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AHA Scientific Session Late Breaking Clinical Trials November 14 th 2011

The PALLAS Study Commentary . AHA Scientific Session Late Breaking Clinical Trials November 14 th 2011. N. A. Mark Estes III M.D. Professor of Medicine Tufts University School of Medicine Director, New England Cardiac Arrhythmia Center The Cardiovascular Center Tufts Medical Center

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AHA Scientific Session Late Breaking Clinical Trials November 14 th 2011

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  1. The PALLAS StudyCommentary AHA Scientific SessionLate Breaking Clinical Trials November 14th 2011 N. A. Mark Estes III M.D. Professor of Medicine Tufts University School of Medicine Director, New England Cardiac Arrhythmia Center The Cardiovascular Center Tufts Medical Center Boston MA

  2. DronedaroneTrials • D was more effective than placebo in maintaining NSR and reducing ventricular rate during AF recurrence. • D increased early mortality related to worsening of heart failure. • D was less effective than amiodarone but had a better safety profile. ATHENA 2011 ADNONIS ANDROMEDA 2010 2009 2008 PALLAS 2007 2006 DIONYSOS 2005 DAPHNE EURIDIS 2004 2003 2002 2001 • D reduced hospitalization due to CV events or death. • D increased the risk of stroke, MI, systemic embolism or CV death hospitalization or death largely due to increases in stroke and CV death.

  3. ATHENA: Primary Outcome Time to First CV Hospitalization or Death 50 HR = 0.76 40 P < .001 30 Cumulative Incidence (%) Placebo 20 Dronedarone 10 0 0 6 12 18 24 30 Months Patients at risk: 0 Months 6 Months 12 Months 18 Months 24 Months 30 Months Placebo 2327 1858 1625 1072 385 3 Dronedarone 2301 1963 1776 1177 403 2 Mean follow-up 21 ± 5 months Hohnloser S et al Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation N Engl J Med 2009;360:668-78

  4. Dronedarone- approved to reduce the risk of CV hospitalization in patients with paroxysmal or persistent AF with a recent episode of AF or AFL and associated CV risk factors (age >70, hypertension, DM, CVA, LA diameter >50 mm or LVEF <40%) who are in NSR or who will becardioverted. • The critical question: • Do the unfavorable results of the PALLAS Study • obtained in patients with permanent AF apply to • patients who using dronaderone for the approved • indication?

  5. 2011 AHA/ACC Guidelines:Antiarrhythmic Approaches to Maintain SR in Patients with Recurrent PAF or Persistent AF Who Require SR* Maintenance of SR No (or minimal)heart disease HTN CAD HF FlecainidePropafenoneSotalol Dronedarone Substantial LVH Dofetilide Dronedarone Sotalol AmiodaroneDofetilide No Yes Amiodarone AmiodaroneDofetilide Catheterablation Amiodarone Catheterablation Catheterablation Dronedarone FlecainidePropafenoneSotalol AmiodaroneDofetilide Catheterablation Catheterablation Wann, AHA/ACC Task Force on Atrial Fibrillation : A Report of the American 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Circulation 2011 123:104-123

  6. ATHENA Trial Hohnloser S et al Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation N Engl J Med 2009;360:668-78

  7. Athena versus PALLAS Demographics ATHENA PALLAS Age (yrs) 75 71 Male (%) 51 65 Perm. AF > 2 yr 0 69 CAD (%) 30 41 69 20 History of HF - LVEF < .45 (%) 12 LVEF < .40 (%) - 20 Outcomes ATHENA PALLAS Follow-up (months) 22 4.2 .84 1.94 Death

  8. Dronedarone should not be used in patients with heart failure or permanent AF. • Further data is needed to answer the critical question: • Do the unfavorable results of the PALLAS Study apply to patients using dronaderone for the approved indication? • Patients taking dronedarone should be monitored regularly (six months) to ensure that they remain within the approved indication and do not progress to permanent AF or new or worsening heart failure. • If clinicians elect to initiate or continue dronedarone they should ensure that patients have and maintain the clinical profile of the ATHENA patients.

  9. The PALLAS StudyCommentary AHA Scientific SessionLate Breaking Clinical Trials November 14th 2011 N. A. Mark Estes III M.D. Professor of Medicine Tufts University School of Medicine Director, New England Cardiac Arrhythmia Center The Cardiovascular Center Tufts Medical Center Boston MA

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