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1.
J Thromb Haemost ; 2020 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-32073218

RESUMO

INTRODUCTION: Pulmonary embolism (PE)-related death is often part of the primary outcome in venous thromboembolism (VTE) studies. The Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis developed a definition for PE-related death and classification of the cause of death. The present survey evaluated a preliminary version of this definition and classification. METHODS: Sixty-nine VTE experts from nine countries were invited for a cross-sectional online survey on January 15, 2019, including multiple-choice and open-ended questions on a seven-subcategory classification of the cause of death. Descriptive statistics were used to describe the results; qualitative comments were summarized. RESULTS: Forty of 69 (58%) invitees completed the survey. All respondents agreed that guidance on classification of the cause of death in VTE studies is required. There was high agreement on the proposal (median overall score, 6; interquartile range, 6-7; scale from 1 [poor] to 7 [excellent]). All respondents approved the wording and content of the seven subcategories, except for one disagreeing vote for two subcategories (A3: "PE is not objectively confirmed, but is most likely the main cause of death" and C1: "Another cause of death is more likely than PE but has not been objectively confirmed"). Suggestions for improvement mainly concerned the extensiveness of the criteria and clinical situations described to define the cause of death. CONCLUSION: Acceptance of the proposal was excellent. Suggestions for improvement were incorporated in the SSC communication on the definition of PE-related death and classification of the cause of death in VTE studies.

2.
PLoS One ; 15(2): e0228788, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32045437

RESUMO

BACKGROUND: Compression ultrasonography (CUS) is the first-line imaging test in the diagnostic management of suspected deep vein thrombosis (DVT) of the lower extremity. Three CUS strategies are used in clinical practice. However, their relative diagnostic accuracy is uncertain. OBJECTIVES: This systematic review and meta-analysis aimed to summarize and compare the diagnostic accuracy of single limited, serial limited, and whole-leg CUS for DVT. METHODS: MEDLINE, Embase, and CENTRAL were searched from January 1st, 1989 to July 23rd, 2019 for studies assessing at least one of the CUS strategies in adults with suspected DVT of the lower extremity, using clinical follow-up for venous thromboembolism or contrast venography as the reference standard. Study selection, data extraction, and risk of bias assessment were performed in duplicate by independent authors. A bivariate random-effects model was used to compute diagnostic accuracy summary estimates. RESULTS: Forty studies (n = 21,250) were included. The venous thromboembolic event rate after a negative CUS (failure rate) of single limited (1.4%; 95% CI, 0.83-2.5), serial limited (1.9%; 95% CI, 1.4-2.5), and whole-leg CUS (1.0%; 95% CI, 0.6-1.6) did not differ significantly. The proportion of positive results was lower with single limited CUS, as was DVT prevalence in this group. CONCLUSIONS: The failure rates of single limited, serial limited, and whole-leg CUS for DVT appeared to be quite comparable. The relative failure rate of single limited CUS remains uncertain, as the DVT prevalence was lower in these studies. Therefore, this CUS strategy may only be safe in a selected group of low-risk patients. Preference for one of the strategies may be based on pretest probability assessment, feasibility, expertise, and perceived clinical relevance of isolated distal DVT.

3.
Eur Radiol ; 2020 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-31953657

RESUMO

OBJECTIVE: To evaluate whether imaging diagnostic test accuracy conference abstracts with positive conclusions or titles are more likely to reach full-text publication than those with negative (or neutral) conclusions or titles. METHODS: Diagnostic accuracy research abstracts were included if they were presented at the 2011 or 2012 Radiological Society of North America conference. Full-text publication status at 5 years post conference abstract submission was determined. Conclusion and title positivity of conference abstracts were extracted, as well as potential confounding factors. The associations of conclusion and title positivity with publication status at 5 years post conference abstract submission were assessed using a multivariable logistic regression model. Conditional odds ratios were calculated to express the strength of associations, adjusting for the confounders. RESULTS: In total, 282/400 (71%) of included conference abstracts reached full-text publication. A total of 246 out of 337 (74%) conference abstracts with positive conclusions resulted in full-text publications, compared with 26/48 (54%) with neutral conclusions and 5/15 (33%) with negative conclusions. In multivariable logistic regression, conclusion positivity was significantly associated with full-text publication (odds ratio 3.6; 95% CI 1.9-6.7 for conference abstracts with positive conclusions, compared with those with non-positive conclusions); this did not apply to title positivity (odds ratio 1.2; 95% CI 0.47-3.0). CONCLUSION: Imaging conference abstracts with positive conclusions were more likely to be published as full-text articles. Title positivity was not associated with publication. This preferential publication pattern may lead to an overrepresentation of positive studies in the literature. An overrepresentation of positive studies may contribute to inflated estimates of test accuracy and has the potential to adversely influence patient care. KEY POINTS: • Imaging diagnostic test accuracy conference abstracts with positive conclusions were more likely to be reported as full-text articles than those with non-positive conclusions. • The majority (75%) of imaging diagnostic test accuracy conference abstracts with positive conclusions were published, compared with only 53% and 33% with neutral and negative conclusions, respectively. • Conclusion positivity remained associated with the full-text publication of conference abstracts when controlling for multiple potential confounding variables.

4.
Eur Respir J ; 55(2)2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31727694

RESUMO

INTRODUCTION: In cancer patients, current guidance suggests similar treatment for incidental and symptomatic venous thromboembolism (VTE), mainly based on retrospective data. We aimed to evaluate anticoagulant therapy in cancer patients with incidental and symptomatic VTE. METHODS: The Hokusai VTE Cancer Study was a randomised controlled trial comparing edoxaban with dalteparin for cancer-associated VTE. The primary outcome was the composite of first recurrent VTE or major bleeding. Secondary outcomes included major bleeding, recurrent VTE and mortality. Outcomes in patients with incidental and symptomatic VTE were evaluated during the 12-month study period. RESULTS: 331 patients with incidental VTE and 679 patients with symptomatic VTE were enrolled, of whom the index event was confirmed by an independent radiologist. Median durations of anticoagulant treatment were 195 and 189 days, respectively. In patients with incidental VTE, the primary outcome occurred in 12.7% of patients, major bleeding in 6.6% of patients and recurrent VTE in 7.9% of patients. Out of the 26 VTE recurrences in patients with incidental VTE, five (31%) were incidental, seven (44%) were symptomatic and four (25%) were deaths for which pulmonary embolism could not be ruled out. In patients with symptomatic VTE, the primary outcome occurred in 13.8% of patients, major bleeding in 4.9% of patients and recurrent VTE in 10.9% of patients. All-cause mortality was similar in both groups. CONCLUSION: Clinical adverse outcomes are substantial in both cancer patients with incidental and symptomatic VTE, supporting current guideline recommendations that suggest treating incidental VTE in the same manner as symptomatic VTE.

5.
J Thromb Haemost ; 17(10): 1590-1607, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31301689

RESUMO

BACKGROUND: Pulmonary embolism (PE)-related death is a component of the primary outcome in many venous thromboembolism (VTE) studies. The absence of a standardized definition for PE-related death hampers study outcome evaluation and between-study comparisons. OBJECTIVES: To summarize definitions for PE-related death used in recent VTE studies and to assess the PE-related death rate. PATIENTS/METHODS: A systematic literature search was conducted on 26 April 2018 from 1 January 2014 up to the search date in MEDLINE, Embase, and CENTRAL. Cohort studies and randomized trials in which PE-related death was included in the primary outcome were eligible. Screening of titles, abstracts, and full-text articles, and data extraction were independently performed in duplicate by two authors. Study outcomes included the definition for PE-related death, VTE case-fatality rate, and death due to PE rate. Descriptive statistics were used to analyze the data. RESULTS: Of the 6807 identified citations, 83 studies were included of which 27% were randomized trials, 31% were prospective, and 42% retrospective cohort studies. Thirty-five studies (42%) had a central adjudication committee. Thirty-eight (46%) reported a definition for PE-related death of which the most frequently used components were "autopsy-confirmed PE" (50%), "objectively confirmed PE before death" (55%), and "unexplained death" (58%). Median VTE case-fatality rate was 1.8% (interquartile range, 0.0-13). CONCLUSIONS: Only half of the included studies reported definitions for PE-related death, which were very heterogeneous. Case-fatality rate of VTE events varied widely across studies. Standardization of the definition and guidance on adjudication and reporting of PE-related death is needed.

6.
Thromb Res ; 181: 59-63, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31352267

RESUMO

BACKGROUND: The Ottawa score was previously developed to predict recurrent venous thromboembolism (VTE) in cancer patients with VTE. The performance of this score in patients with incidental VTE is currently unclear. AIM: To evaluate the performance of the Ottawa risk score in cancer patients with incidental pulmonary embolism included in an international, prospective, observational cohort study. METHODS: The score was used to classify patients as high (≥1), intermediate (0), or low risk (≤-1). The discriminative performance of the score was estimated by calculating the cumulative incidence of recurrent VTE for all groups, the time-dependent c-statistic, and the sub-distribution hazard ratio (SHR), using a competing risk approach. RESULTS: Of the 691 patients for which the Ottawa score could be calculated, 25 (3.6%) had recurrent VTE during 6-month follow-up and 38 (5.5%) during 12-month follow-up. The c-statistics of the continuous score at 6 and 12 months were 0.45 (95% CI, 0.36-0.54) and 0.51 (95% CI, 0.46-0.59), respectively. The 6-month cumulative incidences of recurrent VTE for those at low, intermediate, and high risk were 3.9% (95% CI, 1.5-8.4), 3.6% (95% CI, 1.9-6.2), and 3.6% (95% CI, 1.8-6.5), respectively. A sensitivity analysis restricted to the on-treatment period yielded similar results. None of the Ottawa risk score items were significantly associated with recurrent VTE. CONCLUSION: In cancer patients with incidental pulmonary embolism, the Ottawa risk score has a poor predictive value for recurrent VTE, which does not support the use of the score in this patient population.


Assuntos
Anticoagulantes/uso terapêutico , Neoplasias/complicações , Embolia Pulmonar/etiologia , Tromboembolia Venosa/etiologia , Idoso , Anticoagulantes/farmacologia , Feminino , Humanos , Masculino , Embolia Pulmonar/patologia , Tromboembolia Venosa/patologia
7.
J Clin Oncol ; 37(20): 1713-1720, 2019 07 10.
Artigo em Inglês | MEDLINE | ID: mdl-31116676

RESUMO

PURPOSE: Pulmonary embolism is incidentally diagnosed in up to 5% of patients with cancer on routine imaging scans. The clinical relevance and optimal therapy for incidental pulmonary embolism, particularly distal clots, is unclear. The aim of the current study was to assess current treatment strategies and the long-term clinical outcomes of incidentally detected pulmonary embolism in patients with cancer. PATIENTS AND METHODS: We conducted an international, prospective, observational cohort study between October 22, 2012, and December 31, 2017. Unselected adults with active cancer and a recent diagnosis of incidental pulmonary embolism were eligible. Outcomes were recurrent venous thromboembolism, major bleeding, and all-cause mortality during 12 months of follow-up. Outcome events were centrally adjudicated. RESULTS: A total of 695 patients were included. Mean age was 66 years and 58% of patients were male. Most frequent cancer types were colorectal (21%) and lung cancer (15%). Anticoagulant therapy was initiated in 675 patients (97%), of whom 600 (89%) were treated with low-molecular-weight heparin. Recurrent venous thromboembolism occurred in 41 patients (12-month cumulative incidence, 6.0%; 95% CI, 4.4% to 8.1%), major bleeding in 39 patients (12-month cumulative incidence, 5.7%; 95% CI, 4.1% to 7.7%), and 283 patients died (12-month cumulative incidence, 43%; 95% CI, 39% to 46%). The 12-month incidence of recurrent venous thromboembolism was 6.4% in those with subsegmental pulmonary embolism compared with 6.0% in those with more proximal pulmonary embolism (subdistribution hazard ratio, 1.1; 95% CI, 0.37 to 2.9; P = .93). CONCLUSION: In patients with cancer with incidental pulmonary embolism, risk of recurrent venous thromboembolism is significant despite anticoagulant treatment. Patients with subsegmental pulmonary embolism seemed to have a risk of recurrent venous thromboembolism comparable to that of patients with more proximal clots.

8.
AJR Am J Roentgenol ; 213(2): 397-403, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30995088

RESUMO

OBJECTIVE. The purpose of this study was to examine the existence of selective citation practices in the imaging literature by assessing whether diagnostic accuracy studies with positive titles or conclusions are cited more frequently than those with negative (or neutral) titles or conclusions. MATERIALS AND METHODS. MEDLINE was searched for meta-analyses of diagnostic accuracy studies published in imaging journals from January 2005 to April 2016. Primary studies from the meta-analyses were screened for eligibility. Titles and conclusions were classified independently in duplicate. A negative binomial regression analysis controlling for several confounding variables was performed to obtain regression coefficients; p values were obtained via likelihood ratio testing. RESULTS. A total of 995 primary studies were included. Fifty-one titles (5.1%) and 782 conclusions (78.6%) were positive or positive with qualifiers; 942 titles (94.7%) and 127 conclusions (12.8%) were neutral; and two titles (0.02%) and 86 conclusions (8.6%) were negative. Studies with positive, neutral, and negative titles were cited a mean of 0.66, 0.50, and 0.06 times per month. Studies with positive, neutral, and negative conclusions were cited a mean of 0.54, 0.42, and 0.34 times per month. Regression coefficients were 1.10 (95% CI, -0.08 to 2.20) and 0.91 (95% CI, -0.27 to 2.00) for positive and neutral titles, relative to negative titles. Regression coefficients were 0.19 (95% CI, 0.03-0.35) and 0.08 (95% CI, -0.12 to 0.27) for positive and neutral conclusions, relative to negative conclusions. Title and conclusion positivity demonstrated positive association with citation rate (p = 0.031 for both). CONCLUSION. Studies with positive titles or conclusions are cited more frequently in imaging diagnostic accuracy literature. This difference may contribute to overestimation of the accuracy of a test and, consequently, suboptimal patient outcomes.


Assuntos
Bibliometria , Diagnóstico por Imagem , Viés , Humanos , Projetos de Pesquisa
9.
Eur Radiol ; 29(10): 5386-5394, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30899976

RESUMO

PURPOSE: The purpose of this methodological review was to determine the extent to which comparative imaging systematic reviews of diagnostic test accuracy (DTA) use primary studies with comparative or non-comparative designs. METHODS: MEDLINE was used to identify DTA systematic reviews published in imaging journals between January 2000 and May 2018. INCLUSION CRITERIA: systematic reviews comparing at least two index tests (one of which was imaging-based); review characteristics were extracted. Study design and other characteristics of primary studies included in the systematic reviews were evaluated. RESULTS: One hundred three comparative imaging reviews were included; 11 (11%) included only comparative studies, 12 (11%) included only non-comparative primary studies, and 80 (78%) included both comparative and non-comparative primary studies. For reviews containing both comparative and non-comparative primary studies, the median proportion of non-comparative primary studies was 81% (IQR 57-90%). Of 92 reviews that included non-comparative primary studies, 86% did not recognize this as a limitation. Furthermore, among 4182 primary studies, 3438 (82%) were non-comparative and 744 (18%) were comparative in design. CONCLUSION: Most primary studies included in comparative imaging reviews are non-comparative in design and awareness of the risk of bias associated with this is low. This may lead to incorrect conclusions about the relative accuracy of diagnostic tests and be counter-productive for informing guidelines and funding decisions about imaging tests. KEY POINTS: • Few comparative accuracy imaging reviews include only primary studies with optimal comparative study designs. Among the rest, few recognize the risk of bias conferred from inclusion of primary studies with non-comparative designs. • The demand for accurate comparative accuracy data combined with minimal awareness of valid comparative study designs may lead to counter-productive research and inadequately supported clinical decisions for diagnostic tests. • Using comparative accuracy imaging reviews with a high risk of bias to inform guidelines and funding decisions may have detrimental impacts on patient care.


Assuntos
Diagnóstico por Imagem/normas , Testes Diagnósticos de Rotina/normas , Humanos , Imagem por Ressonância Magnética/normas , Metanálise como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto , Tomografia Computadorizada por Raios X/normas
11.
J Magn Reson Imaging ; 49(7): e51-e64, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30102435

RESUMO

As defined by the Cochrane Collaboration, a systematic review is a review of evidence with a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant primary research, and to extract and analyze data from the studies that are included in the review. Meta-analysis is a statistical method to combine the results from primary studies that accounts for sample size and variability to provide a summary measure of the studied outcome. Systematic reviews of diagnostic test accuracy present unique methodological and reporting challenges not present in systematic reviews of interventions. This review provides guidance and further resources highlighting current best practices in methodology and reporting of systematic reviews of diagnostic test accuracy, with a specific focus on challenges and opportunities for MRI imaging. Level of Evidence: 2 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2018.

12.
Clin Chem ; 65(2): 291-301, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30237150

RESUMO

BACKGROUND: We evaluated the completeness of reporting of diagnostic test accuracy (DTA) systematic reviews using the recently developed Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA)-DTA guidelines. METHODS: MEDLINE® was searched for DTA systematic reviews published October 2017 to January 2018. The search time span was modulated to reach the desired sample size of 100 systematic reviews. Reporting on a per-item basis using PRISMA-DTA was evaluated. RESULTS: One hundred reviews were included. Mean reported items were 18.6 of 26 (71%; SD = 1.9) for PRISMA-DTA and 5.5 of 11 (50%; SD = 1.2) for PRISMA-DTA for abstracts. Items in the results were frequently reported. Items related to protocol registration, characteristics of included studies, results synthesis, and definitions used in data extraction were infrequently reported. Infrequently reported items from PRISMA-DTA for abstracts included funding information, strengths and limitations, characteristics of included studies, and assessment of applicability. Reporting completeness was higher in higher impact factor journals (18.9 vs 18.1 items; P = 0.04), studies that cited PRISMA (18.9 vs 17.7 items; P = 0.003), or used supplementary material (19.1 vs 18.0 items; P = 0.004). Variability in reporting was associated with author country (P = 0.04) but not journal (P = 0.6), abstract word count limitations (P = 0.9), PRISMA adoption (P = 0.2), structured abstracts (P = 0.2), study design (P = 0.8), subspecialty area (P = 0.09), or index test (P = 0.5). Abstracts with a higher word count were more informative (R = 0.4; P < 0.001). No association with word counts was observed for full-text reports (R = -0.03; P = 0.06). CONCLUSIONS: Recently published reports of DTA systematic reviews are not fully informative when evaluated against the PRISMA-DTA guidelines. These results should guide knowledge translation strategies, including journal level (e.g., PRISMA-DTA adoption, increased abstract word count, and use of supplementary material) and author level (PRISMA-DTA citation awareness) strategies.


Assuntos
Técnicas e Procedimentos Diagnósticos/normas , Lista de Checagem , Bases de Dados Factuais , Guias como Assunto , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa/normas
13.
Eur Radiol ; 29(4): 1657-1664, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30443756

RESUMO

OBJECTIVES: To assess the risk of citation bias in imaging diagnostic accuracy research by evaluating whether studies with higher accuracy estimates are cited more frequently than those with lower accuracy estimates. METHODS: We searched Medline for diagnostic accuracy meta-analyses published in imaging journals from January 2005 to April 2016. Primary studies from the meta-analyses were screened; those assessing the diagnostic accuracy of an imaging test and reporting sensitivity and specificity were eligible for inclusion. Studies not indexed in Web of Science, duplicates, and inaccessible articles were excluded. Topic (modality/subspecialty), study design, sample size, journal impact factor, publication date, times cited, sensitivity, and specificity were extracted for each study. Negative binomial regression was performed to evaluate the association of citation rate (times cited per month since publication) with Youden's index (sensitivity + specificity -1), highest sensitivity, and highest specificity, controlling for the potential confounding effects of modality, subspecialty, impact factor, study design, sample size, and source meta-analysis. RESULTS: There were 1016 primary studies included. A positive association between Youden's index and citation rate was present, with a regression coefficient of 0.33 (p = 0.016). The regression coefficient for sensitivity was 0.41 (p = 0.034), and for specificity, 0.32 (p = 0.15). CONCLUSION: A positive association exists between diagnostic accuracy estimates and citation rates, indicating that there is evidence of citation bias in imaging diagnostic accuracy literature. Overestimation of imaging test accuracy may contribute to patient harm from incorrect interpretation of test results. KEY POINTS: • Studies with higher accuracy estimates may be cited more frequently than those with lower accuracy estimates. • This citation bias could lead clinicians, reviews, and clinical practice guidelines to overestimate the accuracy of imaging tests, contributing to patient harm from incorrect interpretation of test results.


Assuntos
Bibliometria , Diagnóstico por Imagem/normas , Viés , Humanos , Fator de Impacto de Revistas , Metanálise como Assunto , Projetos de Pesquisa , Sensibilidade e Especificidade
14.
Blood ; 133(4): 291-298, 2019 01 24.
Artigo em Inglês | MEDLINE | ID: mdl-30478093

RESUMO

Venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism, is a common complication of cancer and is associated with significant morbidity and mortality. Several cancer-related risk factors contribute to the development of VTE including cancer type and stage, chemotherapy, surgery, and patient-related factors such as advanced age and immobilization. Patients with cancer frequently undergo diagnostic imaging scans for cancer staging and treatment response evaluation, which is increasing the underlying risk of VTE detection. The management of cancer-associated VTE is challenging. Over the years, important advances have been made and, recently, randomized controlled trials have been published helping clinicians' management of this patient population. In this review, we will discuss common cancer-associated VTE scenarios and critically review available evidence to guide treatment decisions.


Assuntos
Neoplasias/complicações , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/terapia , Idoso , Cateteres/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
15.
JAMA ; 320(15): 1583-1594, 2018 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-30326130

RESUMO

Importance: Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common and potentially fatal disease. Objective: To summarize the advances in diagnosis and treatment of VTE of the past 5 years. Evidence Review: A systematic search was conducted in EMBASE Classic, EMBASE, Ovid MEDLINE, and other nonindexed citations using broad terms for diagnosis and treatment of VTE to find systematic reviews and meta-analyses, randomized trials, and prospective cohort studies published between January 1, 2013, and July 31, 2018. The 10th edition of the American College of Chest Physicians Antithrombotic Therapy Guidelines was screened to identify additional studies. Screening of titles, abstracts, and, subsequently, full-text articles was performed in duplicate, as well as data extraction and risk-of-bias assessment of the included articles. Findings: Thirty-two articles were included in this review. The application of an age-adjusted D-dimer threshold in patients with suspected PE has increased the number of patients in whom imaging can be withheld. The Pulmonary Embolism Rule-Out Criteria safely exclude PE when the pretest probability is low. The introduction of direct oral anticoagulants has allowed for a simplified treatment of VTE with a lower risk of bleeding regardless of etiology or extent of the VTE (except for massive PE) and has made extended secondary prevention more acceptable. Thrombolysis is best reserved for patients with massive PE or those with DVT and threatened limb loss. Insertion of inferior vena cava filters should be avoided unless anticoagulation is absolutely contraindicated in patients with recent acute VTE. Graduated compression stockings are no longer recommended to treat DVT but may be used when acute or chronic symptoms are present. Anticoagulation may no longer be indicated for patients with isolated distal DVT at low risk of recurrence. Conclusions and Relevance: Over the past 5 years, substantial progress has been made in VTE management, allowing for diagnostic and therapeutic strategies tailored to individual patient characteristics, preferences, and values.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/terapia , Administração Oral , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Humanos , Trombólise Mecânica , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/terapia , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia
16.
Thromb Res ; 170: 102-108, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30153564

RESUMO

INTRODUCTION: Anticoagulant treatment in patients with liver cirrhosis is challenging. The aim of this systematic review was to evaluate clinical outcomes of direct oral anticoagulant (DOAC) therapy in cirrhosis patients. MATERIALS AND METHODS: A systematic search was performed in MEDLINE, Embase, and conference proceedings up to November 7th, 2017, for studies that evaluated the efficacy and safety of DOACs in cirrhosis patients with venous thromboembolism (VTE), splanchnic vein thrombosis (SVT), or atrial fibrillation (AF). Two authors independently screened titles, abstracts, and full-text articles, and assessed risk of bias. A meta-analysis could not be performed due to heterogeneity of the included studies. RESULTS: Of the 2927 articles assessed, five retrospective cohort studies were included (n = 239, including 20 patients overlap). All studies had fair methodological quality. Two studies evaluated DOAC treatment only, and three also evaluated vitamin K antagonists (VKAs) or low-molecular-weight heparins (LMWHs). Recurrent VTE (DOAC n = 12, LMWH/VKA n = 8) or ischemic stroke (DOAC n = 37, LMWH/VKA n = 9) occurred in none of the patients. Progression of VTE was 8% with DOACs (n = 12) and 13% with VKAs and LWWH (n = 8). Recurrent SVT occurred in 0 to 4% with DOACs (n = 31). Progression of SVT was 0 to 5% with DOACs (n = 24) and 0 to 47% with VKAs and LMWH (n = 33). Major bleeding risk ranged from 4 to 15% with DOACs (n = 172) and from 7 to 28% with VKAs and LMWH (n = 67). All-cause mortality risk was 6% with DOACs (n = 36). CONCLUSIONS: There is paucity of data on the efficacy and safety of DOACs in patients with cirrhosis. This analysis suggests that DOACs may be effective and safe for treatment of VTE, SVT, and AF in these patients.


Assuntos
Anticoagulantes/uso terapêutico , Cirrose Hepática/tratamento farmacológico , Administração Oral , Anticoagulantes/farmacologia , Feminino , Humanos , Masculino , Estudos Retrospectivos
17.
Thromb Haemost ; 118(8): 1439-1449, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30060256

RESUMO

In the Hokusai VTE Cancer study, edoxaban was non-inferior to dalteparin for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in 1,050 patients with cancer-associated VTE. The absolute rate of recurrent VTE was 3.4% lower with edoxaban, whereas the absolute rate of major bleeding was 2.9% higher. The present analysis focuses on the sites, clinical presentation, course and outcome of bleeding events, and the associated tumour types. Major bleeds and their severity (categories 1-4) were blindly adjudicated by a committee using a priori defined criteria, and data were analysed in the safety population. Major bleeding occurred in 32 of 522 patients given edoxaban (median treatment duration, 211 days) and in 16 of 524 patients treated with dalteparin (median treatment duration, 184 days); no patients had more than one major bleed. There were no fatal bleeds with edoxaban, and two with dalteparin. Severe bleeding at presentation (category 3 or 4) occurred in 10 (1.9%) and 11 (2.1%) patients in the edoxaban and dalteparin groups, respectively. The excess of major bleeding with edoxaban was confined to patients with gastrointestinal cancer. However, severe major bleeding at presentation (category 3 or 4) in this sub-group occurred in 5 of 165 (3.0%) and in 3 of 140 (2.1%) patients given edoxaban or dalteparin, respectively.In conclusion, this analysis suggests that while oral edoxaban is an appropriate alternative to subcutaneous dalteparin for treatment of cancer-associated VTE, the use of edoxaban in patients with gastrointestinal cancer requires careful benefit-risk weighting.


Assuntos
Anticoagulantes/efeitos adversos , Dalteparina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Hemorragia/induzido quimicamente , Neoplasias/complicações , Piridinas/efeitos adversos , Tiazóis/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Idoso , Anticoagulantes/administração & dosagem , Tomada de Decisão Clínica , Dalteparina/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Feminino , Hemorragia/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Seleção de Pacientes , Piridinas/administração & dosagem , Recidiva , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Tiazóis/administração & dosagem , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologia
18.
Lancet Haematol ; 5(7): e289-e298, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29885940

RESUMO

BACKGROUND: Venous thromboembolism is a common complication of cancer, but the risk of developing venous thromboembolism varies greatly among individuals and depends on numerous factors, including type of cancer. We aimed to develop and externally validate a clinical prediction model for cancer-associated venous thromboembolism. METHODS: We used data from the prospective Vienna Cancer and Thrombosis Study (CATS) cohort (n=1423) to select prognostic variables for inclusion in the model. We then validated the model in the prospective Multinational Cohort Study to Identify Cancer Patients at High Risk of Venous Thromboembolism (MICA) cohort (n=832). We calculated c-indices to show how the predicted incidence of objectively confirmed venous thromboembolism at 6 months compared with the cumulative 6-month incidences observed in both cohorts. FINDINGS: Two variables were selected for inclusion in the final clinical prediction model: tumour-site risk category (low or intermediate vs high vs very high) and continuous D-dimer concentrations. The multivariable subdistribution hazard ratios were 1·96 (95% CI 1·41-2·72; p=0·0001) for high or very high versus low or intermediate and 1·32 (95% CI 1·12-1·56; p=0·001) per doubling of D-dimer concentration. The cross-validated c-indices of the final model were 0·66 (95% CI 0·63-0·67) in CATS and 0·68 (0·62-0·74) in MICA. The clinical prediction model was adequately calibrated in both cohorts. INTERPRETATION: An externally validated clinical prediction model incorporating only one clinical factor (tumour-site category) and one biomarker (D-dimer) predicted the risk of venous thromboembolism in ambulatory patients with solid cancers. This simple model is a considerable improvement on previous models for predicting cancer-associated venous thromboembolism, and could aid physicians in selection of patients who will likely benefit from thromboprophylaxis. FUNDING: Austrian Science Fund, Austrian National Bank Memorial Fund, and participating hospitals.


Assuntos
Neoplasias/complicações , Neoplasias/epidemiologia , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Idoso , Áustria/epidemiologia , Biomarcadores , Estudos de Coortes , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Neoplasias/terapia , Prognóstico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Análise de Regressão , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/prevenção & controle
19.
Thromb Haemost ; 118(7): 1270-1278, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29864787

RESUMO

Venous thromboembolism (VTE) may be the first sign of an undiagnosed cancer. In patients with unprovoked VTE, the risk is approximately 5% in the year following VTE diagnosis. Cancer-specific screening is therefore often considered in these patients, but the optimal screening strategy remains controversial. Recently, two risk classification scores have been proposed that may help in identifying patients at high risk of occult cancer in whom extensive screening may be warranted. In the present post hoc analysis of the Hokusai-VTE study, we evaluated the performance of the Registro Informatizado de Pacientes con Enfermedad TromboEmbólica (RIETE) and Screening for Occult Malignancy in Patients with Idiopathic Venous Thromboembolism (SOME) scores for occult cancer in patients with acute VTE. A total of 8,032 patients were included in the analysis of whom 218 (2.7%; 95% confidence interval [CI], 2.4-3.1) developed cancer between 30-day and 12-month follow-up. The c-statistics of the RIETE and SOME scores were 0.62 (95% CI, 0.57-0.66) and 0.59 (95% CI, 0.55-0.62), respectively. In patients classified as 'high risk', the cumulative incidence of cancer diagnosis during follow-up was 2.9% (95% CI, 2.1-3.9) for the RIETE score and 2.7% (95% CI, 1.9-3.7) for the SOME score, corresponding to hazard ratios of 1.8 (95% CI, 1.3-2.5) and 1.5 (95% CI, 1.04-2.2), respectively. In conclusion, the performance of both scores was poor. When used dichotomously, the scores were able to identify a group of patients with a significantly higher risk of occult cancer, although it remains unknown whether this translates into improved clinical important outcomes.


Assuntos
Técnicas de Apoio para a Decisão , Neoplasias/epidemiologia , Embolia Pulmonar/epidemiologia , Tromboembolia Venosa/epidemiologia , Trombose Venosa/epidemiologia , Adulto , Idoso , Anticoagulantes/uso terapêutico , Tomada de Decisão Clínica , Detecção Precoce de Câncer , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Neoplasias/diagnóstico , Valor Preditivo dos Testes , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Fatores de Tempo , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/diagnóstico , Trombose Venosa/tratamento farmacológico
20.
Thromb Haemost ; 118(1): 174-181, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29304537

RESUMO

Cancer patients with venous thromboembolism (VTE) have a two- to six-fold increased risk of anticoagulant-related major bleeding events compared with VTE patients without cancer. It is unknown whether major bleeding events are more severe in cancer patients than in those without cancer. Individual patient data from four randomized phase III trials that compared factor Xa inhibitors and vitamin K antagonists for the treatment of VTE were used to compare the severity of major bleeding events in patients with and without cancer. Using predefined criteria, the severity of the clinical presentation and course of major bleeding events were classified into four categories of increasing severity. A one-stage meta-analysis was used to evaluate the effect of cancer on the severity of the clinical presentation and course by estimating crude odds ratios (ORs) and ORs adjusted for age, sex and anticoagulant type with 95% confidence intervals (CIs). The study group comprised 290 patients with major bleeding, of whom 50 (17%) had cancer. The clinical presentation was judged to be severe (category 3 or 4) in 38% of patients with cancer and 44% of patients without cancer (adjusted OR, 0.90; 95% CI, 0.47-1.72). The clinical course was found to be severe in 20 and 25% of patients with and without cancer, respectively (adjusted OR, 0.75; 95% CI, 0.35-1.61). The present study suggests that the clinical presentation and course of anticoagulant-related major bleeding events are not more severe in cancer patients than in patients without cancer. This may be reassuring for physicians who treat cancer patients with anticoagulant-related bleeding.


Assuntos
Anticoagulantes/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Hemorragia/tratamento farmacológico , Neoplasias/complicações , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle , Idoso , Transfusão de Sangue , Método Duplo-Cego , Feminino , Hemorragia/complicações , Hemorragia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Razão de Chances , Estudos Prospectivos , Piridinas/uso terapêutico , Rivaroxabana/uso terapêutico , Tiazóis/uso terapêutico , Tromboembolia Venosa/complicações
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