Back to Search
Start Over
Mortality in the Survival With ORal D-sotalol (SWORD) trial: why did patients die?
- Source :
-
The American journal of cardiology [Am J Cardiol] 1998 Apr 01; Vol. 81 (7), pp. 869-76. - Publication Year :
- 1998
-
Abstract
- The Survival With ORal D-sotalol (SWORD) trial tested the hypothesis that the prophylactic administration of oral d-sotalol would reduce total mortality in patients surviving myocardial infarction (MI) with a left ventricular ejection fraction (LVEF) of < or = 40%. Two index MI groups were included: recent (6 to 42 days) and remote (> 42 days) with clinical heart failure (n = 915 and 2,206, respectively). The trial was discontinued when the statistical boundary for harm was crossed (RR = 1.65; p = 0.006). All baseline variables known to be associated with mortality risk (e.g., LVEF, heart failure class, age) as well as variables related to torsades de pointes (e.g., time from beginning of therapy, QTc, gender, potassium, renal function, dose of d-sotalol) were assessed for interaction of each variable with treatment assignment, computing RR and 95% confidence interval (CI) from Cox regression models. The d-sotalol-associated mortality was greatest in the group with remote MI and LVEFs of 31% to 40% (RR = 7.9; 95% CI 2.4 to 26.2). Most variables known to be associated with torsades de pointes were not differentially predictive of d-sotalol-associated risk, except female gender (RR = 4.7; 95% CI 1.4 to 16.5). These findings suggest that (1) most of the d-sotalol-associated risk was in patients remote from MI with a LVEF of 31% to 40%; comparable placebo patients had a very low mortality (0.5%); and (2) very little objective data supports torsades de pointes or any specific proarrhythmic mechanism as an explanation for d-sotalol-associated mortality risk.
- Subjects :
- Administration, Oral
Anti-Arrhythmia Agents administration & dosage
Anti-Arrhythmia Agents therapeutic use
Arrhythmias, Cardiac mortality
Arrhythmias, Cardiac prevention & control
Female
Humans
Male
Middle Aged
Potassium Channel Blockers
Proportional Hazards Models
Risk Factors
Sex Factors
Sotalol administration & dosage
Sotalol therapeutic use
Stroke Volume
Survival Analysis
Time Factors
Torsades de Pointes chemically induced
Torsades de Pointes mortality
Anti-Arrhythmia Agents adverse effects
Arrhythmias, Cardiac chemically induced
Myocardial Infarction drug therapy
Myocardial Infarction mortality
Sotalol adverse effects
Ventricular Dysfunction, Left mortality
Subjects
Details
- Language :
- English
- ISSN :
- 0002-9149
- Volume :
- 81
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- The American journal of cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 9555777
- Full Text :
- https://doi.org/10.1016/s0002-9149(98)00006-x