Surgery News - April 2008 - (Page 18)

18 THORACIC SURGERY NEWS • A P R I L 2 0 0 8 New Studies Tie Aprotinin to Higher Mortality in CABG B Y M A RY A N N M O O N Else vier Global Medical Ne ws T wo new retrospective studies have fueled the controversy over giving aprotinin to reduce blood loss during coronary artery bypass grafting. After assessing more than 88,000 CABG patients and using extensive statistical analyses to minimize the effect of confounding factors, researchers in both studies reported that the antifibrinolytic drug significantly raises mortality, compared with the alternative agent aminocaproic acid. The combined results “will make it difficult, in the absence of convincing new data, to prescribe this drug, except perhaps in limited circumstances,” wrote Wayne A. Ray, Ph.D., in an editorial comment accompanying the reports. Bayer stopped marketing aprotinin last October after preliminary data from the BART study (Blood Conservation Using Antifibrinolytics: A Randomized Trial in a Cardiac Surgery Population) suggested that aprotinin increased 30-day mortality, compared with aminocaproic acid or tranexamic acid. The first study, a retrospective analysis using a national hospital inpatient database, was done at the request of Bayer HealthCare, manufacturer of aprotinin (Trasylol). But when the results were presented at Food and Drug Administration advisory committee meetings, Bayer representatives and consultants “disagreed with our methods and conclusions,” said Dr. Sebastian Schneeweiss of Harvard New from the American College of Surgeons and Thomson Healthcare I Need an Operation Now What? A Patient’s Guide to a Safe and Successful Outcome I Need an Operation…Now What? gives patients the information they need to boost their chances of having a successful surgical experience, with the best possible results. Written in patient-friendly, nontechnical language, this book is designed to help patients understand the process of having an operation from start to finish. Inside they’ll learn: » How to find a qualified surgeon—one who’s right for them » When to get a second opinion about their treatment—and how to go about finding one » How to ask about the risks and benefits of having an operation » How to prepare for an operation—from what to pack and what to wear to when to stop eating » What to expect, including advice from patients who’ve had various operations, from major gastrointestinal procedures to back surgery—and who will care for them—while in the hospital » Numerous "insider's" tips, such as how to help prevent infection and the best times to schedule an operation » All the costs of the operation » How to ensure a comfortable recovery period The experts agree “Along with your love and support, the greatest gift you can give a loved one or friend facing or weighing the beneﬁts and risks of surgery is a copy of this book. With his thoughtful, clear, very accessible writing, Dr. Russell, with the American College of Surgeons, provides a wealth of informational resources that every patient can draw on. He gives excellent advice on how to ask good questions and become an informed, empowered consumer. Most importantly, he urges you, the patient, to ‘take control and become fully informed about your options.’ This book will help you do that, prepare you for the effects of surgery and how to deal with them and give you conﬁdence as you navigate through the health care system.” Helen Darling, president of the ISBN 13: 978156363-700-1 Pub. Jan 2008 • Paperback $19.95 • 125 pp National Business Group on Health “Like a true professional, Dr. Russell gives surgical patients-to-be all the information and support needed to make decisions that meet their needs as only they can know them. This book is not only practical, but also highly respectful, most educational. Patients can use this book to navigate through their surgical experience while we all push for a better-organized health care delivery system.” Richard J. Umbdenstock, president and CEO of the American Hospital Association “Research shows that people who are well informed about their treatment options enjoy better surgical outcomes and are more satisfied with their results.” To order or for further information visit http://www.facs.org/public_info/patientguidebook.html or call 312/202-5474 Medical School, Boston, and his associates. They studied mortality outcomes in more than 78,000 patients who underwent CABG between 2003 and 2006. A total of 33,517 had been given aprotinin and 44,682 had been given aminocaproic acid during the procedure. After an average of about 1 week, 2,613 patients had died. In unadjusted analyses, in-hospital death occurred in 4.5% of patients given aprotinin, compared with 2.5% of those given aminocaproic acid, for an 83% increase in mortality risk. In further analyses that adjusted for 41 different covariates, the overall risk of death was increased by 64% and the 7-day mortality was increased by 78% with aprotinin, the investigators said (N. Engl. J. Med. 2008;358:771-83). This elevated risk persisted in several further analyses. Because surgeons tended to use aprotinin rather than aminocaproic acid in sicker patients, the researchers adjusted the data to account for 10 additional patient and procedural factors indicative of more severe illness: the presence of diabetes, hypertension, previous percutaneous coronary intervention or CABG, and long duration of the procedure. The higher mortality risk persisted in these analyses, although it was slightly attenuated, the investigators said. In the second study, Dr. Andrew D. Shaw and his associates at Duke University Medical Center, Durham, N.C., reviewed outcomes at their institution on 10,148 consecutive patients who underwent CABG between 1996 and 2005. The overall 30-day mortality was 6.4% among the 1,343 patients who received aprotinin, which was significantly higher than the 2.4% mortality among the 6,776 patients who received aminocaproic acid and the 2.2% mortality among the 2,029 who received no antifibrinolytics. Similarly, 1-year mortality was 15.8% with aprotinin, versus 6.4% with aminocaproic acid and 6.5% with no antifibrinolytics. Patients who received aprotinin were at increased risk for acute renal injury, and the drug did not appear to reduce the need for transfusion, even when the data were adjusted to account for numerous variables. This finding indicates that the potential risks associated with aprotinin may not be outweighed by the potential benefits, Dr. Shaw and his associates said (N. Engl. J. Med. 2008;358:784-93). In his editorial comment, Dr. Ray described aprotinin as “a drug that apparently confers less overall benefit than cheaper alternatives yet has remained on the market for more than 14 years and become the recommended hemostatic agent for high-risk cardiac surgeries.” “When a new drug has alternatives head-to-head comparative trials powered for important clinical end points are needed before the drug is routinely prescribed for large numbers of patients,” said Dr. Ray of Vanderbilt University, Nashville, Tenn. (N. Engl. J. Med. 2008;358:840-2). Dr. Schneeweiss’s study was supported by Bayer HealthCare and Ingenix. Several of the researchers in Dr. Shaw’s study received fees or grants from Bayer and other companies. Dr. Ray reported no conflict of interest relevant to his comments. http://www.facs.org/public_info/patientguidebook.html

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Surgery News - April 2008 Contents Comorbidities Sway Bariatric Outcomes Database Finds Gap in Dissection For Melanoma Future Surgeon Shortage Predicted Dexterity Demo Best for Bile? Health Policy Scan Plan

Surgery News - April 2008

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