Circulation. 1998;97:1514-1521
(Circulation. 1998;97:1514-1521.)
© 1998 American Heart Association, Inc.
Interpretation of Outcomes of Antiarrhythmic Clinical Trials
Design Features and Population Impact
Robert J. Myerburg, MD;
Raul Mitrani, MD;
Alberto Interian, Jr, MD;
; Agustin Castellanos, MD
From the Department of Medicine, Division of Cardiology, University of
Miami School of Medicine, Miami, Fla.
Correspondence to Robert J. Myerburg, MD, University of Miami School of Medicine, PO Box 016960 (D-39), Miami, FL 33101. E-mail rmyerbur@mednet.med.miami.edu
Key Words: antiarrhythmia agents • defibrillation • arrhythmia • trials • death, sudden • population
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Introduction
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The results of the
Cardiac Arrhythmia Suppression Trials (CAST and CAST II) were a
watershed in attitudes about management of cardiac
arrhythmias.1 2 3 On the basis of the
then-prevailing assumption that premature ventricular
contractions (PVCs) in the presence of recent myocardial infarction
identified a risk for life-threatening arrhythmias and that
they also served as the trigger for fatal arrhythmias, it was
logical to determine whether suppression of ambient arrhythmias
would protect against fatal events.4 Despite the
outcomes of these trials, ambient arrhythmias are still viewed
as a marker of risk (perhaps somewhat lower than previously thought)
and as pathophysiological triggers under proper
conditions.5 However, the concept that
suppression of asymptomatic PVCs is an appropriate
preventive strategy has fallen under the weight of evidence from
those studies.6 In addition, new concepts of
proarrhythmia emerged from CAST and other sources of
information.7 After CAST, a variety of trials
testing therapy with other drugs and with implantable devices were
implemented, some of which are now completed. The various trials differ
in regard to therapeutic strategies, designs, and patient populations.
With the flow of new information that has been forthcoming and is
anticipated to continue during the next few years, it is important to
keep the strengths and limitations of clinical trial designs in
perspective and to consider the extent to which the results of any one
trial or group of trials can be generalized.
This review is intended to analyze general features of trial
design that influence their interpretation, application, and clinical
impact. It . . . [Full Text of this Article]
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