Cochicine Treatment for Post- Operative Pericardial Effusion (POPE2)

• change in effusion grade [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  

• frequency of late cardiac tamponade [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  
• number of patients with at least a one-grade decrease in the effusion [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  
• mean change in the width of the effusion measured in millimeters [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  
• evolution of prespecified subgroups [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • patients with inflammatory syndrom : crp > 30 mg/l
  • patients receiving an anticoagulant
  • patients with a post pericardiotomy syndrom
  
  

Clinically insignificant pericardial effusion is common after heart surgery with an incidence of 50 % to 85 % a few days after surgery Cardiac tamponade occurs in about 1-2 % of patients who undergo cardiac surgery and may develop slowly without clear-cut clinical signs. Most tamponade occurs more than 7 days after surgery which is a concern because, at that time, patients often have already been discharged from the hospital.

No study has ever shown the efficacy any drug for this condition.In particular, we published a study demonstrating the absence of efficacy of a non steroidal anti inflammatory drug (Meurin P, Tabet JY, Thabut G, et al.French Society of Cardiology. Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. Ann Intern Med. 2010 Feb2;152(3):137-43) Cochicine is widely used to treat inflammatory pericarditis ; is it efficient to treat post operative pericardial effusions ? this is the question we want to answer to.

Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.

Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.