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COPPS: COlchicine for the Prevention of the Post-pericardiotomy Syndrome: results of the COPPS trial, a multicentre, double-blind, randomised trial

Pericardial Disease




Massimo Imazio
  Presenter
Presenter | see Discussant report Webcasts become available 24h after the session
Imazio, Massimo
(Italy)
Open presentation slides

List of Authors:
M. Imazio, R. Trinchero, A. Brucato, M. E. Rovere, A. Gandino, R. Cemin, S. Ferrua, S. Maestroni, E. Zingarelli, A. Barosi, C. Simon, F. Sansone, D. Patrini, E. Vitali, P. Ferrazzi, D.H. Spodick, Y. Adler on behalf of the COPPS Investigators.

Abstract:


Colchicine is safe and efficacious for the primary prevention of the post-pericardiotomy syndrome.

Aims: No drug has been proven efficacious to prevent the post-pericardiotomy syndrome (PPS), while colchicine seems safe and effective for the treatment and prevention of pericarditis. 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.

Methods and Results: The COPPS study is a multicentre, double-blind, randomised trial. On the third postoperative day, 360 patients (mean age 65.7±12.3 years, 66% males), 180 in each treatment arm, were randomised 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 hospitalisation, 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 to placebo (respectively, 8.9% vs. 21.1%; p=0.002; NNT=8). Colchicine also reduced the secondary endpoint (respectively 0.55% 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 8.8% vs. 5.0%; p=0.213).

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).



Andre Keren, FESC
  Discussant
Discussant | see Presenter abstract Webcasts become available 24h after the presentation
Keren, Andre
(Israel)
Open presentation slides

Report:


Background and aim of the study: Postpercardiotomy syndrome (PPS), a relatively common complication of cardiac surgery, is empirically treated with Aspirin, Non-steroidal anti-inflammatory drugs or Steroids. Colchicine had been recommended and is used in clinical practice for treatment of acute and recurrent pericarditis and for prevention of recurrences.  A prospective randomized preliminary study showed that the drug has the potential of preventing PPS. The aim of the COPPS trial was to evaluate in a large number of patients undergoing cardiac surgery the effect of the drug on primary prevention of PPS.

Methods and main results: The study population included 360 consecutive eligible patients, who received either placebo or Colchicine for 30 days, starting from the 3rd postoperative day. Baseline characteristics were well balanced between the groups. PPS occurred during a 12 months follow up in 8.9% of the treatment and 21.% of the control group patients (p=0.024). The combined rate of disease related morbidity during 18 months follow up (including relapses, hospitalizations, cardiac tamponade and constrictive pericarditis) was 0.55% in the treated and 5.0% in the control group (p=0.024). PPS occurred mostly during the first postoperative month, lending support for the preventive administration of the drug during that period. There was a trend toward more gastrointestinal side effects and medication withdrawals in the treated group, but the difference did not reach  statistical significance.

Importance of the study: COPPS is the first large scale, double-blind, randomized trial to test the efficacy of Colchicine in prevention of PPS. This was a carefully designed and performed trial in which Colchicine proved to be an effective and safe treatment modality: it halved the risk of developing PPS without major side effects.  These results support the use of low dose Colchicine for prevention of PPS in the type of patients included in the COPPS trial.

References


710001 - 710002

SessionTitle:

Clinical Trial Update II
The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.