New Oral Anticoagulants

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1 New Oral Anticoagulants Tracy Minichiello, MD Associate Professor of Medicine Chief, San FranciscoVA Anticoagulation and Thrombosis Service Ansell, J. Hematology Copyright 2010 American Society of Hematology. Copyright restrictions may apply. Approval status Dabigatran Rivaroxaban Apixaban (Pradaxa) (Xarelto) (Eliquis) Nonvalvular Nonvalvular June 28 AFIB AFIB 2012 DVT decision prevention MOA DTI antixa antixa Renal 80% 30-60% 25% metabolism New Oral Antithrombotics Dabigatran Rivaroxaban Apixaban (Pradaxa) (Xarelto) (Eliquis) T1/2 hours CYP3A4* -- Yes Yes pgp Yes Yes -- Antidote None None none monitoring ECT, TT, PT Anti Xa PTT AFIB CVA ICH GIB, BID CVA ICH GIB, QD CVA ICH bleed 1

2 Dabigatran :Prescribing Info Re-Cover: Dabigatran vs Warfarin in VTE: Cumulative Risk of Recurrent VTE or Related Death Indicated for stroke prevention in nonvalvular AFIB 150 mg po twice daily; 75 mg po twice daily if CrCl ml/min. Not recommended if CrCl< 15ml/min TTR 60% Shulman, s et al NEJM 2009 Not monotherapy; LMWH bridge needed RE-LY Results: Select Efficacy and Safety Outcomes Outcome DABI 150 % per yr Stroke/SEE (1 Endpt) Major Age 80 Gastrointestinal Intracranial WARF % per yr RR (95% CI) * ( ) ( ) * ( ) * ( ) Myocardial infarction (MI) ( ) *Statistically significant NNT or NNH NNT=172 N/A NNH=204 NNT=227 N/A Rising Concerns. 2

3 More Concerns.. Patient Selection-Cautions History of GI -unclear source Age > 80 Concomitant therapy with P-gp inhibitors At risk for renal function fluctuation/deterioration Known CAD Rivaroxaban-Prescribing Info 10 mg po QD approved for DVT prophylaxis in TKA (35 days) THR (10 days) Do not use if CrCl < 30 or liver disease Higher bleed risk if CrCl or receiving cyp3a4 inhibitors Do not use with P450 inhibitors: ketoconazole, ritonavir, clarithro, emycin; or inducers (rifampin) Avoid use with feeding tubes Rivaroxaban for DVT prevention RECORD trials Superior to enoxaparin 40 mg daily and 30 mg BID( DVT by 50%, ARR 1.7%) Rivaroxaban no/1000pts Enoxaparin no/1000 pts Major bleed Major bleed and surgical site fewer DVT / more bleeds/1000 p 3

4 EINSTEIN-Rivaroxan in Symptomatic DVT Vte rates 2.1% rivoroxan 3% warfarin MONOTHERAPY Case A 55 year old man presents with acute pulmonary embolism. There is no preceding trauma, surgery, immobilization. He is up to date with cancer screening. What duration of anticoagulation do you 50% recommend? The EINSTEIN Investigators. N Engl J Med 2010;363: Vte rates 1.3% rivoroxan 7.1% placebo DVTby 82% Minor bleed 5.4% v 1.2% A. 3 months B. 6 months C. 12 months D. indefinitely 10% 19% 21% Connolly SJ et al NEJM 2011 A. B. C. D. Risk of VTE Recurrence After Cessation of VTE Risk factor 1st yr Next 5 yrs Distal DVT 3% (6%) <10% Major- Surgical Minor- Nonsurgical 3% 10% 5-6% 15% Unprovoked At least 10% 30% Recurrent > 10% > 30% Kearon, Blood 2005;Iorio Arch Intern Med 2010 Guidelines for Duration of Anticoagulation for VTE Indication First episode of VTE secondary to a transient risk factor First episode of idiopathic (unprovoked) VTE Recurrent VTE 8th ACCP guidelines months (Grade 1B). AHA months (Class I Level A) At least 3 months, At least 6 months, prefer long-term consider indefinite treatment if risk/benefit (Class I Level A) ratio ok (Grade 2B). Long term (Grade 1B). Indefinite Class I Level A). ASH recommendations months 6 months Long term if APLS, AT deficiency or recurrence Kearon et al CHEST suppl Feb 2012;Jaff et al Circulation 2011; Bounsameaux H et al Hematology

5 EINSTEIN-Rivaroxan in Symptomatic PE Management of Bleeding on New Anticoagulants Discontinue drug Maintain adequate diuresis Check PTT and TT(dabi), PT (riva) Dabigtran is dialyzable. 60% of drug may be removed over 2-3 hours Consider FFP,PCC, apcc, Factor VII in life threatening bleed Platelet transfusion if on antiplatelet drug The EINSTEIN PE Investigators. N Engl J Med DOI: /NEJMoa DVT prophylaxis VTE treatment Cautions DABIGATRAN Similar to LMWH in efficacy and Must use LMWH overlap BID ( MI, GI bleed) bleed if GFR, elderly, low weight RIVAROXABA N Approved 5 fewer DVTs 9 more major bleeds monotherapy BID dose reduced to QD after 3 weeks bleed if GFR APIXABAN Not available in US 7 fewer DVTs/1000 patients no in TBD TBD Things to Remember These agents DO need monitoring, just not by INR-transition time critical Proper patient selection critical to avoid potentially fatal complications Patient education perhaps even more important as they will probably not be plugged into an anticoagulation program No reversal agent for any of these. Know your options. Be sure your institution has reversal protocols and stocks the agents you need. 5

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