• Cardiology Clinical Trials
• Cardiology
• Inflammatory Disease
• Interventional Techniques & Devices

• Cardiology Clinical Trials
• Inflammatory Disease
• Interventional Techniques & Devices

Postoperative pericardial effusion (POPE) is present within the first 7 days after cardiac surgery in 50% to 80% of patients, and the risk for early cardiac tamponade ranges from 0.5% to 1%. There is no drug that can treat this local hemorrhagic complication, stated Philippe Meurin, MD, Les Grands Prés, Villeneuve Saint Denis, France. From day 8, patients with POPE are at risk for persistence of the effusion, with the risk for tamponade dependent on its size. Although nonsteroidal anti-inflammatory drugs do not reduce persistent POPE, it is unknown whether the anti-inflammatory drug colchicine (COL) might be effective. COL has been shown to be effective in treating other pericardial conditions, including acute pericarditis [Imazio M et al. N Engl J Med. 2013] and postpericardiotomy syndrome [Imazio M et al. Eur Heart J. 2010].

The Colchicine Treatment for Post-operative Pericardial Effusion [POPE-2; NCT01266694] was a double-blind, placebo-controlled study to evaluate whether COL could reduce the volume of POPE. Conducted at 10 cardiac rehabilitation centers in France, the trial randomized 197 patients with moderate to large pericardial effusion (ie, grades II, III, and IV) on admission echocardiography (8 to 30 days after surgery) to a 14-day treatment course of placebo (n = 99) or COL (n = 99). The dose of COL was adjusted according to patient weight; all patients received 1 mg/day, except those who weighed ≥ 70 kg, who received an additional 1 mg on day 1. The primary end point was the change in mean pericardial effusion grade (MPEG) in the COL arm relative to placebo.

The patients has a mean age of 65 years, and most were men, 89% and 84% of the placebo and COL groups, respectively. At baseline, both groups were similar for the proportion of patients with grade II, III, and IV effusions and for MPEG.

The difference in the reduction of MPEG between the arms was not significant (Table 1).

Development of cardiac tamponade after 14 days of treatment did not significantly differ (log-rank P = .801) between the arms; neither did the requirement for pericardial drainage within 6 months (lo g-rank P = .202). The proportion of patients who had a ≥ 1-MPEG decrease was nonsignificant between the arms (67% and 74% of the placebo and COL groups, respectively; P = .27), as was the presence of atrial fibrillation at the end of the study (12% and 15%, respectively; P = .51). The reductions in the width of the echo-free space were similar at −4.7 and −5.8 mm in the placebo and COL groups, respectively (P = .23).

Furthermore, no difference was found with COL in any of the prespecified subgroups, including C-reactive protein level ≥ 30 mg/L and receiving an oral anticoagulant or in the per protocol analysis.

The POPE-2 study confirmed that a moderate to large POPE persisting > 7 days is a serious condition, with cardiac tamponade occurring in 13 patients (6.6%) and pericardial drainage within 6 months occurring in 22 patients (11.2%) across both arms. COL did not provide any benefit either by echocardiography or on clinical events.

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