Management of VTE ... Burden of VTE ¢â‚¬¢Venous thromboembolism (VTE)...

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Transcript of Management of VTE ... Burden of VTE ¢â‚¬¢Venous thromboembolism (VTE)...

  • 9/23/19

    1

    Outpatient Management of Venous Thromboembolism (VTE)

    Cari Batcheler, PharmD, BCPS Clinical Pharmacy Specialist – Emergency Medicine

    UnityPoint Health – St Luke’s Hospital Cedar Rapids, Iowa

    Carolyn.Batcheler@unitypoint.org

    Disclosure

    • No Conflicts of Interest

    Objectives

    Evaluate Evaluate primary literature to support outpatient management of VTE

    Discuss Discuss advantages and disadvantages of each direct oral anticoagulant

    Utilize Utilize prognostic models to determine disposition for patients with pulmonary embolism

    Describe Describe outpatient treatment regimens for VTE Topics Covered

    Outpatient treatment regimens Disposition

    Topics Not Covered

    Diagnosis Laboratory tests

    Imaging

    Inpatient management Thrombolysis

    Heparin infusions

    Special populations Pregnancy

    Cancer

    Patient Case • 49 year old male presents with chest pain and shortness of breath • No significant past medical history • Family history of factor V Leiden mutation • BP 132/80 mmHg • Pulse 80 beats per minute • Temp 36.4 OC • RR 18 • SpO2 97% on room air • CBC and within normal limits except serum creatinine = 1.18 mg/dL • Troponin

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    Burden of VTE

    • Venous thromboembolism (VTE) affects 900,000 people each year • Includes deep vein thrombosis (DVT) and pulmonary

    embolism (PE) • 100,000 die of PE annually • Mortality rates of PE with shock exceed 30%

    • 30-day morality rate of low-risk PE is less than 1%

    Beckman MG, et al. Am J Prev Med. 2010;38(4 Suppl):S495-501. Kasper W, et al. J Am Coll Cardiol. 1997;30(5):1165-71. Beam DM, et al. Acad Emerg Med. 2015;22(7):788-95.

    Phases of VTE Treatment

    Initial Phase • First 7 days

    Long Term Phase • 7 days to 3 months

    Extended Phase • Beyond 3 months

    Kearon C, et al. Chest. 2016;149(2):315-352.

    Choice of Therapy

    In patients with DVT of the leg or PE and no cancer, as long-term (first 3 months) anticoagulant

    therapy, we suggest dabigatran, rivaroxaban, apixaban, or edoxaban over vitamin K antagonist (VKA) therapy.

    Kearon C, et al. Chest. 2016;149(2):315-352.

    Advantages of Direct Oral Anticoagulants (DOACs)

    Predictable pharmacokinetics

    and pharmacodynamics

    Few drug and food interactions

    No dietary restrictions

    Rapid onset and offset

    Short half-life Less laboratory monitoring Wide therapeutic

    window

    No need for parenteral

    anticoagulation*

    Mekaj YH, et al. Ther Clin Risk Manag. 2015;11:967-77.

    Disadvantages of DOACs

    No standardized test for monitoring

    Rapid offset and short half-life

    Antidotes costly and not widely available

    High cost

    More difficult to monitor compliance

    Mekaj YH, et al. Ther Clin Risk Manag. 2015;11:967-77.

    DOAC Dosing for VTE Treatment

    Drug Dose Trial

    Apixaban 10mg twice daily for 7 days, then 5mg twice daily AMPLIFY a

    Dabigatran Parenteral anticoagulation for 5-10 days, then 150mg twice daily RE-COVER b,c

    Edoxaban Parenteral anticoagulation for 5-10 days, then 60mg once daily Hokusai-VTE d

    Rivaroxaban 15mg twice daily for 3 weeks (21 days), then 20mg once daily EINSTEIN e,f

    a. Agnelli G, et al. N Engl J Med. 2013;369:799-808; b. Schulman S, et al. N Engl J Med. 2009;361:2342-2352; c. Schulman S, et al. Circulation. 2014;129:764-772; d. Hokusai-VTE Investigators. N Engl J Med. 2013;369:1406-1415; e. EINSTEIN Investigators. N Engl J Med. 2010;363:2499- 510; f. EINSTEIN–PE Investigators. N Engl J Med. 2012;366:1287-1297.

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    Choice of Anticoagulant Factor Preferred Agent(s) Agent(s) to Avoid Parenteral therapy to be avoided

    Rivaroxaban, apixaban Dabigatran, edoxaban, VKA

    Once daily oral therapy preferred

    Rivaroxaban, edoxaban, VKA Apixaban, dabigatran

    Liver disease and coagulopathy LMWH DOACs, VKA

    Renal disease and creatinine clearance

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    Rates of Discharge Home

    • Outpatient treatment for DVT is the standard of care

    • Prevalence of discharge home for PE patients is low • 1 to 8%

    Vinson DR, et al. Ann Intern Med. 2018;169(12):855-865.

    Home Treatment of

    PE

    983 emergency department patients with

    pulmonary embolism

    746 patients potentially eligible for outpatient

    treatment

    13 patients (1.7%) treated at home

    733 patients (98.3%) admitted to the hospital

    237 considered ineligible for

    outpatient treatment

    Stein PD, et al. Am J Med. 2016;129(9):974-7.

    Benefits of Outpatient Treatment

    Cost savings

    Patient preference

    Conservation of resources

    Avoid risks associated with inpatient care

    Vinson DR, et al. Ann Intern Med. 2018;169(12):855-865.

    Risks of Hospitalization

    Patients with low-risk PE who were admitted to the hospital were 8 times more likely to develop a hospital acquired condition • 13.3% vs 1.5% (95% CI: 3.77-19.94)

    Bacterial pneumonias were also more common in hospitalized patients

    • 11.7% vs 5.9% (95% CI: 1.24-3.23)

    Among long LOS patients, hospital acquired conditions (52) exceeded adverse PE events (14 recurrent DVT, 5 bleeds)

    Wang L, et al. PLoS ONE. 2017;12(10):e0185022.

    Criteria for Outpatient Treatment of PE

    Clinically stable with good

    cardiopulmonary reserve

    No contraindications

    to anticoagulation

    Recent bleeding

    Severe renal or liver disease

    Severe thrombocytopenia

    (i.e.

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    Timeline

    PESI Score developed

    2005

    Hestia Criteria developed

    2011

    PESI Score validated for outpatient use

    2011

    Rivaroxaban approved for treatment of VTE

    2012

    Apixaban and dabigatran approved for treatment of VTE

    2014

    Edoxaban approved for treatment of VTE

    2015

    Beam, et al.

    2015

    Roy, et al.

    2017

    Mercury PE and eSPEED

    2018

    HoT-PE

    2019

    Hestia Study

    • First published by Zondag and colleagues in 2011 • Objective: to evaluate the efficacy and safety of

    outpatient treatment of selected patients with acute pulmonary embolism • Prospective cohort study included 297 patients with PE • Enrolled subjects from May 2008 to April 2010 • Treated with LMWH and VKA • Discharged immediately from the ED or admitted for less

    than 24 hours (23%)

    Zondag W, et al. J Thromb Haemost. 2011;9(8):1500-7.

    Adapted Hestia Criteria

    • Hemodynamically unstable by clinician judgement • Thrombolysis or embolectomy needed • Active bleeding or high risk for

    bleeding • GI bleeding or surgery ≤2 weeks ago • Stroke ≤1 month ago • Bleeding disorder or platelet count

    180 or DBP >110)

    • Oxygen needed to maintain SaO2 >90% • PE diagnosed while on anticoagulation • Requiring IV pain medication • Medical or social reason for admission • Creatinine clearance

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    Patient Case

    Is this patient a candidate for outpatient treatment?

    Yes 0% mortality in 90 days 2% incidence of VTE recurrence

    Is this patient considered low risk based on the Hestia Criteria?

    Yes

    Pulmonary Embolism Severity Index (PESI) • Originally published by Aujesky and colleagues in 2005 • Retrospective cohort study from 2000 to 2002 • Inpatients >18 years old • Primary or secondary diagnosis of PE

    • 15,531 patients from 186 hospitals were identified • 10,354 (67%) randomly selected for derivation • 5,177 (33%) for internal validation

    • Logistic regression analysis used to identify 11 criteria that were associated with 30-day mortality

    Aujesky D, et al. Am J Respir Crit Care Med. 2005;172(8):1041-6.

    PESI Criteria Predictors Points Assigned Age 1 point per year Male sex 10 Cancer 30 Heart failure 10 Chronic lung disease 10 Pulse ≥ 100 beats/min 20 Systolic blood pressure 30/min 20 Temperature

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    PESI Outpatient Validation Study

    Demonstrated non-inferiority of outpatient management for recurrent PE and death • 1 patient (0.6%) in each group died within 90 days • 1 (0.6%) outpatient and 0 inpatients had a recurrent PE

    Outpatient management also non-inferior to inpatient management for major bleeding up to 14 days

    Narrowly missed non-inferiority margin for outpatient management for bleeding to 90 days • 3 (1.8%) outpatients and 0 inpatients had major

    bleeding events in 90 days

    Aujesky D, et al. Lancet. 2011;378(9785):41-8.

    Beam, et al.

    Prospective observational study

    Two academic emergency departments

    Utilized modified Hestia criteria to identify

    low risk PE patients

    106 patients with VTE

    discharged on

    rivaroxaban

    71 (67%) with DVT

    30 (28%) with PE

    5 (5%) with DVT and PE

    Beam DM, et al. Acad Emerg Med. 2015;22(7):788-95.

    Beam, et al.

    Patients were followed for a mean of 389 days

    No patient developed a recurrent or new VTE

    while on therapy

    3 patients had VTE recurrence after

    completing their prescribed courses of

    anticoagulation