Implantable cardioverter defibrillator endpoints offer a clinical surrogate for sudden death to evaluate antiarrhythmic drugs, despite challenges in extrapolating results to non-ICD populations.
This review highlights the methodological challenges and potential of using ICD endpoints as surrogates for sudden death in antiarrhythmic drug trials.
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.
Pratt et al. (Mon,) conducted a review in Patients with an ICD. Antiarrhythmic drugs was evaluated. Implantable cardioverter defibrillator endpoints offer a clinical surrogate for sudden death to evaluate antiarrhythmic drugs, despite challenges in extrapolating results to non-ICD populations.
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