A Clinical Context Report

Transcription

1 Stroke Prevention in Atrial Fibrillation An Expert Commentary With Kenneth W. Mahaffey, MD A Clinical Context Report

2 Stroke Prevention in Atrial Fibrillation Expert Commentary Jointly Sponsored by: and

3 Stroke Prevention in Atrial Fibrillation Expert Commentary Supported in part by educational grants from Bristol-Myers Squibb and Pfizer

4 Stroke Prevention in Atrial Fibrillation Clinical Context Series The goal of this series is to provide up-todate information and multiple perspectives on the pathogenesis, symptoms, risk factors, and complications of stroke prevention in atrial fibrillation, as well as current and emerging treatments and best practices in the management of stroke prevention in atrial fibrillation.

5 Stroke Prevention in Atrial Fibrillation Clinical Context Series Target Audience Electrophysiologists, cardiologists, primary care physicians, nurses, nurse practitioners, physician assistants, pharmacists, and other healthcare professionals involved in the management of stroke prevention in atrial fibrillation.

6 Activity Learning Objective Upon successful completion of this educational program, participants should be able to: Review the relevance and significance of the activity in the broader context of clinical care

7 CME Information: Physicians Statement of Accreditation This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the University of Pennsylvania School of Medicine and MedPage Today. The University of Pennsylvania School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

8 CME Information Credit Designation The University of Pennsylvania School of Medicine Office of CME designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

9 CME Information: Physicians Credit for Family Physicians MedPage Today "News-Based CME" has been reviewed and is acceptable for up to 2098 Elective credits by the American Academy of Family Physicians. AAFP accreditation begins January 1, Term of approval is for one year from this date. Each article is approved for 0.5 Elective credit. Credit may be claimed for one year from the date of each article.

10 CE Information: Nurses Statement of Accreditation Projects In Knowledge, Inc. (PIK) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation. Projects In Knowledge is also an approved provider by the California Board of Registered Nursing, Provider Number CEP This activity is approved for 0.5 nursing contact hours. DISCLAIMER: Accreditation refers to educational content only and does not imply ANCC, CBRN, or PIK endorsement of any commercial product or service.

11 CE Information: Pharmacists Projects In Knowledge is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program has been planned and implemented in accordance with the ACPE Criteria for Quality and Interpretive Guidelines. This activity is worth up to 0.5 contact hours (0.05 CEUs). The ACPE Universal Activity Number assigned to this knowledge-type activity is H04-P.

12 Discussant Kenneth W. Mahaffey, MD Co-Director, CV Research Director, Clinical Events Classification (CEC) Group Duke Clinical Research Institute Durham, North Carolina

13 Disclosure Information Kenneth W. Mahaffey, MD, has disclosed the following relevant financial relationships: Served as a consultant for: AstraZeneca, Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Ortho/McNeill, Pfizer, Polymedix, sanofiaventis, Schering-Plough Received grants for clinical research from: AstraZeneca, Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Momenta Pharmaceuticals, Novartis, Portola, Pozen, Regado Biotechnologies, sanofi-aventis, Schering-Plough, The Medicines Company

14 Disclosure Information Michael Mullen, MD, Clinical Instructor of Vascular Neurology, University of Pennsylvania; Chris Kaiser; and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner, have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity. The staff of The University of Pennsylvania School of Medicine Office of CME, MedPage Today, and Projects In Knowledge have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

15 New Oral Anticoagulant Trials versus Warfarin RE-LY dabigatran (Pradaxa) versus warfarin in 18,000 patients 1 ROCKET-AF rivaroxaban (Xarelto) versus warfarin in 14,000 patients 2 ARISTOTLE apixaban (Eliquis) versus warfarin in 18,201 patients 3 AVERROES apixaban (Eliquis) bests aspirin in 5,600 patients unsuitable for warfarin 4 ACTIVE A clopidogrel (Plavix) plus aspirin better than aspirin alone in 7,554 patients not taking warfarin 5 SOURCES: 1) N Engl J Med 2009; 361: ; 2) AHA 2010; 3) N Engl J Med 2011; DOI: /NEJMoa ; 4) ACC 2011; Abstract ; 5) N Engl J Med 2009; DOI: / NEJMoa

16 Bleeding Rates RE-LY major bleeding rate 2.71% for low-dose dabigatran versus 3.36% for warfarin ROCKET-AF stroke and blood clots 2.12 for rivaroxaban versus for warfarin per 100 patient-years ARISTOTLE stroke or systemic embolism rate 1.20% for apixaban versus 1.60 for warfarin

17 RE-LY Trial Dabigatran Dosages 150 mg dose twice daily was more effective than warfarin 110 mg dose twice daily was comparable to warfarin The FDA approved 75mg dose of dabigatran for patients with renal insufficiency

18 Potential Antidote for Factor Xa Inhibitors Phase III trial of investigational agent PRT Demonstrates almost complete reversal of rivaroxaban in rats Portola Pharmaceuticals, also developing betrixaban Presented at 2011 European Society of Cardiology meeting

19 Warfarin Eligible and Time in Therapeutic Range 1 Overall, 48% of eligible Afib patients are on warfarin 55% of Afib patients within therapeutic INR range More patients in anticoagulation clinics versus physician setting remain in therapeutic range Source: 1) Manag Care Pharm 2009; 15(3)

20 Multidisciplinary Management of Afib Patients Family physicians General practitioners Cardiologists Hematologists Anticoagulation clinic

21 New Class of Oral Anticoagulants Dabigatran-oral direct thrombin inhibitor Rivaroxaban-oral direct factor Xa inhibitor Apixaban-oral direct factor Xa inhibitor

22 Summary New Oral Anticoagulants for Afib Five trials, three drugs, 55,000 patients worth of data Clear benefit in reduced bleeding Physician & patient education is key to adoption Phase III trial showed promise for factor Xa antidote New oral anticoagulants could help put more eligible patients on stroke medication Best patient management strategy is a multidisciplinary approach