Objectives. Epidemiology. Pathophysiology 4/1/2013

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1 Objectives The New CHEST Guidelines, The Bleeding War Continues Ginger Warren, PharmD., MCSR PGY1 Pharmacy Resident Valley Health System/Bernard J Dunn School of Pharmacy, Shenandoah University April 3 rd, 2013 I have no relevant financial relationships or interests to declare Identify updates/changes in the atrial fibrillation (AF) chapter of the 9 th edition CHEST guideline Choose an appropriate treatment course for a patient based on a CHADS 2 score Recognize strong recommendations as compared to those with weak evidence Select appropriate counseling points for a patient starting on one of the new agents used in atrial fibrillation Epidemiology Pathophysiology Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia 1 Affects almost 3 million people in the United States 1 Prevalence increases with age 1 Approximately 9% of patients 80 years old In 2005, estimated cost of treatment per year including hospitalizations was $6.65 billion 2 Risk of ischemic stroke w/o thromboprophylaxis is 5% per year Shortened action potential & refractory period rapid atrial rate 1. Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. Circulation. 2006;114(7):e , 2. Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum P. Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. Value Health Sep Oct;9(5):

2 Stroke Risk Stratification Risk Factor (CHADS 2 ) PointValue Congestive heart failure/lv dysfunction 1 Hypertension 1 Age 75 years old (yo) 1 Diabetes mellitus 1 Prior history of Stoke or transient ischemic attack 2 Risk Factor (CHADS 2 VASc) Point Value Congestive heart failure/lv dysfunction 1 Hypertension 1 Age 75 yo 2 Diabetes mellitus 1 Prior history of Stoke or transient ischemic attack 2 Vascular Disease 1 Age yo 1 Female Sex 1 Ischemic Stroke and Systemic Embolism Risk Factor Relative Risk Congestive heart failure 1.4 History of hypertension 1.6 Advanced age (continuous, per decade) 1.4 Diabetes mellitus 1.7 Previous stroke or TIA 2.5 Fuster V, et al. J Am Coll Cardiol 2006;48:e149 e246. Gage BF, et al. JAMA 2001;285: Antithrombotic Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence Based Clinical Practice Guidelines Chapter 18: Antithrombotic Therapy for Atrial Fibrillation Level of Evidence Outlines prevention, diagnosis, & treatment of thrombosis Encompasses many clinical conditions: medical surgery, orthopedic surgery, atrial fibrillation, stroke, cardiovascular disease, pregnancy, children, etc. Includes > 600 recommendations in > 800 pages Strong grade 1 Weak grade 2 High quality A Moderate quality B Low quality C Guyatt GH, Akl EA, Crowther M, et al. Introduction to the ninth edition: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):48S 52S. photo/strong.html, 2

3 Antithrombotic Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence Based Clinical Practice Guidelines Chapter 18: Antithrombotic Therapy for Atrial Fibrillation Decision Pathway Start here Atrial fibrillation Patients included: Permanent, persistent, or paroxysmal AF Special situations Cardioversion Patients NOT included: Pre & postinvasive procedures Acute stroke Prosthetic valve Pregnant Single, isolated episode CHADS 2 = 0: No therapy No CAD CHADS 2 1: anticoagulation No mitral stenosis CHADS 2 = 0: patient specific therapy Stable CAD CAD CHADS 2 1: VKA monotherapy Mitral stenosis VKA therapy ACS w/n 12 mths To be continued Low Risk Data for CHADS 2 = 0 No therapy > Antithrombotic therapy Alternatives Aspirin > Oral anticoagulation Aspirin > Aspirin + clopidogrel Grade 2B Grade 2B Grade 2B ASA use for 1 year compared to no treatment prevented 2 nonfatal strokes while causing 3 nonfatal major extracranial bleeds per 1000 patients Use of VKA therapy compared to no therapy resulted in 5 fewer nonfatal strokes and 8 more nonfatal major extracranial bleeds per 1000 patients Reduction in all cause mortality not likely to extend to low risk patients Increased risk for intracranial hemorrhage remains similar to higher risk patients Oral anticoagulation may be favored for patients with multiple non CHADS 2 risk factors for stroke (age 65 74, female sex, vascular disease, etc.) 3

4 Intermediate Risk Dabigatran versus warfarin in patients with atrial fibrillation Randomized Evaluation of Long term anticoagulant therapy (RE LY) trial CHADS 2 = 1 Oral anticoagulation* > No therapy Grade 1B > Aspirin Grade 2B > Aspirin + clopidogrel Grade 2B Alternative (for reasons other than bleeding concerns) Aspirin + clopidogrel > Aspirin Grade 2B Randomized, multicenter, prospective, noninferiority trial dabigatran 110 mg bid or 150 mg bid versus warfarin in patients with nonvalvular AF and 1 of the following: Previous stroke or transient ischemic attack (TIA) Left ventricular ejection fraction (LVEF) < 40% CHF, NYHA class 2 Age 75 yo Age yo with DM, CAD, HTN Primary efficacy outcome: stroke or systemic embolism *Oral anticoagulation Dabigatran 150mg twice daily > Warfarin Grade 2B Primary safety outcome: major hemorrhage Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12): Dabigatran versus warfarin in patients with atrial fibrillation Randomized Evaluation of Long term anticoagulant therapy (RE LY) trial High Risk Results listed as % of patients per year: Event Warfarin (n = 6022) *p < 0.05 compared to warfarin **p < 0.05 compared to dabigatran 150 mg Dabigatran 110 mg (n = 6015) Dabigatran 150 mg (n = 6076) Stroke/systemic embolism * 1.11* Ischemic stroke * Hemorrhagic stroke * 0.1* Major bleed * 3.11 Gastrointestinal (GI) bleed 1.02** Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12): CHADS 2 2 Oral anticoagulation* > No therapy Grade 1A > Aspirin Grade 1B > Aspirin + clopidogrel Grade 1B Alternative (for reasons other than bleeding concerns) Aspirin + clopidogrel > Aspirin Grade 1B *Oral anticoagulation Dabigatran 150mg twice daily > Warfarin Grade 2B 4

5 Data for Question VKA therapy compared to ASA for 1 year resulted in 19 fewer strokes at the expense of 3 more bleeds per 1000 patients VKA therapy compared to ASA + clopidogrel for 1 year resulted in 11 fewer strokes and up to 3 more bleeds per 1000 patients Dual antiplatelet therapy is inferior as compared to VKA therapy for stroke prevention 9th ed: American College of Chest Physicians Evidence Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e531S 75S., ACTIVE Writing Group of the ACTIVE Investigators, Connolly S, Pogue J, Hart R, et al. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet Jun 10;367(9526): Which of the following has been shown to be associated with an increased stroke risk that is identified in CHADS 2 VASc? A) Female sex B) Age yo C) Asian race D) Valvular disease Case Case, part 2 GB is a 67 yo female with atrial fibrillation, rhythm controlled with amiodarone 200 mg daily. Her PMH is significant for migraines, gestational DM, and endometriosis. What is her CHADS 2 score? A) 0 B) 1 C) 2 D) 3 GB is a 67 yo female atrial fibrillation, rhythm controlled with amiodarone 200 mg daily. Her PMH is significant for migraines, gestational DM, and endometriosis. Based on GB s CHADS 2 score, what is the recommended antithrombotic therapy? A) no pharmacological agent B) aspirin 75 mg 325 mg daily C) dose adjusted warfarin with goal INR 2 3 D) aspirin 75 mg 325 mg daily + clopidogrel 75 mg daily 5

6 Decision Pathway ACS w/n 12 mths Special Situations No stent placement Stent placement CHADS 2 = 0: dual antiplatelet therapy x 12 mths CHADS 2 1: VKA therapy + antiplatelet x 12 mths Bare metal Drug eluting CHADS 2 1: ASA + clopidogrel x 12 mths CHADS 2 2: triple therapy x 1 mth CHADS 2 1: ASA + clopidogrel x 12 mths CHADS 2 2: triple therapy x 3 6 mths VKA therapy + antiplatelet x 2 nd 12 th mth VKA therapy + antiplatelet x > 3 6 mths 12 th mth Reassess antithrombotic therapy needs after completion of 12 mths = Stable CAD AF + Mitral Stenosis AF + Stable Coronary Artery Disease CHADS 2 0 Oral anticoagulation* > No therapy Grade 1B > Aspirin Grade 1B > Aspirin + clopidogrel Grade 1B Alternative (for reasons other than bleeding concerns) Aspirin + clopidogrel > Aspirin Grade 1B Patients with coronary artery disease (CAD) are recommended to use ASA for prevention of cardiovascular events 1/3 of AF patients have CAD CHADS 2 0 Warfarin > Warfarin + aspirin Grace 2C *Oral anticoagulation Warfarin 6

7 AF + Non invasive ACS Low or Intermediate Risk + Stent CHADS 2 1 First 12 months after ACS Warfarin + antiplatelet agent > Aspirin + clopidogrel Grace 2C > Warfarin + aspirin + clopidogrel Grade 2C > 12 months after ACS* Warfarin > Warfarin + aspirin Grace 2C *same recommendation as AF + Stable CAD CHADS 2 = 0 1 First 12 months post bare metal OR drug eluting Aspirin + clopidogrel > Warfarin + aspirin + clopidogrel Grade 2C >Warfarin + aspirin Grade 2C > 12 months* Warfarin >Warfarin + aspirin Grade 2C *same recommendation as AF + Stable CAD High Risk + Stent AF + Elective Cardioversion CHADS 2 2 Bare metal: 1 st month Drug eluting: First 3 6 months Warfarin + aspirin + clopidogrel > Aspirin + clopidogrel Bare metal: 2 nd 12 th month Drug eluting: > 3 6 months 12 th month Warfarin + antiplatelet agent > Warfarin Bare metal: > 12 months* Drug eluting: > 12 months* Warfarin > Warfarin + aspirin *same recommendation as AF + Stable CAD Grade 2C Grade 2C Grade 2C AF > 48 hours Before scheduled cardioversion Warfarin, LMWH, or dabigatran x 3 weeks > No therapy After successful cardioversion Warfarin, LMWH, or dabigatran x 4 weeks > No therapy AF 48 hours Before cardioversion LMWH or UFH > Delaying 3 weeks for anticoagulation After successful cardioversion Warfarin, LMWH, or dabigatran x 4 weeks > No therapy 1B 1B 2C 2C 7

8 AF + Immediate Cardioversion Case Before cardioversion Parenteral anticoagulation >No therapy* 2C After successful cardioversion Warfarin, LMWH, or dabigatran x 4 weeks > No therapy 2C *do not delay intervention for initiation of anticoagulation LW is a 78 yo female with atrial fibrillation, rate controlled with metoprolol tartrate 25 mg bid. Her PMH is significant for hypertension, MI in 2008, and asthma. Based on LW s CHADS 2 score, what is the recommended antithrombotic therapy? A) aspirin 75 mg 325 mg daily B) dose adjusted warfarin with goal INR 2 3 C) aspirin 75 mg 325 mg daily + clopidogrel 75 mg daily D) dabigatran 150 mg twice daily Case, part 2 If LW s MI was 11/12 with bare metal stenting, would the recommendation change? A) Yes, dose adjusted warfarin with goal INR aspirin 75 mg 325 mg daily + clopidogrel 75 mg daily B) Yes, dose adjusted warfarin with goal INR aspirin 75 mg 325 mg daily OR dose adjusted warfarin with goal INR clopidogrel 75 mg daily C) No D) Yes, dabigatran 150 mg twice daily + aspirin 75 mg 325 mg daily New Oral Anticoagulants 8

9 The Ideal Anticoagulant Rivaroxaban (Xarelto ) Direct Factor Xa inhibitor Available and effective antidote Low cost Wide therapeutic index Quick onset Minimal drug interactions Once daily dosing Oral Minimal monitoring FDA Indications: Postoperative thromboprophylaxis Treatment of deep vein thrombosis (DVT) & pulmonary embolism (PE) Prevention of stroke & systemic embolism in nonvalvular AF Dose: 20 mg daily with evening meal Pharmacokinetics: Absorption: bioavailability %, take with food for AF indication Metabolism: P glycoprotein, CYP3A4 substrate Elimination: half life of 5 9 h, h (elderly); 66% (renal), 34% (feces) Avoid use in CrCl < 15 ml/min Dose reduction for CrCl ml/min Rivaroxaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com Rivaroxaban (Xarelto ) Direct Factor Xa inhibitor Rivaroxaban (Xarelto ) Direct Factor Xa inhibitor Contraindications/Warnings: Box Warnings: Neuraxial anesthesia or spinal puncture Discontinuation of therapy Hepatic disease Active bleeding Concomitant use with strong CYP3A4 or P glycoprotein inhibitors/inducers Monitoring: routine monitoring not required Anti factor Xa no therapeutic level has been established Prothrombin time (PT)/ INR dose dependent with PT; INR is standardized for warfarin Activated partial thromboplastin time (aptt) not effective, prolongation only seen at peak drug levels Rivaroxaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com Common adverse effects: Bleeding (hip/knee replacement 5.8% ) Serious adverse effects: Syncope (1.2% ) GI hemorrhage (3.1% ) Major bleeding (a fib 5.6%; hip/knee 0.3% ) Epidural/spinal hematoma Anaphylaxis Cerebrovascular accident Rivaroxaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com, Patient Instructions: Do not miss doses Take with evening meal 9

10 Rivaroxaban versus warfarin in nonvalvular atrial fibrillation Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) Randomized, multicenter, double blind, double dummy, prospective, noninferior trial of rivaroxaban 20 mg daily vs warfarin in patients with nonvalvular AF & history of stroke, TIA, or systemic embolism or 2 of the following: LVEF 35% or CHF HTN Age 75 yo DM Primary efficacy outcome: stroke or systemic embolism Primary safety outcome: major or nonmajor clinically relevant bleeding events Results listed as number of events per 100 patient years: Events Warfarin (n = 7004) Rivaroxaban (n = 6958) Stroke/systemic embolism * Ischemic stroke Hemorrhagic stroke * Major bleed GI bleed (listed as %) 2.16** 3.15 *p < 0.05 compared to warfarin **p < 0.05 compared to rivaroxaban Patel MR, Mahaffey KW, Garg J, Pan G, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10): Patel MR, Mahaffey KW, Garg J, Pan G, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10): Dabigatran (Pradaxa ) Direct thrombin inhibitor Dabigatran (Pradaxa ) Direct thrombin inhibitor FDA indications: Postoperative thromboprophylaxis Prevention of stroke &systemic embolism in nonvalvular AF Dose: 150 mg twice daily Pharmacokinetics: Absorption: bioavailability 3 7%; take with or without food Metabolism: P glycoprotein; converted to active moiety by esterasecatalyzed hydrolysis Elimination: half life of h; 80% (renal) Avoid use in CrCl < 15 ml/min Dose reduction for CrCl ml/min Dabigatran. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com Contraindications/Warnings: Active bleeding Prosthetic heart valve Elderly population Discontinuation of therapy Concomitant use with strong P glycoprotein inhibitors/inducers Monitoring: routine monitoring not required aptt value 2.5 x normal may indicate over anticoagulation Dabigatran. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com 10

11 Dabigatran (Pradaxa ) Direct thrombin inhibitor Dabigatran (Pradaxa ) Direct thrombin inhibitor Common adverse effects: Esophagitis, GERD, GI hemorrhage (6.1% ) Bleeding (16.6% ) Serious adverse effects: Major GI hemorrhage (1.6% ) Life threatening bleeding (1.5% ) Major bleeding (3.3% ) Anaphylaxis (< 0.1% ) Intracranial hemorrhage (0.3% ) Dabigatran. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com Patient instructions: Do not miss doses Do not break capsule Keep medication in original bottle Discard medication 120 days after opening bottle Dabigatran. Clinical Pharmacology. Retrieved Jan 5, 2013 from clinical pharmacology.com, Apixaban (Eliquis ) Direct Factor Xa inhibitor Apixaban (Eliquis ) Direct Factor Xa inhibitor FDA approved indication: Prevention of stroke or systemic embolism in nonvalvular AF Dose: 5 mg twice daily 2.5 mg twice daily if 2 of the following: age 80 yo, weight 60 kg, SCr 1.5 mg/dl Pharmacokinetics: Absorption: bioavailability ~50%; take with or without food Metabolism: P glycoprotein; CYP3A4 substrate (minor) Elimination: half life 12 h; 25% (renal), 55% (feces) Avoid use in CrCl < 15 ml/min Apixaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com Contraindications/Warnings: Active bleeding Prosthetic heart valve Hepatic disease Body weight < 50 kg or > 120 kg Neuraxial anesthesia Monitoring: routine monitoring not required PT/INR prolonged aptt prolonged Anti factor Xa linear relationship with plasma concentrations Apixaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com 11

12 Apixaban (Eliquis ) Direct Factor Xa inhibitor Apixaban versus warfain in patients with atrial fibrillation Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation trial (ARISTOTLE) Common adverse effects: Bleeding (6%) Nausea (7%) Vomiting (5%) Constipation (5%) Serious adverse effects: Major bleeding (2.1% ) Anaphylaxis (< 1% ) Intracranial hemorrhage (0.3% ) Patient Instructions: Do not miss doses Randomized, multicenter, double blind, double dummy, prospective, noninferior trial of apixaban 5 mg bid vs warfarin in patients with nonvalvular AF and 1 of the following: Previous stroke, TIA, or systemic embolism LVEF 40% or symptomatic CHF w/n 3mos HTN requiring medication management Age 75 yo DM Primary efficacy outcome: stroke or systemic embolism Primary safety outcome: major bleed Apixaban. Clinical Pharmacology. Retrieved Jan 5, 2013 from clinicalpharmacology.com, receivesresubmission apixaban drug application reduce stroke patients atrial fibrillati Granger CB, Alexander JH, McMurray JJ, Lopes RD, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11): Apixaban versus warfain in patients with atrial fibrillation Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation trial (ARISTOTLE) Question Results listed as % of patients per year: Events Warfarin (n = 9081) Apixaban (n = 9120) Stroke/systemic embolism * Ischemic stroke Hemorrhagic stroke * Major bleed * GI bleed Which of the new oral anticoagulants must be taken with food? A) Rivaroxaban B) Dabigatran C) Apixaban D) All of the above *p < 0.05 compared to warfarin Granger CB, Alexander JH, McMurray JJ, Lopes RD, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):

13 Question Comparison of Oral Anticoagulants Dabigatran should be dispensed in the original bottle and should be discarded after how many months? A) 1 B) 2 C) 3 D) 4 Rivaroxaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com, Dabigatran. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com, Apixaban. Clinical Pharmacology. Retreived Jan 5, 2013 from clinicalpharmacology.com Challenges with New Agents Case Bleeding concern Lack of antidote Cost of reversal and prolonged length of hospitalization Little experience with use in special populations: obesity, renal dysfunction, liver dysfunction, pediatric patients, etc. Little knowledge of concomitant use with dual antiplatelet agents GW is a 72 yo female with atrial fibrillation, rate controlled on metoprolol succinate 25mg daily, hypertension, COPD, and h/o ischemic stroke She is taking dabigatran 150 mg twice daily and minor GI bleeding with continued use. She wonders is she should try a different food to sprinkle the medication on besides applesauce. Any suggestions? A) Switch GW to adjusted dose warfarin goal INR 2 3 B) Recommend to sprinkle on yogurt C) Recommend to not sprinkle on any food but take the capsule whole D) Recommend to continue to sprinkle on applesauce and add a PPI to her medication regimen 13

14 Conclusions The recommendation for low risk AF patients is no antithrombotic therapy The recommendation for CHADS 2 score 1 is dabigatran 150 mg twice daily for patients without CAD and with similarities to those in the RE LY trial Patients with stable CAD on warfarin therapy are not recommended to add ASA to their regimen Rivaroxaban must be taken with food and is once daily while dabigatran and apixaban are twice daily and may be taken with or without food Questions gwarren@valleyhealthlink.com To obtain credit for this CE Sign in and attend entire live activity Register using link from or address below: pharmacy.su.edu/cpe Complete online post test scoring 70% plus online activity evaluation by May 3 rd, 2013 CPE credit will be uploaded to CPE Monitor at the end of June

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