EFFECT OF D-SOTALOL ON MORTALITY IN PATIENTS WITH LEFT-VENTRICULAR DYSFUNCTION AFTER RECENT AND REMOTE MYOCARDIAL-INFARCTION

Background Left ventricular dysfunction after myocardial infarction is associated with an increased risk of death. Other studies have sugges ted that a potassium-channel blocker might reduce this risk with minim al adverse effects. We investigated whether d-sotalol, a pure potassiu m-channel blocker with no clinically significant beta-blocking activit y, could reduce all-cause mortality in these high-risk patients. Metho ds Patients with a left ventricular ejection fraction of 40% or less a nd either a recent (6-42 days) myocardial infarction or symptomatic he art failure with a remote (>42 days) myocardial infarction were random ly assigned d-sotalol (100 mg increased to 200 mg twice daily, if tole rated) or matching placebo twice daily. Findings After 3121 of the pla nned 6400 patients had been recruited, the trial was stopped. Among 15 49 patients assigned d-sotalol, there were 78 deaths (5.0%) compared w ith 48 deaths (3 1%) among the 1572 patients assigned placebo (relativ e risk 165 [95% CI 1.15-2.36], p=0.006). Presumed arrhythmic deaths (r elative risk 1.77 [1.15-2.74], p=0.008) accounted for the increased mo rtality. The effect was greater in patients with a left ventricular ej ection fraction of 31-40% than in those with lower (less than or equal to 30%) ejection fractions (relative risk 4.0 vs 1.2, p=0.007). Inter pretation Among the 1549 patients evaluated, administration of d-sotal ol was associated with increased mortality, which was presumed primari ly to be due to arrhythmias. The prophylactic use of a specific potass ium-channel blocker does not reduce mortality, and may be associated w ith increased mortality in high-risk patients after myocardial infarct ion.