BACKGROUND:Postpericardiotomy syndrome (PPS) is a troublesome complication of cardiac surgery, occurring in 10-45% of cases. Accepted modalities of treatment include nonsteroidal anti-inflammatory drugs, corticosteroids, and pericardiectomy in severe cases. The optimal method for prevention of PPS has not been established. Recent trial data have shown that colchicine is efficient in the secondary prevention of recurrent episodes of pericarditis. The aim of the present study was to evaluate the possible benefit of colchicine for the primary prevention of PPS in patients after cardiac surgery. To the best of our knowledge, this is the first study addressing this issue. PATIENTS AND METHODS: A prospective, randomized, double-blind design was used. The initial study group included 163 patients who underwent cardiac surgery in two centers in Israel between October 1997 and September 1998. On the 3rd postoperative day, the patients were randomly assigned to receive colchicine (1.5 mg/day) or placebo for 1 month. All were evaluated monthly for the first 3 postoperative months for development of PPS. RESULTS: 52 of the 163 patients were excluded because of postoperative complications, noncompliance, or gastrointestinal side effects of treatment. Of the 111 patients who completed the study, 47 (42.3%) receivedcolchicine and 64 (57.7%) placebo. There was no statistically significant difference between the groups in clinical or surgical characteristics. PPS was diagnosed in 19 patients (17.1%), 5/47 cases (10.6%) in the colchicine group and 14/64 (21.9%) in the placebo group. The difference showed a trend toward statistical significance (p < 0.135). CONCLUSIONS:Colchicine may be efficacious for the prevention of PPS in patients after cardiac surgery. Further evaluations in larger clinical trials are warranted.
RCT Entities:
BACKGROUND:Postpericardiotomy syndrome (PPS) is a troublesome complication of cardiac surgery, occurring in 10-45% of cases. Accepted modalities of treatment include nonsteroidal anti-inflammatory drugs, corticosteroids, and pericardiectomy in severe cases. The optimal method for prevention of PPS has not been established. Recent trial data have shown that colchicine is efficient in the secondary prevention of recurrent episodes of pericarditis. The aim of the present study was to evaluate the possible benefit of colchicine for the primary prevention of PPS in patients after cardiac surgery. To the best of our knowledge, this is the first study addressing this issue. PATIENTS AND METHODS: A prospective, randomized, double-blind design was used. The initial study group included 163 patients who underwent cardiac surgery in two centers in Israel between October 1997 and September 1998. On the 3rd postoperative day, the patients were randomly assigned to receive colchicine (1.5 mg/day) or placebo for 1 month. All were evaluated monthly for the first 3 postoperative months for development of PPS. RESULTS: 52 of the 163 patients were excluded because of postoperative complications, noncompliance, or gastrointestinal side effects of treatment. Of the 111 patients who completed the study, 47 (42.3%) received colchicine and 64 (57.7%) placebo. There was no statistically significant difference between the groups in clinical or surgical characteristics. PPS was diagnosed in 19 patients (17.1%), 5/47 cases (10.6%) in the colchicine group and 14/64 (21.9%) in the placebo group. The difference showed a trend toward statistical significance (p < 0.135). CONCLUSIONS:Colchicine may be efficacious for the prevention of PPS in patients after cardiac surgery. Further evaluations in larger clinical trials are warranted.
Authors: Matthew D Elias; Andrew C Glatz; Matthew J O'Connor; Susan Schachtner; Chitra Ravishankar; Christoper E Mascio; Meryl S Cohen Journal: Pediatr Cardiol Date: 2016-11-30 Impact factor: 1.655