Are there alternatives to mortality as an endpoint in clinical trials of atrial fibrillation?

Heart Rhythm

Volumn 1, Issue 2 SUPPL., 2004, Pages 41-44

  Wyse, D George ^a  

^a UNIVERSITY OF CALGARY   (Canada)

Author keywords

Atrial fibrillation; Clinical trials; Composite endpoints; Follow up investigation of rhythm management trial; Mortality; Surrogate endpoints

Indexed keywords

ANTIARRHYTHMIC AGENT;

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COHORT ANALYSIS; DATA ANALYSIS; DEFIBRILLATOR; FOLLOW UP; FREQUENCY ANALYSIS; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART RHYTHM; HEART VENTRICLE ARRHYTHMIA; HOSPITALIZATION; HUMAN; LETHALITY; MEDICAL RESEARCH; MORTALITY; NONBIOLOGICAL MODEL; PRIORITY JOURNAL; RISK ASSESSMENT;

EID: 3042734236     PISSN: 15475271     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.hrthm.2004.03.074     Document Type: Article

References (12)

1. CAST Investigators Preliminary report: effect of encainide and flecainide on mortality in a trial of arrhythmia suppression after myocardial infarction N Engl J Med 321 1989 406-412
2. Prentice R.L. Surrogate endpoints in clinical trials: definition and operational criteria Stat Med 8 1989 431-440
3. Wittes J. Lakatos E. Prostfield J. Surrogate endpoints in clinical trials: cardiovascular diseases Stat Med 8 1989 415-425
4. Fleming T.R. DeMets D.L. Surrogate endpoints in clinical trials: are we being misled? Ann Intern Med 125 1996 605-613
5. Freemantle N. Calvert M. Wood J. Eastaugh J. Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty JAMA 289 2003 2554-2559
6. Hallstrom A.P. Greene H.L. Wilkoff B.L. Zipes D.P. Schron E. Ledingham R.B. Relationships between rehospitalization and future death in patients treated for potentially lethal arrhythmia J Cardiovasc Electrophysiol 12 2001 990-995
7. DAVID Trial Investigators Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator. The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial JAMA 288 2002 3115-3123
8. The AVID Investigators Causes of death in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial J Am Coll Cardiol 34 1999 1552-1559
9. Steinberg J.S. Sadaniantz A. Kron J. Krahn A. Denny M. Daubert J. Campbell W.B. Havranek E. Murray K. Olshansky B. O'Neil G. Sami M. Schmidt S. Storm R. Zabalgoitia M. Miller J. Changler M. Nasco E.M. Greene H.L. Analysis of cause-specific mortality in the Atrial Fibrillation follow-up Investigation of Rhythm Management (AFFIRM) Trial Circulation 109 2004 1973-1980
10. The Planning and Steering Committees of the AFFIRM Study for the NHLBI AFFIRM Investigators Atrial Fibrillation Follow-up Investigation of Rhythm Management: the AFFIRM Study design Am J Cardiol 79 1997 1198-1202
11. The AFFIRM Investigators Baseline characteristics of patients with atrial fibrillation: the AFFIRM Study Am Heart J 143 2002 991-1001
12. The AFFIRM Investigators A comparison of rate control and rhythm control in patients with atrial fibrillation N Engl J Med 347 2002 1825-1833