Treatment of Atrial Fibrillation in Heart Failure

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1 Stockholm, September 1st 2010 Treatment of Atrial Fibrillation in Heart Failure Rhythm control: Which drugs? Stefan H. Hohnloser J.W. Goethe University Frankfurt, Germany Presenter disclosure information: SHH has served as a consultant, investigator, and/or advisory board member for Sanofi-Aventis, St. Jude Medical, BI, ARYx, Cardiome, BMS

2

3 AF-CHF Hypothesis Restoring and maintaining sinus rhythm will reduce cardiovascular mortality ( 25%) compared to a rate-control strategy in patients with congestive heart failure Protocol Prospective multicenter trial with patients randomly allocated to two treatment arms and a minimum follow-up of 2 years AF-CHF Trial Investigators. Am Heart J 2002; 144: 597

4 AF-CHF: Trial design CHF: LVEF 35% and NYHA II-IV NYHA I, only if EF 25% or prior CHF hospitalization Qualifying AF: one episode 6 hours within last 6 months or one episode 10 min within 6 months and prior D/C shock Randomization (openlabel) Rhythm control Antiarrhythmic drug and/or non-pharmacologic therapy in resistant pts Cardioversion if needed Rate control Pharmacologic dosing adjustment AV nodal ablation for pts with inadequate rate control Minimum follow-up 2 years Optimal CHF management with ACE Inhibitors, beta-blockers and anticoagulants AF-CHF Trial Investigators. Am Heart J 2002; 144: 597

5 AF-CHF: Patient flow 1376 Randomized Rhythm control Rate control Lost to F/U Heart Transplant % 7 1.0% % 5 0.7% Completed Trial or Died % % Mean FU: 37 ± 19 months (0.03 to 72 months)

6 Pts. with atrial fibrillation (%) Pts. with atrial fibrillation (%) AF-CHF: AF vs SR Follow-up visits 100 Prevalence of AF at each follow-up visit Rhythm control 80 Rate control Between visits Baseline 3Wk Months Months Roy et al, NEJM 2008;358:2667

7 Survival rate (%) AF-CHF: Primary study endpoint Death from cardiovascular causes Rhythm control Rate control 40 P= Months of follow-up No. at risk Rhythm control Rate control Roy et al, NEJM 2008;358:2667

8 Probability of event free survival (%) Probability of event free survival (%) Probability of survival (%) Probability of event free survival (%) AF-CHF: Secondary study endpoints Death from any cause Months Worsening heart failure Hazard ratio, 0.97 (95% CI, ) P=0.73 Hazard ratio, 0.87 (95% CI, ) P=0.17 Months Months Stroke Hazard ratio, 0.74 (95% CI, ) P=0.32 Composite outcome Hazard ratio, 0.90 (95% CI, ) P=0.20 Months Rhythm control Rate control Roy et al, NEJM 2008;358:2667

9 SCD-HeFT: Mortality NYHA III 0.6 Hazard ratio (97.5% CI) P Value Amiodarone vs. Placebo 1.44 ( ) ICD therapy vs. Placebo 1.16 ( ) Amiodarone (5-yr event rate, 0.528) ICD therapy (5-yr event rate, 0.484) Placebo (5-yr event rate, 0.456) No. at risk Months of follow-up Amiodarone Placebo ICD therapy

10 NEJM 2008;358:

11 ANDROMEDA: Patients age 18 years Inclusion criteria hospitalization for new or worsening CHF with at least 1 episode of NYHA III / IV CHF within the month of admission LVEF 0.35 no restriction related to renal function visits: Patients were seen 5 days post randomization & again after 1 and 3 months NEJM 2008;358:

12 Cumulative incidence (%) ANDROMEDA: All-cause mortality Median follow-up: 2 months Deaths at study termination: - 25 dronedarone pts - 12 placebo pts HR 2.13 ( ; p=0.03) Dronedarone Placebo Days No. at risk Placebo Dronedarone NEJM 2008;358:

13 NEJM 2009;360:668-78

14 Cardiovascular hospitalization & death Post-hoc analysis of patients with systolic heart failure Overall population N HR [95% CI] Interaction P-value [0.69;0.84] LVEF 0.40 and NYHA class II, III at baseline Yes [0.52;1.16] No [0.69;0.84] Dronedarone better Placebo better Hohnloser SH et al, Europ Heart J 2010;31:

15 Cumulative Incidence (%) Cardiovascular hospitalization & death Post-hoc analysis of patients with systolic heart failure 100 HR=0.78 ( ) 75 Placebo 50 Dronedarone Months Patients at risk Placebo Dronedarone Hohnloser SH et al, Europ Heart J 2010;31:

16 ESC Guidelines for the Management of Patients with Atrial Fibrillation Choice of AAD according to underlying pathology Europ Heart J 2010

17 ESC Guidelines for the Management of Patients with Atrial Fibrillation DCC is recommended when a rapid ventricular rate does not respond to pharmacological measures in patients with AF and ongoing myocardial ischaemia, symptomatic hypotension, or symptoms of pulmonary congestion. In patients with AF and severe (NYHA Class III or IV) or recently ( 4 weeks) unstable heart failiure and/or depressed function (EF 35%), the use of antiarrhythmic therapy to maintain sinus rhythm should be restricted to amiodarone. I I C C In patients with AF and stable heart failure (NYHA Class I, II) dronedarone should be considered to reduce cardiovascular hospitalisations IIa C For patients with heart failure and symptomatic persistent AF despite adequate rate control, electrical cardioversion and rhythm control may be considered Catheter ablation (pulmonary vein isolation) may be considered in heart failure patients with refractory symptomatic AF. IIb IIb B B

18 Summary & conclusions Atrial fibrillation is difficult to treat in patients with CHF. Maintenance of SR should only be attempted in symptomatic patients. Safety rather than efficacy determines the choice of drug. The AF-CHF trial showed that amiodarone keeps CHF patients in SR but it failed to demonstrate superiority of rhythm control in terms of survival. ANDROMEDA showed that unstable CHF patients are contraindicated for dronedarone.

19 ESC Guidelines for the Management of Patients with Atrial Fibrillation Choice between ablation and AAD therapy in pts with/without SHD Europ Heart J 2010

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