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New Frontiers in Stroke Prevention for Atrial Fibrillation Focus on Evolving Strategies for Initial Assessment, Risk Stratification, Monitoring, and Pharmacologic.

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Presentation on theme: "New Frontiers in Stroke Prevention for Atrial Fibrillation Focus on Evolving Strategies for Initial Assessment, Risk Stratification, Monitoring, and Pharmacologic."— Presentation transcript:

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2 New Frontiers in Stroke Prevention for Atrial Fibrillation Focus on Evolving Strategies for Initial Assessment, Risk Stratification, Monitoring, and Pharmacologic Interventions for Stroke Prevention in Atrial Fibrillation (SPAF) New Paradigms in the Science and Medicine of Heart Disease Program Chairman Allan V. Abbott, MD Program Chair and Moderator Professor of Clinical Family Medicine Associate Dean of Continuing Medical Education Keck School of Medicine University of Southern California

3 Program Faculty Allan V. Abbott, MD Program Chair and Moderator Professor of Clinical Family Medicine Associate Dean of Continuing Medical Education Education Keck School of Medicine University of Southern California Los Angeles, California Alan K. Jacobson, MD, FACC Assistant Professor Loma Linda University School of Medicine Medicine Director, Anticoagulation Services Associate Chief of Staff for Research Loma Linda Veterans Affairs Medical Center Center Loma Linda, California Scott Kaatz, DO, MSc, FACP Clinical Associate Professor of Medicine Associate Residency Program Director Department of Medicine Director, Anticoagulation Clinics Henry Ford Hospital Detroit, Michigan Annabelle S. Volgman, MD, FACC Associate Professor of Medicine Medical Director Heart Center for Women Rush University Medical College Chicago, Illinois

4 New Frontiers in Stroke Prevention for Atrial Fibrillation Focus on Evolving Strategies for Initial Assessment, Risk Stratification, Monitoring, and Pharmacologic Interventions for Stroke Prevention in Atrial Fibrillation (SPAF) New Paradigms in the Science and Medicine of Heart Disease Program Chairman Allan V. Abbott, MD Program Chair and Moderator Professor of Clinical Family Medicine Associate Dean of Continuing Medical Education Keck School of Medicine University of Southern California

5 A Brief History 1628, William Harvey was probably the first to describe "fibrillation of the auricles" in animals. 1628, William Harvey was probably the first to describe "fibrillation of the auricles" in animals. 1785 William Withering recorded digitalis leaf brought some relief to patients with severe heart failure. 1785 William Withering recorded digitalis leaf brought some relief to patients with severe heart failure. 1900, Sir Thomas Lewis in London was the first to record an electrocardiogram in a patient with atrial fibrillation. 1900, Sir Thomas Lewis in London was the first to record an electrocardiogram in a patient with atrial fibrillation. However the exact mechanisms and importance remained controversial until the 1970s. However the exact mechanisms and importance remained controversial until the 1970s.

6 Epidemiology of Atrial Fibrillation Atrial fibrillation is fairly uncommon in people under 50 years but is found in 0.5% of people aged 50-59, increasing to 8-8% at age 80-89. Atrial fibrillation is fairly uncommon in people under 50 years but is found in 0.5% of people aged 50-59, increasing to 8-8% at age 80-89. Atrial fibrillation may be either chronic or paroxysmal. Atrial fibrillation may be either chronic or paroxysmal. In the Framingham study, hypertension, cardiac failure, and rheumatic heart disease were the commonest precursors of atrial fibrillation. In the Framingham study, hypertension, cardiac failure, and rheumatic heart disease were the commonest precursors of atrial fibrillation. About a third of patients have idiopathic or "lone" atrial fibrillation - no precipitating cause can be identified and no evidence of structural heart disease exists. About a third of patients have idiopathic or "lone" atrial fibrillation - no precipitating cause can be identified and no evidence of structural heart disease exists.

7 Treatment, A Brief History 1982, The epidemiological importance of atrial fibrillation as an important precursor of cardiac and cerebrovascular death was investigated by William Kannell and colleagues. 1982, The epidemiological importance of atrial fibrillation as an important precursor of cardiac and cerebrovascular death was investigated by William Kannell and colleagues. 1980s-1990s, awareness increased of the hazards of sustained atrial fibrillation and the benefits of prophylaxis against thrombosis in preventing stroke. 1980s-1990s, awareness increased of the hazards of sustained atrial fibrillation and the benefits of prophylaxis against thrombosis in preventing stroke. Early treatment was electrical or chemical cardioversion, digitalis for rate control, and warfarin or aspirin for prevention of thromboemboli. Early treatment was electrical or chemical cardioversion, digitalis for rate control, and warfarin or aspirin for prevention of thromboemboli.

8 Treatment, Last Decade Rate control with beta-blockers and/or calcium channel blockers (digoxin or amiodarone if CHF) Rate control with beta-blockers and/or calcium channel blockers (digoxin or amiodarone if CHF) Cardioversion, heparin and electrical or chemical cardioversion then warfarin Cardioversion, heparin and electrical or chemical cardioversion then warfarin Warfarin with its associated risk of bleeding and requirement for frequent monitoring remains standard today Warfarin with its associated risk of bleeding and requirement for frequent monitoring remains standard today

9 Treatment, Evolving Paradigms New treatments End the atrial fibrillation with catheter ablation or surgical approaches End the atrial fibrillation with catheter ablation or surgical approaches Replace warfarin with novel oral anticoagulants ablate Replace warfarin with novel oral anticoagulants ablate

10 Treatment, Evolving Paradigms Ablation Procedures

11 Treatment, Evolving Paradigms Novel oral anticoagulants

12 Epidemiology, Risk Stratification, and Individualized Therapy in Atrial Fibrillation Aligning Stroke-Preventing Strategies with Appropriate Patient Subgroups Annabelle S. Volgman, MD FACC Associate Professor of Medicine Medical Director, Heart Center for Women Rush University Medical Center Chicago, IL New Paradigms in the Science and Medicine of Heart Disease

13 Outline Epidemiology, risk stratification, and individualized therapy in atrial fibrillation Epidemiology, risk stratification, and individualized therapy in atrial fibrillation Aligning stroke-preventing strategies with appropriate patient subgroup Aligning stroke-preventing strategies with appropriate patient subgroup The Role of Risk Stratification for Identifying Antithrombotic Strategies for Stroke Prevention: The Role of Risk Stratification for Identifying Antithrombotic Strategies for Stroke Prevention: Evidence-based options for the family medicine specialist at the front lines of care Evidence-based options for the family medicine specialist at the front lines of care

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15 Pilote, L. et al. CMAJ 2007;176:S1-S44 Prevalence of AF in Adults Aged 65-84 Years (% of Total Population), 1968-1989 Adults 1968- 1970 1971- 1973 1975- 1977 1979- 1981 1983- 1985 1987- 1989 Men3.25.36.57.87.59.1 Women2.83.34.34.33.94.7

16 Atrial Fibrillation: Framingham Study Wolf PA et al. Stroke. 1991;22-983-8. Age AF Prevalence (%) Strokes Attributable to AF (%) 50-590.56.5 60-691.88.5 70-794.818.8 80-898.830.7

17 Lifetime Risk of Developing AF 40 years old 40 years old Men Men Women Women 80 years old 80 years old Men Men Women Women 26% 23% 22% The lifetime risk for AF was approximately 16% in the absence of a history of congestive heart failure or myocardial infarction. of a history of congestive heart failure or myocardial infarction. Lloyd-Jones DM et al. Circulation 2004.

18 Factors that Affect Developing Primary Atrial Fibrillation FactorStudyEffect Obesity/MS/DM VALUE 1 Increase Alcohol WHS 2 Increase Statins Multiple 3 Decrease ACE-I/ARBs Multiple 4 Decrease Fish/Fish oils Multiple 5 Decrease (post-op) Vitamin E WHS 6 No effect 1 Aksnes TA et al. Am J Cardiol. 2008 Mar 1;101(5):634-8 2 Conen, D et al. JAMA Dec 2008, 300 (21):2489-96. 1 Aksnes TA et al. Am J Cardiol. 2008 Mar 1;101(5):634-8 2 Conen, D et al. JAMA Dec 2008, 300 (21):2489-96. 3 Faucier L et al. J Am Coll Cardiol, 2008; 51:828-835, 4 Healey et al. J Am Coll Card, 2005: 45:1832-1839, 3 Faucier L et al. J Am Coll Cardiol, 2008; 51:828-835, 4 Healey et al. J Am Coll Card, 2005: 45:1832-1839, 5 Cheng W et al. J Altern Complement Med. 2008 Oct;14(8):965-74. 6 Ganz LI et al. Heart Rhythm 2008.

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20 Stroke Risk Increases with Age

21 Gender Differences in the Risk of Ischemic Stroke and Peripheral Embolism in AFib Fang,MC et al. Circulation. 2005;112:1687-1691 The AnTicoagulation and Risk factors In Atrial fibrillation (ATRIA) Study

22 Copenhagen City Heart Study Friberg J et al. American Journal of Cardiology 2004; 94: 889-894 The independent effect of AF on stroke rate was 4.6-fold greater in women than in men: The independent effect of AF on stroke rate was 4.6-fold greater in women than in men: Hazard ratio in women 7.8 (95% CI, 5.8 to 14.3) Hazard ratio in women 7.8 (95% CI, 5.8 to 14.3) Hazard ratio in men 1.7 (95% CI, 1.0 to 3.0) Hazard ratio in men 1.7 (95% CI, 1.0 to 3.0) The independent effect of AF on the cardiovascular mortality rate was 2.5-fold greater in women than in men: The independent effect of AF on the cardiovascular mortality rate was 2.5-fold greater in women than in men: Hazard ratio in women 4.4 (95% CI, 2.9 to 6.5) Hazard ratio in women 4.4 (95% CI, 2.9 to 6.5) Hazard ratio in men 2.2 (95% CI, 1.6 to 3.1) Hazard ratio in men 2.2 (95% CI, 1.6 to 3.1)

23 Patients Older than 75 Years Less likely to Receive Therapy for CV Events Patients older than 75 years of age Patients older than 75 years of age <50% chance of receiving clinically proven treatments for cardiovascular events such as MI and atrial fibrillation as compared to younger patients. <50% chance of receiving clinically proven treatments for cardiovascular events such as MI and atrial fibrillation as compared to younger patients. Conclusion: The study results suggest that physicians need to be more aware of and willing to use indicated treatments in the elderly. Conclusion: The study results suggest that physicians need to be more aware of and willing to use indicated treatments in the elderly. Ganz DA et al.Journal of the American Geriatric Society 1999; 47: 145-150

24 AHA/ACC/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Circulation, JACC and Europace, 2006. Risk Factors of Ischemic Stroke & Systemic Embolism in Patients with Nolvalvular Atrial Fibrillation Risk Factors Relative Risk Previous stroke or TIA2.5 Diabetes mellitus1.7 History of hypertension1.6 Heart failure1.4 Advanced age (continuous, per decade)1.4

25 AHA/ACC/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Circulation, JACC and Europace, 2006. Stroke Risk with Nolvalvular AF Not Treated with Anticoagulation According to the CHADS2 Index CHADS 2 Risk Criteria Score Previous stroke or TIA2 Age > 75 years1 Hypertension1 Diabetes mellitus1 Heart failure1 Patients (N = 1733) Adjusted Stroke Rate (%/y) (95% CI) CHADS 2 Score 120 1.9 (1.2 to 3.0) 0 463 2.8 (2.0 to 3.8) 1 523 4.0 (3.1 to 5.1) 2 337 5.9 (4.6 to 7.3) 3 220 8.5 (6.3 to 11.1) 4 65 12.5 (8.2 to 17.5) 5 5 18.2 (10.5 to 27.4) 6

26 Fang MC et al. JACC 2008, 51(6):810-15. Risk Stratification Schemes Use to Predict Thromboembolism with Nonvalvular AF

27 Fang MC et al. JACC 2008, 51(6):810-15. Annual TE Rates Across Risk Groups Using 5 Risk Stratification Schemes Used to Predict AF-Related TE

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29 Meta-analysis of Stroke Prevention for High Risk Atrial Fibrillation Trials Adjusted dose warfarin Adjusted dose warfarin Stroke Risk Reduction – 60% Stroke Risk Reduction – 60% Death Risk Reduction – 25% Death Risk Reduction – 25% Antiplatelet therapy Antiplatelet therapy Stroke Risk Reduction – 20% Stroke Risk Reduction – 20% Advantage of warfarin over antiplatelet therapy Advantage of warfarin over antiplatelet therapy Stroke Risk Reduction– 40% Stroke Risk Reduction– 40% Hart R, Pearce L, Aguilar M. Annals of Internal Medicine. June 2007,146:857-67.

30 Women > 75 years were 54% less likely to receive warfarin and twice as likely to receive aspirin Women > 75 years were 54% less likely to receive warfarin and twice as likely to receive aspirin Warfarin reduced stroke risk by 84% in women and 60% in men Warfarin reduced stroke risk by 84% in women and 60% in men ASA resulted in significantly decreased stroke risk in men (44%) but not in women (23%) ASA resulted in significantly decreased stroke risk in men (44%) but not in women (23%) Analysis of 5 Antithrombotic Trials Pilote L, CMAJ. 2007; 176(6):S1-44.

31 Physician and Patient Reluctance CARAF* demonstrated that women on warfarin were 3.35 times more likely to experience major bleeding. CARAF* demonstrated that women on warfarin were 3.35 times more likely to experience major bleeding. Nine of ten women who experienced major bleeds were < 75 years old. Nine of ten women who experienced major bleeds were < 75 years old. INRs at time of bleeding were elevated, but the levels were similar in men and women. INRs at time of bleeding were elevated, but the levels were similar in men and women. * * Canadian Registry of Atrial Fibrillation Humphries KH et al. Circulation. 2001; 103:2365-70

32 AHA/ACC/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Circulation, JACC and Europace, 2006.

33 Bleeding Risks SPORTIF Trial SPORTIF Trial Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study Stroke Prevention in Atrial Fibrillation (SPAF) studies Stroke Prevention in Atrial Fibrillation (SPAF) studies Women > Men (p=0.001- minor; p=NS major/minor) 1.0% for women versus 1.1% for men Annual bleeding rates were 1.5%, 1.7% and 2.1% both genders Gomberg-Maitland M, Wenger NK, Feyzi J, Lengyel M, Volgman AS, Petersen P, Frison L, Halperin JL. Eur Heart J. 2006; 27:1947-53. Fang MC, et al. Circulation. 2005; 112:1687-91. Lancet. 1996; 348:633-8.

34 Summary Individualize anticoagulation therapy for patients with atrial fibrillation Individualize anticoagulation therapy for patients with atrial fibrillation Low risk patients should be treated with aspirin Low risk patients should be treated with aspirin Intermediate to high risk patients benefit from anticoagulation but bleeding risks may offset benefit Intermediate to high risk patients benefit from anticoagulation but bleeding risks may offset benefit If bleeding risk is minimized, intermediate risk patients would have improved risk/benefit ratio from anticoagulation If bleeding risk is minimized, intermediate risk patients would have improved risk/benefit ratio from anticoagulation

35 The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials Scott Kaatz, DO, MSc, FACP Clinical Associate Professor of Medicine Associate Residency Program Director Department of Medicine Director, Anticoagulation Clinics Henry Ford Hospital Detroit, Michigan New Paradigms in the Science and Medicine of Heart Disease

36 Anticoagulant options in atrial fibrillation Anticoagulant options in atrial fibrillation Warfarin Warfarin Dabigatran Dabigatran Apixaban Apixaban Rivaroxaban Rivaroxaban The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials

37 Stroke Rate per Year with Different Antithrombotic Options in AF Hart RG. Ann Intern Med. 2007 Jun 19;146(12):857-67. PMID: 17577005 Connolly S. Lancet. 2006 Jun 10;367(9526):1903-12. PMID: 16765759 Connolly SJ. N Engl J Med. 2009 May 14;360(20):2066-78. PMID: 19336502 Connolly S. Hotline session at ESC 8.31.10 Connolly SJ. N Engl J Med. 2009 Sep 17;361(12):1139-51. PMID: 19717844 Option Approximate Rate/Year Hart ACTIVE W ACTIVE A AVERROESRELY No treatment4.5%4.5%Thrombin ASA3.5%3.2%Yes3.3%3.3% ASA + Clopidogrel2.5%2.4%2.4% Warfarin1.5%1.8%1.4%1.6% Apixaban1.5%1.5% Dabigatran 1101.5%1.4% Dabigatran 1501.0%1.0%

38 Comparative Pharmacology CharacteristicApixabanRivaroxabanDabigatran Target Factor Xa Thrombin ProdrugNoNoYes Bioavailability60%80%6% Dosing Fixed, b.i.d. Fixed, o.d. Fixed, o.d./bid Half life 12 hours 7 to 11 hours 12-17 hours Renal clearance25%35%80% Routine coag. monitoringNoNoNo Drug interactions Potent CYP3A4 & P-gp inhibitors Potent P-gp inhibitors Courtesy of John Eikelboom

39 Anticoagulant options in AF Anticoagulant options in AF Warfarin Warfarin Dabigatran Dabigatran Apixaban Apixaban Rivaroxaban Rivaroxaban The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials

40 Warfarin http://www.anaesthesia uk.com/images/clotting _cascade.gif

41 In 1951 the failed attempted suicide of a navy recruit who had taken a large dose of rat poison led clinicians to discard dicumarol in favor of warfarin. In 1951 the failed attempted suicide of a navy recruit who had taken a large dose of rat poison led clinicians to discard dicumarol in favor of warfarin. The first clinical study with warfarin was reported in 1955. In the same year, President Eisenhower was treated with warfarin following a heart attack The first clinical study with warfarin was reported in 1955. In the same year, President Eisenhower was treated with warfarin following a heart attack Warfarin Scully. The Biochemist, Feb 2002 http://www.biochemist.org/bio/02401/0015/024010015.pdf Warfarin was launched as the ideal rat poison in 1948. Although it was thought at first to be too toxic for human useWarfarin was launched as the ideal rat poison in 1948. Although it was thought at first to be too toxic for human use

42 Warfarin vs. no Treatment or Placebo Hart RG. Ann Intern Med. 2007 Jun 19;146(12):857-67. PMID: 17577005

43 Anticoagulant options in AF Anticoagulant options in AF Warfarin Warfarin Dabigatran Dabigatran Apixaban Apixaban Rivaroxaban Rivaroxaban The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials

44 Direct Thrombin Inhibitors http://www.anaesthesia uk.com/images/clotting _cascade.gif

45 Scientific interest in leeches date back to ancient India However, the first Western citation is credited to the Greek, Nicander of Colophon (130 BC) This therapeutic use of leeches, the medicinal leech in particular, reached a height between 1825 and 1840. A more contemporary use of leeches was discovered in 1957 by Markwardt hirudinThe leech secretion hirudin was isolated and subsequently its anticoagulant properties with respect to the elucidation of blood clotting mechanisms were examined. http://soma.npa.uiuc.edu/courses/physl490b/models/leech_swimming/leech_swim.html Medicinal Leech (Hirudo Medicinalis)

46 RELY Trial Question: Is Dabigatran oral unmonitored direct thrombin inhibitor as effective and safe as warfarin for stroke prevention in AF? Question: Is Dabigatran oral unmonitored direct thrombin inhibitor as effective and safe as warfarin for stroke prevention in AF? Design: Randomized trial, warfarin was un-blinded Design: Randomized trial, warfarin was un-blinded Patients: 18,113 AF patients with at least on stroke risk factor Patients: 18,113 AF patients with at least on stroke risk factor Interventions: Interventions: Dabigatran 110 mg bid Dabigatran 110 mg bid Dabigatran 150 mg bid Dabigatran 150 mg bid Comparison: Warfarin, INR 2.0-3.0 Comparison: Warfarin, INR 2.0-3.0 Primary outcome: Stoke and systemic embolism Primary outcome: Stoke and systemic embolism Timeframe: Mean follow up was 2.0 years Timeframe: Mean follow up was 2.0 years Connolly SJ. N Engl J Med. 2009 Sep 17;361(12):1139-51. PMID: 19717844

47 RELY

48 RELY

49 RELY

50 Anticoagulant options in AF Anticoagulant options in AF Warfarin Warfarin Dabigatran Dabigatran Apixaban Apixaban Rivaroxaban Rivaroxaban The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials

51 AVERROES Question: Is apixaban superior to ASA in patients with AF who are not candidates for warfarin? Question: Is apixaban superior to ASA in patients with AF who are not candidates for warfarin? Design: RCT, double blinded Design: RCT, double blinded Patients: AF patients not candidates for warfarin Patients: AF patients not candidates for warfarin Intervention: apixaban 5 mg (2.5 mg) bid Intervention: apixaban 5 mg (2.5 mg) bid Comparison: ASA 81-325 mg qd Comparison: ASA 81-325 mg qd Outcome: stroke or systemic embolism Outcome: stroke or systemic embolism Connolly S. Hotline, ESC, 8.31.10

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55 Anticoagulant options in AF Anticoagulant options in AF Warfarin Warfarin Dabigatran Dabigatran Apixaban Apixaban Rivaroxaban Rivaroxaban The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials

56 ROCKET Question: is rivaroxaban non-inferior to warfarin for stroke prevention in AF Question: is rivaroxaban non-inferior to warfarin for stroke prevention in AF Design: RCT, double blinded Design: RCT, double blinded Patients: AF and CHADS 2 > 2 Patients: AF and CHADS 2 > 2 Intervention: rivaroxaban 20 mg qd Intervention: rivaroxaban 20 mg qd Comparison: warfarin Comparison: warfarin Outcome: Outcome: Stroke and systemic embolism Stroke and systemic embolism Major and non-major clinically relevant bleeding Major and non-major clinically relevant bleeding Result expected to be presented at AHA, November 2010 Result expected to be presented at AHA, November 2010 www.clinicaltrials.gov NCT00403767

57 Anticoagulant options in AF Anticoagulant options in AF Warfarin Warfarin Dabigatran Dabigatran Apixaban Apixaban Rivaroxaban Rivaroxaban The Emerging Role of Direct Thrombin and Factor Xa Inhibition for Thrombosis Reduction in Heart Disease Mechanisms and Recent Clinical Trials

58 Optimizing Stroke Prevention in AF with Established and Currently Available Therapies The Role of Vitamin K Antagonists – What Works? What Doesnt? Alan K. Jacobson, MD Director, Anticoagulation Services Loma Linda VA Medical Center Loma Linda, California New Paradigms in the Science and Medicine of Heart Disease

59 Why do we need another warfarin management lecture? Warfarin therapy is: Warfarin therapy is: Highly effective Highly effective Complex to manage Complex to manage Underutilized Underutilized When utilized, managed poorly When utilized, managed poorly … but effective solutions have evolved.

60 Disturbed Flow Disturbed Flow (left atrium) Stroke Risk Stroke Risk Blood Flow in Atrial Fibrillation

61 1.9 2.3 2.1 0.9 Warfarin in Prospective AF Trials Intention-to-treat analysis ControlWarfarin AFASAKSPAFBAATAFCAFASPINAF 825504922490896 825504922490896 p=0.03 p=0.01 p=0.002p>0.2p=0.001 p=0.03 p=0.01 p=0.002p>0.2p=0.001 86420 Stroke Rate (%/year) Adapted from Atwood, Albers, Herz 1993;18:27-38 4.6 3.0 3.6 4.3 person-years p value 7.0 0.4

62 Loma Linda VA Medical Center, 2010 RR79%83%83%73%79%83% Anticoagulant Therapy is Effective

63 Anticoagulation of AF Risk Benefit X OR vs.

64 Oral Anticoagulation - Challenges Narrow therapeutic dosing range Narrow therapeutic dosing range 10-15% dosing window 10-15% dosing window Variable dosage requirement Variable dosage requirement Effect of medications Effect of medications Effect of diet Effect of diet Effect of liver function Effect of liver function Serious consequences if dosing wrong Serious consequences if dosing wrong

65 Burdens of Anticoagulation Restricted diets - NOTHING green, NO Vitamin K Restricted diets - NOTHING green, NO Vitamin K Restricted medications - NO aspirin, NO NSAIDS Restricted medications - NO aspirin, NO NSAIDS Ongoing need for blood tests to check PT/INR Ongoing need for blood tests to check PT/INR Burdens affect patients and providers Burdens affect patients and providers Clinical practice has often been driven more by tradition than science Clinical practice has often been driven more by tradition than science

66 Burdens of Anticoagulation Solutions: Solutions: Diet - CONSISTENT Vitamin K intake Diet - CONSISTENT Vitamin K intake Drug interactions - CONSISTENT if NECESSARY Drug interactions - CONSISTENT if NECESSARY Minimal need for restrictions, in fact, some may benefit from supplementation Minimal need for restrictions, in fact, some may benefit from supplementation Prothrombin time testing and management…. ?? Prothrombin time testing and management…. ??

67 Ongoing Patient Education Ongoing QI Direct Active Management by Qualified Health Care Provider Patient Scheduling and Tracking Accessible, Accurate, and Frequent PT/INR Testing Patient-specific Decision Support and Interaction Systematic Anticoagulation Management Enabling Technologies: POC testing, computerization

68 Quality Question Are you able to identify, on an ongoing basis, which patients are overdue for testing?

69 Active vs. Passive Management

70 Patients Assigned to Warfarin in AF Trials Intensity of Anticoagulation When Stroke Occurred Petersen et al. Lancet 1989:171–75 SPAF. Circ 1991;84:527–39 BAATAF. N Engl J Med 1990; 323:1505–11 Connolly et al. J Am Coll Cardiol 1991;18:349–55 Ezekowitz et al. N Engl J Med 1992;327:1406–12 Hirsh, Dalen, Deykin, Poller. CHEST 1992;312S–326S AFASAK SPAF I BAATAFSPINAFCAFA 1.0 2.0 3.0 4.0 1.7 1.6 1.5 1.4 1.3 1.2 1.1 1.0 INR Ratio PT Ratio (ISI 2.4) ACCP recommendations: INR 2.0–3.0 1.8 Target range for individual study

71 Bleed Risk INR Intensity 12345671234567 PERCEIVED INR Therapeutic Range Clot Risk

72 0 20 40 60 80 100 4.0-4.4 1.5-1.9 1.0-1.42.0-2.42.5-2.9 3.0-3.43.5-3.9 4.5-4.9 5.0-5.4 5.5-5.9 6.0-6.4 6.5 6.5 INR Incidence per 100 Patient-Years INR-Specific Incidence of All Adverse Events (All Episodes of Thromboembolism, All Major Bleeding Episodes, and Unclassified Stroke). The dotted lines indicate the 95 percent confidence interval. Cannegeiter et al ACTUAL INR therapeutic range

73 Incidence Rates of Ischemic Stroke and Intracranial Hemorrhage Adapted from Hylek EM, et al. N Engl J Med. 2003;349:1019-1026.

74 Recommended Range for Warfarin Therapy For Patients in Atrial Fibrillation Target: INR 2.5 Target: INR 2.5 Range: INR 2.0–3.0 Range: INR 2.0–3.0 CHEST 1998;114:579s-589s

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77 Methods of Monitoring - Options Central Laboratory Testing with Professional Management of Results Central Laboratory Testing with Professional Management of Results Point-of-Care Testing (Professional) with Professional Management of Results Point-of-Care Testing (Professional) with Professional Management of Results Point-of-Care Testing (Patient) with Patient or Professional Management Which is best??? Different solutions for different patients in different settings Point-of-Care Testing (Patient) with Patient or Professional Management Which is best??? Different solutions for different patients in different settings

78 Why do we need another warfarin management lecture? Warfarin therapy is: Warfarin therapy is: Highly effective Highly effective Complex to manage Complex to manage Underutilized Underutilized When utilized, managed poorly When utilized, managed poorly … but effective solutions have evolved.

79 Progress of Medicine Out of the enormous number of medicinal agents brought under our notice by puffing advertisements in the press, medical as well as lay, by pamphlets or even large books delivered by post, or by actual 'specimens for trial' which are nowadays so liberally delivered at our residences, comparatively few hold their ground, or stand a fair and candid criticism and investigation of their vaunted merits. Still a certain proportion do and I see every reason to anticipate that, as the result of the systematic researches, scientific and practical, now carried on in so many laboratories, valuable additions will be made from time to time to the medicinal agents at our disposal for the help and comfort of our patients. I only hope that in our love for the new we will not entirely throw out old friends which have done real and effective service in the past and are today as deserving of our regard as ever Out of the enormous number of medicinal agents brought under our notice by puffing advertisements in the press, medical as well as lay, by pamphlets or even large books delivered by post, or by actual 'specimens for trial' which are nowadays so liberally delivered at our residences, comparatively few hold their ground, or stand a fair and candid criticism and investigation of their vaunted merits. Still a certain proportion do and I see every reason to anticipate that, as the result of the systematic researches, scientific and practical, now carried on in so many laboratories, valuable additions will be made from time to time to the medicinal agents at our disposal for the help and comfort of our patients. I only hope that in our love for the new we will not entirely throw out old friends which have done real and effective service in the past and are today as deserving of our regard as ever (Lancet 1899, Dr. F. Roberts). (Lancet 1899, Dr. F. Roberts).

80 Progress of Medicine Out of the enormous number of medicinal agents brought under our notice by puffing advertisements in the press, medical as well as lay, by pamphlets or even large books delivered by post, or by actual 'specimens for trial' which are nowadays so liberally delivered at our residences, comparatively few hold their ground, or stand a fair and candid criticism and investigation of their vaunted merits. Still a certain proportion do and I see every reason to anticipate that, as the result of the systematic researches, scientific and practical, now carried on in so many laboratories, valuable additions will be made from time to time to the medicinal agents at our disposal for the help and comfort of our patients. Out of the enormous number of medicinal agents brought under our notice by puffing advertisements in the press, medical as well as lay, by pamphlets or even large books delivered by post, or by actual 'specimens for trial' which are nowadays so liberally delivered at our residences, comparatively few hold their ground, or stand a fair and candid criticism and investigation of their vaunted merits. Still a certain proportion do and I see every reason to anticipate that, as the result of the systematic researches, scientific and practical, now carried on in so many laboratories, valuable additions will be made from time to time to the medicinal agents at our disposal for the help and comfort of our patients. I only hope that in our love for the new we will not entirely throw out old friends which have done real and effective service in the past and are today as deserving of our regard as ever. (Lancet 1899, Dr. F. Roberts). I only hope that in our love for the new we will not entirely throw out old friends which have done real and effective service in the past and are today as deserving of our regard as ever. (Lancet 1899, Dr. F. Roberts).

81 The Future Refined management of the old drug – warfarin Refined management of the old drug – warfarin Variety of new agents with predictable therapeutic ranges and improved risk benefit but with continued need for education, hemorrhagic risk assessment, and monitoring Variety of new agents with predictable therapeutic ranges and improved risk benefit but with continued need for education, hemorrhagic risk assessment, and monitoring Improved range of options to facilitate stroke prevention in patients with atrial fibrillation Improved range of options to facilitate stroke prevention in patients with atrial fibrillation


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