Key result
Diltiazem fails to reduce post-MI ventricular arrhythmias and doubles sinus pauses vs placebo.
Why the study?
The effect of diltiazem on the frequency and repetitiveness of ventricular arrhythmias after myocardial infarction was uncertain.
RCT (n=2,466)
Yes
Diltiazem was associated with more sinus pauses without reducing post-MI arrhythmias; hypothesis-generating and should not yet change practice.
The a priori hypothesis that diltiazem would reduce the frequency and repetitiveness of ventricular arrhythmias was tested 3 months after myocardial infarction in patients participating in the Multicenter Diltiazem Postinfarction Trial. After 3 months of follow-up, 1,546 of the 2,466 patients enrolled had a 24-hour continuous electrocardiographic recording that contained greater than or equal to 12 hours of analyzable data. They were similar to the patients who survived 3 months but chose not to have a 24-hour electrocardiographic recording (i.e., they were representative of the entire group that survived 3 months). After 3 months of follow-up, there were no significant differences between the diltiazem and placebo groups in the prevalence of atrioventricular block, the frequency of atrial arrhythmias or the frequency or repetitiveness of ventricular arrhythmias. Heart rate was significantly lower (67 +/- 12 vs 71 +/- 12 beats/min) and there was a significantly greater proportion of patients with sinus pauses greater than or equal to 2 seconds in duration in the diltiazem group (6%) than in the placebo group (3%). Comparison with placebo revealed no evidence either for an anti- or proarrhythmic effect of diltiazem. There was no reduction in sudden or arrhythmic death attributable to diltiazem treatment; the fraction of total deaths that were arrhythmic by the Hinkle classification was 41% in the placebo group and 42% in the diltiazem group. It may be that the lack of effect of diltiazem on ventricular arrhythmias is partially responsible for its lack of effect on mortality after myocardial infarction.
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Bigger et al. (1990) conducted an RCT in myocardial infarction (n=2,466). Diltiazem vs. Placebo was evaluated on Frequency and repetitiveness of ventricular arrhythmias. Diltiazem did not reduce ventricular arrhythmias post-myocardial infarction compared to placebo, but increased the incidence of sinus pauses ≥2 seconds (6% vs 3%).
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