Evaluation of antiarrhythmic drug efficacy in patients with an ICD: Unlimited potential or replete with complexity and problems?

Craig M. Pratt, A. John Camm, J. Thomas Bigger, Günter Breithardt, Ronald W F Campbell, Andrew E. Epstein, Lukas J. Kappenberger, Karl heinz Kuck, Stuart Pocock, Sanjeev Saksena, Albert L. Waldo

Research output: Contribution to journalReview article

5 Scopus citations

Abstract

Antiarrhythmic Drug Efficacy in Patients with an ICD. There are a number of novel ways in which implantable cardioverter defibrillator (ICD) endpoints can be used in clinical trials to evaluate antiarrhythmic drugs. The advances in ICD technology (storage, retrieval, and accurate interpretation of ICD electrograms) expand the potential to include the use of an ICD endpoint as a clinical surrogate for sudden death. The ICD also provides the necessary safety net to test new drugs. The frequent need for antiarrhythmic drugs in patients already fitted with an ICD (e.g., for atrial fibrillation) necessitates knowledge of the drugs' effect on defibrillator threshold. There are interpretative problems and challenges associated with all types of ICD trials. A particular difficult issue is the degree to which the results of data on antiarrhythmic drug efficacy and safety acquired in the context of an ICD endpoint trial might be extrapolated to patient populations in which the device is not used. These and other challenging issues are discussed, with the goal of enhancing the design and interpretation of clinical trials featuring ICD endpoints.

Original languageEnglish (US)
Pages (from-to)1534-1549
Number of pages16
JournalJournal of Cardiovascular Electrophysiology
Volume10
Issue number11
DOIs
StatePublished - 1999

Keywords

  • Antiarrhythmic agents
  • Implantable cardioverter defibrillator

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology

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