Title of Trial
Innovative Stratification of Arrhythmic Risk by Means of LVEF and Heart Rate Turbulence (HRT)

Date and Location of Presentation
North American Society of Pacing and Electrophysiology 23rd Annual Scientific Sessions, May 11, 2002 Late-Breaking Clinical Trials II

Date and Citation of Primary Publication(s) or References
Circulation 2003;108(10):1221-1226.

Purpose of the Trial
The goal of this study was to validate HRT as a predictor of late mortality in a large post-myocardial infarction (MI) infarction cohort of patients in the reperfusion era and to establish it as a tool for risk stratification.

Study Categories
Ventricular arrhythmias/Sudden Death

Patient Population
Patients younger than 76 years of age who have survived a recent MI (within the prior 4 weeks) and who are in sinus rhythm.

Inclusion Criteria

• Age < 76 years
• MI within 4 weeks
• Sinus rhythm
• Holter monitor recorded

Exclusion Criteria
Absence of at least 2 of the following findings at the time of admission: chest pain for > 20 minutes, creatine kinase >200 U/L, and ST-segment elevation of > 0.1 mV in 2 or more limb leads or > 0.2 mV in 2 or more contiguous precordial leads.

Study Design
Prospective study validating HRT as a predictor of mortality after MI. HRT onset (TO) and slope (TS) were calculated from Holter records. Patients were classified into the following HRT categories: category 0 if both TO and TS were normal, category 1 if either TO or TS was abnormal, or category 2 if both TO and TS were abnormal.

Primary Endpoint
Death from any cause

Secondary Endpoints
None

Baseline Characteristics
Number of patients: 1,455 patients
Mean Age: 59 years
Gender: % female; 21%
Other characteristics

• LVEF = 56%.
• 90% of patients had percutaneous coronary intervention, 6% received thrombolytics, and 2 % underwent coronary artery bypass grafting surgery.

Years Follow-up: 22 months

Results
Seventy patients died during the follow-up period. On multivariate analysis, HRT category 2 was the strongest predictor of death (hazard ratio, 5.9; 95% CI, 2.9 to 12.2), followed by left ventricular ejection fraction (LVEF) <=30% (4.5; 2.6 to 7.8), diabetes mellitus (2.5; 1.6 to 4.1), age >=65 years (2.4; 1.5 to 3.9), and HRT category 1 (2.4; 1.2 to 4.9).

Sponsor
None

Trial Status: Completed

Review written by Samir Saba, MD