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PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants

PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants. September 2012 - June 2013. PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants. Disclosure of Commercial Support.

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PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants

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  1. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants September 2012 - June 2013

  2. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Disclosure of Commercial Support This activity is supported by educational grants from BoehringerIngelheim Pharmaceuticals, Inc. and Bristol-Myers Squibb and Pfizer Inc. This slide presentation and artwork was independently developed by Boston University School of Medicine’s Powerpoint designer. Boston University School of Medicine’s Disclosure Policy Boston University School of Medicine asks all individuals involved in the development and presentation of Continuing Medical Education (CME) activities to disclose all relationships with commercial interests. This information is disclosed to CME activity participants. Boston University School of Medicine has procedures to resolve any apparent conflicts of interest. In addition, faculty members are asked to disclose when any unapproved use of pharmaceuticals and devices is being discussed.

  3. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Accreditation Information This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Boston University School of Medicine and Anticoagulation Forum. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. Boston University School of Medicine designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Continuing Nursing Education Provider Unit, Boston University School of Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. CNE Contact Hours: 1.00 Nurses will receive contact hours for those sessions attended, after completion of an evaluation and claim for credit form. • Continuing Pharmacy Education Credits • The University of Rhode Island College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Attendance and completion of program evaluations at the conclusion of the program are required for a statement of credit. This knowledge-based activity is approved for 1.0 Contact Hours (0.1 CEUs). UAN: 0060-9999-12- 040-L01-P. Expiration date: September 5, 2013.

  4. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Learning Objectives • At the conclusion of this activity participants will be able to: • Describe benefits of oral anticoagulants for stroke prevention in • atrial fibrillation • Identify the population of patients who would be at risk of stroke with atrial fibrillation • Compare current and new oral anticoagulants with regards to safety, efficacy, pharmacology, cost and convenience • Compare the benefits and risks of oral anticoagulant therapy for reducing the risk of stroke in atrial fibrillation patients • Utilize available decision making tools to stratify the risks and benefits of anticoagulation therapy in patients with atrial fibrillation :

  5. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Highlights • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

  6. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Highlights • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

  7. Question #1 An 82 year old man is in your office for an annual Medicare physical. What is the chance he has atrial fibrillation? • 1% • 5% • 10% • 25%

  8. Prevalence of Diagnosed AF Stratified by Age and Sex Men surpass women in every age range x-axis = % y-axis = # of men/women Go AS, JAMA. 2001 May 9;285(18):2370-5. Pub Med PMID: 11343485

  9. Question #2 A 46 year old male patient is in for an annual physical exam. What is his lifetime risk of developing AF? • 1% • 5% • 10% • 25%

  10. Incidence of AF Lifetime Risk for AF at Selected Index Ages by Sex 1 in 4 Men & women >40 Years will develop AF Lifetime risk if currently free of AF Lloyd-Jones DM, et al. Circulation. 2004 Aug 31;110(9):1042-6. Pub Med PMID: 15313941.

  11. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Highlights • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

  12. Question #3 68 year old female with atrial fibrillation and no other co-morbidities. How would you classify her stroke risk? • Low • Moderate • High

  13. Scoring Systems in Atrial Fibrillation • Given that anticoagulant therapy has both risks (principally bleeding) and benefits (a reduced risk of thrombosis) many authors have attempted to produce scoring systems which estimate the risks of these outcomes • No one scoring system is universally accepted or highly predictive (in individual patients)

  14. Scoring Systems in Stroke Risk • A variety of systems have been published • Outlined on next slide • All use selected clinical characteristics to predict the risk of stroke • Most widely used is the CHADS2 score • All scores provide a rough estimate of risk of thrombosis in a population at similar risk as patient being reviewed

  15. Atrial Fibrillation Risk Stratification 12 Schemes applied to 1000 patients from SPAF III study High Moderate Low Stroke Risk in Atrial Fibrillation Working Group. Stroke. 2008 Jun;39(6):1901-10. Pub Med PMID: 18420954.

  16. CHADS2: Risk of Stroke National Registry of Atrial Fibrillation Participants (NRAF) Scoring: 1 point: Congestive heart failure, HTN, < 75 years, and DM 2 points: Stroke history or transient ischemic attack † Expected stroke rate per 100 pt-yrs from the exponential survival model, assuming aspirin not taken Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. JAMA. 2001 Jun 13;285(22):2864-70. Pub Med PMID: 11401607.

  17. CHA2DS2-VASc 2009 Birmingham Schema Expressed as a Point-Based Scoring System LV = left ventricular; TE = thromboembolism  Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Chest. 2010 Feb;137(2):263-72. Pub Med PMID: 19762550.

  18. CHA2DS2-VASc Stroke or Other TE at One Year Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Chest. 2010 Feb;137(2):263-72. Pub Med PMID: 19762550.

  19. CHA2DS2-VASc and CHADS2Score 0–1 Refines stroke risk stratification in AF patients: nationwide cohort Olesen JB, Torp-Pedersen C, Hansen ML, Lip GY. ThrombHaemost. 2012 Jun;107(6):1172-9. Pub Med PMID: 22473219.

  20. Question #4 78 year old male with atrial fibrillation and hypertension (CHADS2 score = 2 [4% stroke rate per year]). What is his annual major bleeding rate? • 1% • 2% • 3% • 5% • 10%

  21. Bleeding Risk Scores • Variety of scoring systems developed to predict risk of bleeding in patients initiating anticoagulants, as with stroke risk • Less predictive than stroke risk scores, in general • Each score incorporates clinical characteristics and provides estimate of risk of bleeding in a population similar to patients being considered • Unclear whether to include risk scores in decision making for individual patients

  22. Bleeding Risk Scores Widely Used in AF • HAEMORRHAGES1 • HASBLED2 • ATRIA Score3 • Gage BF, et al. Am Heart J. 2006 Mar;151(3):713-9. PMID: 16504638. Pub Med PMID:16504638. • Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. Chest. 2010 Nov;138(5):1093-100. PMID:20299623. • Fang MC, et al. J Am Coll Cardiol. 2011 Jul 19;58(4):395-401. Pub Med PMID:21757117.

  23. Bleeding Risk Scores in AF Hemoglobin <13 g/dl men; <12 g/dl women Estimated glomerular filtration rate <30 ml/min or dialysis-dependent Diagnosed hypertension Systolic blood pressure >160 mmHg Presence of chronic dialysis or renal transplantation or serum creatinine ≥200 mmol/L Chronic hepatic disease (eg cirrhosis) or biochemical evidence of significant hepatic derangement (eg bilirubin 2 x upper limit of normal, in association with aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3 x upper limit normal, etc.) Unstable/high INRs or poor time in therapeutic range (eg <60%) Concomitant use of drugs, such as antiplatelet agents, non-steroidal anti-inflammatory drugs, or alcohol abuse etc. Cirrhosis, two-fold or greater elevation of AST or APT, or albumin <3.6 g/dl Platelets <75,000, use of antiplatelet therapy (eg daily aspirin) or NSAID therapy; or blood dyscrasia Prior hospitalization for bleeding Most recent hematocrit <30 or hemoglobin <10 g/dl CYP2C9*2 and/or CYP2C9*3 Alzheimer's dementia, Parkinson's disease, schizophrenia, or any condition predisposing to repeated falls Apostolakis S, Lane DA, Guo Y, Buller H, Lip GY. J Am Coll Cardiol 2012;60:000–000. 2012 Jul 24. [Epub ahead of print] Online Appendix. PMID: 22858389.

  24. AMADEUS Cohort Stratified by the HEMORR2HAGES, HAS-BLED, and ATRIA Schemes Apostolakis S, Lane DA, Guo Y, Buller H, Lip GY. J Am Coll Cardiol 2012;60:000–000. 2012 Jul 24. [Epub ahead of print] Online Appendix. PMID: 22858389. 24

  25. Risks of Bleeding with Warfarin or Dabigatran in AF Oldgren J, et al. Ann Intern Med. 2011 Nov 15;155(10):660-7, W204. Pub Med PMID: 22084332. 25

  26. Adjusted HR for Death After Stroke, MI, or Major Hemorrhage In Patients Who Received Antiplatelet Therapy in the ACTIVE Trials † Compared to no event ‡ ratio of hazard ratios Connolly SJ, et al. Ann Intern Med. 2011 Nov 1;155(9):579-86. Pub Med PMID: 22041946.

  27. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Highlights • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

  28. Pharmacokinetics of NOACs Kaatz S, et al. Am J Hematol. 2012 May;87 Suppl 1:S141-5. Pub Med PMID: 22473649.

  29. Measuring the Effect of NOACs n/a = not available Garcia DA, et al. In review.

  30. Reversal of NOACs Types of Studies Evaluating Reversal of New Oral Anticoagulants Kaatz S, et al. Am J Hematol. 2012 May;87 Suppl 1:S141-5. Pub Med PMID: 22473649.

  31. Reversal of NOACs Suggestions for Reversal of New Oral Anticoagulants Kaatz S, et al. Am J Hematol. 2012 May;87 Suppl 1:S141-5. Pub Med PMID: 22473649.

  32. Meta-analysis of Efficacy and Safety of New Oral Anticoagulants Dabigatran, Rivaroxaban, Apixaban vs. Warfarin in AF patients All cause stroke/SEE Ischemic and unspecified stroke Hemorrhagic stroke Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Am J Cardiol. 2012 Aug 1;110(3):453-60. Pub Med PMID: 22537354..

  33. Meta-analysis of Efficacy and Safety of New Oral Anticoagulants Dabigatran, Rivaroxaban, Apixaban vs. Warfarin in AF patients Major bleeding Intracranial bleeding GI Bleeding Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Am J Cardiol. 2012 Aug 1;110(3):453-60. Pub Med PMID: 22537354.

  34. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Highlights • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

  35. Question #5 78 year old female with atrial fibrillation, hypertension and CHF. CHADS2= 3 CHA2DS2-VASc = 5 HAS-BLED = 2 What would you use for stroke prevention? • No anti-thrombotics • Aspirin • Aspirin + clopidogrel • VKA antagonist • Dabigatran or Rivaroxaban

  36. European Society of Cardiology Guidelines CHA2DS2-VASc and Stroke Rate Camm AJ. Europace. 2010 Oct;12(10):1360-420. Pub Med PMID: 20876603.

  37. European Society of Cardiology Guidelines Approach to Thromboprophylaxis in Patients with AF Camm AJ. Europace. 2010 Oct;12(10):1360-420. Pub Med PMID: 20876603. Connolly SJ, et al. N Engl J Med 2009;361:1139–1151. PMID: 19717844.

  38. 2011 ACCF/AHA/HRS Guidelines Antithrombotic Therapy for Patients with Atrial Fibrillation Fuster V. Circulation. 2011 Mar 15;123(10): Pub Med PMID: 21382897. Wann LS, et al. J Am Coll Cardiol. 2011 Mar 15;57(11):1330-7. Pub Med PMID: 21324629.

  39. ACCP Guidelines For patients with Nonrheumatic AF, including those with Paroxysmal AF *For patients with AF unsuitable for, or who refuse, oral anticoagulant (for reasons other than concerns about major bleeding) **VKA = adjusted-dose vitamin K antagonist You JJ, et al. Chest. 2012 Feb;141(2 Suppl):e531S-75S. Pub Med PMID: 22315271.

  40. Canadian Cardiovascular Society Guidelines Assess Thromboembolic Risk (CHADS2) CHADS2 = 1 CHADS2 = 2 CHADS2 = 0 CHADS2 = 0 Increasing stroke risk OAC* OAC No anti-thrombotic No anti-thrombotic ASA ASA OAC* OAC* *ASA is a reasonable alternative for some as indicated by risk/benefit *ASA is a reasonable alternative for some as indicated by risk/benefit No additional risk factors for stroke Either female sex or vascular disease Age > 65 yrs or combination female sex and vascular disease No additional risk factors for stroke Either female sex or vascular disease Age > 65 yrs or combination female sex and vascular disease • When OAC therapy is indicated, most patients receive: • Dabigatran, rivaroxaban, or apixaban (after Health Canada approval) • In preference to warfarin • Conditional Recommendation, High-Quality Evidence Skanes AC, et al. Can J Cardiol. 2012 Mar-Apr;28(2):125-36. Pub Med PMID: 22433576.

  41. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Highlights • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

  42. Optimal Candidates for New Drugs Patients who: • Find INR testing burdensome • Despite adherence to provider recommendations, have low ‘time-in-range’ • Can afford (or arrange to get) the new drugs • Have normal renal function

  43. Optimal Candidates for Warfarin Patients who: • Have (borderline) renal insufficiency • Are taking stable dose of warfarin and do not find INR testing burdensome • Have access to self-testing machine • Are concerned about the lack of an evidence-based reversal strategy

  44. TTR per Country in RELY USA: Improvement Needed Wallentin L, et al. Lancet. 2010 Sep 18;376(9745):975-83. PMID: 20801496.

  45. Stroke and Systemic Embolism By Center TTR in RELY • TTR=optimum therapeutic range • cTTR=center's mean TTR Wallentin L, et al. Lancet. 2010 Sep 18;376(9745):975-83. Pub Med PMID: 20801496.

  46. Major Bleeding By Center TTR in RELY • TTR=optimum therapeutic range • cTTR=center's mean TTR Wallentin L, et al. Lancet. 2010 Sep 18;376(9745):975-83. PMID: 20801496.

  47. Stroke and Systemic Embolization by Center Proportion of INR in Therapeutic Range in ROCKET AF N=7061 rivaroxaban N=7082 warfarin P value for interaction=0.736 Time in therapeutic range-2-3 inclusive ‡Center TTR calculated using total INR values in target range from all warfarin subjects within center, divided by total INR values from all warfarin subjects within center §Number of events per 100 patient-years of follow-up II Hazard ratio from Cox proportional hazard model with treatment as a covariate Patel MR, et al. N Engl J Med. 2011 Sep 8;365(10):883-91. Pub Med PMID: 21830957.

  48. PREVENTINGAtrial Fibrillation RelatedSTROKESwith Anticoagulants Summary • Prevalence and incidence of AF • Risk stratification for stroke and bleeding • New oral anticoagulants • Guidelines • Practical considerations for choosing an anticoagulant

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