Pilsicainide for conversion and maintenance of sinus rhythm in chronic atrial fibrillation: a placebo-controlled, multicenter study.
BACKGROUND
Pilsicainide is a newly synthesized antiarrhythmic agent with class Ic properties. Various antiarrhythmic agents have been used to convert atrial fibrillation (AF) to sinus rhythm or decrease the rate of relapse of AF.


METHODS
We randomly assigned 62 patients with chronic AF to oral treatment of either a placebo (10 patients) or 150 mg/day of pilsicainide (52 patients) for 4 weeks before electrical cardioversion. Before oral administration of pilsicainide, 41 patients underwent transesophageal echocardiography to investigate whether there was thrombus formation in the heart chambers. Patients without pharmacologic defibrillation underwent direct current cardioversion to restore sinus rhythm. After successful cardioversion, all patients continued to receive pilsicainide and were monitored for up to 2 years.


RESULTS
Before cardioversion, 11 patients in the pilsicainide group (21%) reverted to sinus rhythm. No patients in the placebo group reverted to sinus rhythm. Direct current cardioversion was performed in 51 patients; however, 8 patients were not converted to sinus rhythm (5 patients receiving pilsicainide, 3 patients receiving placebo), and 3 patients needed intracardiac cardioversion to convert to sinus rhythm. Asymptomatic bradyarrhythmias were observed in 5 patients in the pilsicainide group. During the follow-up period, 33 patients (71%) in the pilsicainide group remained in sinus rhythm at 1 month; this number decreased to 23 patients (49%) at 3 months, 20 (43%) at 6 months, 16 (34%) at 12 months, 16 (34%) at 18 months, and 16 (34%) at 24 months. All patients receiving placebo continued to receive placebo after the cardioversion, and AF recurred a few days after cardioversion in all cases. No independent discriminant variables were identified in the groups between maintenance and nonmaintenance of sinus rhythm. Although no serious side effects regarding pilsicainide have been documented, one patient died of acute myocardial infarction, most likely not related to pilsicainide administration.


CONCLUSIONS
Pilsicainide is effective in restoring or maintaining sinus rhythm in patients with chronic AF lasting longer than an average duration of 22 months. No major adverse effects were observed.
Okishige
K
K
Department of Cardiology, Yokohama Red Cross Hospital, Yokohama-City, Japan.
Nishizaki
M
M
Azegami
K
K
Igawa
M
M
Yamawaki
N
N
Aonuma
K
K
D000284:Administration, Oral; D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000503:physiopathology* / Q000628:therapy*; D002908:Chronic Disease; D004334:Drug Administration Schedule; D004554:Electric Countershock; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011292:Premedication; D011379:Prognosis; D012008:Recurrence; D016896:Treatment Outcome
D000889:Anti-Arrhythmia Agents; D008012:Lidocaine; C042288:pilsicainide