COPPA-II Clinical Trial

Antiarrhythmic drugs have been used with mixed results for the prevention and treatment of atrial arrhythmias that complicate the post-operative course of patients who have coronary artery bypass graft surgery (CABG). A major concern is the safety of continuing a membrane-active drug following hospital discharge. We assessed the efficacy and safety of a short course of propafenone (PFN), on the incidence and economic impact of atrial fibrillation after CABG. A total of 293 patients, mean age 63, 83% men were randomized prospectively at 7 sites. Patients with EF < 40%, Class IV CHF, recent infarction, or incomplete revascularization were excluded. Double-blind treatment consisted of placebo or PFN at a daily dose of 450 mg or 675 mg started within 24 hours of surgery and continued for the duration of hospitalization to a maximum of 15 days. The study endpoint was 5 minutes of AF. During the course of the study, 93% were dosed with digoxin and 84% were given beta-blockers. The main results are illustrated in the table. Discontinuations for adverse effects were approximately equal among the placebo and PFN groups, although cardiovascular adverse effects were slightly more common in the PFN groups including one death and one cardiac arrest. A short course of propafenone in moderate doses was effective for preventing post-operative atrial arrhythmias and was more efficient than digoxin and beta-blocker in combination. This treatment benefit however did not translate into a reduced length of hospital stay.