St. Jude Medical Announces First Enrollment in Study To Understand Appropriate Anti-Clotting Therapy After Tissue Heart Valve Im
July 09 2007 - 4:15PM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) and the Duke Clinical Research
Institute (DCRI) today announced the first enrollment in a major
study designed to better understand appropriate anti-clotting
medication therapies for patients following implantation of tissue
heart valves. The study will gather extensive clinical evidence on
the use of anti-coagulant and anti-platelet (blood-thinning)
medication treatments to reduce the risk of clot formation in the
early months after a tissue valve is implanted. It also will gather
data on the incidence of clotting and bleeding experienced by
patients during the six months after they receive a tissue valve.
Administered by the DCRI, the Anti-coagulation Strategy with
Bioprosthetic Valves: Post-Operative Event Registry (ANSWER) will
enroll at least 2,000 patients at 100 U.S. medical centers.
Enrollment is expected to be completed over the next two years.
Eric Peterson, M.D., M.P.H., associate director and director of
Cardiovascular Research at the DCRI, Durham, N.C., is the ANSWER
coordinating center�s principal investigator. National principal
investigators include cardiac surgeons Kent Jones, M.D., chairman,
Division of Cardiovascular and Thoracic Surgery, Latter Day Saints
Hospital, Salt Lake City; John Laschinger, M.D., chief of Cardiac
Research, Union Memorial Hospital, Baltimore; and Kenton J. Zehr,
M.D., chief, Division of Cardiac Surgery, University of Pittsburgh
Medical Center, Pittsburgh. When complete, the ANSWER Registry is
expected to provide the largest body of prospective clinical
evidence, to date, on anti-clotting therapies prescribed following
implantation of tissue valves. The ANSWER Registry will collect
data from consenting adult patients who are receiving their first
aortic and/or mitral valve replacement and are implanted with a St.
Jude Medical Biocor or Biocor� Supra Stented Tissue Valve. Similar
clinical evidence is being collected in European centers through
the ACTION Registry (Anticoagulation Treatment Influence on
Postoperative Patients), initiated in 2006 and conducted by St.
Jude Medical. �By collecting data across a large community sample,
the ANSWER Registry will play an important role in defining
standard clinical practice,� said Dr. Peterson of the DCRI. �In
addition, we hope to use this information to understand what
constitutes best practice.� An estimated 150,000 Americans undergo
heart valve replacement annually and the majority of them receive
tissue heart valves. Patients implanted with tissue valves are at
risk of blood clots (and potential stroke) and bleeding during the
initial post-operative period while the valve �heals.� To reduce
the risk of clotting, anti-coagulant or anti-platelet (blood
thinning) drug regimens are typically prescribed. Despite
guidelines issued by professional organizations on post-operative
treatments for valve replacement patients, there continues to be a
lack of consensus on best practice in choice or duration of
anti-coagulation therapies. As a result, patients receive varying
regimens over varying periods of time. �The ANSWER Registry aims to
fill a critical void with solid clinical evidence,� said George J.
Fazio, president of St. Jude Medical�s Cardiovascular Division.
�St. Jude Medical is committed to providing support for studies
that help advance the understanding of anti-coagulation management
for patients who receive either tissue or mechanical heart valves.�
St. Jude Medical previously supported the GELIA (German Experience
with Low Intensity Anticoagulation) and ESCAT (Early
Self-Controlled Anticoagulation Trial) studies. These studies
collected data from thousands of patients in European centers and
provided evidence on anti-coagulation treatments following
implantation of mechanical heart valves. The DCRI is the world�s
largest academic clinical research organization, combining clinical
expertise, academic leadership and the full-service operational
capabilities of a contract research organization. With 950 faculty
and staff, the DCRI�s experience includes Phase I through Phase IV
clinical trials, post-market analyses and health economics. About
St. Jude Medical St. Jude Medical is dedicated to making life
better for cardiac, neurological and chronic pain patients
worldwide through excellence in medical device technology and
services. The Company has five major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiac surgery,
cardiology and neuromodulation.�Headquartered in St. Paul, Minn.,
St. Jude Medical employs more than 11,000 people worldwide. For
more information, please visit www.sjm.com. Forward-Looking
Statements This news release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings, and market shares. The statements made
by the Company are based upon management�s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company�s control
and the risk factors and other cautionary statements described in
the Company�s filings with the SEC, including those described in
the Company�s Annual Report on Form 10-K filed on February 28, 2007
(see pages 13-20) and Quarterly Report on Form 10-Q filed on May 9,
2007 (see pages 23-24). The Company does not intend to update these
statements and undertakes no duty to any person to provide any such
update under any circumstance.
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