Breaking Old Habits: Use of the New Oral Anticoagulants in Clinical Practice

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1 Breaking Old Habits: Use of the New Oral Anticoagulants in Clinical Practice

2 Antiplatelets and oral anticoagulants Aspirin Plavix Prasugrel Ticagrelor Apixaban Rivaroxaban Dabigatran- Direct thrombin inhibitor Vorapaxar- PAR 1 inhibitor

3 Aspirin ADP Gp 2b/3a receptor Platelet ADP Fibrinogen COX 1 Activation Necrotic core Collagen Tissue factor Thrombin TXA 2 Aspirin TXA 2 Am J Med 1996;101:

4 Introduction and translational biology

5 Aspirin-overview Membrane Phospholipids Arachadonic Acid COX-1 Aspirin Prostaglandin H 2 Thromboxane A 2 Platelet Aggregation Vasoconstriction Prostacyclin Platelet Aggregation Vasodilation

6 Aspirin has anti-inflammatory actions in humans Blocking leukocyte trafficking to inflamed tissues Aspirin alters the active site of COX-2 permits conversion of arachadonic acid to 15R- HETE (15Rhydroxyeicosatetraenoic acid) in vascular Ecs leukocyte production of proresolving 15-epi-lipoxins limit neutrophil infiltration into inflammatory sites & stimulate nitric oxide (NO) production Proresolving: mediators of inflammation resolution possibly relevant to atherosclerosis Proc Natl Acad Sci U S A. 1995;92:

7 Anti-platelets Clopidogrel bisulfate Ticlopidine hydrochloride Prasugrel hydrochloride Ticagrelor Gp 2b/3a receptor Gp 2b/3a Inhibitors Fibrinogen Aspirin Platelet COX 1 TXA 2 ADP P2Y12 ADP Activation PAR 1 receptor Necrotic core Collagen Tissue factor Thrombin TXA 2 Am J Med 1996;101:

8 Pharmcodynamic overview Acetylsalicylic acid (ASA) Clopidogrel bisulfate Prasugrel hydrochloride Ticagrelor Trade Name Aspirin 1-3 Plavix 5 Effient 6 Brilinta 7 Pharma Salicylate P 2 Y 12 Receptor P 2 Y 12 Receptor P 2 Y 12 Receptor Class Antagonist Antagonist Antagonist Chemical class Cox 1 inhibitor Cox 2 Thienopydridine Thienopydridine CPTP=cyclopentyltriazolopyrimidine Formulation Active Drug Pro-Drug Pro-Drug Active Drug Maintenance Dose mg daily* 75 mg daily 10 mg daily 90 mg BID Reversible No No No Yes

9 Platelet antagonists primarily work on ACTIVATION (Α 2 β 3 Integrin) Platelet Collagen Receptor (GPIa) Platelet vwf Receptor (GP1b) TXA 2 Receptor ADP ADP (P2Y 12 ) Receptor Prasugrel, Clopidogrel, Ticagrelor PAR 1 Vorapaxar Abciximab, eptifibatide, tirofiban GP IIb/IIIa Receptor TXA 2 Intact Endothelium Collagen vwf Endothelial Damage No currently approved antiplatelet agents specifically target Adhesion Aspirin Cox 1-2 Most approved antiplatelet agents affect different aspects of platelet Activation GP IIb/IIIa inhibitors inhibit the final common pathway, Aggregation GP = glycoprotein; vwf = von Willebrand factor; ADP = adenosine diphosphate; TX = thromboxane. Meadows et al. Circulation Res. 2007;100:

10 Mechanism of Action of Thienopyridines Thienopyridine Binding to P2Y 12 Receptor The binding of ADP to the P2Y 12 receptors on the platelet surface is a critical step in platelet activation ADP Thienopyridines bind to the P2Y 12 receptor inhibiting ADP binding This binding is irreversible; the P2Y 12 receptor is inhibited for the life of the platelet Adapted from Husted Cardiovasc Ther. 2009;27: (Husted) van Giezen. Eur Heart J Suppl. 2008;10(suppl D):D23-D29. Meadows et al. Circ Res. 2007;100:

11 Mechanism of Action of CPTPs CPTPs reversibly bind to an area on the P2Y 12 receptor that is distinct from the ADP binding site 1-3 CPTP Binding to P2Y 12 Receptor CPTPs do not interfere with ADP binding; instead it is believed they prevent ADP-mediated receptor activation 1-3 ADP The receptor is functional after dissociation of the CPTP molecule 1,2 The degree of receptor inhibition is dependent on the CPTP concentration 1,2 Cardiovasc Ther. 2009;27: (Husted) van Giezen. Eur Heart J Suppl. 2008;10(suppl D):D23-D29. Meadows et al. Circ Res. 2007;100:

12 IPA (%) Induced by 20 M ADP Faster onset with newer anti-platelets % 79% 88% Ticagrelor + aspirin (n=54) Clopidogrel + aspirin (n=50) Placebo + aspirin (n=12) Loading dose Time (Hours) 180-mg loading dose 600-mg loading dose ONSET/OFFSET study in patients with stable coronary artery disease (CAD) randomized to Ticagrelor, clopidogrel, or placebo on a background of aspirin therapy ( mg per day) for 6 weeks IPA=inhibition of platelet aggregation. Gurbel et al. Circulation. 2009;120(25):

13 Antiplatelets and oral anticoagulants Aspirin Plavix Prasugrel Ticagrelor Apixaban Rivaroxaban Dabigatran- direct thrombin inhibitor Vorapaxar- PAR 1 inhibitor

14 Thrombin receptor (proteaseactivated receptor, PAR-1) antagonist TRACER TRA 2 nd P (TIMI 50) Hx of MI Medical considerations Hx PAD CV death, MI, stroke and urgent coronary revascularization Vorapaxar translational biology U.S. Approval: 05/2014 NDA

15 Mechanism of action Reversible antagonist of the protease-activated receptor-1 (PAR- 1) PAR-1 is a G-coupled cytoplasmic receptor Cells with PAR-1 receptors Platelets Vascular endothelium (vascular permeability & barrier integrity) Others (neurons) low-level activation of PAR-1 in neurons by thrombin is neuroprotective, while high-level activation may be neurodegenerative Blocks thrombin-mediated aggregation Studies of the concentration-response relationship for vorapaxar show large variations in the EC50 values for effects on platelet aggregation In vitro platelet aggregation studies with stimulation by TRAP (Thrombin Receptor Activating Peptide) Schuepbach RA, Feistritzer C, Fernandez JA, Griffin JH, Riewald M. Protection of vascular barrier integrity by activated protein C in murine models depends on protease-activated receptor-1. Thromb.Haemost Apr;101(4):

16 At day 7, the low EC50 model has nearly 100% of subjects at > 80% platelet inhibition with a 2.5 mg dose Mean plasma concentration by hours Half maximal effective concentration (EC 50 ) Dose (mg)

17 Thrombin binds to PAR1 receptor on surface of platelets-releasing ligand portion activating G proteins Metabolism: CYP3A4 enzymes No meaningful renal clearance Long half life (T1/2 >100 hours) Cytoskeletal changes Granule secretion Release of arachidonic acid Cell 1991;64:1057 Adapted from medicalbiochem

18 Vorapaxar in secondary prevention of atherothrombotic events (TIMI-50) 26,449 patients Myocardial infarction, ischemic stroke, or peripheral arterial disease Vorapaxar 2.5 mg/qd vs placebo 28% DAPT with PAD Stroke 8% DAPT 30 month median follow up Primary endpoint: Composite of death from cardiovascular causes, myocardial infarction, or stroke After 2 years, the data and safety monitoring board recommended discontinuation of the study treatment in patients with a history of stroke owing to the risk of intracranial hemorrhage Intracranial hemorrhage in the vorapaxar group (1.0%, vs. 0.5% in the placebo group; P<0.001) N Engl J Med 2012;366:

19 N Engl J Med 2012;366:

20

21 Cardiovascular endpoints N Engl J Med 2012;366:

22 N Engl J Med 2012;366:

23 Acute coronary syndrome and PAR 1 inhibitor vorapaxar Multinational, doubleblind, randomized trial, Compared vorapaxar with placebo 12,944 patients Primary end point: Composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization TRACER N Engl J Med 2012;366:20-33

24 INDICATION: to reduce the risk of heart attacks and stroke in high-risk patients vorapaxar ressannouncements/ucm htm

25 Atrial fibrillation-nonvalvular

26 Apixaban vs warfarin in non valvular atrial fibrillation Randomized, double-blind trial N=18201 for 1.8 yrs Apixaban 5 mg bid vs warfarin (INR 2-3) Afib + 1 stroke risk factor Primary outcomes Ischemic or hemorrhagic stroke or systemic embolization N Engl J Med 2011;365:981-92

27 N Engl J Med 2011;365:981-92

28 N Engl J Med 2011;365:981-92

29 Rivaroxaban Direct, specific, competitive factor Xa inhibitor Half-life 5-13 hours Clearance : 1/3 direct renal excretion 2/3 metabolism via CYP 450 enzymes Oral, once daily dosing without need for coagulation monitoring TF/VIIa X IXa VIIIa Va Fibrinogen Xa II IIa IX Rivaroxaban Apixban Fibrin

30 TF/VIIa Prodrug factor Xa inhibitor Half-life hours Clearance : 80% by kidney Oral, once daily dosing without need for coagulation monitoring X VIIIa Va Xa II IIa Thrombin IXa IX Dabigatran (direct thrombin inhibitor) Fibrinogen Fibrin

31 Contrasting studies with oral direct factor Xa inhibitors ROCKET AF Noninferior to warfarin for the prevention of stroke and systemic embolism in the intention-to-treat analysis The rates of intracranial hemorrhage and fatal bleeding were lower with rivaroxaban than with warfarin No advantage with respect to other major bleeding Direct thrombin inhibitor Dabigatran (RE-LY) 150-mg dose of Dabigatran bid (110 mg less bleeding) Compared to warfarin, Dabigatran reduce the rate of stroke, Similar overall rate of bleeding, although the rate of gastrointestinal bleeding was increased

32 Primary Safety Outcomes Major >2 g/dl Hgb drop Transfusion (> 2 units) Critical organ bleeding Bleeding causing death Rivaroxaban Event Rate or N (Rate) Warfarin Event Rate or N (Rate) HR (95% CI) 1.04 (0.90, 1.20) 1.22 (1.03, 1.44) 1.25 (1.01, 1.55) 0.69 (0.53, 0.91) 0.50 (0.31, 0.79) P- value Intracranial Hemorrhage 55 (0.49) 84 (0.74) 0.67 (0.47, 0.94) Intraparenchymal 37 (0.33) 56 (0.49) 0.67 (0.44, 1.02) Intraventricular 2 (0.02) 4 (0.04) Subdural 14 (0.13) 27 (0.27) 0.53 (0.28, 1.00) Subarachnoid 4 (0.04) 1 (0.01) Rivaroxaban Event Rates are per 100 patient-years Based on Safety on Treatment Population ROCKET AF

33 Significantly less bleeds on Dabigatran p<0.001 N Engl J Med 2009;361:

34 Antiplatelets and oral anticoagulants Aspirin Plavix Prasugrel Ticagrelor Apixaban Rivaroxaban Dabigatran- Direct thrombin inhibitor Vorapaxar- PAR 1 inhibitor

35 3 take home messages Warfarin for non Valvular maybe not be first choice from newer X a inhibitors or dabigtran in many patients // and no needle sticks with reversal agents pending Vorapaxar- PAR 1 inhibitor-difficulty with CNS bleeding but less CV events Platelet inhibitors: newer agents look better, but caution: use only in patient studies proven to work

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