Cardiology Update 2014

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1 Cardiology Update 2014 Update on the Novel Oral Anticoagulants (NOACS) Raymond Kawasaki, MD AMG Cardiology December 6, 2014

2 Disclosures I have no disclosures relevant to this presentation

3 Contents I. The NOACS II. Thoughts on Non-valvular Atrial Fibrillation III. NOACS for AF in the Presence of CAD IV. New Indications for the NOACS V. New NOAC: Edoxaban VI. Underutilization of NOACS VII. Summary

4 The Novel Oral Anticoagulants (NOACS) -or- The Non-Vitamin-K Dependent Oral Anticoagulants (NVKDOAC s)?

5 The NOACS Dabigatran (Pradaxa, Boerhringer Ingelheim) Approved October 19, 2010 Rivaroxaban (Xarelto, Johnson & Johnson) Approved July 1, 2011 Apixaban (Eliquis, Bristol-Myers Squibb) Approved December 28, 2012

6 The NOACS All originally approved for thromboembolic in patients with Non-Valvular Atrial Fibrillation (NVAF) But what is NVAF?

7 Questions What is NVAF? 2014 ACC/AHA/HRS Updated Guidelines Absence of rheumatic mitral valve stenosis, prosthetic valve or mitral valve repair 2001, 2006, 2011 Guidelines absence of rheumatic mitral valve disease or prosthetic heart valve 2012 ESC Guidelines AF related to rheumatic valvular disease or prosthetic heart valves Is the definition relevant to the NOAC trials?

8 Answer? Need to look at study criteria All excluded prosthetic heart valves In addition: ROCKET-AF (rivaroxaban) the only study that used the term NVAF Excluded only hemodynamically significant mitral stenosis RE-LY (dabigatran) Excluded hemodynamically relevant valvular disease needing surgical intervention during study period ARISTOTLE (apixaban) Excluded moderate-severe MS

9 Thoughts Trials created their own indications and exclusions RE-LY (dabigatran) more exclusive? ROCKET (rivaroxaban) and ARISTOTLE (apixaban) inclusive of more valvular issues Take home message for AF patients: Don t use in presence of prosthetic heart valves or mitral repair Don t use dabigatran with hemodynamically significant valvular disease of any kind Don t use with mitral stenosis

10 NOACS for AF in the Presence of CAD? No guidelines or consensus treatment Data to suggest with AF and stable CAD, warfarin alone may suffice +/- ASA (ESC v. AHA/ACCF) No such data yet with the NOACS Registry comparing rivaroxaban v. warfarin in pts. with AF and prior coronary stenting (> 1 year) coming soon

11 NOACS for AF in the Presence of CAD? If treating both, need to consider: Stroke risk CHA 2 DS 2 -VASc score (memorize this score!) ACC and ESC guidelines for CAD risk stratification <1% annual death or MI = low risk 1-3% annual death or MI = intermediate risk >3% annual death or MI = high risk Bleeding risk HAS-BLED, ACTION, CRUSADE, ACUITY/HORIZONS Get the Apps to calculate scores!

12 CHADS 2 Congestive heart failure = 1 point Hypertension = 1 point Age over 75 = 1 point Diabetes = 1 point Stroke = 2 points Anticoagulant for any score 2 or greater

13 CHA 2 DS 2 -VASc Congestive heart failure = 1 point Hypertension = 1 point A 2 ge over 75 = 2 points Diabetes = 1 point S 2 troke = 2 points Vascular disease = 1 point Age = 1 point Sex Category (gender) = female = 1 point Anticoagulation for scores 2 or greater

14 NOACS for AF in Presence of CAD? If treating both, need to consider: Stroke risk CHA 2 DS 2 -VASc score (memorize this score!) ACC and ESC guidelines for CAD risk stratification <1% annual death or MI = low risk 1-3% annual death or MI = intermediate risk >3% annual death or MI = high risk Bleeding risk HAS-BLED, ACTION, CRUSADE, ACUITY/HORIZONS Get the Apps to calculate scores!

15 NOACS for AF in Presence of CAD? If treating both, need to consider: Stroke risk CHA 2 DS 2 -VASc score (memorize this score!) ACC and ESC guidelines for CAD risk stratification <1% annual death or MI = low risk 1-3% annual death or MI = intermediate risk >3% annual death or MI = high risk Bleeding risk scores HAS-BLED, ACTION, CRUSADE, ACUITY/HORIZONS

16 Get the App!

17 Newer Indications for the NOACS All approved for treatment and prophylaxis of DVT/PE Different dosing compared to AF pts. Dabigatran NOT approved for acute treatment of DVT/PE; requires parenteral agent for 5-10 days prior to use

18 New Drug Edoxaban (Savaysa, Daiichi Sankyo) Not yet approved Factor Xa inhibitor studied in the ENGAGE AF- TIMI 48 Trial Non-inferior to warfarin in preventing CVA or VTE, less major bleeding Awaiting approval Subgroup of pts with supranormal renal function fared worse; higher dose of edoxaban not tested

19 Major Reasons why NOACS are Underutilized Cost v. warfarin Lack of reversal agents

20 Cost v. warfarin NOACS cost effectiveness v. warfarin is: 83.6%; 50.7%; 32.7%; When warfarin patient-time-in-therapeutic-range (TTR) is: <60%; 70%; 75% 1 respectively Registry data: Average time in therapeutic INR range is 55%! 2 1 J Gen Intern Med Mar;29(3): J Manag Care Pharm Apr;15(3):244-52

21 Reversal Agents? Scope of the problem 200,000/6 million (1 in 30) on anticoagulants admitted last year for bleeding issues 65,000 of these were on NOACs Vitamin K reversal of warfarin used only 10-25% of the time with major bleeds (ICH and trauma) Real need for reversal agents are for ICH and trauma NOACS inherently reduce risk of ICH and hemorrhagic CVA by half Fear of bleeding with no reversal = reduced utilization of NOACS Unwarranted concern?

22 Reversal Agents Thus far, no FDA approved reversal agents, but development underway Prothrombin Complex Concentrates (PCC) Inactivated/activated Factors II, VII, IX, X; various products No consensus as to use, but some supportive data Andexanet alfa Modified Factor Xa Antidote for Factor Xa inhibitors (rivaroxaban, apixaban and others)

23 Reversal Agents Idarucizumab: Humanized antibody fragment (Fab) for reversal of dabigatran. Immediate, complete and sustained reversal FDA grants breakthrough-therapy designation PER977 Synthetic molecule capable of binding both direct thrombin and Factor Xa inhibitors Rapid, complete reversal Stable at room temperature (storage advantage)

24 Treatment for Bleeding Current recommendations Supportive care Fluids, blood products, surgery if necessary Dialysis for dabigatran Activated charcoal for overdose Time! Vitamin K to reverse warfarin may take up to 24 hours Short half-lives of NOACS

25 Summary NOACS Indicated for stroke prophylaxis for AF and treatment/prophylaxis of DVT/PE Warfarin still has its role in prosthetic heart valves, mitral valve stenosis and repair, and presence of thrombus Memorize CHA 2 DS 2 -VASc scoring Newer agents being developed Underutilized but cost-effective Reversal agents are on the horizon

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