Mortality in Patients after a Recent Myocardial Infarction: A Randomized, Placebo-Controlled Trial of Azimilide Using Heart Rate Variability for Risk Stratification

A. John Camm, Craig M. Pratt, Peter J. Schwartz, Hussein R. Al-Khalidi, Maria J. Spyt, Michael J. Holroyde, Roger Karam, Edmund H. Sonnenblick, Jose M.G. Brum

Research output: Contribution to journalArticle

187 Scopus citations

Abstract

Background - Depressed left ventricular function (LVF) and low heart rate variability (HRV) identify patients at risk of increased mortality after myocardial infarction (MI). Azimilide, a novel class III antiarrhythmic drug, was investigated for its effects on mortality in patients with depressed LVF after recent MI and in a subpopulation of patients with low HRV. Methods and Results - A total of 3717 post-MI patients with depressed LVF were enrolled in this randomized, placebo-controlled, double-blind study of azimilide 100 mg on all-cause mortality. Placebo patients with low HRV had a significantly higher 1-year mortality than those with high HRV (>20 U; 15% versus 9.5%, P<0.0005) despite nearly identical ejection fractions. No significant differences were observed between the 100-mg azimilide and placebo groups for all-cause mortality in either the "at-risk" patients identified by depressed LVF (12% versus 12%) or the subpopulation of "high-risk" patients identified by low HRV (14% versus 15%) or for total cardiac or arrhythmic mortality. Significantly fewer patients receiving azimilide developed atrial fibrillation than did patients receiving placebo (0.5% versus 1.2%, P<0.04). The incidences of torsade de pointes and severe neutropenia (absolute neutrophil count ≤500 cells/μL) were slightly higher in the azimilide group than in the placebo group (0.3% versus 0.1% for torsade de pointes and 0.9% versus 0.2% for severe neutropenia). Conclusions - Azimilide did not improve or worsen the mortality of patients after MI. Low HRV independently identified a subpopulation at high risk of mortality.

Original languageEnglish (US)
Pages (from-to)990-996
Number of pages7
JournalCirculation
Volume109
Issue number8
DOIs
StatePublished - Mar 2 2004

Keywords

  • Antiarrhythmia agents
  • Azimilide
  • Heart rate
  • Trials

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

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