Study highlights:

• A non-steroidal anti-inflammatory drug, diclofenac, failed to reduce fluid accumulation around the heart after cardiac surgery.
• The NSAID after heart surgery also did not reduce the serious problem of cardiac tamponade, compression of the heart by fluid.

ORLANDO, Fla. Nov. 16, 2009 — Routinely giving a non-steroidal anti-inflammatory drug (NSAID), diclofenac, is ineffective in reducing fluid accumulation around the heart in patients with pericardial effusion after cardiac surgery and should be abandoned, researchers reported at the American Heart Association’s Scientific Sessions 2009.

“These results highlight the fact that sometimes it is useful to design clinical studies to determine whether our longstanding habits are truly appropriate for patients’ health,” said Philippe Meurin, M.D., a cardiologist in Villeneuve Saint Denis, France, and principal investigator of the Non-steroidal Anti-Inflammatory Treatment for Post-operative Pericardial Effusion: The POPE Study.

The heart is enclosed in a double-layered membrane called the pericardium, which must be opened during cardiac surgery. In the days after heart surgery, up to 80 percent of patients experience a symptomless build-up of fluid around the heart, which usually disappears within a month. However, the amount of fluid build-up early on can predict the likelihood of a serious complication, cardiac tamponade, in which fluid compresses the heart muscle so much that the fluid must be removed to relieve the pressure.

NSAIDs are widely prescribed after heart surgery in order to try to reduce the volume of these effusions, but no study prior to this one has assessed their usefulness in this indication. In addition, numerous studies have indicated potential drawbacks from using NSAIDS, including gastrointestinal bleeding, particularly in patients on blood thinners, as many heart disease patients are. Therefore, it seemed important to assess the benefit/risk balance of using these drugs after heart surgery.

The multi-center, double-blind, placebo-controlled POPE study randomly assigned 196 patients with moderate to large amounts of fluid around the heart in the first month after surgery to receive 100 milligrams per day of the NSAID diclofenac or a placebo.

The NSAID failed to decrease the study’s primary endpoint: the amount of post operative fluid build-up after 14 days of treatment. It also failed to prevent complications requiring fluid removal.

“We believe that prescribing an NSAID to treat an asymptomatic post-operative fluid build-up around the heart should no longer be advised,” Meurin said. “It is ineffective, as demonstrated by our study.”

Study sponsors are: the French Society of Cardiology and ADETEC (Association Chirurgicale pour le Développement et l’Amélioration des Techniques de Dépistage et de Traitement des Maladies Cardiovasculaires).

Co-authors are: Jean Yves Tabet, M.D.; Gabriel Thabut, M.D., Ph.D.; Pascal Cristofini, M.D.; Titi Farrokhi, M.D.; Michel Fischbach, M.D.; Bernard Pierre M.D.; Ahmed Ben Driss, M.D., Ph.D.; Nathalie Renaud, M.D.; Marie Christine Iliou, M.D.; and Hélène Weber, M.D.

Disclosures: None.

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NR09 – 1170 (SS09/POPE Meurin)