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

2016 ◽  
Vol 116 (07) ◽  
pp. 191-197 ◽  
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.

Hospitalization or Outpatient Treatment for Acute Pulmonary Embolism - a Retrospective Cohort Study of 439 Consecutive Patients with Community-Aquired Pulmonary Embolism

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3416-3416
Author(s):  
Sebastian Werth ◽  
Virginia Kamvissi ◽  
Eberhard Kuhlisch ◽  
Jan Beyer-Westendorf
Keyword(s):  
Pulmonary Embolism ◽  
High Risk ◽  
Outpatient Treatment ◽  
Conflicts Of Interest ◽  
Subjective Assessment ◽  
Early Discharge ◽  
Low Risk ◽  
Hospital Treatment ◽  
Discharge Treatment ◽  
Risk Patients

Abstract Abstract 3416 Introduction: Therapy of pulmonary embolism (PE) today is based on risk stratification scores. Outpatient treatment for selected low-risk patients seems feasible, but data are derived from selected patient cohorts. Little is known about risk factors or clinical outcomes in unselected cohorts. In our hospital, outpatient treatment of low-risk-PE has been standard for nearly ten years. We retrospectively analyzed risk profile and 6-month-outcome of in-hospital or outpatient treatment in patients with community-aquired acute PE (CA-PE). Objectives: To evaluate the proportion of patients with outpatient or early discharge treatment of CA-PE, to evaluate the value of HESTIA score to discriminate between low and high risk patients and to assess 6-month outcome. Methods: Retrospective evaluation of all cases with CA-PE. Inclusion criteria: 1) PE symptoms as reason for hospitalization (exclusion of hospital-aquired PE); 2) symptomatic and confirmed PE (CT or V/Q scan). Evaluation of patient characteristics, hemodynamic and echocardiographic parameters and lab values and group comparisons between outpatient treatment (OT; hospitalized < 24h), early discharge (ED; hospitalized < 72h) and in-hospital treatment (HT) were performed. Result: Between 2000 and 2010, 439 patients were diagnosed with acute CA-PE (table 1). About 25% of patients could be treated as outpatients (n=49; 11.2%) or early discharged (n=63; 14.4%). Patients with in-hospital treatment of PE were significantly older and had more severe PE. Interestingly, the rate of patients with a positive history of VTE was highest in the group of outpatients (45%), followed by the early-discharge group (32%), indicating that these patients are diagnosed at an earlier stage with less severe PE. In contrast, only 25% of patients requiring in-hospital treatment of PE had a positive VTE history. Despite the differences in baseline characteristics, outcomes with regard to recurrent VTE, pulmonary hypertension or mortality were not significantly different between outpatients and early discharge patients. In contrast, outcomes of patients with in-hospital treatment was significantly different with higher mortality (0.0% vs. 3.2% vs. 15.8%). Conclusion: Even before ESC and Hestia scores were implemented, physicians subjective assessment based on hemodynamic, echocardiographic and laboratory parameters clearly discriminated between low, intermediate and high risk PE patients and allowed for outpatient treatment in low-risk PE in 11% of all PE patients. Early discharge was possible in 14% of all patients, despite higher HESTIA scores and a higher rate of elevated troponin levels, initial oxygen requirement or right heart strain in echocardiography. In contrast, patients requiring in-hospital PE treatment were older, had more severe PE and a high 6-month mortality. Despite a positive Hestia score in many patients, about 25% of all community-aquired PE patients can be safely treated as outpatient or early discharge treatment with low 6-month mortality. Disclosures: No relevant conflicts of interest to declare.

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

2018 ◽  
Vol 9 (4) ◽  
pp. 262-270 ◽  
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.

scholarly journals Predictors of unfavourable outcome in clinically stable, low risk acute pulmonary embolism patients (sPESI 0)

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
B K Karolak ◽  
M S Skowronska ◽  
M P Plywaczewska ◽  
A F Furdyna ◽  
M M Machowski ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Cardiac Troponin ◽  
Acute Pulmonary Embolism ◽  
Right Ventricular Dysfunction ◽  
Early Discharge ◽  
Favourable Outcome ◽  
Home Treatment ◽  
Low Risk ◽  
Hospital Death ◽  
Cardio Pulmonary Resuscitation

Abstract Introduction Nowadays one of the most challenging tasks is to identify, within the large group of normotensive and clinically stable acute pulmonary embolism (APE) patients, those who are at “sufficiently low” risk to permit early discharge and home treatment. Current ESC guidelines suggest, that troponin measurement is optional in sPESI 0 patients. Aim The aim of this study was to assess whether right ventricular dysfunction (RVD) in transthoracic echocardiographic examination (TTE) and/or elevated plasma troponin level improves in-hospital risk stratification in sPESI 0 patients. Methods Post-hoc analysis of a prospective study of 1191 patients with at least segmental APE confirmed in computed tomography (CT). Among this group 434 patients (208 F, age median = 52 yrs [39; 67]) were classified to low risk group according to sPESI. TTE and TnT concentration were assessed within the first 24-hours from admission. Echocardiographic criteria for RVD were RV/LV ratio≥1 or tricuspid regurgitant pressure gradient ≥31 mmHg. The sPESI score was calculated from patient records. The combined endpoint (CE) included in-hospital death of any cause and/or haemodynamic deterioration requiring catecholamines i.v., rescue thrombolysis, cardio-pulmonary resuscitation, cardiac surgical intervention or percutaneous catheter-directed treatment. Results Among 434 sPESI 0 patients, cardiac troponin plasma level was assessed in 409 individuals, 136 results were above the normal limit. CE occurred in 6 patients with elevated and 0 with non-elevated troponin concentration (p=0,0013). In 253 cases high-sensitive troponin (hsTnT) assays were used. Median hsTnT concentration was significantly higher in patients with CE (0,032 ng/ml [0,024; 0,127] vs 0,09 ng/ml [0; 0,025]) SPESI and hsTnT assessment showed AUC ROC=0.834 (0.727–0,941; p=0.000) for the CE with suggested threshold 0,024 ng/ml (Fig. 1). Interestingly, no statistically significant differences in RV/LV ratio or TRPG between CE and non-CE group were observed. Furthermore, CE did not occur more often in patients with RVD (7 vs 1; p=0,067). Conclusion SPESI combined with normal cardiac troponin plasma concentration may be used for predicting favourable outcome in patients with APE and thus select candidates for home treatment. We suggest to assess plasma troponin levels in all normotensive patients early, before discharge to home treatment. However, due to relatively low number of endpoints, these findings need to be confirmed in further studies enrolling more patients. FUNDunding Acknowledgement Type of funding sources: None. Figure 1. hsTnT ROC

Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial

2021 ◽  
Author(s):  
Jeffrey A. Kline ◽  
David H. Adler ◽  
Naomi Alanis ◽  
Joseph R. Bledsoe ◽  
Daniel M. Courtney ◽  
...  
Keyword(s):  
Emergency Department ◽  
Venous Thromboembolism ◽  
Venous Thrombosis ◽  
The United States ◽  
Home Treatment ◽  
Low Risk ◽  
Severe Bleeding ◽  
Effectiveness Trial ◽  
Risk Of Death ◽  
Recurrent Vte

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

scholarly journals Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040151
Author(s):  
Christine Baumgartner ◽  
Frederikus A Klok ◽  
Marc Carrier ◽  
Andreas Limacher ◽  
Jeanne Moor ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
The Netherlands ◽  
Ethics Committees ◽  
Low Risk ◽  
Resource Utilisation ◽  
Anticoagulant Treatment ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Clinical Surveillance ◽  
Risk Patients

IntroductionThe clinical significance of subsegmental pulmonary embolism (SSPE) is currently unclear. Although growing evidence from observational studies suggests that withholding anticoagulant treatment may be a safe option in selected patients with isolated SSPE, most patients with this condition receive anticoagulant treatment, which is associated with a 90-day risk of recurrent venous thromboembolism (VTE) of 0.8% and major bleeding of up to 5%. Given the ongoing controversy concerning the risk-benefit ratio of anticoagulation for isolated SSPE and the lack of evidence from randomised-controlled studies, the aim of this clinical trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE.Methods and analysisSAFE-SSPE (Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism, a multicentre randomised placebo-controlled non-inferiority trial) is an international, multicentre, placebo-controlled, double-blind, parallel-group non-inferiority trial conducted in Switzerland, the Netherlands and Canada. Low-risk patients with isolated SSPE are randomised to receive clinical surveillance with either placebo (no anticoagulation) or anticoagulant treatment with rivaroxaban. All patients undergo bilateral whole-leg compression ultrasonography to exclude concomitant deep vein thrombosis before enrolment. Patients are followed for 90 days. The primary outcome is symptomatic recurrent VTE (efficacy). The secondary outcomes include clinically significant bleeding and all-cause mortality (safety). The ancillary outcomes are health-related quality of life, functional status and medical resource utilisation.Ethics and disseminationThe local ethics committees in Switzerland have approved this protocol. Submission to the Ethical Committees in the Netherlands and Canada is underway. The results of this trial will be published in a peer-reviewed journal.Trial registration numberNCT04263038.

scholarly journals Comparison of the effects of edoxaban, an oral direct factor Xa inhibitor, on venous thromboembolism between patients with and without cancer

2018 ◽  
Vol 72 (2) ◽  
pp. 120-127 ◽  
Author(s):  
Satoshi Ikeda ◽  
Seiji Koga ◽  
Yuki Yamagata ◽  
Masamichi Eguchi ◽  
Daisuke Sato ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Factor Xa ◽  
Factor Xa Inhibitor ◽  
Direct Factor
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