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1.
Hypertension ; 75(3): 781-787, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31928113

RESUMO

Hypertension during pregnancy and preeclampsia are associated with increased arterial thrombotic risk in later life. Whether these complications are associated with risk of venous thromboembolism (VTE) on the short term after pregnancy and on the long term, that is, outside pregnancy, is largely unknown. We conducted a nationwide cohort study in women with at least 1 pregnancy and their first VTE risk by linking the Dutch perinatal registry (Perined) to anticoagulation clinics. We used Cox proportional hazard models to estimate hazard ratios (HRs) and corresponding 95% CI for VTE risk in women with hypertension during pregnancy, women with preeclampsia, compared with women with uncomplicated pregnancies (reference). A total of 1 919 918 women were followed for a median of 13.7 (interquartile range, 7.6-19.2) years for a total of 24 531 118 person-years in which 5759 first VTEs occurred; incidence rate: 2.3 (95% CI, 2.3-2.4) per 10 000 person-years. In the first pregnancy and 3-month postpartum period, VTE risk was higher in women with hypertension, HR, 2.0 (95% CI, 1.7-2.4), and highest among women with preeclampsia, HR, 7.8 (95% CI, 5.4-11.3), versus the reference group. On the long term, women with hypertension during pregnancy and preeclampsia had a higher VTE risk: HR, 1.5 (95% CI, 1.4-1.6) and HR, 2.1 (95% CI, 1.8-2.4), respectively, versus the reference group. When excluding events during pregnancy and postpartum, these HRs were 1.4 (95% CI, 1.3-1.5) and 1.6 (95% CI, 1.4-2.0), respectively. In conclusion, hypertension during pregnancy and preeclampsia are associated with an increased VTE risk during pregnancy and postpartum period and in the 13 years after.

2.
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.

3.
Thromb Haemost ; 120(1): 55-64, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31705518

RESUMO

BACKGROUND: Factor V (FV) is proteolytically activated to FVa, which assembles with FXa in the prothrombinase complex. The C-terminus of tissue factor pathway inhibitor-α (TFPIα) inhibits both the activation and the prothrombinase activity of FV(a), but the pathophysiological relevance of this anticoagulant mechanism is unknown. FV Leiden (FVL) is less susceptible to inhibition by TFPIα, while overexpression of FV splicing variants with increased affinity for TFPIα (FV-short) causes bleeding. OBJECTIVE: This study aims to develop a plasma-based assay that quantifies the susceptibility of FV(a) to inhibition by the TFPIα C-terminus. MATERIALS AND METHODS: FV in highly diluted plasma was preactivated with FXa in the absence or presence of the TFPIα C-terminal peptide. After adding prothrombin, thrombin formation was monitored continuously with a chromogenic substrate and prothrombinase rates were obtained from parabolic fits of the absorbance tracings. TFPI resistance was expressed as the ratio of the prothrombinase rates with and without peptide (TFPIr). RESULTS: The TFPIr (0.25-0.34 in 45 healthy volunteers) was independent of FV levels. The TFPIr increased from normal individuals (0.29, 95% confidence interval [CI] 0.28-0.31) to FVL heterozygotes (0.35, 95% CI 0.34-0.37) and homozygotes (0.39, 95% CI 0.37-0.40), confirming TFPI resistance of FVL. Two individuals overexpressing FV-shortAmsterdam had markedly lower TFPIr (0.16, 0.18) than a normal relative (0.29), in line with the high affinity of FV-short for TFPIα. CONCLUSION: We have developed and validated an assay that measures the susceptibility of plasma FV to the TFPIα C-terminus. Once automated, this assay may be used to test whether the TFPIr correlates with thrombosis or bleeding risk in population studies.

5.
BMC Pregnancy Childbirth ; 19(1): 455, 2019 Nov 29.
Artigo em Inglês | MEDLINE | ID: mdl-31783795

RESUMO

BACKGROUND: To determine the risk of cesarean delivery after labor induction among patients with prior placenta-mediated pregnancy complications (pre-eclampsia, late pregnancy loss, placental abruption or intrauterine growth restriction). METHODS: The AFFIRM database includes patient level data from 9 randomized controlled trials that evaluated the role of LMWH versus no LMWH during pregnancy to prevent recurrent placenta-mediated pregnancy complications. The primary outcome of this sub-study was the proportion of women who had an unplanned cesarean delivery after induction of labor compared to after spontaneous labor. RESULTS: There were 512 patients from 7 randomized trials included in our sub-study. There was no difference in the risk of cesarean delivery between women with labor induction (21/148, 14.2%) and spontaneous labor (79/364, 21.7%) (odds ratio (OR) 0.60, 95% CI, 0.35-1.01; p = 0.052). Among 274 women who used LMWH prophylaxis during pregnancy, the risk of cesarean delivery was lower among those that underwent labor induction (9.8%) compared to spontaneous labor (22.4%) (OR 0.38, 95% CI, 0.17-0.84; p = 0.01). CONCLUSIONS: The risk of cesarean delivery is not increased after labor induction among a higher risk patient population with prior pregnancy complications. Our results suggest that women who receive LMWH during pregnancy might benefit from labor induction.

6.
Lancet Respir Med ; 2019 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-31615719

RESUMO

BACKGROUND: European estimates of the burden imposed by pulmonary embolism are not available to this date. We aimed to assess pulmonary embolism-related mortality and time trends in the WHO European Region. METHODS: We analysed vital registration data from the WHO Mortality Database (2000-15) covering subregions of the WHO European Region: Eastern Europe, Northern Europe, Southern Europe, Western Europe, and Central Asia. Deaths were considered pulmonary embolism-related if International Classification of Disease-10 code for acute pulmonary embolism (I26) or any code for deep or superficial vein thrombosis was listed as the primary cause of death. We used locally estimated scatterplot smoothing weighted by size of the Member State population to calculate proportionate mortality and time trends in age-standardised mortality. FINDINGS: In the 3-year period between 2013 and 2015, an average of 38 929 pulmonary embolism-related deaths occurred annually in the 41 Member States with available data and a population of 650 950 921; among individuals aged 15-55 years, pulmonary embolism accounted for 8-13 per 1000 deaths in women and 2-7 per 1000 deaths in men. Between 2000 and 2015, age-standardised annual pulmonary embolism-related mortality rates decreased linearly from 12·8 (95% CI 11·4-14·2) to 6·5 (5·3-7·7) deaths per 100 000 population without substantial sex-specific differences. INTERPRETATION: The observed decreasing trends in pulmonary embolism-related mortality might reflect improved management of the disease, in line with case fatality data from cohort studies. Additional, or alternative, explanations might include the absence of a uniform case definition and changes in coding practices and performing autopsy. Pulmonary embolism still imposes a relevant medical and societal burden. Continuing efforts are warranted to improve awareness and implement effective preventive and therapeutic measures. FUNDING: German Federal Ministry of Education and Research.

7.
Res Pract Thromb Haemost ; 3(4): 607-614, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31624780

RESUMO

Online patient registries are used to collect data on clinical conditions with rare occurrence or unclear diagnostic and management practices. The success of these registries depends on clear definition of goals, correct identification of patient population/inclusion criteria, availability of appropriate setup and maintenance tools, and the quality of dissemination. The Scientific and Standardization Committee (SSC) for Women's Health Issues in Thrombosis and Hemostasis, one of 20 committees of the International Society on Thrombosis and Haemostasis (ISTH) has developed 6 registries for women's bleeding and thrombotic conditions over the past 2 years and are currently in various stages of progress. Here, we provide information about these registries, including rationale, objectives, and methods for data collection. The aim is to enhance worldwide participation and thus promote the success of these registries. We used ISTH REDCap, a mature and secure Web application for building and managing online surveys and databases, and the ISTH advertising platform to maximize participation. Registries (links and project details available on ISTH and Women's SSC Web sites) include: (1) WiTEAM, project on thrombophilia and placenta-mediated obstetric complications; (2) a registry for disseminated intravascular coagulation in pregnancy; (3) severe congenital protein C deficiency-an obstetric study; (4) obstetric and gynecologic outcomes of women with platelet function disorders; (5) thrombolysis and invasive treatments for massive pregnancy-related pulmonary embolism; (6) pregnancy and exposure to direct oral anticoagulants. The ISTH promotes online registries on women's issues to enhance understanding of current practices, identify knowledge gaps, promote research, and ultimately improve patient safety and quality of life.

10.
J Thromb Haemost ; 17(11): 1790-1797, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31465627

RESUMO

The medical care of transgender patients relies on the use of sex hormones to develop and maintain the physical characteristics consistent with gender identity as the first step in transitioning. Hormonal therapy is usually continued indefinitely, even following gender-affirming surgeries. The use of hormonal treatments is associated with a multitude of positive effects as well as complications and side effects. The risk of venous thromboembolism (VTE) is a major concern. Transgender patients are often referred to coagulation specialists for advice regarding an individual patient's risk for VTE, especially if there is a personal or family history of VTE. Coagulation specialists need to be familiar with endocrine therapy including the goals of treatment and the VTE risks associated with currently used hormone regimens. We will review common referral questions and the available data and their limitations for the use of hormonal therapy in transgender patients focusing on the risk of VTE.

11.
J Thromb Haemost ; 17(9): 1417-1429, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31220399

RESUMO

Sex matters when it comes to venous thromboembolism (VTE). We defined 5P's - period, pill, prognosis, pregnancy, and postthrombotic syndrome - that should be discussed with young women with VTE. Menstrual blood loss (Period) can be aggravated by anticoagulant therapy. This seems particularly true for direct oral anticoagulants. Abnormal uterine bleeding can be managed by hormonal therapy, tranexamic acid, or modification of treatment. The use of combined oral contraceptives (Pill) is a risk factor for VTE. The magnitude of the risk depends on progestagen types and estrogen doses used. In women using therapeutic anticoagulation, concomitant hormonal therapy does not increase the risk of recurrent VTE. Levonorgestrel-releasing intrauterine devices and low-dose progestin-only pills do not increase the risk of VTE. In young women VTE is often provoked by transient hormonal risk factors that affects prognosis. Sex is incorporated as predictor in recurrent VTE risk assessment models. However, current guidelines do not propose using these to guide treatment duration. Pregnancy increases the risk of VTE by 4-fold to 5-fold. Thrombophilia and obstetric risk factors further increase the risk of pregnancy-related VTE. In women with a history of VTE, the risk of recurrence during pregnancy or post partum appears to be influenced by risk factors present during the first VTE. In most women with a history of VTE, antepartum and postpartum thromboprophylaxis with low-molecular-weight heparin is indicated. Women generally are affected by VTE at a younger age then men, and they have to deal with long-term complications (Post-thrombotic syndrome) of deep vein thrombosis early in life.

13.
J Thromb Haemost ; 17(8): 1297-1304, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31054196

RESUMO

BACKGROUND: The risk of venous thromboembolism (VTE) in young women can predominantly be attributed to exogenous hormone use. The influence of (abnormalities in) endogenous sex hormones, as in polycystic ovary syndrome (PCOS) or primary ovarian insufficiency (POI), on VTE risk is uncertain. OBJECTIVES: Th assess the association between endogenous sex hormone levels and VTE risk. METHODS: Women aged ≤45 years from the MEGA case-control study who provided a blood sample in the absence of exogenous hormone exposure or pregnancy were included. Sex hormone-binding globulin (SHBG), estradiol, follicle-stimulating hormone (FSH) and testosterone were measured. The free androgen index (FAI) and estradiol to testosterone ratio (E:T) were calculated. VTE risk was assessed according to quartiles (Qs) of levels and clinical cut-offs as proxies for PCOS (FAI > 4.5) and POI (FSH > 40 U/L). Logistic regression models were used to estimate adjusted odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Six hundred and sixty-five women (369 cases; 296 controls) were eligible for the analyses. Testosterone and FSH levels, E:T and POI (FSH > 40 U/L vs FSH ≤ 40 U/L) were not associated with VTE risk. For estradiol, VTE risk was increased with levels in Q4 vs Q1 (OR 1.6; 95% CI 1.0-2.5). There was a dose-response relationship between SHBG levels and VTE risk, with the highest OR at Q4 vs Q1: 2.0 (95% CI 1.2-3.3). FAI > 4.5 (PCOS proxy) vs FAI ≤ 4.5 was associated with increased VTE risk (OR 3.3; 95% CI 0.9-11.8). CONCLUSIONS: Estradiol, SHBG and FAI were associated with VTE risk, suggesting a role for endogenous sex hormones in the pathophysiology of VTE in young women.

14.
J Hypertens ; 37(7): 1467-1474, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31145714

RESUMO

OBJECTIVE: Hypertensive disorders in pregnancy pose a major burden during pregnancy and are also associated with an increased risk for hypertension later in life. Plasma creatine kinase activity is identified in the general population as an independent risk factor for hypertension. We hypothesize that plasma creatine kinase activity is similarly associated with blood pressure during pregnancy. METHODS: Women who participated in the 'Amsterdam Born Children and their Development-study' were eligible for the current study. The associations between plasma creatine kinase activity and blood pressure measurements during pregnancy, and between plasma creatine kinase activity and hypertensive disorders in pregnancy (gestational hypertension, HELLP, preeclampsia and eclampsia) were evaluated using multiple linear regression and logistic regression models. RESULTS: In 3619 pregnant women, plasma creatine kinase activity was significantly associated with all blood pressure outcomes. This was most pronounced for the mean SBP throughout pregnancy, with a regression coefficient of 3.48 mmHg (CI 1.67-5.28, P < 0.001) per 1-unit logCK. With respect to the hypertensive disorders in pregnancy, we found a significant association between severe gestational hypertension diagnosed before 34 weeks of gestation (OR 9.16, CI 1.32-63.86, P = 0.025) per 1-unit logCK activity. HELLP and preeclampsia were not significantly associated. CONCLUSION: Our data show that plasma creatine kinase activity measured in early pregnancy is associated with blood pressure during pregnancy and associated with severe gestational hypertension diagnosed before 34 weeks of gestation, whereas no significant association was found between creatine kinase and other hypertensive disorders in pregnancy.

15.
J Heart Lung Transplant ; 38(7): 731-738, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30962147

RESUMO

BACKGROUND: Chronic thromboembolic pulmonary hypertension (CTEPH) is often diagnosed after a long delay, even though signs may already be present on the computed tomography pulmonary angiogram (CTPA) used to diagnose a preceding acute pulmonary embolism (PE). In this setting of suspected acute PE, we evaluated the diagnostic accuracy of dedicated CTPA reading for the diagnosis of already existing CTEPH. METHODS: Three blinded expert radiologists scored radiologic signs of CTEPH on initial CTPA scans with confirmed acute PE in 50 patients who were subsequently diagnosed with CTEPH during follow-up (cases), and in 50 patients in whom sequential echocardiograms performed >2 years after the acute PE diagnosis did not show any signs of pulmonary hypertension (controls). All 50 control index CTPA scans had signs of right ventricular (RV) overload. Sensitivity and specificity of expert CTPA reading was calculated, and best-predicting radiologic parameters were identified. RESULTS: The overall expert reading yielded a sensitivity of 72% (95% confidence interval [CI] 58%-84%) and a specificity of 94% (95% CI 83%-99%) for CTEPH diagnosis. Multivariate analysis identified 6 radiologic parameters as independent predictors: intravascular webs; pulmonary artery retraction or dilatation; bronchial artery dilatation; right ventricular (RV) hypertrophy; and interventricular septum flattening. The presence of 3 or more these parameters was associated with a sensitivity of 70% (95% CI 55%-82%), a specificity of 96% (95% CI 86%-100%), and a c-statistic of 0.92. CONCLUSIONS: Standardized reading of CTPA scans performed for acute PE can be useful for the diagnosis of CTEPH when structured identification of 6 characteristics is employed during interpretation. The use of this strategy may help reduce diagnostic delay of CTEPH.

16.
Res Pract Thromb Haemost ; 3(2): 234-241, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31011707

RESUMO

Background: Venous thromboembolism (VTE) is relatively common in children with acute lymphoblastic leukemia (ALL). Thrombotic risk factors in ALL are asparaginase and steroids. However, within the ALL populations treated on the same regimen, it is less clear which other risk factors play a role. Furthermore, few data are available on the effect of VTE on ALL outcomes. Methods: In 778 children (1-18 years) with newly diagnosed precursor-B-lineage or T-lineage ALL, treated in the Dutch Childhood Oncology Group (DCOG) ALL-10 protocol in the Netherlands (October 2004 to April 2013), we conducted a nested case control study with 59 VTE cases and 118 controls to identify risk factors for VTE. Results: Fifty-nine of 778 ALL patients developed VTE (7.6%), with cerebral venous sinus thrombosis (CVST) in 26 of 59 patients (44.1%). VTE occurred during induction treatment in 59.3% (n = 35) and in 40.7% (n = 24) during medium risk intensification. Conditional multivariable logistic regression analysis showed that age and ALL subtype were significantly associated with VTE (age ≥7 years: OR 2.72, 95% CI 1.33-5.57; ALL subtype T-ALL: OR 2.95, 95% CI 1.02-8.57). A multivariable Cox model showed no association between the occurrence of VTE and event free survival. In CVST patients, permanent disability was present in 34.6%. Conclusion: Within this large pediatric ALL cohort, we demonstrated a high morbidity in CVST patients. Age ≥7 years at diagnosis and T-ALL subtype were the main risk factors for VTE, and should be considered in preventive strategies.

17.
Pregnancy Hypertens ; 15: 118-122, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30825907

RESUMO

OBJECTIVES: High plasma creatine kinase (CK) activity is associated with hypertension in the general and pregnant population. We hypothesize that women with a history of early-onset preeclampsia are prone to hypertension due to a high CK activity level. STUDY DESIGN: Nine to 16 years after pregnancy, serum CK activity and blood pressure were measured in 117 women with a history of early-onset preeclampsia and 50 women with a history of an uncomplicated pregnancy. MAIN OUTCOME MEASURES: CK activity levels of the two groups were compared using the Mann-Whitney U test. The association between CK activity and blood pressure was evaluated by means of multivariable regression analysis. RESULTS: There was no significant difference in median (interquartile range) CK activity between women with a history of early-onset preeclampsia and an uncomplicated pregnancy (59.00 [47.00-85.00] vs. 58.00 [46.50-75.25], respectively, p = 0.774). The association between CK and systolic blood pressure was significant in women with a pregnancy history of early-onset preeclampsia (regression coefficient [95% confidence interval]: 0.123 mmHg [0.020-0.226], p = 0.019), and a trend was found for diastolic blood pressure (p = 0.069). CK and blood pressure were not significantly associated in women with a history of an uncomplicated pregnancy. CONCLUSIONS: Median CK did not significantly differ between the two groups. Serum CK activity was significantly associated with systolic blood pressure in women with a history of early-onset preeclampsia. These data suggest that CK is not a predominant factor in the increased risk of hypertension in women with a history of early-onset preeclampsia.


Assuntos
Pressão Sanguínea , Creatina Quinase/sangue , Hipertensão/sangue , Pré-Eclâmpsia/enzimologia , Adulto , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Hipertensão/etiologia , Pessoa de Meia-Idade , Pré-Eclâmpsia/fisiopatologia , Gravidez , Estatísticas não Paramétricas , Sístole
18.
N Engl J Med ; 380(12): 1139-1149, 2019 03 21.
Artigo em Inglês | MEDLINE | ID: mdl-30893534

RESUMO

BACKGROUND: Pulmonary embolism is one of the leading causes of maternal death in the Western world. Because of the low specificity and sensitivity of the d-dimer test, all pregnant women with suspected pulmonary embolism undergo computed tomographic (CT) pulmonary angiography or ventilation-perfusion scanning, both of which involve radiation exposure to the mother and fetus. Whether a pregnancy-adapted algorithm could be used to safely avoid diagnostic imaging in pregnant women with suspected pulmonary embolism is unknown. METHODS: In a prospective study involving pregnant women with suspected pulmonary embolism, we assessed three criteria from the YEARS algorithm (clinical signs of deep-vein thrombosis, hemoptysis, and pulmonary embolism as the most likely diagnosis) and measured the d-dimer level. Pulmonary embolism was ruled out if none of the three criteria were met and the d-dimer level was less than 1000 ng per milliliter or if one or more of the three criteria were met and the d-dimer level was less than 500 ng per milliliter. Adaptation of the YEARS algorithm for pregnant women involved compression ultrasonography for women with symptoms of deep-vein thrombosis; if the results were positive (i.e., a clot was present), CT pulmonary angiography was not performed. All patients in whom pulmonary embolism had not been ruled out underwent CT pulmonary angiography. The primary outcome was the incidence of venous thromboembolism at 3 months. The secondary outcome was the proportion of patients in whom CT pulmonary angiography was not indicated to safely rule out pulmonary embolism. RESULTS: A total of 510 women were screened, of whom 12 (2.4%) were excluded. Pulmonary embolism was diagnosed in 20 patients (4.0%) at baseline. During follow-up, popliteal deep-vein thrombosis was diagnosed in 1 patient (0.21%; 95% confidence interval [CI], 0.04 to 1.2); no patient had pulmonary embolism. CT pulmonary angiography was not indicated, and thus was avoided, in 195 patients (39%; 95% CI, 35 to 44). The efficiency of the algorithm was highest during the first trimester of pregnancy and lowest during the third trimester; CT pulmonary angiography was avoided in 65% of patients who began the study in the first trimester and in 32% who began the study in the third trimester. CONCLUSIONS: Pulmonary embolism was safely ruled out by the pregnancy-adapted YEARS diagnostic algorithm across all trimesters of pregnancy. CT pulmonary angiography was avoided in 32 to 65% of patients. (Funded by Leiden University Medical Center and 17 other participating hospitals; Artemis Netherlands Trial Register number, NL5726.).


Assuntos
Algoritmos , Angiografia por Tomografia Computadorizada , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hemoptise , Complicações Cardiovasculares na Gravidez/diagnóstico , Embolia Pulmonar/diagnóstico , Tromboembolia Venosa , Doença Aguda , Adulto , Feminino , Humanos , Gravidez , Complicações Cardiovasculares na Gravidez/diagnóstico por imagem , Estudos Prospectivos , Embolia Pulmonar/diagnóstico por imagem , Tromboembolia Venosa/diagnóstico , Trombose Venosa/diagnóstico
19.
N Engl J Med ; 380(14): 1326-1335, 2019 04 04.
Artigo em Inglês | MEDLINE | ID: mdl-30730782

RESUMO

BACKGROUND: Andexanet alfa is a modified recombinant inactive form of human factor Xa developed for reversal of factor Xa inhibitors. METHODS: We evaluated 352 patients who had acute major bleeding within 18 hours after administration of a factor Xa inhibitor. The patients received a bolus of andexanet, followed by a 2-hour infusion. The coprimary outcomes were the percent change in anti-factor Xa activity after andexanet treatment and the percentage of patients with excellent or good hemostatic efficacy at 12 hours after the end of the infusion, with hemostatic efficacy adjudicated on the basis of prespecified criteria. Efficacy was assessed in the subgroup of patients with confirmed major bleeding and baseline anti-factor Xa activity of at least 75 ng per milliliter (or ≥0.25 IU per milliliter for those receiving enoxaparin). RESULTS: Patients had a mean age of 77 years, and most had substantial cardiovascular disease. Bleeding was predominantly intracranial (in 227 patients [64%]) or gastrointestinal (in 90 patients [26%]). In patients who had received apixaban, the median anti-factor Xa activity decreased from 149.7 ng per milliliter at baseline to 11.1 ng per milliliter after the andexanet bolus (92% reduction; 95% confidence interval [CI], 91 to 93); in patients who had received rivaroxaban, the median value decreased from 211.8 ng per milliliter to 14.2 ng per milliliter (92% reduction; 95% CI, 88 to 94). Excellent or good hemostasis occurred in 204 of 249 patients (82%) who could be evaluated. Within 30 days, death occurred in 49 patients (14%) and a thrombotic event in 34 (10%). Reduction in anti-factor Xa activity was not predictive of hemostatic efficacy overall but was modestly predictive in patients with intracranial hemorrhage. CONCLUSIONS: In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with andexanet markedly reduced anti-factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327.).


Assuntos
Coagulantes/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Fator Xa/uso terapêutico , Hemorragia/tratamento farmacológico , Proteínas Recombinantes/uso terapêutico , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/metabolismo , Inibidores do Fator Xa/uso terapêutico , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/tratamento farmacológico , Hemorragia/induzido quimicamente , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/tratamento farmacológico , Masculino , Curva ROC
20.
Stroke ; 50(2): 501-503, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30621526

RESUMO

Background and Purpose- Pregnancy and the postpartum period are generally considered to be risk factors for cerebral venous thrombosis (CVT), but no controlled studies have quantified the risk. Methods- Case-control study using data of consecutive adult patients with CVT from 5 academic hospitals and controls from the Dutch MEGA study (Multiple Environmental and Genetic Assessment of risk factors for venous thrombosis). Men, women over the age of 50, women using oral contraceptives or with a recent abortion or miscarriage were excluded. We adjusted for age and history of cancer, and stratified for pregnancy versus postpartum, and 0 to 6 versus 7 to 12 weeks postpartum. Results- In total 163/813 cases and 1230/6296 controls were included. Cases were younger (median 38 versus 41 years) and more often had a history of cancer (14% versus 4%) than controls. In total 41/163 (25%) cases and 82/1230 (7%) controls were pregnant or postpartum (adjusted odds ratio, 3.8; 95% CI, 2.4-6.0). The association was fully attributable to an increased risk of CVT during the postpartum period (adjusted odds ratio, 10.6; 95% CI, 5.6-20.0). We found no association between pregnancy and CVT (adjusted odds ratio, 1.2; 95% CI, 0.6-2.3). The risk was highest during the first 6 weeks postpartum (adjusted odds ratio, 18.7; 95% CI, 8.3-41.9). Conclusions- Women who have recently delivered are at increased risk of developing CVT, while there does not seem to be an increased risk of CVT during pregnancy.


Assuntos
Trombose Intracraniana , Período Pós-Parto , Complicações na Gravidez , Adulto , Fatores Etários , Estudos de Casos e Controles , Feminino , Humanos , Trombose Intracraniana/epidemiologia , Trombose Intracraniana/etiologia , Gravidez , Complicações na Gravidez/epidemiologia , Complicações na Gravidez/etiologia , Fatores de Risco
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