The Medicines Company announced this week that poor blood pressure control during cardiac surgery is associated with a higher risk of 30-day death, stroke, myocardial infarction and renal dysfunction, compared to patients with tight blood pressure control, according to a post-hoc analysis of the ECLIPSE trial.

“In this analysis, what we found was clear: the worse the blood pressure control, the poorer the outcome in these cardiac surgery patients,” said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. “These data support the need to more effectively manage blood pressure in the surgical and critical care settings.”

The ECLIPSE trial enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex™ (clevidipine butyrate) injectable emulsion to nitroglycerin, sodium nitroprusside or nicardipine. In this post-hoc analysis, 1507 ECLIPSE patients were stratified by precision of blood pressure control measured as excursions and time out of a pre-specified range. Adverse outcomes, assessed as death, myocardial infarction, stroke and renal dysfunction at 30 days post-discharge, were significantly higher in patients with poor blood pressure control (14.4%) than in patients with tight blood pressure control (8.8%).

“These critical new findings underscore the risk posed by uncontrolled blood pressure during cardiac surgery and emphasize the need for tight blood pressure control in these patients,” said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. “Cleviprex, recently approved by the FDA, provides physicians with an important, new clinical tool for achieving rapid and predictable blood pressure control.”