Interpretation of Clinical Trials: How Mortality Trials Relate to the Therapy of Atrial Fibrillation

Electrophysiological Disorders of the Heart

Volumn , Issue , 2005, Pages 189-206

  Waldo, Albert L ^a,b   Pratt, Craig M ^c,d,e  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^c BAYLOR COLLEGE OF MEDICINE   (United States)

^d DeBakey Heart Center   (United States)

^e HOUSTON METHODIST HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33746354701     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-443-06570-5.50017-4     Document Type: Chapter

References (59)

1. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators: (1989) Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 321 406-412.
2. The Cardiac Arrhythmia Suppression Trial-II (CAST) Investigators: (1992) Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med 327 227-233.
3. JT Bigger Jr, JL Fleiss, R Kleiger, et al. (1984) The relationships among ventricular arrhythmias, left ventricular dysfunction and mortality in the 2 years after myocardial infarction. Circulation 69 250-258.
4. The Multicenter Postinfarction Research Group: (1983) Risk stratification and survival after myocardial infarction. N Engl J Med 309 331-336.
5. The Multicenter Diltiazem Postinfarction Trial Research Group: (1988) The effect of diltiazem on mortality and reinfarction after myocardial infarction. N Engl J Med 319 385-392.
6. W Ruberman, E Weinblatt, JD Goldberg, et al. (1981) Ventricular premature complexes and sudden death after myocardial infarction. Circulation 64 297-305.
7. The Miami Trial Research Group: (1985) Metoprolol in acute myocardial infarction (MIAMI): A randomized placebo-controlled international trial. Eur Heart J 6 199-226.
8. J Mukharji, RE Rode, K Poole, et al. (1982) Late sudden death following acute myocardial infarction: Importance of combined presence of repetitive ectopy and left ventricular dysfunction. Clin Res 30 108A.
9. AJ Moss, HT Davis, J DeCamilla and LW Bayer (1979) Ventricular ectopic beats and their relation to sudden and non-sudden cardiac death after myocardial infarction. Circulation 60 998-1003.
10. SC Vlay (1985) How the university cardiologist treats ventricular premature beats: A nationwide survey of 65 University Medical Centers. Am Heart J 110 904-912.
11. J Morganroth, JT Bigger Jr and JL Anderson (1990) Treatment of ventricular arrhythmias by United States cardiologists: A survey before the Cardiac Arrhythmia Suppression Trial results were available. Am J Cardiol 65 40-48.
12. J Morganroth (1984) Premature ventricular complexes. JAMA 252 673-676.
13. JT Bigger Jr (1984) Identification of patients at high risk for sudden cardiac death. Am J Cardiol 54 3D-8D.
14. J Morganroth, C Oshrain and PP Steele (1985) Comparative efficacy and safety of oral tocainide and quinidine for benign and potentially lethal arrhythmias. Am J Cardiol 56 581-585.
15. J Morganroth (1987) Comparative efficacy and safety of mexiletine and quinidine in benign or potentially lethal ventricular arrhythmias. Am J Cardiol 60 1276-1281.
16. The CAPS Investigators: (1986) The Cardiac Arrhythmia Pilot Study. Am J Cardiol 57 91-95.
17. The Cardiac Arrhythmia Pilot Study (CAPS) Investigators: (1988) Effects of encainide, flecainide, imipramine and moricizine on ventricular arrhythmias during the year after acute myocardial infarction: The CAPS. Am J Cardiol 61 501-509.
18. HL Greene, DM Roden, RJ Katz, et al. (1992) The Cardiac Arrhythmia Suppression Trial: First CAST … then CAST-II. J Am Coll Cardiol 19 894-898.
19. Beta-blocker Heart Attack Trial Research Group: (1982) A randomized trial of propranolol in patients with myocardial infarction: I. Mortality results. JAMA 247 1707-1717.
20. Norwegian Multicenter Study Group: (1981) Timolol-induced reduction in mortality and reinfarction in patients surviving acute myocardial infarction. N Engl J Med 304 801-807.
21. A Hjalmerson, D Elmfeldt, J Herlitz, et al. (1981) Effect on mortality of metoprolol in acute myocardial infarction. A double-blind randomized trial. Lancet iv 823-827.
22. CM Pratt and L Moye (1990) The Cardiac Arrhythmia Suppression Trial: Background, interim results, and implications. Am J Cardiol 65 20B-29B.
23. S Goldstein, MM Brooks, R Ledingham, et al. (1995) Association between ease of suppression of ventricular arrhythmia and survival. Circulation 91 79-83.
24. S Nattel, DH Pederson and DP Zipes (1981) Alterations in regional myocardial distribution and arrhythmogenic effects of aprindine produced by coronary artery occlusion in the dog. Cardiovasc Res 15 80-85.
25. WH Kou, SD Nelson, JJ Lynch, et al. (1987) Effect of flecainide acetate on prevention of electrical induction of ventricular tachycardia and occurrence of ischemic ventricular fibrillation during the early post myocardial infarction period: Evaluation of a conscious canine model of sudden death. J Am Coll Cardiol 9 359-365.
26. DS Echt, PR Liebson, LB Mitchell, et al. (1991) Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324 781-788.
27. JL Anderson, EV Platia, RW Hallstrom, et al. (1994) Interaction of baseline characteristics with hazard of encainide, flecainide, and moricizine therapy in patients with myocardial infarction; possible explantation for increased mortality in the Cardiac Arrhythmia Suppression Trial (CAST). Circulation 90 2843-2852.
28. CAST database.
29. KK Teo, S Yusuf and CD Furberg (1993) Effects of prophylactic antiarrhythmic drug therapy in acute myocardial infarction: An overview of results from randomized control trials. JAMA 270 1589-1595.
30. V Fuster, LE Ryden, RW Asinger, et al. (2001) ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: Executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to develop guidelines for the management of patients with atrial fibrillation). Developed in collaboration with the North American Society of Pacing and Electrophysiology. Circulation 104 2118-2150.
31. JC Geller, M Geller, MD Carlson and AL Waldo (2001) Efficacy and safety of moricizine in the maintenance of sinus rhythm in patients with recurrent atrial fibrillation. Am J Cardiol 87 172-177.
32. J Steinberg, A Regan, R Sciacca, et al. (1992) Predicting arrhythmic events after acute MI using the signal-averaged electrocardiogram. Am J Cardiol 69 13-21.
33. O Odemuyiwa, M Malik, TG Farrell, et al. (1991) Comparison of the predictive characteristics of heart rate variability index and left ventricular ejection fraction for all-cause mortality, arrhythmic events and sudden death after acute myocardial infarction. Am J Cardiol 68 434-439.
34. PJ Schwartz, MT LaRovere and E Vanoli (1992) Autonomic nervous system and sudden cardiac death. Circulation 85(suppl I), 78-91.
35. SOLVD Investigators (1991) Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 325 293-302.
36. AL Waldo, AJ Camm, H deRuyter, et al. (1995) Survival with ORal d-Sotalol in patients with left ventricular dysfunction after myocardial infarction: Rationale, design, and methods (the SWORD Trial). Am J Cardiol 75 1023-1027.
37. AL Waldo, AJ Camm, H deRuyter, et al. (1996) Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. Lancet 348 7-12.
38. CM Pratt, AJ Camm, W Cooper, et al. (1998) Mortality in the Survival With ORal d-Sotalol (SWORD) Trial: Why did patients die? Am J Cardiol 81 869-876.
39. SG Priori, L Diehl and PJ Schwartz (1995) Torsades de pointes. PJ Podrid, PR Kowey (Eds) Cardiac Arrhythmia; Mechanisms, Diagnosis and Management Baltimore: Williams & Wilkins 951-963.
40. AJ Moss, W Zareba, J Hall, et al. (2002) Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 346 877-883.
41. AE Buxton, KL Lee, JD Fisher, et al. (1999) Multicenter Unsustained Tachycardia Trial Investigators. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med 341 1882-1890.
42. DIAMOND Study Group: (1997) Dofetilide in patients with left ventricular dysfunction and either heart failure or acute myocardial infarction: Rationale, design, and patient characteristics of DIAMOND study. Clin Cardiol 20 704-710.
43. C Torp-Pedersen, M Moller, PE Bloch-Thomsen, et al. (1999) Dofetilide in patients with congestive heart failure and left ventricular dysfunction. N Engl J Med 341 857-865.
44. S Singh, RG Zoble, L Yellen, et al. (2000) Efficacy and safety of oral dofetilide in converting to and maintaining sinus rhythm in patients with chronic atrial fibrillation and flutter. The Symptomatic Atrial Fibrillation Investigation Research on Dofetilide (SAFIRE-D) Study. Circulation 2385-2390.
45. L Kober, PE Bloch Thomsen, M Moller, et al. (2000) Effect of dofetilide in patients with recent myocardial infarction and left ventricular dysfunction: A randomized trial. Lancet 356 2052-2058.
46. OD Pedersen, H Bagger, N Keller, et al. (2001) Efficacy of dofetilide in the treatment of atrial fibrillation-flutter in patients with reduced ventricular function: A Danish Investigation of Arrhythmia and Mortality ON Dofetilide (DIAMOND) substudy. Circulation 104 292-296.
47. ML Sedgwick, HS Rasmussen and SM Cobbe (1992) Clinical and electro-physiologic effects of intravenous dofetilide (UK-68,798), a new class III antiarrhythmic drug, in patients with angina pectoris. Am J Cardiol 69 513-517.
48. DG Julian, RJ Prescott, FS Jackson and P Szekely (1982) Controlled trial of sotalol for one year after myocardial infarction. Lancet 1 1142-1147.
49. SH Singh, RD Fletcher, SG Fisher, et al. (1995) for the Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure: Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia. N Engl J Med 333 77-82.
50. DG Julian, AJ Camm, G Frangin, et al. (1997) for the European Myocardial Infarct Amiodarone Trial investigators: Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. Lancet 349 667-674.
51. JA Cairns, SJ Connolly, R Robert and M Gent (1997) for the Canadian Amiodarone Myocardial Infarction Arrhythmia Trial investigators: Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarisations: CAMIAT. Lancet 349 675-682.
52. DW Cockcroft and MH Gault (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16 31-41.
53. Dofetilide (Tikosyn) presentation at the Cardiorenal Advisory Board meeting of the Food and Drug Administration, Bethesda, MD, Jan. 14, 1999.
54. L Ceremuzynski, E Kleczar, M Krzeminska-Pakula, et al. (1992) Effect of amiodarone on mortality after myocardial infarction: A double-blind, placebo-controlled, pilot study. J Am Coll Cardiol 20 1056-1062.
55. D Roy, M Taljic, P Dorian, et al. (2000) for the Canadian Trial of Atrial Fibrillation investigators: Amiodarone to prevent recurrence of atrial fibrillation. N Engl J Med 342 913-920.
56. JM Herre, MJ Sauve, P Malone, et al. (1989) Long-term results of amiodarone therapy in patients with recurrent sustained ventricular tachycardia or ventricular fibrillation. J Am Coll Cardiol 13 442-449.
57. DL Dries, DV Exner, BJ Gersh, et al. (1998) Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: A retrospective analysis of the SOLVD trials. J Am Coll Cardiol 32 695-703.
58. SF Assmann, SJ Pocock, LE Enos and LE Kasten (2000) Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 355 1064-1069.
59. PC Deedwania, BN Singh, K Ellenbogen, et al. (1998) for the Department of Veterans Affairs CHF-STAT investigators: Spontaneous conversion and maintenance of sinus rhythm by amiodarone in patients with heart failure and atrial fibrillation. Circulation 98 2574-2579.