UPDATE: Large Study Questions Value Of Stents
08 June 2009 - 8:33AM
Dow Jones News
The value of stent surgery are in question again as a study
released Sunday showed the heart devices, combined with drug
therapy, did no better at reducing deaths or heart attacks among
certain diabetes patients when compared against drugs alone.
The study, formally released at the American Diabetes
Association conference and simultaneously published in the New
England Journal of Medicine, will surely be hotly debated among
leading stent makers such as Johnson & Johnson (JNJ) and Abbot
Laboratories Ltd. (ABT), and the broader medical community.
The results essentially replicate the findings of a study
released in 2007, called Courage, that shook the medical community,
said Dr. William Boden and Dr. David Taggart in a NEJM editorial
that accompanied the study.
The two studies do have significant differences, though. The
recent study, called BARI 2D, focused on a more limited patient
group - those who have Type 2 diabetes and evidence of limited
blood flow to a major organ, also called ischemia. The Courage
study followed diabetic and non-diabetic patients with stable
coronary heart disease.
Analysts and medical device makers predict the recent study will
have minimal impact on major medical device makers because many
people expected the new study to have results similar to Courage.
Indeed, Abbott Laboratories doesn't expect the study to "have any
impact on stent volumes," said spokesman Jonathon Hamilton.
Hamilton said the company based its decision on the fact that most
patients were given bare-metal stents instead of drug-eluting
stents, considered the newest generation of the devices, which prop
open arteries and use medication to stop the artery from
renarrowing.
Dr. Robert Frye, professor of medicine at the Mayo Clinic, said
at a press briefing that wider use of drug-eluting stents wouldn't
have made much of a difference, citing studies showing the new
generation of stents don't reduce deaths or heart attacks any
better than older version.
Other doctors questioned the design of the study. "These
patients don't represent every diabetes patient that walks through
the door," said Dr. Steven Bailey, president of the Society for
Cardiovascular Angiography and Interventions. He also said the
"incredible" drug treatment these patients were given is hard to
replicate in the real world, where patients often don't show up on
time and variables such as insurance play a factor in how someone
is treated.
Bailey is on the speakers' bureaus of several medical device
makers, including Abbott and Medtronic Inc. (MDT).
The study was sponsored by the National Institutes of Health and
several drug companies, and set out to answer several questions,
including whether diabetes drugs that help the body use insulin
more effectively work better than injecting insulin.
The study shows that patients on GlaxoSmithKline Plc's (GSK)
Avandia or Takeda Pharmaceutical Co.'s (4502.T0) Actos had a
similar death rate than those taking insulin. The study also noted
no increase in heart attacks with Avandia, a drug that has been
dogged by concerns that it boosts heart risks.
The study also highlights the important role comparative
effectiveness research plays in making medical decisions, said Dr.
Richard Kahn, chief scientific and medical officer of the American
Diabetes Association.
President Barack Obama has said research comparing medical
treatments, known as comparative effectiveness, is a hallmark of
health care reform and committed $1.1 billion for such studies.
Kahn said this study "is what comparative effectiveness is all
about."
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com