May 26, 2005
The Growing Case For Heart Surgery
Large Study Cites Better Outcomes for Patients Who Get Bypass Procedure
Instead of Stents
By JOHN HECHINGER
Staff Reporter of THE WALL STREET JOURNAL

In a finding with significant implications for heart patients,
researchers say a popular minimally invasive procedure carries a higher
risk of death over the long term than does open-heart bypass surgery as
a treatment for blocked coronary arteries.

The large-scale study, which builds on similar findings in smaller
studies, calls into question one of the most significant changes in the
treatment of severe heart disease in recent years: the shift away from
bypass surgery in favor of angioplasty -- which involves sliding a
balloon into an artery through a small incision and then propping it
open with a wire-mesh stent. Angioplasty, with its much-shorter
recovery time and lower risk of in-hospital complications, is performed
more than one million times a year in the U.S. -- about three times as
often as bypass operations.

This latest research, released yesterday by the New England Journal of
Medicine, shows that stent-and-angioplasty procedures aren't as
effective as bypass for the sickest patients. In a review of almost
60,000 patients with serious heart disease in two government databases
in New York state, researchers concluded that those with three blocked
arteries who got stents were 1.56 times as likely to die within three
years as those who had bypass surgery. Those with two blocked arteries
who got stents were 1.33 times as likely to die as those who had bypass
surgery.

In addition, more than a third of patients who received stents needed
either surgery or additional angioplasties with stents within three
years. Only 5% of the patients who received bypass surgery needed to
get either of those treatments in that period. The results, which
covered cases from 1997 through 2000, were adjusted for the severity of
the patients' conditions, according to the researchers, who were led by
Edward L. Hannan, chairman of the Department of Health Policy
Management and Behavior at the University at Albany School of Public
Health. Prof. Hannan's research was supported by the New York State
Department of Health.

Makers of stents note that the research doesn't include the newer
generation of drug-coated stents, which may improve the outcome for
angioplasty. Many cardiologists said the findings are likely to slow
the move to stents as the standard treatment for patients with
more-severe heart disease -- that is, those with two or three blocked
arteries. That could boost overall medical costs because heart surgery
is significantly more expensive than angioplasty. Hospitals generally
charge $23,000 to $30,000 for bypass surgery, compared with $12,000 to
$15,000 for angioplasty.

An estimated 700,000 Americans each year die from coronary heart
disease, which afflicts 13 million in the U.S. Anywhere from three
million to more than five million of those patients have multiple
blockages, according to estimates. An editorial in the medical journal
called the implications of the study "profound" and suggested that
strategies for treating heart disease "are not as clear cut as
originally thought," though it stopped short of recommending a
wholesale change in treatment.

The report could have an impact on the fast-growing $5 billion market
for stents, which is led by Boston Scientific Corp., Guidant Corp. and
Johnson & Johnson. Spokesmen for Boston Scientific and Johnson &
Johnson's Cordis division, which makes stents, said the newest
generation of drug-coated stents help keep arteries from blocking again
after a procedure -- which is what doctors are now looking at when
weighing bypass vs. angioplasty. Officials at Guidant didn't return
phone calls.

In recent years, angioplasty has become accepted as a less risky and
equally effective alternative to the former gold standard, coronary
artery bypass surgery, for many patients with blockages. Not all
patients are candidates to choose one over the other. Patients
generally aren't considered for surgery if they have only one blocked
artery, and those with the most severe cases of multiple blockages tend
to be referred to the operating table. But many patients fall in
between.

In the past, some studies have shown that angioplasty, including stents
to keep vessels from closing, is comparable to surgery in avoiding
deaths over time. It is also more comfortable for patients. The
procedure can take as little as 15 minutes per artery and require no
more than one night in the hospital. In a coronary bypass operations,
surgeons crack open a patient's chest, then take an artery from
somewhere else in the body to create a new pathway for the blood.
Patients often have to stay in the hospital for five or six days and
may take longer than a month to recover.

Open-heart surgery also carries its own risks -- another reason
patients and doctors often avoid it. The in-hospital death rate for
bypass surgery is 2.4%, compared to just under 1% for angioplasty,
according to the American Heart Association.

In this latest study of New York state data, 37,212 patients underwent
bypass surgery, compared with 22,102 patients who received stents.
Prof. Hannan says that, based on his analysis, 539 deaths over the
three years could have been averted if the patients had received
surgery. "Some people will be shocked" with these findings, Prof.
Hannan says.

The results were most dramatic for the patients whose hearts were most
severely compromised. Of the 20,857 sickest patients with three blocked
arteries who received bypass surgery, almost 11% died within three
years. Of the 2,165 patients in that category who received stents, 15%
died. Those figures were similar when adjusted for the severity of the
cases.

In the report, the researchers note the advent of drug-coated stents
(often called drug-eluting), and say "future studies will be needed to
compare long-term outcomes for drug-eluting stents with those for
[bypass] in patients with various types of risk factors before the
procedure."

The study isn't the first to find an advantage to bypass surgery.
Earlier research found that patients with diabetes and heart disease
tended to have better survival rates with bypass surgery. Last year, a
study in the journal Circulation also found that coronary bypass
surgery had longer-lasting benefits than did angioplasty -- at least in
high-risk patients. Researchers in the Cleveland Clinic followed 6,033
heart patients for five years after surgery or angioplasty, and found
the risk of death over time more than twice as high in the angioplasty
group.

That study had been questioned because it involved a small sample at
one of the nation's most highly regarded heart-surgery centers --
presumably skewing the results toward bypass surgery.

Eric Topol, chairman of cardiovascular medicine at Cleveland, said the
new study answers that concern since it involves all patients in New
York state at 34 different hospitals. Dr. Topol, an interventional
cardiologist who performs stent procedures but not bypass surgery, said
the study suggests doctors may have become too "exuberant" in
advocating stents over bypass surgery.

The reason many experts believe that heart surgery is more effective
over the long term is that it creates a new pathway, he says, rather
than merely opening up a diseased artery that is then prone to develop
other blockages.

Dr. Topol and other experts noted that both the Cleveland Clinic and
New York studies involved a review of registry data -- not the
rigorously controlled clinical trials that the medical field considers
the best form of evidence. In registry studies, researchers must go
back in time and try to adjust existing data for various factors, such
as the sickness of patients -- a process that can lead to debate and
criticism. Advocates of registry data point out that it can involve
much larger groups of patients and "real world" medical practices.

Spencer King, an Atlanta interventional cardiologist who performs stent
procedures and reviewed the New York study before publication for the
New England Journal of Medicine, said the research may give some
physicians pause before they refer complex cases for stents. Dr. King,
a former president of the American College of Cardiology who has given
paid speeches for stent makers, said doctors still will have room for
clinical judgment in these cases. But, given the dramatic rise of
stents, he called the study "a bit sobering."

WEIGHING CHOICES

Bypass
· Better long-term survival rates in some studies.
· Higher in-hospital death rate.
· More invasive procedure with longer recovery time.

Angioplasty With Stent
· Minimally invasive procedure with shorter recovery time.
· Fixes one blockage at a time and may need to be repeated.
· Lower long-term survival rates in studies.