A Controlled Trial of Verapamil in Patients after Acute myocardial infarction: Results of the Calcium, Antagonist Reinfarction Italian Study - CRIS

Feb 04, 2002
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Date Published:
01/01/1996
Date Updated:
02/04/2002
Original Posted Date:
02/04/2002
References

Description:

Verapamil for mortality, reinfarction, and angina following acute MI.

Hypothesis:

Verapamil decreases mortality, reinfarction, and angina in patients following acute myocardial infarction.

Study Design

Study Design:

Patients Screened: 3,459
Patients Enrolled: 1,073
NYHA Class: not given
Mean Follow Up: 23.5 months
Mean Patient Age: 56
Female: 9
Mean Ejection Fraction: not given

Patient Populations:

Patients 30 to 75 years old admitted from January 1985 through December 1987 who survived five days after an acute myocardial infarction.

Exclusions:

Severe heart failure (NYHA Class III or IV)
WPW Syndrome
Allergy to Verapamil
Recent cardiac surgery
Pacemaker required
Right ventricular failure
Co-morbidity
Premenopausal women
Beta blocker therapy
Hemodynamic and stability

Primary Endpoints:

All cause mortality

Secondary Endpoints:

Cardiac death
Sudden cardiac death
Reinfarction
Angina
First major event (death or reinfarction)
First new cardiac event (cardiac death, reinfarction, hospitalization for chest pain)

Drug/Procedures Used:

Verapamil 120 mg Q 8 hrs

Concomitant Medications:

Antiarrhythmics (9%)
Digitalis (8%)
Diuretic (14%)
Antihypertensives (4%)
Nitrates (80%)

Principal Findings:

Intention-to-treat analysis showed no difference in total mortality (placebo 5.4% and Verapamil 5.6%), cardiac death, and sudden death between Verapamil and placebo groups.

Less angina in Verapamil group (18.8% vs 24.3%).

Nonsignificant reductions in reinfarction (-19%), first major event (-13%) and first new cardiac event (-21%) with Verapamil.

Interpretation:

This study was not adequately powered to detect an impact of Verapamil on mortality. Mortality was lower than expected in the placebo group. Although the trend to reduction in reinfarction was observed with a concomitant significant decrease in angina in the Verapamil group, the mortality question post infarct still needs to be addressed.

Few patients in this particular heart failure trial actually had heart failure.

References:

1. Am J Cardiol 1996;77:365-369. Final results

Keywords: Myocardial Infarction, Intention to Treat Analysis, Heart Failure, Verapamil, Death, Sudden, Cardiac, Calcium Channel Blockers


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