Saudi Heart Association February 22, 2011

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1 Pharmacological Therapy of Atrial Fibrillation: Recent Advances Dr Martin Green Professor of Medicine (Cardiology) University of Ottawa Saudi Heart Association February 22, 2011

2 Atrial Fibrillation

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18 Drugs for Conversion - Class III ibutilide: : iv only torsades risk 2-8% efficacy good but depends on patient population Also decreases DFT and facilitates electrical CV

19 Dose response for ibutilide in Afib/flutter Ellenbogen et al; JACC; vol 28; July 1996

20 Drugs for Conversion - Class III amiodarone: : iv or po Slower onset of action also useful for rate control long duration: therefore may prevent recurrence

21 IV ibutilide vs procainamide for Afib/flutter Stambler et al. Circulation; vol 96; Dec 1997.

22 IV ibutilide for Afib/flutter Ellenbogen et al; JACC; vol 28; July 1996.

23 IV ibutilide vs procainamide for Afib\flutter flutter Volgman et al. JACC; vol31; May 1998.

24 Drugs for Conversion - Class I Flecainide: po useful in ER for conversion about 75% conversion within 6 hours in recent onset Afib with single 300 mg dose should not be used in patients with structural heart disease

25 Drugs for Conversion - Class I Propafenone: : po useful in ER for conversion of recent onset Afib about 75% conversion within 6 hours of a single 600 mg dose should not be used in structural heart disease

26 Pill in the Pocket Approach Conversion Rates from AF to Sinus Rhythm at 3 and 8 hours /58 (59%) 45/58 (78%) 31/61 (51%) 44/61 (72%) 60 24/62 (%) (39%) 3 hours 40 8 hours 20 11/62 (18%) 0 flecainide placebo propafenone 300mg 600 mg p < vs placebo for both drugs Capucci A et al. Am J Card 1994;

27 Digoxin for Conversion of Recent Onset AF A Randomised Double-blind blind Placebo Controlled Trial FalkRH et al Ann Int Med 1987; 106

28 Effect of magnesium in acute atrial fibrillation ill Brodsky et al: Am J Card Vol 73; 1994.

29 ACT 3: Conversion rates for atrial fibrillation and atrial flutter patients Atrial-fibrillation patients RSD1235 Vernakalant Placebo p Overall (3 h-45 d) 41 4 < Recent-onset atrial fibrillation (3 h-7 d)* 52 4 < Longer-duration atrial fibrillation (8 d-45 d) 9 3 NS Atrial flutter 7 0 NS *Primary end point

30 Antiarrhythmic Drugs for AF Amiodarone - CTAF Amiodarone Propafenone Sotalol Sinus Rh hythm (%) Time (days) Roy et al. NEJM 2000;342:

31 Rate Control vs Rhythm Control AFFIRM RACE PIAF AF-CHF

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34 AF-CHF Primary outcome: CV mortality Roy et al N Engl J Med 2008;358:

35 AF-CHF: Secondary Outcomes Roy et al N Engl J Med 2008;358:

36 RACE Van Gelder IC et al; New England Journal of Medicine. 347(23): , 2002

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40 Atrial Fibrillation/Dronedarone Nearly 1/10 aged > 80yrs HF, CVA & Death (±27/ to 70/100K: ATRIA JAMA 2001) Restoration S/R m.b. offset by AAD events (AFFIRM) Absorption ± 70-94%. Bioavailability ± 15% (cf.20-55%) CSS 7d & t1/2 24hrs CYP3A4 & CYP2D6 Inhibitor Digoxin/Verapamil/Simvastatin/Metoprolol

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43 ATHENA

44 ATHENA Trial: Study Design 4,628 patients >75 years with atrial fibrillation or years with atrial fibrillation and at least one additional cardiovascular risk factor prior to randomization. Double blind. Randomized. Placebo controlled. International multicenter. Mean follow-up 21 months. R dronedarone 400 mg BID Placebo mos. follow-up Primary Endpoint: composite of all-cause mortality combined with cardiovascular hospitalization Secondary Endpoint: death from any cause, cardiovascular death, hospitalization for cardiovascular reasons JCE 2008; 19.1/Heart Rhythm 2008

45 Methods Double blind, placebo controlled, 12months f-up 37 countries 551 centres; June 2005 to Dec 2006 Sponsored by Sanofi & designed by Steering Committee in collaboration with Sanofi. Randomized: 400mg bid Dronedarone or Placebo Patients with paroxysmal or persistent A Fib & least 1 of: 70yrs [amended Mar 06: 75yrs w/out other risks, 70yrs + risk factor(s)] Diabetes Mellitus Previous CVA or TIA or systemic embolism Hypertension ( 2 Rx) LA size 50mm LVEF 40% 2 ECGs: within 6/12 before randomization - A.Fib or A.Fl - Sinus rhythm

46 Permanent A. Fib. Exclusion Criteria Haemodynamically unstable condition w/in 6/12 NYHA class IV Planned major surgery PR > 280ms Sinus node disease or HR < 50/min w-out PPM Acute myocarditis Class I or III AAD Non-cardiac: life expectancy, pregnancy- risk, K<3.5, GFR < 10

47 Study Outcomes Primary 1 st hospitalization d/t CVE Death from any cause Secondary 1 st hospitalization d/t CVE Death from any cause Death from CVE Death Classification - Rhythm - Non-rhythm - Non-cardiac but vascular - Non-cardiovascular Unplanned Hospitalization - CV or No-CV

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49 Baseline characteristics ATHENA Connolly, S. J. et al. Circulation 2009;120:

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55 Cumulative risk of stroke (A) and composite outcome of stroke, acute coronary syndrome, or cardiovascular death (B) ATHENA Connolly, S. J. et al. Circulation 2009;120:

56 Specific subgroup analysis for stroke - ATHENA Connolly, S. J. et al. Circulation 2009;120:

57 OAC use (A) and international normalized ratio in range (B) at study visits Connolly, S. J. et al. Circulation 2009;120:

58 Summary of Annual Stroke Rates and Treatment t Effects Connolly, S. J. et al. Circulation 2009;120:

59 Multivariable Predictors of Stroke Risk ATHENA Connolly, S. J. et al. Circulation 2009;120:

60 Celivarone Kowey et al; Heart Rhythm

61 Vernakalant Patient disposition Roy, D. et al. Circulation 2008;117:

62 Cumulative success rates (proportion) based on time after the start of study drug infusion for the short-duration AF primary efficacy set Roy, D. et al. Circulation 2008;117:

63 Success rates in the short-duration, long-duration, and overall AF populations Roy, D. et al. Circulation 2008;117:

64 Pharmacological therapy for Atrial Fibrillation Rhythm Control for symptoms Antiarrhythmic drugs to maintain sinus rhythm don t work that well and have negative effects Atrial specific drugs are being developed d More clinical trials needed for significant outcomes

65 Thank You

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