Increasing Prevalence of Atrial Fibrillation and Flutter in the United States

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2 Increasing Prevalence of Atrial Fibrillation and Flutter in the United States The present retrospective study estimated the current and projected prevalence of AF and atrial flutter (AFL) in the United States using a large national database. Of the 21,648,681 patients in the databases, 242,903 (1.12%) had nontransient AF and/or AFL (222,605 AF only, 5,376 AFL only, and 14,922 AF and AFL). Nacarelli GV et al. Am J Cardiol 2009;104:

3 Increasing Prevalence of Atrial Fibrillation and Flutter in the United States The present retrospective study estimated the current and projected prevalence of AF and atrial flutter (AFL) in the United States using a large national database. Of the 21,648,681 patients in the databases, 242,903 (1.12%) had nontransient AF and/or AFL (222,605 AF only, 5,376 AFL only, and 14,922 AF and AFL). Nacarelli GV et al. Am J Cardiol 2009;104:

4 Increasing Prevalence of Atrial Fibrillation and Flutter in the United States Co-morbid conditions in patients with AF and/or AFL and in matched controls Nacarelli GV et al. Am J Cardiol 2009;104:

5 Development of a risk score for atrial fibrillation (Framingham Heart Study): a community-based cohort study We assessed 4764 participants in the Framingham Heart Study from 8044 examinations (55% women, years of age) undertaken between June, 1968, and September, Thereafter, participants were monitored for the first event of atrial fibrillation for a maximum of 10 years. Multivariable Cox regression identified clinical risk factors associated with development of atrial fibrillation in 10 years. Schnabel RB et al. Lancet 2009; 373:

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7 Atrial Fibrillation at Baseline and During Follow-Up in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) Estimated ORs and Corresponding SEs and 95% Cis for Prevalence of AF/AFL during follow-up Haywood LJ et al. JACC 2009; 54:

8 Kaplan-Meier event curves for all-cause mortality, coronary heart disease (CHD), stroke, and heart failure (HF) among chlorthalidone, amiodipine, and lisinopril participants with atrial fibrillation (AF) or atrial flutter (AFL) at trial entry (n 334) compared with those without AF/AFL (n 30,370). Haywood LJ et al. JACC 2009; 54:

9 Kaplan-Meier cumulative event curves for all-cause mortality in chlorthalidone, amiodipine, and lisinopril participants with AF/AFL at trial entry or occurring during follow-up (n 821) compared with mortality in those without AF/AFL (n 27,247). Haywood LJ et al. JACC 2009; 54:

10 Risk of atrial fibrillation in dipper and nondipper sustained hypertensive patients The occurrence of AF was evaluated in 1141 patients aged >=40 years with sustained hypertension (clinic BP >=140 and/or 90mmHg and daytime BP >=135 and/or 85 mmhg). During the follow-up (6.1 ±3.2, range years), AF occurred in 43 patients. The AF rate per 100 patient-years in dippers and nondippers was 0.38 and 1.13, respectively. AF free survival was significantly different between the groups (P = ). Goto S et al. Am Heart J 2008;156:

11 Prevalence, clinical profile, and cardiovascular outcomes of atrial fibrillation in patients with atherothrombosis FA prevalence 6,2 % 12,5 % 13.7 % 11,5 % The REduction of Atherothrombosis for Continued Health (REACH) Registry is a large, contemporary, representative, and geographically diverse cohort of stable outpatients with or at high risk of atherothrombosis. A total of 68,236 patients with either established atherothrombotic disease (coronary artery disease [CAD], peripheral artery disease [PAD], cerebrovascular disease [CVD]) or at least 3 risk factors [RFO] for athrothrombosis were enrolled. Goto S et al. Am Heart J 2008;156:

12 Prevalence, clinical profile, and cardiovascular outcomes of atrial fibrillation in patients with atherothrombosis Event rates for CV death/mi and stroke of patients with versus without history of AF (adjusted for age, sex, smoking, diabetes, hypertension, hypercholesterolemia). Goto S et al. Am Heart J 2008;156:

13 Relation of Kidney Function and Albuminuria With Atrial Fibrillation (from the Heart and Soul Study) The Heart and Soul Study is a prospective cohort study designed to examine the impact of psychosocial factors on CAD progression. Vagaonescu TD et al. Hypertension. 2008;51:

14 Relation of Kidney Function and Albuminuria With Atrial Fibrillation (from the Heart and Soul Study) Vagaonescu TD et al. Hypertension. 2008;51:

15 Dabigatran versus Warfarin in Patients with Atrial Fibrillation Stuart J. Connolly, M.D., Michael D. Ezekowitz, M.B., Ch.B., D.Phil., Salim Yusuf, F.R.C.P.C., D.Phil., John Eikelboom, M.D., Jonas Oldgren, M.D., Ph.D., Amit Parekh, M.D., Janice Pogue, M.Sc., Paul A. Reilly, Ph.D., Ellison Themeles, B.A., Jeanne Varrone, M.D., Susan Wang, Ph.D., Marco Alings, M.D., Ph.D., Denis Xavier, M.D., Jun Zhu, M.D., Rafael Diaz, M.D., Basil S. Lewis, M.D., Harald Darius, M.D., Hans-Christoph Diener, M.D., Ph.D., Campbell D. Joyner, M.D., Lars Wallentin, M.D., Ph.D., and the RE- LY Steering Committee and Investigators* The New England Journal of Medicine September 17, 2009 vol. 361 no. 12

16 16 RE-LY TRIAL UNITED STATES SITES

17 RE-LY Trial Participating Countries Worldwide 17

18 RE-LY Dabigatran for Stroke Prevention in Atrial Fibrillation Non-valvular atrial fibrillation at moderate to high risk of stroke or systemic embolism (at least one high risk factor) Warfarin 1 mg, 3 mg, 5 mg PO (INR ) N=6000 Dabigatran Etexilate 110 mg b.i.d. PO N=6000 Dabigatran Etexilate 150 mg b.i.d. PO N=6000 Primary objective: Noninferiority to warfarin Minimum 1 year of follow-up, maximum of 3 years and mean of 2 years of follow-up Primary end point: Stroke + systemic embolism Ezekowitz MD Wallentin l et al. Am Heart J. 2009;157:

19 RE LY: 1 Endpoint Dabigatran superior Dabigatran noninferior Dabigatran 110 vs. warfarin Non-inferiority P < Superiority P 0.34 AC experience < AC naïve Dabigatran 150 vs. warfarin AC experience AC naïve Margin = 1.46 < < < < HR (95% CI) Ezekowitz MD. ESC 2009; Connolly SJ, Ezekowitz MD, et al. N Engl J Med. 2009;361:

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21 Atrial Fibrillation Phase 3 Study Estimated Timelines Dabigatran Rivaroxaban Idraparinux Edoxaban RELY Complete ROCKET Estimated completion June 2010 BOREALIS Estimated completion 2011 ENGAGE-AF Estimated completion November 2009 AVERROES Estimated completion April 2010 ARISTOTLE Estimated completion November Apixiban