ACUTE VENOUS THROMBOEMBOLISM: ED DISCHARGE. Harish Kinni EM/IM/CCM PGY 3 2/19/2015

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1 ACUTE VENOUS THROMBOEMBOLISM: ED DISCHARGE Harish Kinni EM/IM/CCM PGY 3 2/19/2015

2 Case 71 YO female with PMH of HTN, OSA, GERD, and asthma who presented to the ED with SOB and chest pain x 2 days. VS: BP 142/80 Pulse 55 Temp(Src) 37 C (98.6 F) (Oral) Resp 18 SpO2 96% Labs neg; tropx2 negative; EKG: non ischemic CXR negative CTPE: right proximal descending pulmonary artery filling defect What to do???

3 Objectives Background on VTE Review Coagulation Cascade Therapy for VTE Review NOAC and safety profile Cost of NOAC Henry Ford ED pathway

4 Venous Thromboebolism VTE affects 1 to 2 per 1000 annually 3 rd most common cause of vascular death Pulmonary Embolism Incidence: 70 cases per 100,000 Cost due to thrombosis and complications: >500,000 million dollars Treatment Standard therapy with parenteral heparin with overlapping vitamin K antagonist After first year, major bleeding risk: 1-2% Decreases the risk of recurrent disease from 25% to 3%

5 Treament Heparin + Warfarin Lovenox + Warfarin Lovenox Fondaparinux Direct Thrombin inhibitors X a inhibitors

6

7 Treatment Advantages over Tradition therapy Laboratory monitoring No need for INR or coagulation monitoring Pharmacokinetics Less variability in drug effect Biology Benefit in Percutaneous cardiac interventions Inhibition of clot bound thrombin Heparin Induced thrombocytopenia

8 Treatment Disadvantages Prosthetic heart valves Pregnancy Renal Impairment Compliance Dosing convenience Cost Reversal Issues

9 Treatment Dabigatran (Pradaxa): Direct Thrombin (II) inhibitor RE-COVER RE-COVER II Rivaroxaban (Xarelto) : X a Inhibitor EINSTEIN EINSTEIN- PE Apixaban (Eliquis): X a Inhibitor AMPLIFY AMPLIFY EXT

10

11 Randomized, double blinded Non inferiority trial Primary outcome 6 month incidence of recurrent, symptomatic VTE and related deaths Dabigatran: 30/1274 vs Warfarin: 27/1265 Safety Outcome Bleeding events, Acute Coronary syndrome, other adverse events, and LFTs

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15 Randomized, open label, non inferiority study event driven 3, 6, 12 months Double blind, randomized, event driven superiority study for addition 6 or 12 months (after completion of 6 or 12 months of treatment) Primary efficacy outcome: recurrent VTE 36/1731 Rivaroxaban vs 51/1718 Warfarin (Acute DVT) Primary safety outcome Initial trial: major bleed or clinically relevant non-major bleeding Continued treatment trial: Major bleeding

16 Acute DVT study

17 Continued treatment

18

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20 Randomized, double blinded, non inferiority Primary efficacy outcome Recurrent symptomatic VTE or death related to VTE 59/2609 (2.3%) Apixaban vs 71/2635 (2.7%) Conventional therapy Primary Safety outcome Major bleeding Overt and associated with 2g/dL or more drop, transfusion with 2pRBC or more, critical site, or contributed to death Secondary safety outcome Composite major bleeding and clinically relevant non major bleeding

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24 Bleeding concerns Dabigatran and Postmarketing Reports of Bleeding (2013) FDA Mini-Sentinel database analysis revealed no increase in event compared to warfarin The impact of bleeding complications in patients receiving target-specific oral anticoagulants: a systematic review and meta-analysis (2014) 12 RCTs involving 102,607 patients Significantly reduced risk of major bleed, fatal bleeds, intracranial bleeds, clinically relevant non major bleeding, and total bleeds

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26 Bleeding concerns Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis 5 RCTs involving 24,455 patients Comparable efficacy with significant lower risk of bleeding

27 Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta analysis Journal of Thrombosis and Haemostasis Volume 12, Issue 3, pages , 5 MAR 2014 DOI: /jth

28 Will you consider one of the newer anticoagulants???

29 Cost Comparison of differences in medical costs when new oral anticoagulants are used for the treatment of patients with non-valvular atrial fibrillation and venous thromboembolism vs warfarin or placebo in the US (2014) Combined NVAF, acute VTE, and extended VTE patient populations, medical-cost differences were $10.0, $10.9, $21.0, and $21.0 million for dabigatran, rivaroxaban, 2.5 mg apixaban, and 5 mg apixaban, respectively Cost of treating venous thromboembolism with heparin and warfarin versus home treatment with rivaroxaban (2014) Median hospital charges for six months after diagnosis were $11,128 (IQR $8,110- $23,390) for controls vs $4,787 (IQR $3,042- $7,596) for cases

30 So now you re considering using one of the NOAC..

31 Henry Ford Workflow

32 Henry Ford Workflow

33 Henry Ford Workflow

34 Henry Ford Workflow

35 Thank you Questions????

36 References Rudd, Kelly M., and Elizabeth (Lisa) M. Phillips. New Oral Anticoagulants in the Treatment of Pulmonary Embolism: Efficacy, Bleeding Risk, and Monitoring. Thrombosis 2013 (2013): PMC. Web. 29 Jan Schulman, Sam, Clive Kearon, Ajay K. Kakkar, Patrick Mismetti, Sebastian Schellong, Henry Eriksson, David Baanstra, Janet Schnee, and Samuel Z. Goldhaber. "Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism." New England Journal of Medicine (2009): Web. "Oral Rivaroxaban for Symptomatic Venous Thromboembolism." New England Journal of Medicine (2010): Web "Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism." New England Journal of Medicine (2012): Web. Agnelli, Giancarlo, Harry R. Buller, Alexander Cohen, Madelyn Curto, Alexander S. Gallus, Margot Johnson, Urszula Masiukiewicz, Raphael Pak, John Thompson, Gary E. Raskob, and Jeffrey I. Weitz. "Oral Apixaban for the Treatment of Acute Venous Thromboembolism." New England Journal of Medicine (2013): Web. Campbell, Allison R., Richard Mcknight, and Harakh V. Dedhia. "New Anticoagulants for Thrombo-embolic Disease: Clinical Implications." Journal of Pharmacogenomics & Pharmacoproteomics (2011): n. pag. Web. Southworth, Mary Ross, Marsha E. Reichman, and Ellis F. Unger. "Dabigatran and Postmarketing Reports of Bleeding." New England Journal of Medicine (2013): Web. Chai-Adisaksopha, Chatree, Mark Crowther, Tetsuya Isayama, and Wendy Lim. "The Impact of Bleeding Complications in Patients Receiving Target-specific Oral Anticoagulants: A Systematic Review and Meta-analysis." Blood (2014): n. pag. Web.

37 References Hulle, Tom Van Der, Judith Kooiman, Paul L. Den Exter, Olaf M. Dekkers, Frederikus A. Klok, and Menno V. Huisman. "Effectiveness and Safety of Novel Oral Anticoagulants Compared with Vitamin K- antagonists in the Treatment of Acute Symptomatic Venous Thromboembolism- a Systematic Review and Meta-analysis." Journal of Thrombosis and Haemostasis (2013): N/a. Web. Amin, Alpesh, AManda Bruno, Jeffery Trocio, Jay Jin, and Melissa Lingohr-Smith. "Comparison of Differences in Medical Costs When New Oral Anticoagulants Are Used for the Treatment of Patients with Non-valvular Atrial Fibrillation and Venous Thromboembolism vs Warfarin or Placebo in the US." Journal of Medical Economics 0th ser. 0.0 (2015): Web. KlineJA, Roy PM, Than MP, Hernandez J, Courtney DM, Jones AE, et al. Cost of treating venous thromboembolism with heparin and warfarin versus home treatment with rivaroxaban Society of Academic Emergency Medicine. Abstract. (2014)

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