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J Thorac Cardiovasc Surg 2008;135:492-494
© 2008 The American Association for Thoracic Surgery

Editorial

Aprotinin and Cardiac Surgery

Montefiore Medical Center/Albert Einstein College of Medicine, Department of Cardiovascular and Thoracic Surgery, Bronx, NY

Received for publication November 16, 2007; accepted for publication December 7, 2007.

^_* Address for reprints: Abe DeAnda Jr, Montefiore Medical Center/Albert Einstein College of Medicine, Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Park, 1575 Blondell Avenue Suite 125, Bronx, NY 10461. (Email: adeanda@montefiore.org).

The first 300 words of the full text of this article appear below.

See related article on page 495.

 

"These, Gentlemen, are the opinions upon which I base my facts."

— Sir Winston Churchill

Of the recent issues affecting the practice of cardiothoracic surgery, perhaps none has affected or evoked more passionate debate (and angst) than the controversy surrounding the use of the antifibrinolytic aprotinin (Trasylol, Bayer Pharmaceuticals, West Haven, Conn). Aprotinin first appeared as a potent therapy for pancreatitis; it soon became apparent that the antifibrinolytic properties of this serine proteinase inhibitor could have a beneficial effect on postoperative bleeding in patients after cardiopulmonary bypass surgery. Cosgrove and colleagues,¹ in a small, randomized trial, confirmed the benefits of aprotinin in reducing postoperative chest tube output and transfusion requirements, but they also noted a statistically nonsignificant increase in Q-wave myocardial infarction (and in some cases graft thrombosis) in the low-dose and high-dose aprotinin arms of their study. In 1993, the Food and Drug Administration (FDA) approved aprotinin for use in patients undergoing coronary artery bypass grafting (CABG), with subsequent changes in labeling in 1994 and 1998.

In 2006, Mangano and colleagues² and Karkouti and colleagues³ published studies that generated much controversy and prompted the FDA to convene an advisory committee meeting in September of 2006. Both studies were observational analyses of prospectively collected data, and both used a statistical technique of propensity matching. The expressed purpose of the advisory meeting was to elicit advice in response to the studies' findings that the use of aprotinin was associated with an increased risk of adverse cardiovascular and renal events. In addition, the panel wanted to reexamine data on anaphylactic reactions seen with the re-dosing of aprotinin. At the close of the meeting, the Committee provided the FDA with their conclusions and recommendations (summarized in Table 1). The FDA then modified aprotinin labeling in . . . [Full Text of this Article]