Diltiazem Reinfarction Study - Diltiazem Reinfarction Study

Description:

Diltiazem vs placebo in non-Q wave MI.

Hypothesis:

To determine whether diltiazem would reduce the incidence of early reinfarction in non-Q wave patients.

Study Design

Study Design:

Patients Screened: 1603
Patients Enrolled: 576
NYHA Class: N/A
Mean Follow Up: 14 days
Mean Patient Age: average 61 years
Female: 22%
Mean Ejection Fraction: Not reported

Patient Populations:

Non–Q-wave MI (elevated CK-MB and either ischemic pain for 30 minutes or ST-segment deviation [elevation or depression ≥1 mm or T-wave inversions in at least two leads]).

Exclusions:

New Q-waves, conduction disturbances that would mask development of Q waves, HR <50 bpm, advanced heart block, cardiogenic shock or sustained SBP<100 mmHg, therapy with a calcium-channel blocker, oral anticoagulants, or full-dose heparin that could not be discontinued, coronary bypass surgery in past 3 months, documented or suspected pregnancy.

Primary Endpoints:

Reinfarction at 14 days (defined as increase of 50% or more in CK-MB above preceding baseline level in at least two samples taken a minimum of 4 hrs apart within a 24 hr interval and an absolute value of 14 IU/L or greater in1 or more of these samples).

Secondary Endpoints:

Postinfarction angina of any severity, refractory angina not associated with abnormal CK-MB elevation, death within 14 days of randomization.

Drug/Procedures Used:

Randomized at 24–72 hours to diltiazem 90 mg every 6 hours, or placebo.

Concomitant Medications:

Beta-blockers in 61%

Principal Findings:

Diltiazem was associated with a significantly lower 14-day reinfarction rate (5.2% vs. 9.3%; p = 0.03) and 50% less refractory angina (3.5% vs 6.9%, p=0.03). There was no significant difference between the groups in all-cause mortality rates (3.1% vs. 3.8%). Adverse reactions were common in the diltiazem group (overall 24% vs 6% [AV block: 6% vs 2%, SBP <90mmHg: 8% vs 2%]); however, only 4.9% of the diltiazem patients discontinued therapy because of the adverse effects.

Interpretation:

Diltiazem was associated with a reduction in early reinfaction and severe angina after non-Q-wave MI. This trial is now 16 years old and preceded the use of glycoprotein 2b3a inhibitors, intracoronary stenting, and plavix.

References:

N Engl J Med 1986;315:423-9.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, EP Basic Science

Keywords: Diltiazem, Atrioventricular Block, Myocardial Infarction, Creatine Kinase, MB Form, Ticlopidine, Calcium Channel Blockers


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