COPPS-2: Perioperative colchicine reduced incidence of postpericardiotomy syndrome

BARCELONA, Spain — Perioperative use of oral colchicine reduced the incidence of postpericardiotomy syndrome in patients undergoing cardiac surgery, but did not lower the risk for postoperative atrial fibrillation or postoperative pericardial/pleural effusion, according to new data from the COPPS-2 trial.

Colchicine was, however, associated with increased risk for gastrointestinal adverse effects in this patient population, Massimo Imazio, MD, FESC, said during a press conference at the ESC Congress.

The COPPS-2 trial included 360 patients undergoing cardiac surgery at 11 centers in Italy. Patients were randomly assigned to receive oral colchicine (n=180) or placebo (n=180) at 0.5 mg twice daily or 0.5 mg once daily if weight was less than 70 kg. Treatment was administered starting between 48 and 72 hours before surgery without a loading dose, and continued for 1 month after surgery.

Massimo Imazio

The primary outcome of postpericardiotomy syndrome (PPS) within 3 months was reported in 19.4% of patients assigned colchicine compared with 29.4% assigned placebo, according to results of the intention-to-treat analysis.

Imazio and colleagues reported no significant differences between the treatment groups for postoperative AF (colchicine, 33.9%; placebo, 41.7%) or postoperative pericardial/pleural effusions (colchicine, 57.2%; placebo, 58.9%), although there was a trend toward reduction of postoperative AF in the colchicine group. Rates of cardiac tamponade, pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, overall mortality and stroke were also similar.

Adverse events occurred in 20% of patients assigned colchicine compared with 11.7% assigned placebo. The higher rate of adverse events was primarily related to an increased incidence of gastrointestinal intolerance (colchicine, 14.4%; placebo, 6.7%).

“The increased risk of gastrointestinal events reduced the potential benefits of colchicine in this setting,” Imazio, from the cardiology department at Maria Vittoria Hospital in Torino, Italy, said.

The two groups had a similar rate of discontinuation. “About 20% of all patients enrolled in the trial discontinued [the] study drug; this relatively high rate may have affected the overall efficacy of the drug, especially for postoperative AF prevention,” the researchers wrote in their corresponding publication in JAMA.

The higher rate of adverse events among patients assigned colchicine “is a reason for concern and suggests that colchicine should be considered only in well-selected patients,” they concluded. – by Katie Kalvaitis

For more information:

Imazio M. Hot Line I. Cardiovascular disease: Novel therapies. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Imazio M. JAMA. 2014;doi:10.1001/jama.2014.11026.

Disclosure: Imazio reports no relevant financial disclosures.