Table 3.
Colchicine in post pericardiotomy syndrome (PPS) and pericardial effusion.
| First author (study name) | Study type | Patient number | Clinical setting | Colchicine dosage and duration | Adverse events | Summary and Comment | ||
|---|---|---|---|---|---|---|---|---|
| Finkelstein Y [27], 2002 | Prospective, randomized, double-blind trial | 111 | primary prevention of PPS following cardiac surgery | 1.5mg/day for 1 months starting from the 3rd postoperative day. | 11.7%, NS | - incidence of PPS: colchicine 10.6% vs placebo 21.9%, p=0.135, NS. | ||
| Imazio M [28], 2010 (COPPS trial) |
Prospective, randomized, double-blind, placebo-controlled, multicenter trial | 360 | primary prevention of PPS following cardiac surgery | 1.0 mg BD for the 1st day, then 0.5 mg BD daily for 1 month starting from the 3rd post-operative day. | 8.9%, NS | - incidence of PPS: colchicine 8.9% vs placebo 21.1%, p=0.002, NNT 8. – incidence of pericardial effusion: colchicine 12.8% vs placebo 22.8%, p = 0.019. | ||
| Imazio M [29], 2014 (COPPS-2 trial) |
Prospective, double-blind, placebo-controlled, randomized multicenter trial | 360 | Primary prevention of PPS, postoperative AF, and postoperative pericardial/pleural effusions. | 0.5mg BD for patient >70kg, or 0.5mg daily for patient <70kg, starting 48 and 72 hours before surgery and continued for 1 month after surgery. | Colchicine 20%, vs placebo 11.7%, NNH 12. | - Incidence of PPS: colchicine 19.4% vs placebo 29.4%, NNT 10. - Incidence of post-operative AF colchicine 33.9% vs placebo 41.7%, NS. - incidence of pericardial/pleural effusion: Colchicine 57.2% vs placebo 58.9%, NS. |
||
| Meurin P [30], 2015 (POPE-2 trial) |
Randomized, double-blinded, placebo-controlled, parallel-group study |
197 | Pericardial effusion persisting >7 days after heart surgery. | 1mg daily for 14 days. | 10.2% | - mean change of pericardial effusion: colchicine -1.3 grade vs placebo -1.1 grade, p=0.23, NS. | ||
| Izadi Amoli A [31], 2015 | Prospective, randomized, triple-blind, placebo-controlled single-center trial | 149 | Pericardial effusion persisting >3 weeks after CABG. | 1mg daily for 2 weeks | 0% | - mean change of pericardial effusion: colchicine -5mm vs placebo -5mm, p=0.932, NS. | ||
NS = non-significant, NNH = number needed to harm, NNT = number needed to treat.