Innovations in Treating VTE, Using the EDOU

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1 Innovations in Treating VTE, Using the EDOU Disclosures No financial conflicts or disclosures Kelly Sawyer, MD, MS Observation Symposium 2013 Objectives Overview of VTE Treatment Guidelines/Controversies (ACCP9) New Treatment Options DVT in the EDOU PE in the EDOU NOACs Epidemiology of VTE Increasing Incidence? Higher risk population? Poor risk assessments? Increasing Rate of Diagnosis? Annually > ,000 VTE events 1/3 of VTE deaths follow surgery Vulnerable Patients OCP / HRT / Pregnancy Unprovoked Age > History of prior VTE or thrombophilic disorder Obesity Cigarette Smoking Long Travel Unknown or unidentified predisposing factor Provoked Surgery / Trauma Prolonged Immobility Pregnancy / Hormones Comorbidities cancer Infection, Inflammation Sepsis, Central Access, IBD, Immune disorders CAD? Overall Risk 1

2 VTE Recurrence Anticoagulants Standard Vit K Antagonists (VKA) Warfarin (PO) Acenocoumarol (PO) Antithrombin Activators Heparin (PTT or ACT) LMWHs (anti Xa assay, SC) Enoxaparin Dalteparin Fondaparinux (synthetic, SC) Standard Therapy Pro Effective Safety Established Familiar Antidote Measureable Effect Cheap Long Half Life Con Slow onset (VKA) Individualized Dosing Narrow Therapeutic Range Monitoring Required Many Interactions Long Half Life Anticoagulants NOACs Direct Xa Inhibitors Rivaroxaban (Xarelto, PO) Apixaban (Eliquis, PO) Edoxaban (PO, pending) Betrixaban (PO, pending) Direct Thrombin Inhibitors Bivalirudin (reversible, IV) Argatroban (IV) Dabigatran (Pradaxa, PO) 2

3 NOACs Pro Less bleeding? Oral w/ immediate onset No monitoring One size fits all? (per indication) Few interactions Short Half Life Con No easy antidote Long term, real life experience lacking Less familiar Unable to monitor effect Expensive Short Half Life LE DVT: Standard Treatment No good prediction tool for PTS Early initiation of VKA (ie, same day as parenteral therapy is started) Continuation of parenteral anticoagulation for a minimum of 5 days and until the INR is 2.0 or above for at least 24 h (Grade 1B). LMWH or Fondaparinux > Heparin (Grade 2C) LMWH once/day ONLY IF twice the bid dose DVT that involves the iliac and common femoral veins are at highest risk for PTS greatest potential to benefit from thrombus removal/lysis strategies Below Knee DVT To Treat or Not? Highly symptomatic treat Risks for extension: positive D-dimer thrombosis that is extensive or close to the proximal veins (eg, > 5 cm in length, involves multiple veins, > 7 mm in maximum diameter) no reversible, provoking factor for DVT active cancer history of VTE inpatient status 3

4 Standard Treatment Duration Standard Treatment: Pregnancy 3 months ± extended therapy Associated w/ active cancer (Grade 1B) even if high risk for bleeding (Grade 2B) Unprovoked w/ low bleeding risk (Grade 2B) Physician discretion Continue Treatment 6 wks post-partum or 3 months total, which ever comes last (2C) LMWH during gestation (1A) VKA, UFH, LMWH if lactating Standard Treatment: Cancer Pt Parenteral therapy is preferred over VKA Chemo/XRT often assoc w/ N/V, anorexia Poor absorption, dehydration affect VKA levels *Same would be true for NOACs LE DVT: Summary Treatment for at least 3 mo *If not treating, f/u US in ~7 days Location, symptoms guide treatment Consider intervention for High Risk clots Early Ambulation (2C) Compression stockings to reduce PTS (2B)? Compression Stockings Compression Stockings: ankle pressure of mmhg, lower pressure higher up the leg (eg, graduated pressure) Wear for 2 years, longer if helpful Compliance is problematic Evidence is uncertain* SOX Trial 4

5 UE DVT 5% to 10% of VTE involve the upper extremities 75% of UE DVT are secondary (eg, central line) If not catheter-related, often involves dominant arm Catheter-associated DVT: if functional & needed, leave in place, continue LMWH until removed Treatment: Same considerations as for LE DVT Superficial Vein Thrombosis Associated with: chronic venous insufficiency, malignancy, pregnancy or estrogen therapy, obesity, long-distance travel, history of VTE 2/3 s involve long/great saphenous v SVT Risks for complications: extensive SVT involvement above the knee, particularly if close to the saphenofemoral junction (GSV) severe symptoms history of VTE or SVT active cancer recent surgery Treatment: Similar considerations as for DVT Role of EDOU Diagnosis Simple case awaiting US Anticoagulant teaching Esp Traditional Treatment option Coordination of Care Consultant input Rx Copays, Expected costs Outpatient INR monitoring / follow up DVT Pathway/Order Set is Key Inclusion/Exclusion criteria Screening labs Contact Consultant, PCP to expedite plans Consult Care Management/Pharmacy A few examples 5

6 Exclusions 2010 Maine Medical Center Maine Medical Center Maine Medical Center Get around No PCP issue? Admit Medical/Free Clinic Anticoag Clinic On-Call DVT Physician Maine Medical Center 6

7 How will NOACs change pathways? Rivaroxaban Still need Inclusion/Exclusions Still need screening labs Still need to consider consultants Still need to ensure follow up Still need to verify drug coverage & educate on expected costs Indication Renal Function Dose Non-valvular Afib Proph s/p Ortho Surg CrCl > 50 ml/min CrCl ml/min CrCl < 15 ml/min CrCl >30 ml/min CrCl < 30ml/min 20mg daily 15mg daily Avoid 10mg daily (12-35 days) Avoid VTE treatment CrCl > 30ml/min 15mg bid x 21 days then 20mg daily VTE extended proph CrCl > 30ml/min 20mg daily Einstein Studies Big Studies Mean age 57, >90% CrCl was > 50, cancer <5% Rivaroxaban non-inferior to Standard INR therapeutic only 50-60% however Rivaroxaban superior to placebo for prevention of recurrence Apixaban Dose Comment 5 mg Standard for non-valvular Afib 2.5 mg Use if 2 of: age 80, weight 60kg, or scr 1.5 Avoid CrCl <15 or requires HD AMPLIFY Study Acute VTE Treatment Adherence to bid schedule >80%, Cancer 3% AMPLIFY Extension Prevent recurrence non-inferior to warfarin, superior to placebo Dabigatran Dose Comment 150 mg bid CrCl > 30, non-valvular Afib 75 mg bid CrCl CrCl and on P-gp drugs Avoid CrCl < 15, requires HD, or CrCl and on P-gp drugs RE-COVER & RE-COVER II Studies Acute VTE Treatment Dabigatran initiated after >5 d parenteral therapy Extension Studies: RE-MEDY, RE-SONATE Prevent recurrence non-inferior to warfarin, superior to placebo Summary NOACs All studies were non-inferiority All have caveats but large N All can be dissected post-hoc Great Potential for VTE Rx simplicity Will there be a head to head trial? Who would pay for that? 7

8 Chronic Thromboembolic Pulmonary Hypertension 3% patients treated for PE Underlying cardiopulmonary impairment Recurrent PE even more likely to be fatal Pulmonary vascular remodeling severe Pulmonary HTN R heart failure anticoagulate long term (1B) short term increased risk of death PE in General Stable, small, subsegmental PE s w/o risk factors treat like DVT LMWH or Fondaparinux > Heparin Early VKA to INR 2-3 for 3 months Early discharge home treat at home? Start in the Obs Unit Who should we consider for Inclusion? What should we do during their stay? Phase 1: developed suitability criteria Phase 2: applied criteria and did f/u 8

9 Median LOS: 1 day vs 5 days No adverse events related to VTE in 3 mo f/u Low Risk 2 High Risk 3 Low Risk, Treat at Home Treat at home? Lancet 2011 PESI class I or II ~1% w/ active cancer or h/o cancer Low event rate, No diff Readmissions/Revisits PESI Risk Categories: 30d mortality Simplified PESI Risk Categories Very Low Risk = 0-1.6% Low Risk = % Intermediate = % High Risk = % Very High Risk = % 0 points = low risk, 1.1% risk of death at 30 d 1.5% having recurrent VTE or non-fatal bleeding >0 points = high risk, 8.9% risk of death at 30 d 9

10 % Mortality 9/18/2013 Factors Considered after excluding RV s/sx of overload Age Chronic Heart Failure Afib at admission Heart Rate at admission Troponin I Creatinine C-Reactive Protein Glycaemia Results: Better sensitivity & NPV than Geneva & spesi RV Dysfunction & Mortality RV Dysfunction 20.9% Normal RV Function 14.8% Days from Diagnosis Goldhaber et al. Lancet 1999: 353. Potential Role for EDOU Still need Inclusion/Exclusions Still need screening labs Still need to consider consultants Trend biomarkers, do LE doppler Still need to ensure follow up Still need to verify drug coverage & educate on expected costs Initiate further work up? i.e. hypercoag state, malignancy 10

11 LE DVT: Treatment Location determines risk, morbidity Sural V vs. Popliteal V vs. Femoral V More Symptoms More reason to treat Provided there is no great risk for bleeding IVC Filter for DVT? For DVT: Only if anticoagulants are contraindicated Retrievable filters are often forgotten! Maine Medical Center 11

12 Derbyshire CDU Clinic From: Simplification of the Pulmonary Embolism Severity Index for Prognostication in Patients With Acute Symptomatic Pulmonary Embolism Arch Intern Med. 2010;170(15): doi: /archinternmed Figure Legend: Original and Simplified Pulmonary Embolism Severity Index (PESI) Date of download: 9/11/2013 Copyright 2012 American Medical Association. All rights reserved. DVT: Diagnosis Clinical Signs/SX Concerning for DVT Pretest Probability should guide testing for diagnosis of 1 st DVT (2B) D-dimer Imaging: Ultrasound Low/Mod Risk: HS D-dimer 1st + US Low/Mod Risk: US 1st + Treat * High Risk: US Negative check D-dimer &/or Repeat 1 wk - No DVT - Check D-dimer &/or Repeat 1 week 12

13 D-dimer and VTE Clinical suspicion, s/sx guide testing D-dimer cut off arbitrary? D-dimer + for many others reasons Therefore: Neg. US + Positive D-dimer Chest CT 13

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