Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial.
BACKGROUND
The incidence of asymptomatic pericardial effusion is high after cardiac surgery. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in this setting, but no study has assessed their efficacy.


OBJECTIVE
To assess whether the NSAID diclofenac is effective in reducing postoperative pericardial effusion volume.


METHODS
Multicenter randomized, double-blind, placebo-controlled study. (Clinical trials.gov registration number: NCT00247052)


METHODS
5 postoperative cardiac rehabilitation centers.


METHODS
196 patients at high risk for tamponade because of moderate to large persistent pericardial effusion (grade 2, 3, or 4 on a scale of 0 to 4, as measured by echocardiography) more than 7 days after cardiac surgery.


METHODS
Random assignment at each site in blocks of 4 to diclofenac, 50 mg, or placebo twice daily for 14 days.


METHODS
The main end point was change in effusion grade after 14 days of treatment. Secondary end points included frequency of late cardiac tamponade.


RESULTS
The initial mean pericardial effusion grade was 2.58 (SD, 0.73) for the placebo group and 2.75 (SD, 0.81) for the diclofenac group. The 2 groups showed similar mean decreases from baseline after treatment (-1.08 grades [SD, 1.20] for the placebo group vs. -1.36 (SD, 1.25) for the diclofenac group). The mean difference between groups was -0.28 grade (95% CI, -0.63 to 0.06 grade; P = 0.105). Eleven cases of late cardiac tamponade occurred in the placebo group and 9 in the diclofenac group (P = 0.64). These differences persisted after adjustment for grade of pericardial effusion at baseline, treatment site, and type of surgery.


CONCLUSIONS
The sample was not large enough to find small beneficial effects of diclofenac or assess the cardiovascular tolerance of diclofenac.


CONCLUSIONS
In patients with pericardial effusion after cardiac surgery, diclofenac neither reduced the size of the effusions nor prevented late cardiac tamponade.


BACKGROUND
French Society of Cardiology.
Meurin
Philippe
P
Les Grands Prés, 27 rue Sainte Christine, 77174 Villeneuve Saint Denis, France. philippemeurin@hotmail.com
Tabet
Jean Yves
JY
Thabut
Gabriel
G
Cristofini
Pascal
P
Farrokhi
Titi
T
Fischbach
Michel
M
Pierre
Bernard
B
Driss
Ahmed Ben
AB
Renaud
Nathalie
N
Iliou
Marie Christine
MC
Weber
Hélène
H
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010490:Pericardial Effusion / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac