Limitations of VKA Therapy

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1 Fibrillazione Atriale Non Valvolare Ischemia o Emorragia le Due Utopie Rivali nella Scelta dei NAO Gianluca Botto, MD, FESC, UO Elettrofisiologia, Dip Medicina

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3 Limitations of VKA Therapy Unpredictable response Narrow therapeutic window (INR range ) Slow onset/ offset of action VKA therapy has several limitations that make it difficult to use in practice Numerous food drug interactions Numerous drug drug interactions Warfarin resistance Routine coagulation monitoring Frequent dose adjustments Ansell J. Chest 2008; 133; 160S-198S. Umer Ushman MH. J Interv Card Electrophysiol 2008; 22: Nutescu EA. Cardiol Clin 2008; 26:

4 Patient With High INR Variability

5 Hazards of Warfarin Budnitz DS. M Engl J Med 2011; 365:

6 Rationale of a Replacement for Warfarin in NV-AF W is an effective agent for stroke prevention in NV-AF, however: Pts find frequent INR monitoring difficult Phisicians are reluctant to use W due to the increased risk for bleeds The potential for improvement in bleeding and possibly stroke prevention was seen with more targeted NOAC therapy

7 Selecting the most appropriate antithrombotic therapy for a pt is one of the most important management decisions in AFIB The net clinical benefit associated with a given therapeutic choice should guide this decision.

8 The net clinical benefit associated with a given therapeutic choice should guide this decision.

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10 Anticoagulation Use Balancing Stroke Prevention and Risk of Bleeding

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13 Anticoagulation In Pts With Non-Valvular AF Annual Rates Of Major Hemorrhage Fuster V. ACC/AHA/ESC Practice Guidelines 2006

14 CHADS 2 annual stroke risk (%) 4-6 8,5 3 5,9 2 4,0 1 2,8 0 1,9 Ann Intern Med. 2009; 151:

15 AVERROES Primary Efficacy and Safety Outcome Connolly SJ. N Engl J Med 2011; 364:

16 2011; 155:

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18 Net Clinical Benefit for Warfarin and NOAs by CHA 2 DS 2 -VASc and HAS-BLED Score Banerjee A. Thrombosis Haemost 2012; 107:

19 Comparison Between Annualized Thromboembolic Risk Stratified by CHADS 2 Risk Score and CHA 2 DS 2 -VASc Risk Score

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21 Atrial Fibrillation HAS-BLED Bleeding Risk Score A score 3 indicates High Risk and cautions and regular review of the pt is needed

22 Although Stroke Is Generally More Feared By Patients, There Is A Strong Bias Among Physician Not To Cause Harm

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26 Allocation to a NOAs significantly reduced the composite of stroke or systemic embolic events by 19% as compared to WRF The overall beneficial effect was mainly driven by a large reduction in haemorrhagic stroke (RR on combined data: 0.49, 95%CI: , P<0.0001) All-cause mortality was significantly reduced with NOAs vs. WRF (RR: 0.90, 95%CI: , P=0.0003), while ischemic stroke and myocardial infarction were not

27 NOAs vs Warfarin in Pts with AF ALL-CAUSE STROKE or SE ISCHEMIC STROKE HEMORRHAGIC STROKE Miller CS. Am J Cardiol 2012; 110:

28 Major Bleeding in the NOACs SPAF Trial

29 Intracranial Hemorrage

30 NOACs Are Associated with Significant Fewer Intracranial Bleeds than Warfarin

31 ENGAGE-AF Fatal Bleeding Giuliano RP. ESC Annual Meeting, Barcelona (abstract)

32 Intracerebral/Hemorragic Stroke and Mortality in SPAF ICH has a mortality rate of 40-50% Much worse than ischemic stroke, MI, GI bleed NNT to prevent ICH vs Warfarin Chatterrjee S. JAMA Neurol 2013; 70:

33 Risk of ICH in Pts with Chonic Cerebral Microbleeds on Gradient Echo MRI 68% of spontaneous ICH Microbleeds increase the risk of Warfarin-associated ICH 12 fold Van Etten ES. Stroke 2014: 45;

34 Reducing the Risk for ICH in SPAF Pts Receiving Anticoagulation Rx Assesses risk factors Aggressive risk factor reduction Do not add AP to anticoagulant unless pts has recently had a coronary stent deployed Switch from an AVK to a NAOC

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36 Major GI Bleeding in the NOAC SPAF Trials

37 Flexible Dosing to Prevent Bleeding High vs low-dose regimens - more ischemic events but less bleeding Dose modification/reduction - preventing excess dose exposure in vulnerable pts Once-daly vs twice-daily dosing - different plasma concentration carries differen bleeding risk

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40 Rivaroxaban Dosing Overlap B/ween OD and BID Regimens Maximun (C max ) and minimun (C trough ) blood concentration of rivaroxaban in bid and od studies, with 25 and 75 percentiles (orizontal lines) and 5 and 95 percentili (dots) Rivaroxaban C max (µg/l) bid od C max Rivaroxaban C valle (µg/l) bid od C trough Rivaroxaban daily dose (mg) Rivaroxaban daily dose (mg) Mueck W. Thromb Haemost 2008; 100:

41 Anticoagulation Rx in Pts With NV-AF Projected Costs, Cost-Efficacy and Cost-Benefit Harrington AR. Stroke 2013 in press

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43 The VKA Habit is Under Pressure but Overall Usage is Still on High Level Global AC Market Volume Shares in % (based on SU) Volume in SU (000) , % 69% 700, , , VKAs 400, Novel OACs Others* 300, % 6% 19% 200, , Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Feb Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Feb * Others = mainly B1B1 Unfractionated Heparin and B1B2 LMWH IMS MIDAS Database Monthly Sales

44 Italy: The Paradox Effect of NOAs IMS MIDAS Database Monthly Sales

45 Summary Appropriate AC is required to prevent TE events in pts with NV-AF while minimizing the risk for bleeding NOACs provide a similar level of protection from ischemic stroke as VKAs but are associated with a significant lower rate of intracranial bleeding NOACs are powerful drugs, can cause serious bleeding and should be used in strict accordance with their specific scientific evidence

46 New Guidelines for Anticoagulation of Pts With AF Particular emphasis on identification of pts at low risk that don t need any antithrombotic Rx ASA just for few pts for whom anticoagulation cannot be proposed NOAs significantly reduce the major bleeding Primarily driven by a substantial reduction in ICH NOAs are poised to replace warfarin for the majority of the pts

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ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ. Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν The AF epidemic Mayo Clinic data (assuming a continued increase in the AF incidence) Mayo

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