March
2010 Archives:
March 29, 2010 -- 7:30pm EDT
Does Less Angioplasty in Women Having a
Heart Attack Lead to Worse Outcomes?
This was the conclusion of a much-publicized
study presented at the American College of Cardiology meeting
two weeks ago by French cardiologist, Dr. Francois Schiele. The
study of 3,000 patients who were admitted to a hospital for a
heart attack showed that far fewer women were sent to the cath
lab for an angiogram, angioplasty or stent. It also showed that
women were twice as likely to die within a month of the heart
attack. Yet when groups of men and women who received similar
treatments were compared, there was no mortality difference,
implying that fewer women are being offered angioplasty: the
interventional treatment that is considered the "gold
standard" for heart attack .
One possible reason was given by Dr. Rita Redberg,
a cardiologist at the University of California, San Francisco, as
reported by theheart.org:
...the treatment gap between men and women
shown in the study could be caused by the perception among
interventionists that their female patients are more likely
to have complications with thrombolysis or angioplasty. She
pointed out that "there are pretty consistent data that
women have higher rates of procedural complications and higher
rates of bleeding complications than men. That could be limiting
some of the invasive treatments we are seeing."
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Dr. Schiele agreed and speculated whether the rates
of angiography and angioplasty in women could be safely increased
with better stents for smaller arteries, greater use of radial (wrist)
access and better antithrombotic regimens.
Almost to answer the question, the current issue
of Cardiac Interventions Today features two articles on
the transradial approach. "The
role of radial artery access in the evolution of percutaneous angioplasty
and in minimizing complications" specifically discusses
how the use of the radial approach in patients with acute coronary
syndrome (ACS) and heart attack virtually eliminates procedural bleeding
complications, complications which have been associated with increased
mortality.
The
second article, "The
Transradial Approach: Does your fellowship training program teach
it?", is by Dr. Jennifer Tremmel, Director of Transradial
Interventions at Stanford Medical Center and Clinical Director of Women's
Heart Health at Stanford Clinic. In this she addresses the lack
of training in the radial approach during interventional fellowships
in the U.S. And Dr. Tremmel understands this problem first-hand.
As she told Angioplasty.Org in her
exclusive interview:
I knew that my women patients were more
prone to having bleeding complications. I could say to them, "Well,
you're more prone to having this problem," and they always
looked at me like, "So what are you going to do about
it?" and I couldn't really give them a good answer. The
answer certainly was not vascular closure devices because those
don’t decrease bleeding complication rates....
[Then] one day I saw an article which said
that both sexes have significantly lower bleeding rates with
transradial intervention, particularly women.... So when
I saw that, I was like, "This is it!".... I felt
a real obligation to figure out a way to lower bleeding complications
just because I'm a women's heart health specialist and that's
my job: how do I improve the outcomes of the women that I
take care of? In my mind, transradial was the answer.
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As a result, Dr. Tremmel flew to New York, took
a transradial course with Dr.
John Coppola, went back to Stanford -- and now does almost all
of her cases via the wrist with hardly any bleeding complications.
And with increased outcomes for her female patients.
Any cardiologist or fellow interested in the transradial
approach should definitely check out Dr. Tremmel's recent
article.
March 11, 2010 -- 10:10pm EST
Three Months of Plavix After Stent: When
Less May Be More
"All
stents are not the same," Dr. Fausto Feres told me
in his
interview on Angioplasty.Org. He was talking about the OPTIMIZE
trial and why, even though everyone else is testing 12 months
or 30 months of dual antiplatelet therapy, why his trial of over
3,000 patients is going in the opposite direction: testing only
three months.
A little background: from 2003-2006 patients were
given six months of Dual AntiPlatelet Therapy (DAPT, usually Plavix
plus aspirin) after getting a drug-eluting stent to prevent blood
clots (stent thrombosis) from forming inside the stent. It was assumed
that after six months, the stent struts would be covered and thrombosis,
would not be an issue.
Then came "the
firestorm" of the 2006 European Society of Cardiology
meeting where papers were presented showing a risk of very late
stent thrombosis six months, a year, two years after stenting.
The interventional community was thrown into shock and this issue
was debated in every meeting, culminating in a two-day FDA panel
on stent safety. Following this meeting, new guidelines recommended
12 months minimum of DAPT and more, if patients were not experiencing
any adverse effects (bleeding being the main one).
But, as Dr. Eric Topol told me in his
interview, this recommendation wasn't based on scientific data,
because there wasn't any -- it was an intuitive decision that more
DAPT would reduce this new found albeit infrequent problem of late
stent thrombosis.
So the idea of designing a 3,000-plus patient trial
testing whether three months of DAPT is sufficient goes against this
intuitive concept. Well, things are different. in 2006 there were
only two DES: Taxus and Cypher. And Dr. Feres gives his patients
12 months of DAPT when he uses those, except that he rarely uses
those. Mostly he is using the second-generation Endeavor stent from
Medtronic which numerous imaging studies have shown to "heal" more
quickly. OCT imaging has shown almost 100% strut coverage at 3-6
months, even better than bare metal stents. And Dr. Feres has been
giving patients only three months of Plavix and aspirin with no problems
so far. So the OPTIMIZE Trial, taking place in 30 centers in Brazil
will see if there is any difference in three or twelve months.
If three months turns out to be "as good",
it will actually be "better" and here's why. Plavix costs
$4/day. That's $1,100 per patient better. Plus, there are bleeding
and other complications associated with Plavix and aspirin. It's
estimated about 5%. Hospitalization, transfusions, not to mention
poorer patient outcomes. Eliminating those -- that's also better.
Finally, patients who get stents also often need other surgeries:
dental surgery, knee replacements, biopsies, etc. and many of these
procedures are difficult or impossible to do when the patient is
on Plavix and aspirin. Reducing the DAPT period to three months reduces
this problem as well.
For more on the OPTIMIZE Trial, read my
interview with Dr. Fausto Feres of Instituto Dante Pazzanese
de Cardiologia in São Paulo, Brazil.
March 3, 2010 -- 3:50pm PST
Functional Measurement Functioning Well
at Volcano
To
stent or not to stent? The question is more than a rhetorical
one when a patient is on the cath lab table and a coronary blockage
is seen on the angiogram. Luckily, there are methods available
to help give a more scientific answer to this question. Equipment
for two of these techniques, Intravascular Ultrasound (IVUS)
and Fractional Flow Reserve (FFR -- a.k.a. "functional measurement")
is manufactured by Volcano Corporation (Nasdaq: VOLC) a San Diego-based
device company that announced its fourth
quarter results earlier today.
And if the company's results are any indication,
both technologies are increasingly finding a place in the interventional
cardiologist's armamentarium. Volcano's sales of IVUS catheters were
up 29%, but their FFR product was up a whopping 92% over the previous
fourth quarter.
One reason might be the increasing evidence that
FFR or Functional Measurement (FM) is a valid decision-making technology.
A major driver for heart docs to look at FFR was last January's FAME
study, which showed better outcomes (and fewer stents placed)
when FFR was used to guide treatment and ensure that stenting was
a benefit for the patient. The strength of IVUS is more in the area
of performing the stenting procedure optimally. I wrote about the
differences between these technologies a few weeks ago (IVUS
vs. FFR -- Boston Style) but these sales figures translate to
increased adoption of technologies to make angioplasty, stenting
and PCI procedures safer for the patient with better outcomes for
the procedure.
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