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- Title
Evaluation of Antiarrhythmic Drug Efficacy in Patients with an ICD: Unlimited Potential or Replete with Complexity and Problems?
- Authors
Craig M. Pratt; Camm, A. John; Bigger Jr., J. Thomas; Breithardt, Günter; Campbell, Ronald W.F.; Epstein, Andrew E.; Kappenberger, Lukas J.; Kuck, Karl-Heinz; Pocock, Stuart; Saksena, Sanjeev; Waldo, Albert L.
- 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.
- Subjects
MYOCARDIAL depressants; IMPLANTABLE cardioverter-defibrillators; IMPLANTED cardiovascular instruments; DEFIBRILLATORS; CARDIOVASCULAR agents; DRUGS
- Publication
Journal of Cardiovascular Electrophysiology, 1999, Vol 10, Issue 11, p1534
- ISSN
1045-3873
- Publication type
Article
- DOI
10.1111/j.1540-8167.1999.tb00212.x