Colchicine 'Useless' for Postop Pericardial Effusion: POPE-2

Marlene Busko

August 31, 2014

BARCELONA, SPAIN — In the Post-Operative Pericardial Effusion-2 (POPE-2) trial, once again, the anti-inflammatory drug colchicine was not effective for warding off complications following cardiac surgery[1]. Specifically, colchicine did not decrease postoperative pericardial effusion volume or prevent cardiac tamponade, said Dr Philippe Meurin (Le centre de réadaptation cardiaque Les Grands Prés, Villeneuve Saint Denis, France), in a press conference here at the European Society of Cardiology (ESC) 2014 Congress .

At the same session, the audience heard how, in COPPS-2 , colchicine failed to prevent atrial fibrillation after cardiac surgery, although it did help avert postpericardiotomy syndrome, as reported by heartwire .

Although POPE-2 was negative, it does provide information about the rate of postoperative complications. "We can confirm that [among patients with moderate to large] persistent pericardial effusion for more than seven days after cardiac surgery, 6.6% will develop life-threatening cardiac tamponade within two weeks [and] another 5% will require pericardial drainage within six months," Meurin said.

However, the trial showed that "colchicine administration [to prevent potential cardiac tamponade] seems to be useless," he concluded. As shown in their earlier POPE study[2], "[nonsteroidal anti-inflammatory drug] NSAID administration is also useless," he noted.

Perhaps colchicine failed to reduce postoperative pericardial effusion because inflammation is not the predominant mechanism in most cases, he suggested.

"Brutal, Life-Threatening Complication"

Dr Philippe Meurin

"What do we fear concerning the pericardium after cardiac surgery? We fear cardiac tamponade, a very brutal, life-threatening complication," Meurin explained.

In the first week after cardiac surgery, most patients are free of pericardial complications, but about 1% have cardiac tamponade, he added. However at this stage, patients are still in the hospital, "and the diagnosis is easily made and the treatment is done."

In contrast, after seven days, patients are discharged to return home or go a rehabilitation center, where it is more difficult to diagnose or treat complications.

Two very different types of complications may occur, according to Meurin. Patients who develop postpericardiotomy syndrome have chest pain, fever, and a small volume of pericardial effusion and thus, a very small risk of cardiac tamponade. Patients who develop postoperative pericardial effusion have no chest pain or fever but have a medium to large volume of effusions and thus a heightened risk of tamponade.

Since colchicine was shown to be effective in other pericardial conditions (to treat pericarditis and prevent postpericardiotomy syndrome), the researchers hypothesized that it might be useful to treat postoperative pericardial effusion—a dangerous yet asymptomatic condition for which there is still no known treatment, Meurin said.

POPE-2 was conducted in 10 postoperative cardiac rehabilitation centers in France. The researchers screened more than 8000 patients, of which 197 patients met the study criteria; participants had moderate to large postoperative pericardial effusion (grade 2, 3, or 4) between seven and 30 days after cardiac surgery.

The subjects had a mean age of about 64 years, and 86% were male. They were randomized to receive placebo or colchicine for 14 days. Patients who weighed at least 70 kg received a loading dose of 1 mg twice daily on day 1, followed by a 1-mg/day maintenance dose. Patients weighing less than 70 kg received the same maintenance dose, with no loading dose.

The primary end point was the change in pericardial effusion grade after treatment, and the development of cardiac tamponade was a secondary end point.

After 14 days of treatment, the mean decrease in the grade of pericardial effusion from baseline in the colchicine group was similar to the placebo group (-1.3 vs -1.1, respectively; p=0.23).

There was also a similar number of cases of cardiac tamponade in the placebo group (seven cases) and in the colchicine group (six cases, p=80).

Asked to comment, session cochair Prof Hector Bueno (Hospital General Universitario Gregorio Marañón, Madrid, Spain) told heartwire that, taken together, the message from POPE-2 and COPPS is that that while colchicine was slightly positive in COPPS-2—it reduced the incidence of postpericardiotomy syndrome—both studies rule out the routine use of this drug to prevent complications following cardiac surgery.

The study was funded by the French Society of Cardiology and the French Federation of Cardiology, and Laboratoires Mayoly-Spindler provided colchicine and the matched placebo. The investigators report no conflicts of interest.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....