Eric R. Bates, MD
Does adding colchicine to standard therapy reduce risk for the postpericardiotomy syndrome (PPS) after cardiac surgery?
Randomized placebo-controlled trial (COlchicine for the Prevention of the Post-pericardiotomy Syndrome [COPPS] study). ClinicalTrials.gov NCT00128427.
Blinded (patients, clinicians, data managers, and clinical endpoint adjudication committee).*
Mean 18.5 to 20.2 months.
6 hospitals in Italy.
360 patients ≥ 18 years of age (mean age 66 y, 66% men) who had cardiac surgery and no unfavorable short-term prognosis or contraindication to colchicine. Exclusion criteria included severe liver disease or transaminase levels > 1.5 times the upper normal limit, blood dyscrasia, gastrointestinal disease, myopathy or elevated preoperative levels of creatine kinase, serum creatinine levels > 2.5 mg/dL, and current colchicine treatment.
Standard therapy plus colchicine, 1 mg twice daily on day 1 and then 0.5 mg twice daily for 1 month in patients ≥ 70 kg, with half doses given to persons who weighed < 70 kg or were intolerant of the highest dose (n = 180), or standard therapy plus placebo (n = 180). Treatment was started on postoperative day 3.
PPS (≥ 2 of pleuritic chest pain, friction rub, pleural effusion, new or worsening pericardial effusion, and fever continuing after postoperative wk 1 without evidence of systemic or focal infection) at 12 months. Other outcomes were combination of disease-related hospitalizations, cardiac tamponade, and constrictive or recurrent pericarditis (secondary endpoint); and adverse effects.
100% (intention-to-treat analysis).
Adding colchicine to standard therapy reduced risk for PPS at 12 months and the combined secondary endpoint at 18 months (Table). 85% of PPS events occurred within 30 days. Groups did not differ for adverse effects (8.9% vs 5.0%, P = 0.21), and no patients had severe adverse effects.
Adding colchicine to standard therapy after cardiac surgery reduced risk for the postpericardiotomy syndrome.
Colchicine vs placebo after cardiac surgery†
†PPS = the postpericardiotomy syndrome; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from data in article.
‡≥ 2 of the following for colchicine vs placebo: pleuritic chest pain (3.9% vs 13%, P = 0.004), friction rub (2.7% vs 8.3%, P = 0.04), pleural effusion (12% vs 26%, P = 0.002), new or worsening pericardial effusion (13% vs 23%, P = 0.02), and fever continuing after postoperative week 1 (3.3% vs 3.9%, P = 0.98).
§For colchicine vs placebo: disease-related hospitalizations (0.6% vs 3.3%, P = 0.13), cardiac tamponade (0% vs 0.6%, P = 0.99), constrictive pericarditis (0% in both groups), and recurrent pericarditis (0% vs 1.1%, P = 0.49).
Bates ER. Adding colchicine to standard therapy after cardiac surgery reduced risk for the postpericardiotomy syndrome. Ann Intern Med. ;154:JC2–10. doi: 10.7326/0003-4819-154-4-201102150-02010
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Published: Ann Intern Med. 2011;154(4):JC2-10.
Cardiology, Pericardial Disease.
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