1. Amiodarone versus Sotalol for Atrial Fibrillation N Engl J Med 2005;352:1861-72 Bramah N. Singh, M.D., D.Sc., Steven N. Singh, M.D., Domenic J. Reda, Ph.D., X. Charlene Tang, M.D., Ph.D., Becky Lopez, R.N., Crystal L. Harris, Pharm.D., Ross D. Fletcher, M.D., Satish C. Sharma, M.D., J. Edwin Atwood, M.D., Alan K. Jacobson, M.D., H. Daniel Lewis, Jr., M.D., Dennis W. Raisch, Ph.D., and Michael D. Ezekowitz, M.B., Ch.B., Ph.D., for the Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) Investigators*

2. Background Atrial fibrillation –Conversion to sinus rhythm –Maintenance of sinus rhythm Unblinded trial –Rhythm control did not offer a survival advantage over rate control with anticoagulant »N Engl J Med 2002;347:1825-33 SAFE-T (double-blind Sotalol Amiodarone Atrial Fibrillation Efficacy Trial)

3. Objective : –Whether Amiodarone is superior to sotalol and whether both superior to placebo in maintaining sinus rhythm in patients with persistent atrial fibrillation

4. Method Patients –AF for at least 72hrs on ECG –AF at randomization, receiving anticoagulants –Exclusion criteria Atrial flutter, paroxysmal atrial fibrillation, NYHA class III or IV HF Caculated CrCL < 60ml/min Intolerance of beta-blocker History of long QT syndrome AF > 12 months

5. Am J Cardiol 2003;92:468–472 Protocol Design (SAFE-T)

6. Method Randomization, Therapy, and follow-up – permuted-block randomization –Follow-up : every 4 weeks –Spontaneous conversion not occurred by day 28 after randomization  DC cardioversion –After conversion, monthly follow-up –Study drug withdrawn second AF attempts or failed DC cardioversion Statistical analysis 800mg/day600mg/day300mg/day200mg/day 14 days28 days 1 year 7 days Amiodarone Sotalol 80mgx2/day160mgx2/day

7. Result

8. 1998.4.1 ~ 2002.10.31

13. Conclusion Amiodarone and sotalol are equally efficacious in converting atrial fibrillation to sinus rhythm. Amiodarone is superior for maintaining sinus rhythm, but both drugs have similar efficacy in patients with ischemic heart disease. Sustained sinus rhythm is associated with an improved quality of life and improved exercise performance.