Extended-Duration Betrixaban Reduces the Risk of Rehospitalization Associated With Venous Thromboembolism Among Acutely Ill Hospitalized Medical Patients: Findings From the Apex Trial (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban Trial)

Chi, Gerald; Yee, Megan K.; Amin, Akhtar; Goldhaber, S.Z.; Hernandez, Adrian F.; Hull, Russel

doi:10.1016/j.jvsv.2018.05.017

Cited by 6 publications

(11 citation statements)

References 1 publication

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“…45 Patients receiving full-dose betrixaban also demonstrated significant reductions in VTE-related rehospitalization at day 42 (0.24% vs 0.93%; p=0.002) and at day 77 (0.46% vs 1.25%; p=0.002) compared with patients receiving enoxaparin/placebo. 46 Although not significant at day 42 (0.31% vs 0.59%), there was a > 50% reduction in VTErelated mortality with betrixaban at day 77 (0.34% vs 0.79%; p=0.035) compared with enoxaparin/placebo. 47 Unlike the prior extended-duration trials, extended prophylaxis with betrixaban was not associated with an increase in ISTH-defined major bleeding compared with standard duration enoxaparin (Table 6).…”

Section: Betrixabanmentioning

confidence: 85%

“…Other hard end points have a somewhat larger NNT. With full‐dose betrixaban, the NNT to prevent one irreversible event is 63, one symptomatic VTE is 102, one VTE‐related hospitalization is 127, one VTE‐related death is 223, and one ischemic stroke is 233; the NNH for one major bleed remains 3334 . Although these NNTs are higher than that for the primary end point, the impact within the first 77 days could be rather significant.…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, the entire course of therapy would be ~$500 to $600, with most of the cost incurred in the outpatient setting. Patients will likely neglect to pay this full amount for a month of therapy, and payers will need to determine if this therapy is cost‐effective based on reductions in VTE events, VTE‐related rehospitalizations, ischemic strokes, and VTE‐related mortality . Although institutions may consider using enoxaparin during hospitalization and switching to betrixaban upon discharge, this practice would not be prudent.…”

Section: Discussionmentioning

confidence: 99%

“…With full-dose betrixaban, the NNT to prevent one irreversible event is 63, one symptomatic VTE is 102, one VTE-related hospitalization is 127, one VTE-related death is 223, and one ischemic stroke is 233; the NNH for one major bleed remains 3334. [44][45][46][47][48] Although these NNTs are higher than that for the primary end point, the impact within the first 77 days could be rather significant. Considering 3.5 million potentially eligible patients for extended betrixaban therapy annually in the United States, 34,300 symptomatic VTE events, 27,500 VTErelated hospitalizations, 15,600 VTE-related deaths, and 15,000 ischemic strokes could be prevented per year in this at-risk population, at the excess of 1050 more major bleeds.…”

Section: Discussionmentioning

confidence: 99%

“…Almost all of the reduction in ischemic stroke was demonstrated in patients who entered the trial with an ischemic stroke or heart failure (0.63% vs 1.38%; p=0.014) . Patients receiving full‐dose betrixaban also demonstrated significant reductions in VTE‐related rehospitalization at day 42 (0.24% vs 0.93%; p=0.002) and at day 77 (0.46% vs 1.25%; p=0.002) compared with patients receiving enoxaparin/placebo . Although not significant at day 42 (0.31% vs 0.59%), there was a > 50% reduction in VTE‐related mortality with betrixaban at day 77 (0.34% vs 0.79%; p=0.035) compared with enoxaparin/placebo…”

Section: Trials Of Extended Prophylaxis In Medically Ill Patientsmentioning

confidence: 95%

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Extended Venous Thromboembolism Prophylaxis in Medically Ill Patients

2018

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Prophylaxis for venous thromboembolism (VTE) in hospitalized acutely ill medical patients is a well-established practice. Despite the increased use of inpatient prophylaxis, the duration of hospitalization is typically shorter than the duration of VTE prophylaxis provided in clinical trials. In addition, VTE events after hospitalization are not unusual, with most events occurring within 30 days of hospital discharge. Therefore, the 30-day time period postdischarge has been identified as a stage in which patients are still at high risk of developing VTE. Attempts to provide extended prophylaxis with enoxaparin, rivaroxaban, or apixaban in patients with acute medical illness have been met with mixed results. Although some of these agents have reduced the incidence of VTE with extended prophylaxis, all of these agents have also demonstrated a significant increase in major bleeding that seems to offset any potential benefit. A recent trial of a new direct factor Xa inhibitor, betrixaban, demonstrated a reduction in VTE events with extended prophylaxis without significantly increasing the risk of major bleeding. Understanding appropriate patient selection, dosing, and outcomes associated with betrixaban will be important to potentially reducing the continued risk of VTE in patients with acute medical illness.

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Section: Betrixabanmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Trials Of Extended Prophylaxis In Medically Ill Patientsmentioning

confidence: 95%

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Extended Venous Thromboembolism Prophylaxis in Medically Ill Patients

2018

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Current and Emerging Direct Oral Anticoagulants: State-of-the-Art

Lippi

Gosselin

Favaloro

2019

Semin Thromb Hemost

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Anticoagulant drugs comprise a specific subcategory of antithrombotic agents that act to inhibit blood coagulation at various stages, reducing clot development and ultimately lowering the risk of developing new-onset or recurrent thrombosis. Although the long history of anticoagulant drugs has been characteristically shaped by coumarin and heparin derivatives, a new generation of direct oral anticoagulants (DOACs), which specifically inhibit thrombin or activated factor X, combine many advantages of their progenitor drugs, and hence are prepotently revolutionizing the landscape of antithrombotic therapy. Several drugs (apixaban [BMS-562247], dabigatran [BIBR953], edoxaban [DU-1766], rivaroxaban [BAY 59–7939]) have already received widespread approval by national or supranational medicinal agencies. This narrative article provides a state-of-the-art for these and for several other DOACs at different stages of clinical evaluation (betrixaban, darexaban, eribaxaban, letaxaban, nokxaban), and certain others whose development has been discontinued (AZD-0837, fidexaban, LY517717, odiparcil, otamixaban, TTP889, and ximelagatran). What clearly emerges from our analysis is that DOACs sharing very similar mechanisms of action are still characterized by different efficacy and safety profiles. This not only depends on biochemical, biological, and pharmacokinetic characteristics, but also on lack of standardization between different clinical trials in terms of targeted disease, patient recruitment, sample size, duration and endpoints, as well as lack of harmonization around procedures used for drug licensing. These factors contribute to challenging the minds of physicians, who may find difficulty navigating their way through multiple indications, different pharmacological profiles, various side effects, and specific drug-to-drug interactions. Such considerations also burden laboratory professionals, who may face organizational and economic challenges in developing and/or implementing multiple assays to assess the pharmacodynamics (effect on coagulation) or pharmacokinetics (drug levels) of DOACs.

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

et al. 2020

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Venous 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.

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Extended-Duration Betrixaban Reduces the Risk of Rehospitalization Associated With Venous Thromboembolism Among Acutely Ill Hospitalized Medical Patients: Findings From the Apex Trial (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban Trial)

Cited by 6 publications

References 1 publication

Extended Venous Thromboembolism Prophylaxis in Medically Ill Patients

Extended Venous Thromboembolism Prophylaxis in Medically Ill Patients

Current and Emerging Direct Oral Anticoagulants: State-of-the-Art

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

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