Survival with Oral D-Sotalol Trial - SWORD

Description:

Sotolol for mortality in acute MI.

Hypothesis:

All cause mortality is reduced in patients with ischemic heart disease, acute myocardial infarction, and left ventricular dysfunction or symptomatic heart failure when D-Sotolol is administered.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 3,121
NYHA Class: I=(7%), II=(72%), III=(22%)
Mean Follow Up: 28 months (36 months)
Mean Patient Age: 60
Female: 14
Mean Ejection Fraction: 31%

Patient Populations:

Adult men and women with ejection fraction < 40%
Either recent post myocardial infarction (six to 42 days) or remote myocardial infarction (> 42 days) with overt NYHA Class II/III heart failure

Exclusions:

Unstable angina pectoris
NYHA class IV heart failure
History of life-threatening arrhythmia unrelated to myocardial infarction
Sick sinus syndrome or high grade AV block untreated by pacemaker
Recent PTCA or CABG
Electrolyte abnormalities
Concomitant antiarrhythmic agents

Primary Endpoints:

All cause mortality

Secondary Endpoints:

Cardiac mortality
Cardiovascular mortality
Presumed arrhythmic death
Nonfatal severe arrhythmic event
Hospital admission for cardiovascular causes
Combinations of these endpoints

Drug/Procedures Used:

D-Sotolol (100mg increased to 200mg twice daily, if tolerated).

Concomitant Medications:

Diuretics (49%)
Digoxin (27%)
ACE inhibitors (71%)
Nitrates (54%)
Beta blockers (33%)
Calcium channel blockers (19%)
Aspirin (65%)

Principal Findings:

Among 1,549 patients assigned D-Sotolol, the death rate was 5% compared to 3.1% assigned placebo.
Relative risk of death 1.65 in Sotolol treated group (95% CI 1.15-2.36; p = 0.006).

Presumed arrhythmic deaths (relative risk 1.77) accounted for the increased mortality.

Effect was greater in patients with a left ventricular ejection fraction of 31 to 40% than in those with lower (< 30%) ejection fractions (relative risk 4.0 versus 1.2; p = 0.007).

Interpretation:

Among patients evaluated and treated with D-Sotolol there was an increased mortality which was presumed principally secondary to arrhythmias. The investigators indicate that prophylactic use of this potent antiarrhythmic agent does not reduce mortality in this patient population and may be associated with increased death risk in patients with left ventricular systolic dysfunction after myocardial infarction.

References:

1. Lancet 1996;348:7-12. Final results
2. Am J Cardiol 1998;81(7):869-76. Review

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Risk, Myocardial Infarction, Heart Failure, Stroke Volume, Sotalol, Ventricular Dysfunction, Left


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