Disclosure. New Agents for Treatment of DVT. Prevalence of DVT VTE. Normal Hemostasis 7/17/2015. Mark Oliver, MD, RVT, RPVI,FSVU

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1 New Agents for Treatment of DVT Disclosure PI Adopt and Amplify trials Mark Oliver, MD, RVT, RPVI,FSVU BMS and Pfizer Speaker VTE Venous Thromboembolism Recognized DVT s New : 170,000 Recurrent : 90,000 Prevalence of DVT Deep Vein Thrombosis(DVT) and or Pulmonary Embolism(PE) Unrecognized Total: 500,000 year Normal Hemostasis Coagulation Cascade Blood Flow Fibrin Degradation Products Fibrinolytic Cascade Platelet Activated Platelet Fibrin Stabilized Platelet Plug Vascular Endothelial Damage 1

2 Management of VTE Warfarin The Mainstay of the Management of VTE is Anticoagulation Vitamin K antagonist Causes defective Vitamin K coagulant proteins (i.e., prothrombin, factor VII, factor IX, factor X) Slow onset of action Many drug interactions and dietary restrictions Oral Completely, rapidly absorbed from GI tract Dose response varies widely Requires monitoring with prothrombin time (PT) Heparin Heparin / ATIII complex Irreversibly binds with and inactivates thrombin and factor Xa Inhibits platelet function Pre 1960 Treatment of DVT/PE Supportive measures,? Anticoagulants 1960 Anticoagulation proven; In hospital days 1970 s-1980 s Heparin, warfarin after 4-7 days; In hospital days Late 1980 s-90 s Heparin and warfarin on day 1; In hospital 5-7 days Subcutaneous Enoxaparin Once or Twice Daily Compared with Intravenous Unfractioned Heparin for Treatment of Venous Thromboembolic Disease Ann Intern Med. 2001;134: Advantages of LMWH Observation Lack of protein binding Predictable dose response Longer half-life Smaller molecule Less effect on platelets and endothelium Advantage Good Bioavailability Predictable dose response Resistance not encountered Fixed or weight-based dosing Monitoring not required Once or twice daily dosing Improved subcutaneous absorp Less thrombocytopenia and bleeding 2

3 Pentasaccharide (Fondaparinux Arixtra) Produced by chemical synthesis Pure anti Xa activity; no anti-thrombin act 98% bound to AT; no protein binding 100% bioavailable by subcutaneous route Rapid onset 25 min; peak concern 2 hr Long half-life (~15hrs); QD dosing Minimal effect on aptt No platelet effects (? No thrombocytopenia) Cleared by the kidneys XII Intrinsic XI Coagulation Cascade Rivaroxaban(Xarelto) IX New Paradigm Oral agents VIII X V VII Extrinsic In 3449 pts. A randomized open label study(einstein) compared rivaroxaban alone to standard Rx LMWH enoxaparin with Vitamin K antagonist for Rx of acutevte II I Fibrin Clot Apixaban(Eliquis) Edoxaban In 5395 pts. A 6mo. Randomized double blind trial compared apixaban alone to enoxaparin with warfarin for Rx of acutevte In 8240 pts. A randomized, double blind study first Rxed with unfractioned heparin or LMWH,once daily edoxaban compared to warfarin in the Rx of VTE 3

4 Dabigatran etexilate(pradaxa) In 2539 pts. a 6mo. randomized double blind trialre- COVER) compared dabigatran to warfarin after initial Rx with a parenteral anticoagulant for RX of acute DVT NOACS(New Oral Anticoagulants) No food interactions Very few drug interactions Require no monitoring No antitode for bleeding NOACS(New Oral Anticoagulants) All were non-inferior to standard Rx in reducing rate of recurrent DVT Small number of pts. >andor=75y/o,ccl<50cc/m,ca Edoxaban-significant lower rate of major and clinically relevant non major bleeding Apixaban-significant lower rate of major bleeding Medical Letter Vol56 Issue 1433 Jan 6,2014 FDA Approval for Rxof DVT/PE and reduction in risk of recurrent DVT/PE following initial Rx Dabigatran-direct thrombin inhibitor Rivaroxaban-direct factor Xa inhibitor Apixaban-direct factor Xa inhibitor Edoxaban-direct factor Xa inhibitor Drug by Class TreatmentDosage Half-Life Renal Clearance, % Direct factor Xa inhibitions Rivoroxaban Apixaban 15 mg orally, twice daily for 3 weeks, then 20 mg orally every 24 hours 10 mg orally, twice daily for 7 d, then 5 mg twice daily Edoxaban 60 mg orally every 24 h after 7 to 10 d of low-molecularweight heparin Direct factor IIa inhibitors Dabigatran 150 mg orally, twice daily after 7 to 10 d of low-molecularweight heparin 7-11 h h h h 80 Conclusion Mainstay of DVT Rx is Anticoagulation Traditional(Heparin-parenteral,plts, Coumadin-drug interactions,dietary restrictions and monitoring) LMWH,Fondaparinux-parenteral,less effect on plts, outpt. Role for Alternate Anticoagulants(NOACS)-oral, same efficacy, no dietary restrictions, few drug interactions, less major bleeding, although no specific antitode, cost and clinical setting(new) also considerations. JAMA February 19, 2014 Volume 311, Number 7 4

5 Bibliography Bibliography continued Barrit DW, Jordan SC. Anticoagulant Drugs in the Treatment of Pulmonary Embolism: A Controlled Clinical Trial. Lancet 1960; 1: Merli G et al. Subcutaneous Enoxaparin Once or Twice Daily Compared with Intravenous Unfractionated Heparin for Treatment of Venous Thromboembolic Disease. ANN of INTERN MED. 2001; 134(3): Guyatt GH et al. Antithrombotic Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence Based Guidelines. Chest 2012; 141(2) (Suppl.): 7S-47S. Wells PS et al. Treatment of Venous Thromboembolism: JAMA 2014; 311(7): Skeik N et al. The role of novel anticoagulants in the management of venous thromboembolism: Vascular Medicine 2014; 19(3):

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