Key result
Appropriate ICD shocks present significant methodological challenges as surrogate mortality endpoints in antiarrhythmic trials.
Highlights the methodological challenges of using appropriate ICD shocks as surrogate endpoints for mortality in clinical trials testing antiarrhythmic drugs.
Clinicians should interpret antiarrhythmic trials using ICD shocks as surrogates with caution; challenges their validity and leaves optimal endpoints open for future validation.
A report from a Study group, proposed by A. J. Camm, London, of the Working Groups on Arrhythmias and Cardiac Pacing of the European Society of Cardiology; co-sponsored by the North American Society of Pacing and Electrophysiology. The Study Group was convened on 29 August 1997 at Saltsjöbaden, near Stockholm. The meeting was chaired by A. J. Camm, London, and C. M. Pratt, Houston. Based on the presentation and discussions, a first draft of the documents was prepared by C. Pratt and J. Camm which was then circulated to all members three times for their review. All members of the Study Group approved the final manuscript. This report represents the opinion of the members of this Study Group and does not necessarily reflect the official position of either society.The meeting of the Study Group was made possible by unrestricted educational grants from Medtronic, Guidant, Proctor & Gamble, Berlex and Sanofi.Also, presented, in part, at the Cardio-Renal Drugs Advisory Board meeting of the Food and Drug Administration, Bethesda, Maryland, on 30 April 1999.
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Craig M. Pratt (1999) conducted a review in High risk for arrhythmic death with an ICD. Antiarrhythmic drugs was evaluated. Using appropriate implantable cardioverter-defibrillator shocks as a surrogate endpoint for mortality in antiarrhythmic drug trials presents significant methodological complexities and challenges.
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