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

A. J. Camm
2004 Circulation  
on Behalf of the AzimiLide post Infarct surVival Evaluation (ALIVE) Investigators 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
more » ... 17 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 (Ͼ20 U; 15% versus 9.5%, PϽ0.0005) 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%, PϽ0.04). The incidences of torsade de pointes and severe neutropenia (absolute neutrophil count Յ500 cells/L) 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. (Circulation. 2004;109:990-996.)
doi:10.1161/01.cir.0000117090.01718.2a pmid:14967728 fatcat:mrhms2whdbbxjikg7pzth7htra