Naproxen as prophylaxis against atrial fibrillation after cardiac surgery: the NAFARM randomized trial.
OBJECTIVE
We sought to assess the effect of naproxen versus placebo on prevention of atrial fibrillation after coronary artery bypass graft (CABG) surgery.


METHODS
In this randomized, double-blind, placebo-controlled, single-center trial of 161 consecutive patients undergoing CABG surgery, patients received naproxen 275 mg every 12 hours or placebo at the same dosage and interval over 120 hours immediately after CABG surgery. The primary outcome was the occurrence of atrial fibrillation in the first 5 postoperative days.


RESULTS
The incidence of postoperative atrial fibrillation was 15.2% (12/79) in the placebo versus 7.3% (6/82) in the naproxen group (P=.11). The duration of atrial fibrillation episodes was significantly lower in the naproxen (0.35 hours) versus placebo group (3.74 hours; P=.04). There was no difference in the overall days of hospitalization between placebo (17.23±7.39) and naproxen (18.33±9.59) groups (P=.44). Intensive care unit length of stay was 4.0±4.57 days in the placebo and 3.23±1.25 days in the naproxen group (P=.16). The trial was stopped by the data monitoring committee before reaching the initial target number of 200 patients because of an increase in renal failure in the naproxen group (7.3% vs 1.3%; P=.06).


CONCLUSIONS
Postoperative use of naproxen did not reduce the incidence of atrial fibrillation but decreased its duration, in a limited sample of patients after CABG surgery. There was a significant increase in acute renal failure in patients receiving naproxen 275 mg twice daily. Our study does not support the routine use of naproxen after CABG surgery for the prevention of atrial fibrillation.
Division of Invasive Clinical Electrophysiology, Department of Cardiology, Universidade Federal de São Paulo, Brazil.
Stevie J
SJ
Horbach
Renato D
RD
Lopes
João C V
JC
da C Guaragna
Felipe
F
Martini
Rajendra H
RH
Mehta
João B
JB
Petracco
Luis C
LC
Bodanese
Adauto C
AC
Filho
Cláudio
C
Cirenza
Angelo A V
AA
de Paola
D058186:Acute Kidney Injury / Q000139:chemically induced; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D001938:Brazil; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009288:Naproxen