COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial

Imazio, Massimo; Trinchero, Rita; Brucato, Antonio; Rovere, Maria Elena; Gandino, Anna; Cemin, Roberto; Ferrua, Stefania; Maestroni, Silvia; Zingarelli, Edoardo; Barosi, Alberto; Simon, Caterina; Sansone, Fabrizio; Patrini, Davide; Vitali, Ettore; Ferrazzi, Paolo; Spodick, David H.; Adler, Yehuda

doi:10.1093/eurheartj/ehq319

Cited by 230 publications

(205 citation statements)

References 27 publications

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“…Several strategies (aspirin, corticosteroids, colchicine) have beenexamined in clinical trials for primary prevention of post-pericardiotomy syndrome 22 .In the COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS) trial colchicine appeared to be safe and efficacious in the prevention of the PPS and its related complications 23 ; this results were confirmed by the following COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2) trial 24 . Consequently, a 30-day course of colchicine beginning one to three days following surgery (0.5 mg twice daily for patients ≥ 70 kg, 0.5 mg daily for those <70kg) should be considered according to the latest ESC guidelines for the prevention of PPS …”

Section: Preventionmentioning

confidence: 95%

Post-cardiac injury syndrome in the Emergency Department: mini-review

Voza¹

2018

J Immunological Sci

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The term post-cardiac injury syndrome (PCIS) defines a group of inflammatory diseases involving predominantly the pericardium. The syndrome results from a cardiac injury and refers mainly to post-myocardial infarction pericarditis, post-pericardiotomy syndrome and post-traumatic pericarditis (including iatrogenic conditions appearing after percutaneous interventions).Signs and symptoms are similar to those seen in acute pericarditis and pericardial effusion in other clinical settings. The diagnosis is clinical and could be challenging in the Emergency Department (ED). PCIS should be considered as an alternative diagnosis to acute pericarditis in case of unilateral right-sided, massive, or transudative pleural effusion.Although typically a benign condition, PCIS may result in significant morbidity and potential mortality; tamponade and constrictive pericarditis represent the leading complications. Therefore, early detection is clinically relevant. Currently, a combination of nonsteroidal anti-inflammatory drugs and colchicine is the mainstay treatment for this condition. Colchicine has also appeared to be effective in primary prevention of PCIS after cardiac surgery.The purpose of this article is to review the principle clinical characteristics of PCIS in order to achieve an early diagnosis.

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Section: Preventionmentioning

confidence: 95%

Post-cardiac injury syndrome in the Emergency Department: mini-review

Voza¹

2018

J Immunological Sci

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“…[3][4][5] Similarly, the postpericardiotomy syndrome (PPS) occurs in 10% to 40% of patients 1 week to several months following cardiac surgery. 7,8 Although a standardized definition and universal diagnostic criteria are lacking, this immune-mediated syndrome is characterized by the presence of 2 or more of the following signs or symptoms: noninfectious fever lasting beyond the first postoperative week, pleuritic chest pain, friction rub, pleural effusion, or new/worsening pericardial effusion. Most commonly resulting in increased patient morbidity and health care costs, Critical Care (ConT.…”

Section: Postoperative Atrial Fibrillation and Postpericardiotomy Synmentioning

confidence: 99%

“…7,8 Multiple pharmacologic interventions have been studied for the prevention of POAF, including betablockers, antiarrhythmic agents, cardiac glycosides, and numerous anti-inflammatory agents. Among these, published guidelines endorse beta-blockers as the pharmacologic agents of choice.…”

Section: Postoperative Atrial Fibrillation and Postpericardiotomy Synmentioning

confidence: 99%

“…8 Two prospective, randomized, double-blind, placebo-controlled trials have sought to evaluate the role of colchicine in the prevention of PPS and POAF. 4,8,12 The COPPS (Colchicine for the Prevention of the Postpericardiotomy Syndrome) study randomized 360 patients to receive placebo or colchicine at a dose of 1 mg twice daily on postoperative day (POD) 3, followed by 0.5 mg twice daily for 1 month. 8 Doses were halved in patients weighing less than 70 kg or those intolerant to higher doses.…”

Section: Postoperative Atrial Fibrillation and Postpericardiotomy Synmentioning

confidence: 99%

“…4,8,12 The COPPS (Colchicine for the Prevention of the Postpericardiotomy Syndrome) study randomized 360 patients to receive placebo or colchicine at a dose of 1 mg twice daily on postoperative day (POD) 3, followed by 0.5 mg twice daily for 1 month. 8 Doses were halved in patients weighing less than 70 kg or those intolerant to higher doses. The primary endpoint of PPS at 12 months was significantly reduced in patients receiving colchicine prophylaxis (8.9% vs 21.1%; P = .002).…”

Section: Postoperative Atrial Fibrillation and Postpericardiotomy Synmentioning

confidence: 99%

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Beyond Gout: Colchicine Use in the Cardiovascular Patient

et al. 2015

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Colchicine is one of the oldest medications still in use today and is commonly used for the treatment of gout and familial Mediterranean fever. Its anti-inflammatory properties have raised the question of its utility in managing several cardiovascular diseases, including postoperative atrial fibrillation and pericarditis. This article will review the evidence for colchicine in these conditions and provide recommendations for use.

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Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation

Imazio

Brucato

Ferrazzi

et al. 2014

JAMA

279

201

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MD; for the COPPS-2 Investigators IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postop-erative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients 70 kg or 0.5 mg once daily in patients <70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotomy syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, −2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, −8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastro-intestinal adverse effects reduced the potential benefits of colchicine in this setting.

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COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial

Abstract: 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.

Cited by 230 publications

References 27 publications

Post-cardiac injury syndrome in the Emergency Department: mini-review

Post-cardiac injury syndrome in the Emergency Department: mini-review

Beyond Gout: Colchicine Use in the Cardiovascular Patient

Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation

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