Essentials
Factor Xa inhibitors cause more abnormal menstrual bleeding (AUB) than vitamin‐K antagonists (VKA).
We analyzed data of AUB in women, evaluating dabigatran versus VKA.
We observed a 41% ...lower risk of AUB in women on dabigatran compared to those on VKA.
Our findings of lower AUB risk on dabigatran should be corroborated in future studies.
Summary
Introduction
Although direct oral anticoagulants (DOACs) are associated with a better safety profile than warfarin in patients with acute venous thromboembolism (VTE), direct factor Xa inhibitors involve a higher risk of abnormal uterine bleeding (AUB). We aimed to determine the risk of AUB during anticoagulation with dabigatran compared with warfarin.
Methods
Post‐hoc analysis of the pooled RE‐COVER studies and the RE‐MEDY trial. Incidences of AUB, based on a defined preferred terms search for adverse events, in female patients aged 18–50 years treated with dabigatran, were compared with those in women treated with warfarin.
Results
Of the 2964 women included in the above‐mentioned trials, 1280 women were in the relevant age category (18–50 years) and included in the current analysis. A total of 643 patients were randomized to treatment with dabigatran and 637 to treatment with warfarin. The overall rate of AUB was 8.1%, 5.9% for the women treated with dabigatran and 9.6% in those treated with warfarin, for an odds ratio for dabigatran‐treated patients of 0.59 (95% confidence interval CI, 0.39–0.90; P = 0.015). In the dabigatran‐treated patients, three (0.5%) suffered major bleeding (MB) vs. five (0.8%) in the warfarin‐treated patients (HR, 0.65; 95% CI, 0.15–2.72). MB or non‐major relevant bleeding occurred in 30 (4.7%) patients randomized to receive dabigatran and 57 (8.9%) randomized to receive warfarin (HR, 0.53; 95% CI, 0.34–0.83). None of the bleeding events was fatal.
Conclusion
Dabigatran treatment was associated with a significantly (41%) lower risk of AUB than warfarin. Future studies in daily practice are needed to corroborate these findings.
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FZAB, GEOZS, GIS, IJS, IMTLJ, IZUM, KILJ, KISLJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBJE, SBMB, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Since the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, most attention has focused on containing transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and ...addressing the surge of critically ill patients in acute care settings. Indeed, as of 29 April 2020, over 3 million confirmed cases have been accounted for globally 1. In the coming weeks and months, emphasis will gradually involve also post-acute care of COVID-19 survivors. It is anticipated that COVID-19 may have a major impact on physical, cognitive, mental and social health status, also in patients with mild disease presentation 2. Previous outbreaks of coronaviruses have been associated with persistent pulmonary function impairment, muscle weakness, pain, fatigue, depression, anxiety, vocational problems, and reduced quality of life to various degrees 3–5.
An ordinal tool is proposed to measure the full spectrum of functional outcomes following COVID-19. This “Post-COVID-19 Functional Status (PCFS) scale” can be used for tracking functional status over time as well as for research purposes.
https://bit.ly/3cofGaa
Pulmonary infarction results from occlusion of the distal pulmonary arteries leading to ischemia, hemorrhage and ultimately necrosis of the lung parenchyma. It is most commonly caused by acute ...pulmonary embolism (PE), with a reported incidence of around 30%. Following an occlusion of the pulmonary artery, the bronchial arteries are recruited as primary source of perfusion of the pulmonary capillaries. The relatively higher blood pressure in the bronchial circulation causes an increase in the capillary blood flow, leading to extravasation of erythrocytes (i.e. alveolar hemorrhage). If this hemorrhage cannot be resorbed, it results in tissue necrosis and infarction. Different definitions of pulmonary infarction are used in literature (clinical, radiological and histological), although the diagnosis is nowadays mostly based on radiological characteristics. Notably, the infarcted area is only replaced by a fibrotic scar over a period of months. Hence and formally, the diagnosis of pulmonary infarction cannot be confirmed upon diagnosis of acute PE. Little is known of the impact and relevance of pulmonary infarction in acute PE, and whether specific management strategies should be applied to prevent and/or treat complications such as pain, pneumonia or post-PE syndrome. In this review we will summarize current knowledge on the pathophysiology, epidemiology, diagnosis and prognosis of pulmonary infarction in the setting of acute PE. We highlight the need for dedicated studies to overcome the current knowledge gaps.
•Nearly 30% of acute pulmonary embolism patients show signs of pulmonary infarction.•Various pulmonary infarction definitions are used (clinical/radiological/histological).•Whether pulmonary infarction requires specific treatment is unknown.•Future research should focus on long-term clinical outcomes of pulmonary infarction.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Because pregnant women have an increased risk of venous thromboembolism (VTE) and at the same time normal pregnancy is associated with symptoms, mimicking those present in the setting of ...acute pulmonary embolism (PE), the latter diagnosis is frequently suspected in this patient category. Since imaging tests expose both mother and foetus to ionizing radiation, the ability to rule out PE based on non-radiological diagnostic tests is of paramount importance. However, clinical decision rules have only been scarcely evaluated in the pregnant population with suspected PE, while D-dimer levels lose diagnostic accuracy due to a physiological increase during normal pregnancy. Consequently, clinical guidelines provide contradicting and weak recommendations on this subject and the optimal diagnostic strategy remains highly debated. With this systematic review, we aimed to summarize current evidence on the safety and efficacy of clinical decision rules and biomarkers used in the diagnostic management of suspected acute PE in pregnant patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Abstract Purpose International guidelines do not provide strong recommendations on the duration and intensity of follow-up after acute pulmonary embolism (PE), nor on screening-programs for chronic ...thromboembolic pulmonary hypertension (CTEPH). We aimed to address this gab by performing an external validation of the easy “CTEPH rule-out-criteria” based on a normal NT-proBNP level and the absence of 3 ECG characteristics. Methods 134 patients underwent clinical follow-up 6 months after PE. Predefined transthoracic echocardiographic (TTE) criteria were used to categorize patients as “PH unlikely” or “PH possible/likely”. The latter patients underwent further (invasive) diagnostic procedures to confirm and classify the diagnosis of pulmonary hypertension. NT-proBNP and ECGs, both assessed at the day of echocardiography, were evaluated post-hoc. Results Sixty-three patients (47%) scored none of the “CTEPH rule-out criteria” positive, of whom 61 had normal TTE (97%). Twenty-five patients (19%) were categorized by TTE as “PH possible/likely”; of those, 6 were diagnosed with CTEPH. The sensitivity of rule-out criteria for CTEPH was 100% (95%CI 56-100%; 6/6 patients identified), and for “PH possible/likely” on TTE 92% (95%CI 74-99%; 23/25 patients identified): 2 asymptomatic patients with estimated systolic pulmonary arterial pressure of 36 mmHg and 38 mmHg, respectively, who remained stable during further 2-year follow-up, were not identified. Inter-observer agreement for the adjudication of the ECG characteristics was excellent (kappa-statistic 0.97). Conclusions In this external validation cohort, we confirmed the diagnostic accuracy and reproducibility of the “CTEPH rule-out criteria”. These results provide a solid ground for future outcome trials applying this algorithm.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
•COVID-19 had a major impact on Thrombosis Research.•The number of submitted papers in 2020 increased by 150% compared to 2019.•Thrombosis Research published 100 papers on COVID-19 in 2020.•Number of ...downloads and citations of published papers increased considerably.•The Editors thank our reviewers and the editorial assistance offered by Elsevier.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective
To investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).
Design and setting
Post ...hoc analysis of the Hokusai‐VTE study, a multicentre, randomised, double‐blind trial comparing edoxaban with warfarin for acute symptomatic VTE.
Population
Women below 50 years receiving edoxaban or warfarin for treatment of VTE.
Methods
We collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.
Main outcome measures
Occurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.
Results
In all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person‐years (py) (95% CI 11–19) in women receiving edoxaban and 9/100 py (95% CI 6–12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1–2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin odds ratio (OR) 2.8; 95% CI 0.8–10.8, and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0–2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.
Conclusions
Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.
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Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.
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Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
COVID-19 pneumonia has been associated with high rates of thrombo-embolic complications, mostly venous thromboembolism (VTE), which is thought to be a combination of conventional VTE and in situ ...immunothrombosis in the pulmonary vascular tree. The incidence of thrombotic complications is dependent on setting (intensive care unit (ICU) versus general ward) and the threshold for performing diagnostic tests (screening versus diagnostic algorithms triggered by symptoms). Since these thrombotic complications are associated with in-hospital mortality, all current guidelines and consensus papers propose pharmacological thromboprophylaxis in all hospitalized patients with COVID-19. Several trials are ongoing to study the optimal intensity of anticoagulation for this purpose. As for the management of thrombotic complications, treatment regimens from non-COVID-19 guidelines can be adapted, with choice of anticoagulant drug class dependent on the situation. Parenteral anticoagulation is preferred for patients on ICUs or with impending clinical deterioration, while oral treatment can be started in stable patients. This review describes current knowledge on incidence and pathophysiology of COVID-19 associated VTE and provides an overview of guideline recommendations on thromboprophylaxis and treatment of established VTE in COVID-19 patients.
Abstract
This position paper provides a comprehensive guide for optimal follow-up of patients with acute pulmonary embolism (PE), covering multiple relevant aspects of patient counselling. It serves ...as a practical guide to treating patients with acute PE complementary to the formal 2019 European Society of Cardiology guidelines developed with the European Respiratory Society. We propose a holistic approach considering the whole spectrum of serious adverse events that patients with acute PE may encounter on the short and long run. We underline the relevance of assessment of modifiable risk factors for bleeding, of acquired thrombophilia and limited cancer screening (unprovoked PE) as well as a dedicated surveillance for the potential development of chronic thromboembolic pulmonary hypertension as part of routine practice; routine testing for genetic thrombophilia should be avoided. We advocate the use of outcome measures for functional outcome and quality of life to quantify the impact of the PE diagnosis and identify patients with the post-PE syndrome early. Counselling patients on maintaining a healthy lifestyle mitigates the risk of the post-PE syndrome and improves cardiovascular prognosis. Therefore, we consider it important to discuss when and how to resume sporting activities soon after diagnosing PE. Additional patient-relevant topics that require Focused counselling are travel and birth control.
Graphical Abstract
Graphical Abstract
Overview of main conclusions of the position paper. APS, antiphospholipid antibody syndrome; aPTT, activated partial thromboplastin time; CTEPH, chronic thromboembolic pulmonary hypertension; PE, pulmonary embolism.
Summary Background The exact prevalence and etiology of exertional dyspnea in the clinical course of acute pulmonary embolism (PE) have not yet been established. Methods A large cohort of consecutive ...patients diagnosed with acute PE was subjected to a dyspnea questionnaire and invited for cardiopulmonary work-up including the 6-min walk test, spirometry and echocardiography. The prevalence, severity, determinants and underlying diseases of exertional dyspnea were evaluated. Results Of the registered 877 patients, 259 (30%) had died and 11 (1.3%) were excluded for geographical reasons. From the remaining 607 patients, 217 reported exertional dyspnea (36%; 95% CI 32–40%) 3.6 ± 1.7 years after the PE. In 76% this dyspnea had developed or worsened after the acute PE. 421 patients completed the cardiopulmonary work-up. Cardiopulmonary comorbidity (OR 12; 95% CI 6.5–20), advanced age (OR 1.02 per year; 95% CI 1.01–1.03), higher BMI (OR 1.06 per kg/m2 ; 95% CI 1.01–1.1) and a smoking history (OR 1.6; 95% CI 1.02–2.6) were identified as independent predictors of exertional dyspnea. A pre-defined dyspnea explaining diagnosis could be established in all patients with exertional dyspnea. In only 4 patients, this diagnosis was directly correlated to the acute PE. Increased severity of dyspnea was associated with decreased exercise performance ( p < 0.001) and a higher number of dyspnea-related diagnoses ( p < 0.001). Conclusion Exertional dyspnea is a frequent symptom in the long term clinical course of acute PE. More severe dyspnea results in decreased exercise capacity and increased burden of cardiopulmonary comorbidity. This dyspnea is likely to be unrelated to the past thromboembolic event in the vast majority of patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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