scholarly journals Risk of Severe Bleeding With Extended Rivaroxaban to Prevent Venous Thromboembolism in Acute Medically Ill Patients With Bronchiectasis

2021 ◽  
Vol 27 ◽  
pp. 107602962110533
Author(s):  
Concetta Lipardi ◽  
C. Gregory Elliott ◽  
Chiara L. Sugarmann ◽  
Lloyd Haskell ◽  
Alex C. Spyropoulos ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Pulmonary Hemorrhage ◽  
Severe Bleeding ◽  
Medical Illness ◽  
Medically Ill ◽  
Subcutaneous Enoxaparin ◽  
Pulmonary Bleeding ◽  
Post Hoc ◽  
Medically Ill Patients

Background: Bronchiectasis is a chronic inflammation of the bronchi with recurrent infections and hemoptysis. The MAGELLAN study compared oral rivaroxaban, 10 mg once daily (QD), for 35 ± 4 days with subcutaneous enoxaparin 40 mg QD for 10 ± 4 days followed by placebo for 25 ± 4 days to prevent venous thromboembolism in patients hospitalized with an acute medical illness. MAGELLAN included a subset of patients with bronchiectasis. In a post hoc analysis, we evaluated the incidence and severity of pulmonary bleeding in patients with bronchiectasis who were hospitalized for an acute medical illness. This analysis included MAGELLAN patients diagnosed with bronchiectasis at baseline. Patients were evaluated by treatment group for International Society on Thrombosis and Haemostasis major bleeding, non-major clinically relevant (NMCR) bleeding, and the composite of the 2 (ie, clinically relevant bleeding). Results: Medically ill patients with bronchiectasis were randomized to rivaroxaban (n = 60) or enoxaparin/placebo (n = 61). There were 2 fatal pulmonary bleeds and 1 fatal gastrointestinal bleed in the rivaroxaban arm and no fatal or major bleeding in the enoxaparin/placebo arm. The incidence of major bleeding was 5% in the rivaroxaban arm. One NMCR bleed occurred in the rivaroxaban arm and 2 NMCR bleeds occurred in the enoxaparin/placebo arm. The incidence of clinically relevant bleeding was 6.7% versus 3.3% in the rivaroxaban and enoxaparin/placebo groups, respectively (relative risk = 2.06 [95% confidence interval: 0.351-12.046]). Conclusion: In-patients hospitalized with bronchiectasis and an acute medical illness, clinically relevant bleeding, including fatal pulmonary hemorrhage, occurs more frequently with extended rivaroxaban thromboprophylaxis than with enoxaparin followed by placebo.

Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients: A U.S. Perspective

2020 ◽  
Vol 120 (06) ◽  
pp. 924-936 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Walter Ageno ◽  
Alexander T. Cohen ◽  
C. Michael Gibson ◽  
Samuel Z. Goldhaber ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Clinical Benefit ◽  
Clinical Pathways ◽  
Hospital Length Of Stay ◽  
Patient Specific ◽  
Medical Illness ◽  
Medically Ill ◽  
Oral Agents ◽  
Net Clinical Benefit ◽  
Medically Ill Patients

AbstractVenous thromboembolism (VTE) remains a major cause of morbidity and mortality in hospitalized medically ill patients. These patients constitute a heterogeneous population, whose VTE risk is dependent upon the acute medical illness, immobility status, and patient-specific risk factors that have been incorporated into individualized VTE risk assessment models. Randomized placebo-controlled trials (RCTs) have shown both efficacy and net clinical benefit of in-hospital thromboprophylaxis, which is supported by guideline recommendations. The data for extended posthospital discharge thromboprophylaxis are more nuanced. RCTs comparing standardized duration low-molecular weight heparin versus extended duration direct oral anticoagulants, such as betrixaban and rivaroxaban, have shown efficacy and net clinical benefit in select groups of high VTE and low-bleed risk populations of hospitalized medically ill patients. These oral agents are now approved for both in-hospital and extended thromboprophylaxis. However, the most recent guidelines do not recommend routine use of these agents for extended thromboprophylaxis. Longitudinal studies in medically ill patients have shown that the majority of VTE events occur in the posthospital discharge setting within 6 weeks of hospitalization. This, coupled with the short hospital length-of-stay and lack of routine postdischarge thromboprophylaxis in U.S. health care settings, has dampened quality improvement efforts aimed at reducing hospital-acquired VTE. The aim of this multidisciplinary document is to provide an evidence-based framework to guide clinicians in assessing VTE and bleeding risk in hospitalized medically ill patients using an individualized, risk-adapted, and patient-centered approach, with the aim of providing clinical pathways toward the use of appropriate type and duration of available thromboprophylactic agents.

Disease burden and unmet needs for prevention of venous thromboembolism in medically ill patients in Europe show underutilisation of preventive therapies

2011 ◽  
Vol 106 (10) ◽  
pp. 600-608 ◽  
Author(s):  
Sharon Welner ◽  
Maria Kubin ◽  
Kerstin Folkerts ◽  
Sylvia Haas ◽  
Hanane Khoury
Keyword(s):  
Venous Thromboembolism ◽  
Care Delivery ◽  
Risk Groups ◽  
Considerable Proportion ◽  
Medical Illness ◽  
Medical Patients ◽  
Vte Prophylaxis ◽  
Medically Ill ◽  
Medical Inpatients ◽  
Clear Identification

SummaryIt was the aim of this review to assess the incidence of venous thromboembolism (VTE) and current practice patterns for VTE prophylaxis among medical patients with acute illness in Europe. A literature search was conducted on the epidemiology and prophylaxis practices of VTE prevention among adult patients treated in-hospital for major medical conditions. A total of 21 studies with European information published between 1999 and April 2010 were retrieved. Among patients hospitalised for an acute medical illness, the incidence of VTE varied between 3.65% (symptomatic only over 10.9 days) and 14.9% (asymptomatic and symptomatic over 14 days). While clinical guidelines recommend pharmacologic VTE prophylaxis for patients admitted to hospital with an acute medical illness who are bedridden, clear identification of specific risk groups who would benefit from VTE prophylaxis is lacking. In the majority of studies retrieved, prophylaxis was under-used among medical inpatients; 21% to 62% of all patients admitted to the hospital for acute medical illnesses did not receive VTE prophylaxis. Furthermore, among patients who did receive prophylaxis, a considerable proportion received medication that was not in accord with guidelines due to short duration, suboptimal dose, or inappropriate type of prophylaxis. In most cases, the duration of VTE prophylaxis did not exceed hospital stay, the mean duration of which varied between 5 and 11 days. In conclusion, despite demonstrated efficacy and established guidelines supporting VTE prophylaxis, utilisation rates and treatment duration remain suboptimal, leaving medical patients at continued risk for VTE. Improved guideline adherence and effective care delivery among the medically ill are stressed.

scholarly journals The Safety and Efficacy of Full Versus Reduced Dose Betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention with Extended Duration Betrixaban (APEX) Trial

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3824-3824
Author(s):  
Alexander T Cohen ◽  
Rim Halaby ◽  
Serge Korjian ◽  
Yazan Daaboul ◽  
Donald Szlosek ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Major Bleeding ◽  
Primary Analysis ◽  
Advisory Committees ◽  
Medically Ill ◽  
Reduced Dose ◽  
Efficacy Outcome ◽  
Venous Thromboembolism Prevention ◽  
Extended Duration

Abstract Background: The exposure of all the currently licenced DOACs is increased in renal impairment and by certain drug interactions. The Acute Medically Ill VTE (Venous Thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among acutely ill medical patients. The full 80 mg dose of betrixaban was halved to 40 mg among subjects with severe renal insufficiency (calculated creatinine clearance <30ml/min), or receiving a concomitant strong P-glycoprotein (P-gp) inhibitor. Objectives and Methods: The goal of this analysis is to assess the efficacy and safety of full (80 mg) and reduced dose (40 mg) betrixaban relative to enoxaparin in the APEX trial. Subjects were stratified into the two dose groups prior to randomization according to the pre-specified dosing criteria. The primary efficacy outcome was the composite of asymptomatic proximal and symptomatic venous thromboembolism (proximal or distal deep-vein thrombosis, symptomatic nonfatal pulmonary embolism, or death from venous thromboembolism). The principal safety outcome was major bleeding. Results: The median concentration of betrixaban among subjects administered the 80 mg dose was higher than that of the 40 mg dose (19 ng/ml vs 11 ng/ml, p<0.0001). In the primary analysis Cohort 1 (the elevated D-dimer +ve patients), the primary efficacy outcome was significantly reduced among subjects treated with 80 mg of extended dose betrixaban vs enoxaparin [6.3% (95/1516) vs 8.4% (130/1549), RRR = 0.26 (0.04-0.42), p=0.023]. A similar reduction was observed in the entire modified Intention to Treat (mITT) population [4.87% (122/2506) vs 7.06% (181/2562), RRR = 0.30 (0.13 - 0.44), p=0.001]. In contrast, among subjects receiving 40 mg of betrixaban there was no significant difference in the primary outcomes compared with enoxaparin across Cohorts 1, 2, and 3. There was no excess of major bleeding associated with administration of either the full 80 mg dose or the reduced 40 mg dose of betrixaban as compared with enoxaparin. Conclusion: For extended duration prophylaxis against VTE in hospitalized medically ill patients, the full 80 mg dose of extended duration betrixaban achieves higher serum concentrations than the 40 mg dose and is associated with improved efficacy across all cohorts relative to standard dose enoxaparin, without an excess risk of major bleeding. Based upon the approximate halving of plasma concentrations in this analysis and the lack of improvement in clinical outcomes, the reduced 40 mg dose may have been excessively downwardly adjusted. Conversely, the 80 mg dose was efficacious in all cohorts, including cohort 1. The inclusion of the 40 mg dose in the primary analysis may explain at least in part the marginal statistical result in the original report. Disclosures Cohen: Takeda: Consultancy; Medscape: Speakers Bureau; XO1: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Speakers Bureau; Daiichi Sankyo: Consultancy, Honoraria, Speakers Bureau; Portola: Consultancy, Honoraria, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Speakers Bureau; NHS: Membership on an entity's Board of Directors or advisory committees; Lifeblood: Membership on an entity's Board of Directors or advisory committees; Department of Health: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy, Speakers Bureau; Bayer: Consultancy, Honoraria, Speakers Bureau; Sanofi: Consultancy, Honoraria; Janssen: Consultancy; Aspen: Consultancy, Speakers Bureau; Boehringer Ingelheim: Consultancy, Speakers Bureau; Colation to Prevent Venous Thromboembolism: Other: Founder; Leo Pharma: Consultancy; UK Government Health Select Committee: Membership on an entity's Board of Directors or advisory committees; Johnson & Johnson: Consultancy, Honoraria, Speakers Bureau; ONO: Consultancy, Honoraria. Goldhaber:Portola: Consultancy. Hull:Portola: Consultancy. Hernandez:Portola: Consultancy. Gold:Portola Pharmaceuticals: Employment. Wiens:Portola: Employment, Equity Ownership. Harrington:Portola: Consultancy. Gibson:Portola: Consultancy.

scholarly journals Venous Thromboembolism in COVID-19

2020 ◽  
Vol 120 (12) ◽  
pp. 1642-1653 ◽  
Author(s):  
Sam Schulman ◽  
Yu Hu ◽  
Stavros Konstantinides
Keyword(s):  
Venous Thromboembolism ◽  
Potential Role ◽  
Treatment Guidelines ◽  
Swine Flu ◽  
Thrombolytic Treatment ◽  
Medically Ill ◽  
Risk Assessment Models ◽  
Consensus Statements ◽  
Medically Ill Patients

AbstractThe coronavirus disease 2019 (COVID-19) is our latest pandemic, preceded by the H1N1 swine flu in 2009, which lasted approximately 19 months. One of the special characteristics of COVID-19 is the propensity to cause venous thromboembolism (VTE). Thromboinflammation seems to play a prominent role in the pathogenesis. We will here review some mechanisms in the pathogenesis and discuss some hematological biomarkers, and also whether they serve as useful risk factors for VTE. The role of general risk assessment models for medically ill patients specifically in COVID-19 is appraised. The type of prophylaxis and particularly whether standard or augmented doses of chemoprophylaxis should be used is reviewed based on available evidence. We are also comparing recommendations from 10 different guidance or position/consensus statements. Treatment recommendations for patients with COVID-19 and pulmonary embolism are discussed with current general treatment guidelines as reference. Specifics for patients with COVID-19 are pointed out and the potential role of thrombolytic treatment is explored.

scholarly journals Venous Thromboembolism Prophylaxis and Risk for Acutely Medically Ill Patients Stratified by Different Ages and Renal Disease Status

2019 ◽  
Vol 25 ◽  
pp. 107602961882328 ◽  
Author(s):  
Alpesh Amin ◽  
W. Richey Neuman ◽  
Melissa Lingohr-Smith ◽  
Brandy Menges ◽  
Jay Lin
Keyword(s):  
Venous Thromboembolism ◽  
Renal Disease ◽  
Age Groups ◽  
Disease Status ◽  
The United States ◽  
Hospitalized Patients ◽  
Thromboembolism Prophylaxis ◽  
Vte Prophylaxis ◽  
Medically Ill ◽  
Medically Ill Patients

The objectives of this study were to examine venous thromboembolism (VTE) prophylaxis patterns and risk for VTE events during hospitalization and in the outpatient continuum of care among patients hospitalized for acute illnesses in the United States with stratification by different age groups and renal disease status. Acutely ill hospitalized patients were identified from the MarketScan databases (January 1, 2012-June 30, 2015) and grouped by age (<65, 65-74, ≥75 years old) and whether or not they had a baseline diagnosis of renal disease, separately. Of acutely ill hospitalized patients, 60.1% (n = 10 748) were <65 years old, 15.7% (n = 2803) were 65 to 74 years old, and 24.3% (n = 4344) were ≥75 years old; 32.9% (n = 5892) had baseline renal disease. Among the study cohorts, the majority of patients received no VTE prophylaxis regardless of age or baseline renal status (52.1%-63.6%). Rates of VTE during hospitalization and in the 6 months postdischarge were 4.7%, 4.6%, and 4.5% for patients <65, 65 to 74, and ≥75 years old, respectively, and 6.3% and 3.8% for patients with and without baseline renal disease. The risk for VTE was elevated for 30 to 40 days after index admission regardless of age and renal disease status.

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