Immediate Discharge and Home Treatment With Rivaroxaban of Low‐risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One‐year Preplanned Analysis

BACKGROUND: The objective was to test if low-risk emergency department patients with vitamin K antagonist (venous thromboembolism [VTE]; including venous thrombosis and pulmonary embolism [PE]) can be safely and effectively treated at home with direct acting oral (monotherapy) anticoagulation in a large-scale, real-world pragmatic effectiveness trial. METHODS: This was a single-arm trial, conducted from 2016 to 2019 in accordance with the Standards for Reporting Implementation Studies guideline in 33 emergency departments in the United States. Participants had newly diagnosed VTE with low risk of death based upon either the modified Hestia criteria, or physician judgment plus the simplified PE severity index score of zero, together with nonhigh bleeding risk were eligible. Patients had to be discharged within 24 hours of triage and treated with either apixaban or rivaroxaban. Effectiveness was defined by the primary efficacy and safety outcomes, image-proven recurrent VTE and bleeding requiring hospitalization >24 hours, respectively, with an upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0% for both outcomes. RESULTS: We enrolled 1421 patients with complete outcomes data, including 903 with venous thrombosis and 518 with PE. The recurrent VTE requiring hospitalization occurred in 14/1421 (1.0% [95% CI, 0.5%–1.7%]), and bleeding requiring hospitalization occurred in 12/1421 (0.8% [0.4%–1.5%). The rate of severe bleeding using International Society for Thrombosis and Haemostasis criteria was 2/1421 (0.1% [0%–0.5%]). No patient died, and serious adverse events occurred in 2.5% of venous thrombosis patients and 2.3% of patients with PE. Medication nonadherence was reported by patients in 8.0% (6.6%–9.5%) and was associated with a risk ratio of 6.0 (2.3–15.2) for VTE recurrence. Among all patients diagnosed with VTE in the emergency department during the period of study, 18% of venous thrombosis patients and 10% of patients with PE were enrolled. CONCLUSIONS: Monotherapy treatment of low-risk patients with venous thrombosis or PE in the emergency department setting produced a low rate of bleeding and VTE recurrence, but may be underused. Patients with venous thrombosis and PE should undergo risk-stratification before home treatment. Improved patient adherence may reduce rate of recurrent VTE. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03404635

Download Full-text

Prophylaxis of venous thromboembolism in general surgery: guidelines differ and we still need local policies

Annals of The Royal College of Surgeons of England ◽

10.1308/003588411x580926 ◽

2011 ◽

Vol 93 (5) ◽

pp. 370-374

Author(s):

D Veeramootoo ◽

L Harrower ◽

R Saunders ◽

D Robinson ◽

WB Campbell

Keyword(s):

At Risk ◽

Venous Thromboembolism ◽

High Risk ◽

Risk Groups ◽

Low Risk ◽

Vte Prophylaxis ◽

Risk Patients ◽

Local Policies ◽

One Year ◽

The Uk

INTRODUCTION Venous thromboembolism (VTE) prophylaxis has become a major issue for surgeons both in the UK and worldwide. Sev-eral different sources of guidance on VTE prophylaxis are available but these differ in design and detail. METHODS Two similar audits were performed, one year apart, on the VTE prophylaxis prescribed for all general surgical inpatients during a single week (90 patients and 101 patients). Classification of patients into different risk groups and compliance in prescribing prophylaxis were examined using different international, national and local guidelines. RESULTS There were significant differences between the numbers of patients in high, moderate and low-risk groups according to the different guidelines. When groups were combined to indicate simply ‘at risk’ or ‘not at risk’ (in the manner of one of the guidelines), then differences were not significant. Our compliance improved from the first audit to the second. Patients at high risk received VTE prophylaxis according to guidance more consistently than those at low risk. CONCLUSIONS Differences in guidance on VTE prophylaxis can affect compliance significantly when auditing practice, depending on the choice of ‘gold standard’. National guidance does not remove the need for clear and detailed local policies. Making decisions about policies for lower-risk patients can be more difficult than for those at high risk.

Download Full-text

243 Cost of Medical Care for Low-Risk Emergency Department Patients With Venous Thromboembolism: Comparison of Usual Care With Warfarin versus Home Treatment With Rivaroxaban

Annals of Emergency Medicine ◽

10.1016/j.annemergmed.2014.07.270 ◽

2014 ◽

Vol 64 (4) ◽

pp. S87

Author(s):

Z.P. Kahler ◽

D.M. Beam ◽

J.A. Kline

Keyword(s):

Emergency Department ◽

Venous Thromboembolism ◽

Medical Care ◽

Usual Care ◽

Home Treatment ◽

Low Risk ◽

Emergency Department Patients

Download Full-text

Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban

Thrombosis and Haemostasis ◽

10.1160/th16-01-0004 ◽

2016 ◽

Vol 116 (07) ◽

pp. 191-197 ◽

Cited By ~ 22

Author(s):

Stefano Barco ◽

Mareike Lankeit ◽

Harald Binder ◽

Sebastian Schellong ◽

Michael Christ ◽

...

Keyword(s):

Pulmonary Embolism ◽

Venous Thromboembolism ◽

Significant Proportion ◽

Factor Xa ◽

Early Discharge ◽

Home Treatment ◽

Low Risk ◽

Hospital Treatment ◽

Resource Utilisation ◽

Factor Xa Inhibitor

SummaryPulmonary embolism (PE) is a potentially life-threatening acute cardiovascular syndrome. However, more than 95 % of patients are haemodynamically stable at presentation, and among them are patients at truly low risk who may qualify for immediate or early discharge. The Home Treatment of Pulmonary Embolism (HoT-PE) study is a prospective international multicentre single-arm phase 4 management (cohort) trial aiming to determine whether home treatment of acute lowrisk PE with the oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe. Patients with confirmed PE, who have no right ventricular dysfunction or free floating thrombi in the right atrium or ventricle, are eligible if they meet none of the exclusion criteria indicating haemodynamic instability, serious comorbidity or any condition mandating hospitalisation, or a familial/social environment unable to support home treatment. The first dose of rivaroxaban is given in hospital, and patients are discharged within 48 hours of presentation. Rivaroxaban is taken for at least three months. The primary outcome is symptomatic recurrent venous thromboembolism or PE-related death within three months of enrolment. Secondary outcomes include quality of life and patient satisfaction, and health care resource utilisation compared to existing data on standard-duration hospital treatment. HoT-PE is planned to analyse 1,050 enrolled patients, providing 80 % power to reject the null hypothesis that the recurrence rate of venous thromboembolism is >3 % with α≤0.05. If the hypothesis of HoT-PE is confirmed, early discharge and out-of-hospital treatment may become an attractive, potentially cost-saving option for a significant proportion of patients with acute PE.

Download Full-text

Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial

BMJ Open ◽

10.1136/bmjopen-2020-045905 ◽

2021 ◽

Vol 11 (6) ◽

pp. e045905

Author(s):

Delphine Douillet ◽

Jeremie Riou ◽

Maximilien Thoma ◽

Thomas Moumneh ◽

Astrid Darsonval ◽

...

Keyword(s):

Venous Thromboembolism ◽

Lower Limb ◽

Emergency Departments ◽

Low Risk ◽

Anticoagulant Treatment ◽

Stepped Wedge ◽

Cluster Randomised ◽

Limb Trauma ◽

Risk Patients ◽

Lower Limb Trauma

IntroductionPatients with lower limb trauma requiring orthopaedic immobilisation may be at risk of venous thromboembolism but opinions differ about who may benefit from thromboprophylactic anticoagulant treatment.The aim of this CASTING study is to demonstrate the safety of thromboprophylaxis based on the Thrombosis Risk Prediction for patients with cast immobilisation (TRiP(cast) score with regards to the 3-month incidence of symptomatic venous thromboembolism events in low-risk patients not receiving thromboprophylaxis, as well as the usefulness of this strategy on the rate of patients receiving anticoagulant treatment in comparison to current practice.Methods and analysisCASTING will be a stepped-wedge cluster randomised controlled clinical trial, performed in 15 emergency departments in France and Belgium. With their informed consent, outpatients admitted to one of the participating emergency departments for a lower limb trauma requiring orthopaedic immobilisation without surgery will be included. All centres will begin the trial with the ‘observational period’ and, every 2 weeks, 1 centre will be randomly assigned to switch to the ‘interventional period’ and to apply the TRiP(cast) score, in which only patients with a score ≥7 will receive thromboprophylactic anticoagulant treatment. The primary endpoint is the rate of clinical thromboembolic events within 90 days following the inclusion of low-risk patients not receiving thromboprophylaxis.Ethics and disseminationThe protocol has been approved by the Comité de Protection des Personnes Sud I (Ethics Review ID-RCB: 2019-A01829-48) for France and the Comité d’éthique hôpital-facultaire Saint Luc (N° B403201941338) for Belgium. It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT04064489.

Download Full-text

Validation of simplified PESI score for identification of low-risk patients with pulmonary embolism: From the COMMAND VTE Registry

European Heart Journal Acute Cardiovascular Care ◽

10.1177/2048872618799993 ◽

2018 ◽

Vol 9 (4) ◽

pp. 262-270 ◽

Cited By ~ 8

Author(s):

Yugo Yamashita ◽

Takeshi Morimoto ◽

Hidewo Amano ◽

Toru Takase ◽

Seiichi Hiramori ◽

...

Keyword(s):

Pulmonary Embolism ◽

Venous Thromboembolism ◽

Hospital Discharge ◽

Major Bleeding ◽

Home Treatment ◽

Low Risk ◽

Early Hospital Discharge ◽

Recurrent Venous Thromboembolism ◽

Significant Difference ◽

Risk Patients

Background: The simplified pulmonary embolism severity index (sPESI) score has been reported to be useful in predicting 30-day mortality for patients with pulmonary embolism, which helps the identification of low-risk patients for early hospital discharge or home treatment. However, therapeutic decision-making should also be based on the risks of adverse events other than mortality. Methods: The COMMAND VTE Registry is a multicentre registry enrolling consecutive patients with acute symptomatic venous thromboembolism in Japan between January 2010 and August 2014, and the current study population consisted of 1715 patients with pulmonary embolism. We calculated the sPESI score for each patient, and compared 30-day rates of mortality, recurrent venous thromboembolism and major bleeding between sPESI scores of 0 and 1 or greater. Results: Patients with a sPESI score of 0 accounted for 383 (22%) patients, and 110 (6.4%) patients died within 30 days. The cumulative 30-day incidence of mortality was lower in patients with a sPESI score of 0 than those with a sPESI score of 1 or greater (0.5% vs. 8.1%, log rank P<0.001). There was no significant difference in the cumulative 30-day incidence of recurrent venous thromboembolism between patients with a sPESI score of 0 and 1 or greater (1.3% vs. 2.8%, log rank P=0.11). The cumulative 30-day incidence of major bleeding was lower in patients with a sPESI score of 0 than those with a sPESI score of 1 or greater (1.1% vs. 4.0%, log rank P=0.005). Conclusions: In patients with a sPESI score of 0, the 30-day mortality, recurrent venous thromboembolism and major bleeding rates were reasonably low. The sPESI score could be useful to identify candidates for early hospital discharge or home treatment.

Download Full-text

8 Dissemination of a Protocol to Expedite Home Treatment of Low-Risk Patients With Venous Thromboembolism With Monotherapy Anticoagulation

Annals of Emergency Medicine ◽

10.1016/j.annemergmed.2017.07.032 ◽

2017 ◽

Vol 70 (4) ◽

pp. S4 ◽

Cited By ~ 1

Author(s):

C.L. Hall ◽

J.S. Garrett ◽

H. Wang ◽

E. Johnson ◽

J. Thammavong ◽

...

Keyword(s):

Venous Thromboembolism ◽

Home Treatment ◽

Low Risk ◽

Risk Patients

Download Full-text

Identification of Patients with Unprovoked Venous Thromboembolism and a Low Risk of Recurrence Estimated By the Vienna Prediction Model: A Prospective Cohort Management Study

Blood ◽

10.1182/blood-2021-150934 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 775-775

Author(s):

Sabine Eichinger ◽

Lisbeth Eischer ◽

Hana Šinkovec ◽

Paul Gressenberger ◽

Thomas Gary ◽

...

Keyword(s):

Venous Thromboembolism ◽

Prospective Cohort ◽

Cumulative Risk ◽

Recurrence Risk ◽

Low Risk ◽

Study Group ◽

Risk Of Recurrence ◽

One Year ◽

D Dimer

Abstract Introduction: Patients with unprovoked venous thromboembolism (VTE) have a high recurrence risk, and, according to guidelines, should receive extended oral anticoagulation (OAC). OAC prevents recurrence in most patients but may cause major bleeding. Patients with a low recurrence risk could therefore benefit from limited OAC duration. The Vienna prediction model (VPM) estimates the recurrence risk of patients with a first unprovoked deep vein thrombosis (DVT) of the leg and/or pulmonary embolism (PE) based on the patient's sex, site of index VTE and D-Dimer measured after stopping OAC (Eichinger et al., Circulation 2010). In a prospective cohort management study, we evaluated whether the VPM can identify patients with an unprovoked VTE at low recurrence risk. Methods: The study was performed between January 2013 and May 2021 at two tertiary Austrian hospitals. Patients >18 years with a first symptomatic DVT of the leg and/or symptomatic PE were eligible. The diagnosis of VTE was established by compression ultrasonography (CUS), spiral computed tomography, or lung scanning. We excluded patients with previous VTE, VTE provoked by a temporary risk factor including surgery, trauma, pregnancy, immobilisation, or female hormone intake, with cancer, OAC duration longer than 7 months or OAC for reasons other than VTE. OAC was discontinued 3 to 7 months after VTE diagnosis. D-Dimer was measured by a quantitative assay 3 weeks later and the probability of recurrence was estimated by the VPM. In patients with <180 risk points (corresponding to a predicted one-year recurrence risk of <4.4%), OAC was not resumed. CUS of both legs was performed at the time of discontinuation of OAC for reference baseline imaging in case of suspected recurrence. Patients were seen after 3, 12 and 24 months or at recurrence. Patients with a high recurrence risk (>180 VPM risk points) were excluded and their management was left to the discretion of their local practitioner. The main outcome measure was independently adjudicated recurrence of symptomatic DVT of the leg and/or symptomatic PE. The study was approved by the local ethics committees and all patients gave written informed consent. Statistical analysis: Baseline characteristics of patients were described by median and interquartile range (IQR) or by absolute frequency and percentage. The cumulative risk of recurrent VTE after discontinuation of OAC was estimated using the Kaplan-Meier method. Recurrence risk was also predicted with the VPM for each patient, and predictions were averaged over the study group. Results: Of 818 eligible patients, 520 (65%) had a risk score of <180 points and were classified as being at low risk of recurrence. They were included in the study and did not resume OAC. Their median age was 52 (42-65) years, and 289 (56%) were men. 226 (43%) patients had PE, 206 (40%) proximal and 88 (17%) distal DVT as index VTE. Median duration of anticoagulation was 3.9 (3.3-5.7) months, and the median time of follow-up was 23.9 (23.8, 23.9) months. Ten (1.9%) patients were lost to follow-up.52 patients (of which 30 were male) had non-fatal recurrent VTE (5.8 events per 100 patient-years, 95% CI 4.4-7.7). 28 (54%) patients had PE, 17 (33%) proximal and 7 (13%) distal DVT at recurrence. The cumulative risk of recurrence at one and two years was 5.2% (95% CI 3.2-7.2) and 11.2% (95% CI 8.3-14), respectively (Figure 1). The corresponding predicted recurrence risk for the study group was 4% and 7%, respectively. Conclusion: The VPM identifies patients with unprovoked VTE at low risk of recurrence. Applying the VPM refines risk stratification which could facilitate treatment decisions on the duration of OAC for patients and physicians. The model was well calibrated at one year. The apparent underestimation of the recurrence risk at two years could be countered by recalibration. Figure 1 Figure 1. Disclosures Eichinger: Takeda: Speakers Bureau; Daiichi-Sankyo: Speakers Bureau; BMS: Speakers Bureau; Bayer: Speakers Bureau; Pfizer: Speakers Bureau; Boehringer-Ingelheim: Speakers Bureau; CSL Behring: Speakers Bureau.

Download Full-text

Outpatient management of patients presenting with venous thromboembolism: Retrospective cohort study at 11 community hospitals

Journal of Thrombosis and Thrombolysis ◽

10.1007/s11239-020-02328-9 ◽

2020 ◽

Author(s):

Rasha Khatib ◽

Kara Nitti ◽

Marc McDowell ◽

Rick Szymialis ◽

Chris Blair ◽

...

Keyword(s):

Clinical Practice ◽

Venous Thromboembolism ◽

Clinical Practice Guidelines ◽

Practice Guidelines ◽

Real World ◽

Emergency Departments ◽

Hospital Admissions ◽

Hospital Management ◽

Low Risk ◽

Outpatient Management

Abstract A gap exists between clinical practice guidelines and real-world practice. We aim to investigate hospital admissions among patients presenting to emergency departments of 11 hospitals with venous thromboembolism (VTE). Eligible patients’ first emergency department VTE visit were retrospectively collected between 2013 and 2018 from electronic medical records (EMR). Patients were categorized at low risk of VTE complications if they were diagnosed with deep vein thrombosis (DVT) of the leg or if they were diagnosed with pulmonary embolism (PE) and had a PE score index < 85. Multivariable logistic regression models were constructed to measure the adjusted odds ratios (OR) and 95% confidence intervals (CI) of hospital admissions before and after clinical practice guidelines were updated to recommend outpatient management of DVT and PE with low risk of complications. A total of 13,677 patients were included in the analysis, of which 55% were diagnosed with DVT. Mean age was 65 ± 17 years, 54% were females, and 62% were Caucasian. Overall, 9281 patients were categorized at low risk VTE complications, of whom 77% were admitted for in-hospital management. The rate of in-hospital management declined from 81% in 2013 to 73% in 2018. Patients visiting emergency departments between 2016 and 2018 (post-guidelines) were equally likely to be admitted compared to patients visiting the emergency departments between 2013 and 2015 (pre-guidelines; OR = 0.99; 95% CI: 0.88, 1.11). Results from this real-world study indicate that most low-risk VTE patients are admitted for in-hospital management, despite recommendations in clinical practice guidelines.

Download Full-text

Risk of venous thromboembolism following surgical treatment of superficial venous incompetence

VASA ◽

10.1024/0301-1526/a000656 ◽

2017 ◽

Vol 46 (6) ◽

pp. 484-489 ◽

Cited By ~ 7

Author(s):

Tom Barker ◽

Felicity Evison ◽

Ruth Benson ◽

Alok Tiwari

Keyword(s):

Venous Thromboembolism ◽

Varicose Vein ◽

Lower Incidence ◽

Varicose Veins ◽

Secondary Data ◽

Foam Sclerotherapy ◽

Increased Risk ◽

Significant Difference ◽

Chi Squared ◽

One Year

Abstract. Background: The invasive management of varicose veins has a known risk of post-operative deep venous thrombosis and subsequent pulmonary embolism. The aim of this study was to evaluate absolute and relative risk of venous thromboembolism (VTE) following commonly used varicose vein procedures. Patients and methods: A retrospective analysis of secondary data using Hospital Episode Statistics database was performed for all varicose vein procedures performed between 2003 and 2013 and all readmissions for VTE in the same patients within 30 days, 90 days, and one year. Comparison of the incidence of VTEs between procedures was performed using a Pearson’s Chi-squared test. Results: In total, 261,169 varicose vein procedures were performed during the period studied. There were 686 VTEs recorded at 30 days (0.26 % incidence), 884 at 90 days (0.34 % incidence), and 1,246 at one year (0.48 % incidence). The VTE incidence for different procedures was between 0.15–0.35 % at 30 days, 0.26–0.50 % at 90 days, and 0.46–0.58 % at one year. At 30 days there was a significantly lower incidence of VTEs for foam sclerotherapy compared to other procedures (p = 0.01). There was no difference in VTE incidence between procedures at 90 days (p = 0.13) or one year (p = 0.16). Conclusions: Patients undergoing varicose vein procedures have a small but appreciable increased risk of VTE compared to the general population, with the effect persisting at one year. Foam sclerotherapy had a lower incidence of VTE compared to other procedures at 30 days, but this effect did not persist at 90 days or at one year. There was no other significant difference in the incidence of VTE between open, endovenous, and foam sclerotherapy treatments.

Download Full-text