COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial.
OBJECTIVE
No drug has been proven efficacious to prevent the post-pericardiotomy syndrome (PPS), but colchicine seems safe and effective for the treatment and prevention of pericarditis. The aim of the COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS) trial is to test the efficacy and safety of colchicine for the primary prevention of the PPS.


RESULTS
The COPPS study is a multicentre, double-blind, randomized trial. On the third post-operative day, 360 patients (mean age 65.7 ± 12.3 years, 66% males), 180 in each treatment arm, were randomized to receive placebo or colchicine (1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). The primary efficacy endpoint was the incidence of PPS at 12 months. Secondary endpoint was the combined rate of disease-related hospitalization, cardiac tamponade, constrictive pericarditis, and relapses. Baseline characteristics were well balanced between the study groups. Colchicine significantly reduced the incidence of the PPS at 12 months compared with placebo (respectively, 8.9 vs. 21.1%; P = 0.002; number needed to treat = 8). Colchicine also reduced the secondary endpoint (respectively, 0.6 vs. 5.0%; P = 0.024). The rate of side effects (mainly related to gastrointestinal intolerance) was similar in the colchicine and placebo groups (respectively, 8.9 vs. 5.0%; P = 0.212).


CONCLUSIONS
Colchicine is safe and efficacious in the prevention of the PPS and its related complications and may halve the risk of developing the syndrome following cardiac surgery. ClinicalTrials.gov number, NCT00128427.
Imazio
Massimo
M
Department of Cardiology, Maria Vittoria Hospital, Via Cibrario 72, 10141 Torino, Italy. massimo_imazio@yahoo.it
Trinchero
Rita
R
Brucato
Antonio
A
Rovere
Maria Elena
ME
Gandino
Anna
A
Cemin
Roberto
R
Ferrua
Stefania
S
Maestroni
Silvia
S
Zingarelli
Edoardo
E
Barosi
Alberto
A
Simon
Caterina
C
Sansone
Fabrizio
F
Patrini
Davide
D
Vitali
Ettore
E
Ferrazzi
Paolo
P
Spodick
David H
DH
Adler
Yehuda
Y
D000368:Aged; D002305:Cardiac Tamponade / Q000209:etiology; D003078:Colchicine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010493:Pericarditis / Q000209:etiology; D011185:Postpericardiotomy Syndrome / Q000517:prevention & control*; D012008:Recurrence; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use*
D050257:Tubulin Modulators; D003078:Colchicine