|
Don't Cancel Your Angioplasty
or Heart Stent Yet,
Say Patient Advocates
|
 |
April 7, 2007 -- After headlines
around the country recently declared that drugs are as good as angioplasty
and stents for heart disease sufferers with chest pain, patients
have reportedly begun questioning their cardiologists, even canceling
appointments.
"While it's encouraging that two-thirds of the
low-risk heart disease patients in the recent COURAGE trial did well
without receiving stents, these patients got much more than prescriptions," says
patient advocate Burt Cohen.
According to Cohen, who testified on behalf
of patients at a December 2006 FDA Panel on stent safety, the study
offered a level of on-going care not available to the majority of Americans.
"This was a study of hand-picked patients at
low risk for heart attack who were receiving subsidized healthcare
through the Canadian health system and the Veterans Administration.
These patients got what is known as 'optimal medical therapy,' including
free medications and continual free support services for five years
from healthcare personnel who made sure they took their drugs, changed
their diets, stopped smoking, exercised and reduced stress."
"Optimal Miracle Therapy"
At a recent panel of 10 leading cardiologists, convened by theheart.org,
several physicians referred to the care offered to COURAGE trial participants
as "optimal miracle therapy".
"There would be less angioplasty, stenting and
bypass surgeries if patients in this country received optimal preventative
medical care, but it will take a change in healthcare delivery and
reimbursement to make that happen," says Deborah Shaw, patient education
editor of Angioplasty.Org, a popular website for cardiologists and
patients.
"The real take away from the COURAGE trial,
is not just that medication is useful, which we know, but that patients
benefit from substantial compliance education and lifestyle support.
Patients need to participate in treatment decisions, so that they understand
their treatment options and can commit to a course of action," says
Shaw.
"Patients have to change their lives in order
to lower their heart attack risk factors, and to reduce angina without
intervention. But managed care allows doctors only 10-15 minutes with
patients in a typical appointment. A lot of people have trouble complying
with prescriptions -- 1
in 7 heart attack victims stops taking medication after leaving the
hospital, and what's more motivational than a heart attack?"
Nothing New: Most Angina Patients Don't
Get Stents
"COURAGE really does not present anything new...there are no surprises in this
trial," says leading cardiologist Dr. Eric Topol, whose efforts contributed to
the Vioxx recall. Indeed, the conclusions of the COURAGE study read: "Our findings
reinforce existing guidelines."
All current treatment guidelines recommend that
stable angina patients begin with "optimal medical therapy" and only
receive stents if their chest pain continues. And, in fact, one third
of the patients in the COURAGE Trial had to cross over from medication
to stents in an effort to get relief from chest pain.
According to the American Heart Association 9
million Americans suffer from stable angina; only a minority of
these angina sufferers is among the one million individuals receiving
interventions with angioplasty and stents each year.
Stents Can Save Lives
"It's unfortunate, potentially harmful, that the COURAGE study resulted in the
public getting a misleading, negative message that this study proves stents are
not helpful," says
Cohen.
15% of all stents go into people who are having
heart attacks, a proven life-saving intervention. According to the
December FDA stent safety panel, 60% of all stents are used "off-label," to
improve quality of life in patients whose disease is generally more
complex than in the group of patients looked at in the COURAGE Trial.
The COURAGE trial included "a very modest subgroup
of patients and excluded the majority of patients with cardiovascular
disease that we (implant stents for) now," Ralph Brindis, head of cardiology
for Northern California at Kaiser Permanente, told Reuters.
A Call To Action
"Some low risk patients who could reduce their pain with medication and lifestyle
changes do indeed get stents. But the COURAGE Trial will only help these heart
patients," says Shaw, "if it inspires a widespread call for an investment of
time and money in the on-going patient support, lifestyle and compliance programs
that are needed to make 'optimal medical therapy' work in the real world." |
