This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (7)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Surgical Interventions  • Cardiovascular/ Cardiothoracic Surgery  • Cardiovascular Intervention  • Revascularization  • Adverse Effects  • Alert me on articles by topic

T. Bruce Ferguson, Jr, MD

JAMA. 2007;297:527-529.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

This past year has been a complicated one for aprotinin, an antifibrinolytic serine protease inhibitor used to lessen bleeding in patients undergoing cardiac surgery with cardiopulmonary bypass. Thirteen years after the initial approval of aprotinin by the US Food and Drug Administration,¹ the report by Mangano and colleagues² in this issue of JAMA will intensify the debate about the benefits and risks associated with use of this drug. Perhaps more important, this aprotinin story illuminates the larger issue of postmarket safety evaluation surrounding drugs and devices in the current medical environment.

In this article, the investigators report 5-year, all-cause mortality data from patients enrolled in an international registry of on-pump coronary artery bypass graft surgery. The authors conclude that use of aprotinin in routine and complex coronary artery bypass graft surgery is associated with an increased risk of late mortality as compared with use of . . . [Full Text of this Article]

Author Affiliations: Division of Cardiothoracic and Vascular Surgery, Division of Clinical Effectiveness, Department of Surgery and Brody School of Medicine at East Carolina University.

RELATED ARTICLE

Mortality Associated With Aprotinin During 5 Years Following Coronary Artery Bypass Graft Surgery
Dennis T. Mangano, Yinghui Miao, Alain Vuylsteke, Iulia C. Tudor, Rajiv Juneja, Daniela Filipescu, Andreas Hoeft, Manuel L. Fontes, Zak Hillel, Elisabeth Ott, Tatiana Titov, Cynthia Dietzel, Jack Levin, and for the Investigators of The Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation
JAMA. 2007;297(5):471-479.
ABSTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Ethics, Industry, and Outcomes
Merry
SEMIN CARDIOTHORAC VASC ANESTH 2008;12:7-11.
ABSTRACT  

Learning from Aprotinin -- Mandatory Trials of Comparative Efficacy and Safety Needed
Ray
NEJM 2008;358:840-842.
FULL TEXT  

Safety Concerns Persist About Aprotinin
Journal Watch Cardiology 2007;2007:1-1.
FULL TEXT