Preliminary Mortality Results from the Survival with Oral D-Sotalol (SWORD) Trial

The SWORD trial was designed to enroll 6400 patients to test the hypothesis that d-Sotalol would reduce total mortality in high risk survivors of myocardial infarction (MI). Patients (pts) ≥ 18 years of age with an LVEF ≤ 40% and recent (6-42 days) MI or remote (> 42 days) MI with overt heart failure (NYH class II or III) were randomized to placebo or d-Sotalol (100 mg bid, or 200 mg bid if tolerated) for follow up ≥ 18 mos. The trial was stopped on 11/1/95 after enrolling 3119 pts (mean follow UP = 156 days) because the boundary for harm was crossed (z = −2.8). 42 (2.7%) pts died on placebo; 71 (4.6%) died on d-Sotalol (p = 0.005). All baseline comparisons between placebo and d-Sotalol showned no significant difference; mean LVEF was 30.8%; 29.2% pts had recent MI; 70.8% of pts had remote MI. Conclusion: Prophylactic therapy with oral d-Sotalol in post MI population with LV dysfunction resulted in significantly increased mortality.