucesivas. En relación con el diagnóstico, recomendamos no utilizar la escala Pulmonary Embolism Rule Out Criteria (PERC) de forma aislada para descartar la TEP y, cuando haya indicación de dímero D, recomendamos emplear un punto de corte ajustado a la edad. Sugerimos utilizar la angiotomografía computerizada de tórax como prueba de imagen para el diagnóstico de la mayoría de los pacientes con sospecha de la enfermedad. Se recomienda utilizar anticoagulantes de acción directa (en vez de antagonistas de la vitamina K) para el tratamiento de la mayoría de los pacientes con TEP, y se sugiere utilizar anticoagulación para la mayoría de los pacientes con TEP subsegmentaria. Se recomienda no colocar un filtro de vena cava inferior en la mayoría de los pacientes. Si se indica tratamiento de reperfusión, el panel recomienda utilizar fibrinolisis sistémica a dosis completas. La duración de la anticoagulación está condicionada principalmente por la presencia (o ausencia) y el tipo de factor de riesgo para enfermedad tromboembólica venosa, y recomendamos no realizar estudios de trombofilia para decidir la duración de la anticoagulación a la mayoría de los pacientes con TEP. Finalmente, sugerimos no realizar cribado extendido de cáncer oculto en pacientes con TEP.
Autores:
Jiménez, D. (Autor de correspondencia); Rodríguez, C.; Pintado, B.; et al.
Revista:
FRONTIERS IN CARDIOVASCULAR MEDICINE
ISSN:
2297-055X
Año:
2022
Vol.:
9
Págs.:
872115
Background: A recent trial showed that management driven by prognostic assessment was effective in reducing the length of stay (LOS) for acute stable pulmonary embolism (PE). The efficacy and safety of this strategy in each subgroup of risk stratification remains unknown. Methods: We conducted a post-hoc analysis of the randomized IPEP study to evaluate the effect of a management strategy guided by early use of a prognostic pathway in the low- and intermediate-high risk subgroups defined by the European Society of Cardiology (ESC) model. These subgroups were retrospectively identified in the control arm. The primary outcome was LOS. The secondary outcomes were 30-day clinical outcomes. Results: Of 249 patients assigned to the intervention group, 60 (24%) were classified as low-, and 30 (12%) as intermediate-high risk. Among 249 patients assigned to the control group, 66 (27%) were low-, and 13 (5%) intermediate-high risk. In the low-risk group, the mean LOS was 2.1 +/- 0.9) days in the intervention group and 5.3 (+/- 2.9) days in the control group (P < 0.001). In this group, no significant differences were observed in 30-day readmissions (0% vs. 3.0%, respectively), all-cause (0% vs. 0%) and PE-related mortality rates (0% vs. 0%), or severe adverse events (0% vs. 1.5%). In the intermediate-high risk group, the mean LOS was 5.3 (+/- 1.8) days in the intervention group and 6.5 (+/- 2.5) days in the control group (P = 0.08). In this group, no significant differences were observed in 30-day readmissions (3.3% vs. 3.0%, respectively), all-cause (6.7% vs. 7.7%) and PE-related mortality rates (6.7% vs. 7.7%), or severe adverse events (16.7% vs. 15.4%). Conclusion: The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE without comprising safety across subgroups of risk stratification.
Autores:
de Winter, M. A.; Dorresteijn, J. A. N.; Ageno, W.; et al.
Revista:
THROMBOSIS AND HAEMOSTASIS
ISSN:
0340-6245
Año:
2022
Vol.:
122
N°:
5
Págs.:
818 - 829
Background Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice. Objectives To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model. Methods In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event (CAT-BLEED). Results Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50-0.57; poor calibration). Internal validation of the pragmatic classification and CAT-BLEED showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration). Conclusion Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with CAT-BLEED, but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated.
Autores:
Jaureguizar, A.; Jiménez, D. (Autor de correspondencia); Bikdeli, B.; et al.
Revista:
CHEST
ISSN:
0012-3692
Año:
2022
Vol.:
161
N°:
2
Págs.:
524 - 534
BACKGROUND: The association between heart rate (HR) and pulmonary embolism (PE) outcomes has not been well studied. Furthermore, optimal cutoffs to identify low-risk and intermediate- to high-risk patients are not well known. RESEARCH QUESTION: Does an association exist between baseline HR and PE outcome across the continuum of HR values? STUDY DESIGN AND METHODS: The current study included 44,331 consecutive nonhypotensive patients with symptomatic PE from the Registro Informatizado de la Enfermedad Trom-boEmbolica registry between 2001 and 2021. Outcomes included 30-day all-cause and PE-specific mortality. We used hierarchical logistic regression to assess the association between admission HR and outcomes. RESULTS: A positive relationship was found between admission HR and 30-day all-cause and PE-related mortality. Considering an HR of 80 to 99 beats/min as a reference, patients in the higher HR strata showed higher rates of all-cause death (adjusted OR, 1.5 for HR of 100-109 beats/min; adjusted OR, 1.7 for HR of 110-119 beats/min; adjusted OR, 1.9 for HR of 120-139 beats/min; and adjusted OR, 2.4 for HR of >= 140 beats/min). Patients in the lower strata of HR showed significantly lower rates of 30-day all-cause mortality compared with the same reference group (adjusted OR, 0.6 for HR of 60-79 beats/min; and adjusted OR, 0.5 for HR of < 60 beats/min). The findings for 30-day PE-related mortality were similar. For identification of low-risk patients, a cutoff value of 80 beats/min (vs 110 beats/min) increased the sensitivity of the simplified Pulmonary Embolism Severity Index (sPESI) from 93.4% to 98.8%. For identification of intermediate- to high-risk patients, a cutoff value of 140 beats/ min (vs 110 beats/min) increased the specificity of the Bova score from 93.2% to 98.0%. INTERPRETATION: In nonhypotensive patients with acute symptomatic PE, a high HR portends an increased risk of all-cause and PE-related mortality. Modifying the HR cutoff in the sPESI and the Bova score improves prognostication of patients with PE.
Autores:
de Jong, C.M.M.; Blondon, M.; Ay, C.; et al.
Revista:
BLOOD
ISSN:
0006-4971
Año:
2022
Vol.:
140
N°:
16
Págs.:
1764 - 1773
Preliminary data and clinical experience have suggested an increased risk of abnormal uterine bleeding (AUB) in women of reproductive age treated with anticoagulants, but solid data are lacking. The TEAM-VTE study was an international multicenter prospective cohort study in women aged 18 to 50 years diagnosed with acute venous thromboembolism (VTE). Menstrual blood loss was measured by pictorial blood loss assessment charts at baseline for the last menstrual cycle before VTE diagnosis and prospectively for each cycle during 3 to 6 months of follow-up. AUB was defined as an increased score on the pictorial blood loss assessment chart (>100 or >150) or self-reported AUB. AUB-related quality of life (QoL) was assessed at baseline and the end of follow-up using the Menstrual Bleeding Questionnaire. The study was terminated early because of slow recruitment attributable to the COVID-19 pandemic. Of the 98 women, 65 (66%) met at least one of the 3 definitions of AUB during follow-up (95% confidence interval [CI], 57%-75%). AUB occurred in 60% of women (36 of 60) without AUB before VTE diagnosis (new-onset AUB; 95% CI, 47%-71%). Overall, QoL decreased over time, with a mean Menstrual Bleeding Questionnaire score increase of 5.1 points (95% CI, 2.2-7.9), but this decrease in QoL was observed only among women with new-onset AUB. To conclude, 2 of every 3 women who start anticoagulation for acute VTE experience AUB, with a considerable negative impact on QoL. These findings should be a call to action to increase awareness and provide evidence-based strategies to prevent and treat AUB in this setting.
Revista:
THROMBOSIS AND HAEMOSTASIS
ISSN:
0340-6245
Año:
2022
Vol.:
122
N°:
9
Págs.:
1594 - 1602
Background: The natural history of patients with hematologic cancer and venous thromboembolism (VTE) has not been consistently evaluated. We aimed to compare the rates of symptomatic recurrent VTE, major bleeding or death during anticoagulant therapy in patients with VTE associated to hematologic vs. solid cancers.
Methods: Consecutive patients with active cancer recruited in RIETE were evaluated. Their baseline characteristics, treatments and outcomes during the course of anticoagulation were compared. Univariate and multivariate competing-risk analysis were performed.
Results: As of December 2020, 16,694 patients with cancer and VTE were recruited. Of these, 1,062 (6.4%) had hematologic cancers. Hematologic patients were less likely to initially present with pulmonary embolism (48% vs. 63%) and more likely with upper-extremity deep vein thrombosis (25% vs. 18%). They also were more likely to have severe thrombocytopenia at baseline (5.6% vs. 0.7%) or to receive chemotherapy (67% vs. 41%). During the course of anticoagulation (median, 150 vs. 127 days), 1,071 patients (6.4%) developed VTE recurrences, 806 (4.8%) suffered major bleeding and 4,136 (24.8%) died. Patients with hematologic cancers had lower rates of recurrent VTE (rate ratio [RR]: 0.73; 95% confidence interval [CI]: 0.56-0.95), major bleeding (RR: 0.72; 95%CI: 0.53-0.98) or all-cause death (RR: 0.49; 95%CI: 0.41-0.57) than those with solid cancers. Patients with multiple myeloma showed the best outcomes.
Conclusions: Patients with hematologic cancers, particularly multiple myeloma, and VTE had better outcomes than those with solid cancers. These findings are relevant for the interpretation of previous clinical trials and the design of future studies.
Autores:
Jiménez, D. (Autor de correspondencia); Rodríguez, C.; León, F.; et al.
Revista:
EUROPEAN RESPIRATORY JOURNAL
ISSN:
0903-1936
Año:
2022
Vol.:
59
N°:
2
Págs.:
2100412
Background The length of hospital stay (LOS) for acute pulmonary embolism (PE) varies considerably. Whether the upfront use of a PE prognostic assessment and management pathway is effective in reducing the LOS remains unknown. Methods We conducted a randomised controlled trial of adults hospitalised for acute PE: patients were assigned either to a prognostic assessment and management pathway involving risk stratification followed by predefined criteria for mobilisation and discharge (intervention group) or to usual care (control group). The primary end-point was LOS. The secondary end-points were the cost of prognostic tests and of hospitalisation, and 30-day clinical outcomes. Results Of 500 patients who underwent randomisation, 498 were included in the modified intention-to-treat analysis. The median LOS was 4.0 days (interquartile range (IQR) 3.7-4.2 days) in the intervention group and 6.1 days (IQR 5.7-6.5 days) in the control group (p<0.001). The mean total cost of prognostic tests was EUR 174.76 in the intervention group, compared with EUR 233.12 in the control group (mean difference EUR -58.37, 95% CI EUR -84.34 to -32.40). The mean total hospitalisation cost per patient was EUR 2085.66 in the intervention group, compared with EUR 3232.97 in the control group (mean difference EUR -1147.31, 95% CI EUR -1414.97 to -879.65). No significant differences were observed in 30-day readmission (4.0% versus 4.8%), all-cause mortality (2.4% versus 2.0%) or PE-related mortality (0.8% versus 1.2%) rates. Conclusions The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE.
Revista:
THROMBOSIS AND HAEMOSTASIS
ISSN:
0340-6245
Año:
2022
Vol.:
122
N°:
2
Págs.:
295 - 299
Thromboprophylaxis with low molecular weight heparin in hospitalized patients with COVID-19 is mandatory, unless contraindicated. Given the links between inflammation and thrombosis, the use of higher doses of anticoagulants could improve outcomes. We conducted an open-label, multicenter, randomized, controlled trial in adult patients hospitalized with nonsevere COVID-19 pneumonia and elevated D-dimer. Patients were randomized to therapeutic-dose bemiparin (115 IU/kg daily) versus standard prophylaxis (bemiparin 3,500 IU daily), for 10 days. The primary efficacy outcome was a composite of death, intensive care unit admission, need of mechanical ventilation support, development of moderate/severe acute respiratory distress, and venous or arterial thrombosis within 10 days of enrollment. The primary safety outcome was major bleeding (International Society on Thrombosis and Haemostasis criteria). A prespecified interim analysis was performed when 40% of the planned study population was reached. From October 2020 to May 2021, 70 patients were randomized at 5 sites and 65 were included in the primary analysis; 32 patients allocated to therapeutic dose and 33 to standard prophylactic dose. The primary efficacy outcome occurred in 7 patients (22%) in the therapeutic-dose group and 6 patients (18%) in the prophylactic-dose (absolute risk difference 3.6% [95% confidence interval [CI], -16% -24%]; odds ratio 1.26 [95% CI, 0.37-4.26]; p = 0.95). Discharge in the first 10 days was possible in 66 and 79% of patients, respectively. No major bleeding event was registered. Therefore, in patients with COVID-19 hospitalized with nonsevere pneumonia but elevated D-dimer, the use of a short course of therapeutic-dose bemiparin does not appear to improve clinical outcomes compared with standard prophylactic doses. Trial Registration: ClinicalTrials.gov NCT04604327.
Autores:
Chaib, F. B.; Jiménez Hernández, S.; Pedrajas Navas, J. M.; et al.
Revista:
EMERGENCIAS
ISSN:
1137-6821
Año:
2021
Vol.:
33
N°:
6
Págs.:
433 - 440
Objectives. To describe the characteristics of patients with isolated lower-limb superficial vein thrombosis (SVT) treated in hospital emergency departments and to evaluate adherence to clinical practice guidelines on diagnosis (vein ultrasound imaging) and therapeutic management (start of anticoagulant therapy).
Methods. Retrospective cohort study in 18 Spanish emergency departments. We included all patients with a final emergency department diagnosis of lower-limb SVT aged 18 years or older between January 2016 and May 2017. Backward stepwise multiple logistic regression analysis was used to evaluate adherence to clinical practice guidelines on ordering vein ultrasound imaging and starting anticoagulant therapy.
Results. A total of 1166 patients were included. The mean patient age was 59.6 years, and 67.9% were women. About a quarter of the patients (24.4%) had a history of venous thromboembolic disease. Complications developed in 8.9% within 180 days: 4.6% experienced a recurrence and 3.6% progressed to SVT and 1.8% to deep vein thrombosis; pulmonary thromboembolism occurred in 0.9%. Hemorrhagic complications developed in 17 patients (1.5%). Sixteen patients (1.4%) died. Vein ultrasound imagine was ordered for 703 patients (60.3%). ...
Autores:
Beddar Chaib, F.; Jiménez Hernández, S.; Pedrajas Navas, J. M.; et al.
Revista:
EMERGENCIAS
ISSN:
1137-6821
Año:
2021
Vol.:
33
N°:
6
Págs.:
433 - 440
Objectives. To describe the characteristics of patients with isolated lower-limb superficial vein thrombosis (SVT) treated in hospital emergency departments and to evaluate adherence to clinical practice guidelines on diagnosis (vein ultrasound imaging) and therapeutic management (start of anticoagulant therapy).
Methods. Retrospective cohort study in 18 Spanish emergency departments. We included all patients with a final emergency department diagnosis of lower-limb SVT aged 18 years or older between January 2016 and May 2017. Backward stepwise multiple logistic regression analysis was used to evaluate adherence to clinical practice guidelines on ordering vein ultrasound imaging and starting anticoagulant therapy. ...
Autores:
Altali Alhames, K.; Martin-Sánchez, F. J. (Autor de correspondencia); Ruiz, Pedro Celso; et al.
Revista:
REVISTA ESPAÑOLA DE QUIMIOTERAPIA
ISSN:
0214-3429
Año:
2021
Vol.:
34
N°:
3
Págs.:
220 - 227
Objective. Main objective was whether the combination of C-Reactive Protein (CRP) and Alvarado Score (AS) increase the diagnosis accuracy of AS among 2-to-20-year-old patients with suspected acute appendicitis presenting to Emergency Departments. Materials and methods. This is a secondary analysis of prospective cohort study consecutively including all patients from 2 to 20 years of age attended for suspected acute appendicitis in 4 Spanish Emergency Departments during 6-month period. We collected demographic, clinical, analytic and radiographic, and surgical data. AS categories were retrospectively calculated as low (0-4 points), intermediate (5-6 points) or high (7-10 points). The cut-off levels were >0.5 mg/dl for CRP. The outcome was diagnosis of acute appendicitis within 14 days of the index visit. Results. A total of 331 patients with suspected of acute appendicitis (mean age 11.8 (SD 3.8) years; 52.9% males) were recruited. According to AS, 108 (32.6%) were at low risk, 76 at (23.0%) intermediate risk and 147 (44.4%) at high risk of acute appendicitis. One hundred and sixteen (35.0%) cases had confirmed histopathological diagnosis of acute appendicitis. The AUCs of ROC were 0.76 (0.70-0.81) for AS and 0.79 (95% CI 0.75-0.84) for CRP-AS being the difference statistically significant (p=0.003). The CRP for diagnosis acute appendicitis in low risk AS group had negative predictive value of 95.8% (95%CI 87.3-98.9) and likelihood ratio negative of 0.4 (95%CI 0.2-1.0). Conclusions. CRP-AS has shown to increase the diagnostic accuracy of AS for acute appendicitis. This approach may be useful to rule out the diagnosis of acute appendicitis in paediatric patients attended for abdominal pain suggestive of acute appendicitis.
Autores:
Jiménez, D. (Autor de correspondencia); Agustí, A.; Tabernero, E.; et al.
Revista:
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
ISSN:
0098-7484
Año:
2021
Vol.:
326
N°:
13
Págs.:
1277 - 1285
Question Does an active search for pulmonary embolism (PE) improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD)? Findings This multicenter randomized clinical trial included 746 patients who required hospitalization for exacerbation of COPD and were randomized to receive usual care plus an active strategy for diagnosing PE or usual care alone. The primary outcome (a composite of nonfatal symptomatic venous thromboembolism, readmission for COPD, or death within 90 days after randomization) occurred in 29.7% of patients in the intervention group vs 29.2% in the control group, a difference that was not statistically significant. Meaning Among patients hospitalized for an exacerbation of COPD, addition of an active diagnostic strategy for PE to usual care compared with usual care alone did not improve a composite set of health outcomes. Importance Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD). Objective To compare usual care plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation. Design, Setting, and Participants Randomized clinical trial conducted across 18 hospitals in Spain. A total of 746 patients were randomized from September 2014 to July 2020 (final follow-up was November 2020). Interventions Usual care plus an active strategy for diagnosing PE (D-dimer testing and, if positive, computed tomography pulmonary angiogram) (n = 370) vs usual care (n = 367). Main Outcomes and Measures The primary outcome was a composite of nonfatal symptomatic venous thromboembolism (VTE), readmission for COPD, or death within 90 days after randomization. There were 4 secondary outcomes, including nonfatal new or recurrent VTE, readmission for COPD, and death from any cause within 90 days. Adverse events were also collected. Results Among the 746 patients who were randomized, 737 (98.8%) completed the trial (mean age, 70 years; 195 [26%] women). The primary outcome occurred in 110 patients (29.7%) in the intervention group and 107 patients (29.2%) in the control group (absolute risk difference, 0.5% [95% CI, -6.2% to 7.3%]; relative risk, 1.02 [95% CI, 0.82-1.28]; P = .86). Nonfatal new or recurrent VTE was not significantly different in the 2 groups (0.5% vs 2.5%; risk difference, -2.0% [95% CI, -4.3% to 0.1%]). By day 90, a total of 94 patients (25.4%) in the intervention group and 84 (22.9%) in the control group had been readmitted for exacerbation of COPD (risk difference, 2.5% [95% CI, -3.9% to 8.9%]). Death from any cause occurred in 23 patients (6.2%) in the intervention group and 29 (7.9%) in the control group (risk difference, -1.7% [95% CI, -5.7% to 2.3%]). Major bleeding occurred in 3 patients (0.8%) in the intervention group and 3 patients (0.8%) in the control group (risk difference, 0% [95% CI, -1.9% to 1.8%]; P = .99). Conclusions and Relevance Among patients hospitalized for an exacerbation of COPD, the addition of an active strategy for the diagnosis of PE to usual care, compared with usual care alone, did not significantly improve a composite health outcome. The study may not have had adequate power to assess individual components of the composite outcome. This randomized clinical trial examines the effect of an active strategy for the diagnosis of pulmonary embolism in addition to usual care on clinical outcomes, including nonfatal symptomatic venous thromboembolism, readmission for chronic obstructive pulmonary disorder (COPD), or death within 90 days after randomization, among individuals hospitalized for an exacerbation of COPD.
Revista:
TH OPEN
ISSN:
2567-3459
Año:
2021
Vol.:
5
N°:
3
Págs.:
e319 - e328
The performance of validated bleeding risk scores in patients with venous thromboembolism (VTE) could be different depending on the time after index event or the site of bleeding. In this study we compared the "classic" Registro Informatizado de Enfermedad TromboEmbólica (RIETE) score and the more recently developed VTE-BLEED score for the prediction of major bleeding in patients under anticoagulant therapy in different time intervals after VTE diagnosis. Out of 82,239 patients with acute VTE, the proportion of high-risk patients according to the RIETE and VTE-BLEED scores was 7.1 and 62.3%, respectively. The performance of both scores across the different study periods (first 30 days after VTE diagnosis, days 31-90, days 91-180, and days 181-360) was similar, with areas under the receiving operating characteristics (ROC) curve (AUC) ranging between 0.69 and 0.72. However, the positive predictive values were low, ranging between 0.6 and 3.9 (better for early major bleeding than for later periods). A sensitivity analysis limited to patients with unprovoked VTE showed comparable results. Both scores showed a trend toward a better prediction of extracranial than intracranial major bleeding, the RIETE score resulting more useful for early extracranial bleeding and the VTE-BLEED for late intracranial hemorrhages. Our study reveals that the usefulness of available bleeding scores may vary depending on the characteristics of the patient population and the time frame evaluated. ...
Autores:
Carriel Mancilla, J. (Autor de correspondencia); Jiménez Hernández, S.; Martín-Sánchez, F. J.; et al.
Revista:
EMERGENCIAS
ISSN:
1137-6821
Año:
2021
Vol.:
33
N°:
2
Págs.:
107 - 114
Objetivos. Evaluar el pronóstico a 180 días de los pacientes diagnosticados de enfermedad tromboembólica venosa (ETV) en urgencias, en función de una clasificación por perfiles clínicos. Los objetivos secundarios fueron evaluar la mortalidad y el reingreso por todas las causas de manera individual, y describir las características clínicas y formas de presentación de trombosis venosa profunda (TVP) y tromboembolismo pulmonar (TEP), según dichos perfiles.
Método. Análisis secundario del registro ESPHERIA que incluye pacientes consecutivos con ETV sintomática de 53 servicios de urgencias (SU). Se dividió la muestra en 4 perfiles: ETV no provocada (perfil 1), ETV provocada por factores de riesgo transitorios (perfil 2), cáncer (perfil 3) y baja reserva cardiopulmonar (perfil 4). La variable de resultado primaria fue la compuesta mortalidad o reingreso por cualquier causa a 180 días.
Resultados. Se incluyeron 773 pacientes de los cuales 450 (58,2%) fueron clasificados en el perfil 1, 128 (16,6%) en el perfil 2, 115 pacientes (14,9%) en el perfil 3 y 80 (10,3%) en el perfil 4. Se documetaron diferencias demográficas, de comorbilidad, presentación clínica, tipo de ETV, manejo, ubicación y resultados entre los perfiles clínicos. Ciento noventa y cinco pacientes (25,2%) presentaron un resultado adverso compuesto a los 180 días, de los cuales 69 (8,9%) fallecieron y 179 (23,2%) sufrieron un nuevo ingreso por cualquier causa. La ETV asociada a baja reserva cardiopulmonar (HR 1,73; IC 95% 1,12-2,68; p = 0,01) y la ETV asociada a cáncer (HR 3,10; IC 95% 2,22-4,34; p < 0,001) se asociaron de forma independiente con sufrir un resultado adverso en los primeros 180 días.
Conclusiones. Clasificar a los pacientes con ETV según factores de riesgo y comorbilidades en 4 perfiles (no provocada, provocada por factores transitorios, asociada a cáncer y asociada a baja reserva cardiopulmonar) resulta útil al momento del diagnóstico de la ETV para estimar el pronóstico en términos de mortalidad y reingreso a 180 días. Esta clasificación podría ayudar a establecer un plan de cuidados y seguimiento al alta en la ETV diagnosticada en urgencias.
Autores:
Barco, S.; Schmidtmann, I.; Ageno, W.; et al.
Revista:
EUROPEAN RESPIRATORY JOURNAL
ISSN:
0903-1936
Año:
2021
Vol.:
57
N°:
2
Págs.:
2002368
Introduction: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes. Methods: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire) and generic (five-level five-dimension EuroQoL (EQ-5D-5L) scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale (ACTS)) after pulmonary embolism. Results: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean +/- sD PEmb-QoL decreased from 28.9 +/- 20.6% at 3 weeks to 19.9 +/- 15.4% at 3 months, a mean change (improvement) of -9.1% ( p<0.0001). Improvement was consistent across all PFmb-Qol, dimensions. The EQ-5D-5L was 0.89 +/- 0.12 at 3 weeks after enrolment and improved to 0.91 +/- 0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age was associated with faster worsening of generic quality of life. The ACTS burden score improved from 40.5 +/- 6.6 points at 3 weeks to 425 +/- 5.9 points at 3 months (p<0.0001). Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.
Autores:
Mancilla, J. C. (Autor de correspondencia); Hernandez, S. J.; Martin-Sanchez, F. J.; et al.
Revista:
EMERGENCIAS
ISSN:
1137-6821
Año:
2020
Vol.:
32
N°:
1
Págs.:
40 - 44
Objective. To determine the impact of chronic obstructive pulmonary disease (COPD) on prognosis in patients diagnosed with venous thromboembolic disease (VTED) in Spanish emergency departments. Methods. Secondary analysis of data from the ESPHERIA (Spanish acronym for Risk Profile of Patients VTED Attended in Spanish Emergency Departments) registry. Results. A total of 801 patients, 71 (9%) with COPD, were included. Pulmonary thromboembolism was recorded in 77.%% of the patients with COPD (vs in 47.1% of patients without COPD; P<.001). Patients with COPD had evidence of right ventricular dysfunction on computed tomography angiography more often than other VTED patients (18.2% vs 13.1%; P<.001) and more often required ventilatory support (7% vs 0.5%; P<.001). VTED patients with COPD also had a higher rate of readmission or mortality at 180 days (hazard ratio, 1.52; 95% CI, 1.00-2.29; P = .048)] than patients without COPD. Conclusions. COPD affects the prognosis of patients diagnosed with VTED in Spanish emergency departments as evidenced by hospital readmission and mortality.
Autores:
Barco, S.; Schmidtmann, I.; Ageno, W.; et al.
Revista:
EUROPEAN HEART JOURNAL
ISSN:
0195-668X
Año:
2020
Vol.:
41
N°:
4
Págs.:
509 - 518
Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for >= 3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of alpha = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). Conclusion Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
Revista:
THROMBOSIS RESEARCH
ISSN:
0049-3848
Año:
2020
Vol.:
195
Págs.:
139 - 145
Introduction: Treatment of venous thromboembolism (VTE) in cancer patients with thrombocytopenia is challenging due to perceived higher risk of bleeding. Material and methods: We used the RIETE registry to compare the 10- and 30-day outcomes in cancer patients with acute VTE, according to platelet count at baseline. Results: As of December 2018, 15,337 cancer patients with VTE were included: 166 (1.1%) had < 50 x 10(9) platelets/L (severe thrombocytopenia), 711 (4.6%) had 50-99 x 10(9)/L (mild thrombocytopenia) and 14,460 (94.3%) had >= 100 x 10(9)/L (normal count). Most patients in all subgroups received initial therapy with low-molecular-weight heparin (LMWH), but 62% of those with severe thrombocytopenia received < 150 IU/kg/day LMWH, 42% received < 100 IU/kg/day. The mortality rate progressively decreased with increasing platelet counts (12%, 9.4% and 3.3% respectively at 10 days, 27%, 18% and 9.4% at 30 days), but the major bleeding rates did not (1.2%, 2.5% and 1.3% respectively at 10 days, 2.4%, 4.4% and 2.2% at 30 days). On multivariable analysis, patients with severe thrombocytopenia had a similar risk for major bleeding at 10 days (OR 0.84; 95%CI 0.20-3.49) and at 30 days (OR 0.90; 95%CI 0.32-2.49), but those with mild thrombocytopenia were at increased risk both at 10 days (OR 2.11; 95%CI 1.27-3.49) and at 30 days (OR 1.91; 95%CI 1.29-2.84). Conclusions: Cancer patients with acute VTE and baseline thrombocytopenia often receive initial lower-than recommended doses of LMWH. Although caution is required, this practice seems to be safe in patients with severe thrombocytopenia. Nonetheless, there was an inverse correlation between baseline platelet count and mortality.
Autores:
Valle, H. A. (Autor de correspondencia); Ezquerra, P. G. ; Gonzalez, I. S. ; et al.
Revista:
EUROPEAN JOURNAL OF EMERGENCY MEDICINE
ISSN:
0969-9546
Año:
2020
Vol.:
27
N°:
5
Págs.:
379 - 380
Autores:
Hernandez, S. J. (Autor de correspondencia); Linares, R. C.; Ruiz, Pedro Celso
Revista:
EMERGENCIAS
ISSN:
1137-6821
Año:
2019
Vol.:
31
N°:
4
Págs.:
295 - 295
Autores:
Martin-Sanchez, F. J. (Autor de correspondencia); Triana, F. C.; Bossello, X. ; et al.
Revista:
EUROPEAN JOURNAL OF INTERNAL MEDICINE
ISSN:
0953-6205
Año:
2019
Vol.:
65
Págs.:
69 - 77
Background: Little is known about the prevalence and impact of risk of malnutrition on short-term mortality among seniors presenting with acute heart failure (AHF) in emergency setting. The objective was to determine the impact of risk of malnutrition on 30-day mortality risk among older patients who attended in Emergency Departments (EDs) for AHF. Material and methods: We performed a secondary analysis of the OAK-3 Registry including all consecutive patients >= 65 years attending in 16 Spanish EDs for AHF. Risk of malnutrition was defined by the Mini Nutritional Assessment Short Form (MNA-SF) < 12 points. Unadjusted and adjusted logistic regression models were used to assess the association between risk of malnutrition and 30-day mortality. Results: We included 749 patients (mean age: 85 (SD 6); 55.8% females). Risk of malnutrition was observed in 594 (79.3%) patients. The rate of 30-day mortality was 8.8%. After adjusting for MEESSI-AHF risk score clinical categories (model 1) and after adding all variables showing a significantly different distribution among groups (model 2), the risk of malnutrition was an independent factor associated with 30-day mortality (adjusted OR by model 1 = 3.4; 95% CI 1.2-9.7; p = .020 and adjusted OR by model 2 = 3.1; 95% CI 1.1-9.0; p = .033) compared to normal nutritional status. Conclusions: The risk of malnutrition assessed by the MNA-SF is associated with 30-day mortality in older patients with AHF who were attended in EDs. Routine screening of risk of malnutrition may help emergency physicians in decision-making and establishing a care plan.
Autores:
Jimenez, D. (Autor de correspondencia); Bikdeli, B.; Quezada, A.; et al.
Revista:
BMJ (ONLINE)
ISSN:
1756-1833
Año:
2019
Vol.:
366
Págs.:
l4416
OBJECTIVES To evaluate the association between experience in the management of acute pulmonary embolism, reflected by hospital case volume, and mortality. DESIGN Multinational population based cohort study using data from the Registro Informatizado de la Enfermedad TromboEmbolica (RIETE) registry between 1 January 2001 and 31 August 2018. SETTING 353 hospitals in 16 countries. PARTICIPANTS 39 257 consecutive patients with confirmed diagnosis of acute symptomatic pulmonary embolism. MAIN OUTCOME MEASURE Pulmonary embolism related mortality within 30 days after diagnosis of the condition. RESULTS Patients with acute symptomatic pulmonary embolism admitted to high volume hospitals (>40 pulmonary embolisms per year) had a higher burden of comorbidities. A significant inverse association was seen between annual hospital volume and pulmonary embolism related mortality. Admission to hospitals in the highest quarter (that is, >40 pulmonary embolisms per year) was associated with a 44% reduction in the adjusted odds of pulmonary embolism related mortality at 30 days compared with admission to hospitals in the lowest quarter (<15 pulmonary embolisms per year; adjusted risk 1.3% v 2.3%; adjusted odds ratio 0.56 (95% confidence interval 0.33 to 0.95); P=0.03). Results were consistent in all sensitivity analyses. All cause mortality at 30 days was not significantly reduced between the two quarters (adjusted odds ratio 0.78 (0.50 to 1.22); P=0.28). Survivors showed little change in the odds of recurrent venous thromboembolism (odds ratio 0.76 (0.49 to 1.19)) or major bleeding (1.07 (0.77 to 1.47)) between the low and high volume hospitals. CONCLUSIONS In patients with acute symptomatic pulmonary embolism, admission to high volume hospitals was associated with significant reductions in adjusted pulmonary embolism related mortality at 30 days. These findings could have implications for management strategies.