• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Trasylol(R) (Aprotinin Injection) Reduced Bleeding in Patients Receiving Anti-Platelet Therapy Prior to Coronary Artery Bypass Graft Surgery

Posted on: Tuesday, 9 November 2004, 12:00 CST

NEW ORLEANS, Nov. 9 /PRNewswire-FirstCall/ -- Patients undergoing coronary artery bypass graft surgery (CABG) -- who were taking anti-platelet drugs like clopidogrel (Plavix(R)) prior to their operation -- experienced less bleeding and a decreased need for blood transfusions when they received intraoperative Trasylol(R) (aprotinin injection), according to results from studies presented this week at the American Heart Association's (AHA) Scientific Sessions. Two studies examined the use of Trasylol in CABG patients who received clopidogrel and aspirin or clopidogrel alone less than five days before surgery.(1,2)

"These studies are significant because many coronary artery disease patients taking anti-platelet therapies need CABG surgery under conditions which may not allow sufficient time for or warrant discontinuation of treatment," said Jan van der Linden, MD, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden. "These data demonstrate the importance of aprotinin therapy in the clinical setting."

Trasylol has the only U.S. Food and Drug Administration (FDA) approved indication to reduce bleeding and the need for blood transfusions with prophylactic use in patients undergoing cardiopulmonary bypass (CPB) in the course of CABG surgery.

Patients with coronary artery disease are often prescribed anti-platelet drugs to help prevent the occurrence of acute cardiovascular events, particularly myocardial infarction, by reducing the formation of blood clots by keeping platelets from sticking together.(3) Clopidogrel has been available to patients since 1998 and physicians have prescribed the drug either alone or with aspirin to more than 22 million people worldwide.(4) Current recommendations for most patients include discontinuation of anti- platelet therapy prior to surgery to reduce the risk for perioperative bleeding and blood transfusion.(5)

Of those patients receiving clopidogrel therapy, many will need coronary artery bypass graft surgery under conditions where discontinuation of this treatment may not be warranted or possible.(6,7) Research has suggested that continuation of these drugs less than five days prior to surgery may result in an increased risk of perioperative bleeding and need for transfusion.(7) However, these studies suggest that the use of Trasylol during CABG surgery reduces blood loss and the need for transfusion in those patients that remained on anti-platelet therapy up until the time of surgery. The studies also suggest that patients can continue to benefit from the effects of anti- platelet therapy with reduced risk of bleeding during CABG surgery.(1,2)

"Hundreds of thousands of patients undergo CABG procedures each year, so it is important that we continue to conduct research on the role of Trasylol in managing blood loss and transfusion requirements in all CABG/CPB patients," said Dr. van der Linden.

About the Studies

* A Randomized Double Blind Comparison Of Two Strategies For Managing

Patients On Aspirin And Clopidogrel Therapy Requiring Urgent Coronary

Revascularization. V. Shrivastava, MD et al. Abstract 1699/C91 (poster

session). The study compared the effects of Trasylol on blood loss and

transfusion in patients (n=100) requiring urgent CABG surgery receiving

a combination of clopidogrel and aspirin with those administered placebo

and not receiving clopidogrel and aspirin. Results demonstrated that

administering Trasylol during surgery significantly reduced blood loss

and transfusion requirements in these patients.(1)

* Aprotinin Decreases Postoperative Bleeding and Number of Transfusions in

Patients on Clopidogrel undergoing CABG: A Randomized Clinical Trial.

J. van der Linden, MD. Abstract 1981 (oral session). This randomized,

controlled study investigated the effects of Trasylol therapy in 73

consecutive patients with unstable angina taking clopidogrel less than

five days before CABG surgery. Results demonstrated that Trasylol, when

administered to patients on CPB undergoing CABG surgery, decreased

postoperative bleeding and reduced the need for blood transfusions in

patients receiving clopidogrel less than five days prior to the

operation.(2)

About CABG

CABG surgery is a form of heart surgery that redirects blood around clogged arteries to increase blood flow and oxygen to the heart.(8) A patient may undergo one, two, three or more bypasses depending on how many coronary arteries are blocked. CABG surgery is the most commonly performed major surgery,(9) with more than 300,000 procedures conducted in the United States each year.(8) Complications associated with CABG surgery include stroke, heart attack, abnormal heart beat, bleeding, and death.(10)

About Trasylol

Trasylol, a natural broad-spectrum proteinase inhibitor, modulates the systemic inflammatory response (SIR) associated with cardiopulmonary bypass (CPB) surgery.

Approved by the FDA in 1993, Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing CPB in the course of CABG surgery. Full prescribing and warning information is also available at http://www.trasylol.com.(11/)

The effects of Trasylol use in CPB involves a reduction of inflammatory response which translates into a decreased need for allogeneic blood transfusions, reduced bleeding and decreased mediastinal re-exploration for bleeding.

Important Safety Considerations

Anaphylactic or anaphylactoid reactions are possible when Trasylol(R) is administered. Hypersensitivity reactions are rare in patients with no prior exposure to aprotinin. The risk of anaphylaxis is increased in patients who are reexposed to aprotinin-containing products. The benefit of Trasylol(R) to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis should a second exposure to aprotinin be required. (See WARNINGS and PRECAUTIONS in the Trasylol(R) prescribing information.)

Trasylol is generally well tolerated. Graft patency, myocardial infraction, renal or hepatic dysfunction and mortality were comparable to placebo.

Anaphylactic reactions are possible. In clinical studies, hypersensitivity and anaphylactic reactions were:

* rare (<0.1%) in patients with no prior exposure to Trasylol

* 2.7% overall reaction rate upon re-exposure

- within 6 months, the incidence was 5 percent

- after 6 months, the incidence was 0.9 percent(11)

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is part of the worldwide operations of Bayer HealthCare AG, a subgroup of Bayer AG.

Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

* PLAVIX is a registered trademark of Sanofi-Synthelabo Inc. and is co-licensed with Bristol Myers Squibb Company .

(1) Shrivastava, V., et al. "Randomized and Double Blind Comparison of

Two Strategies for Managing Patients on Aspirin and Clopidogrel

Therapy Requiring Urgent Coronary Revascularization." Presented on

Sunday, November 7, 2004 at the American Heart Association's

Scientific Sessions.

(2) Lindvall, G. et al. "Aprotinin Decreases Postoperative Bleeding and

Number of Transfusions in Patients on Clopidogrel Undergoing CABG - A

Randomized Clinical Trial." Presented Monday, November 8, 2004 at

the American Heart Associations Scientific Sessions.

(3) "Antiplatelets." Retrieved November 3, 2004 from

http://www.heartcenteronline.com/myheartdr/common/articles.cfm?Artid=

350&startpage=1
.

(4) "Bristol-Myers Squibb Company 2003 Annual Report." Retrieved

November 4, 2004 from

http://www.bms.com/static/annual/2003ar/annual_report/data

/2003bmsar.pdf

(5) Ferraris VA, Ferraris SP, Moliterno DJ, et al. Aspirin and other

anti-platelet agents during operative coronary revascularization.

The Society of Thoracic Surgeons Practice Guideline Series.

Available from: CTSNet.org/doc/9117. Accessed November 4, 2004.

(6) Hongo, R. et al. "The Effect of Clopidogrel in Combination with

Aspirin When Given Before Coronary Artery Bypass Grafting." Journal

of the American College of Cardiology 2002; 40: 231-237.

(7) Chen, L. et al. "Clopidogrel and bleeding in patients undergoing

elective coronary artery bypass grafting." The Journal of Thoracic

and Cardiovascular Surgery 2004; 128: 425-431

(8) Heart Disease and Stroke Statistics - 2004 Update. Retrieved August

16, 2004 from

http://www.americanheart.org/downloadable/heart/1079736729696HDS

Stats2004UpdateREV3-19-04.pdf.

(9) "Coronary Artery Bypass Graft Surgery." Retrieved October 27, 2004

from http://www.heartcenteronline.com/myheartdr/common/articles.cfm?

ARTID=332.

(10) "Medline Plus: Heart Bypass Surgery." Retrieved August 16, 2004 from

http://www.nlm.nih.gov/medlineplus/ency/article/002946.htm.

(11) Trasylol Prescribing Information. Retrieved August 20, 2004 from

http://www.trasylol.com/.

Bayer Pharmaceuticals Corporation

CONTACT: Staci Gouveia of Bayer Pharmaceuticals Corporation,+1-203-812-6152, fax, +1-203-812-3504

Web site: http://www.bayer.com/http://www.trasylol.com/http://www.bayerpharma.com/

Source: PRNewswire-FirstCall

More News in this Category