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March
24,
2009 -- 1:55pm EDT
Is The Scaffolding Coming Down?
Today's good news about Abbott's
bioabsorbable stent brings the
following analogy to mind.
Scaffolding
on
Building |
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A stent
is often described as a "scaffold" inside
the artery. Indeed, in the era of POBA (Plain
Ol' Balloon Angioplasty) elastic recoil of the arterial plaque
could reblock the freshly-opened artery, or the ragged interior
surface left after the balloon fractured the plaque would lead
to increased rates of restenosis. |
So
angioplasty pioneers developed the stent, a scaffold to hold
the artery
open. Recoil virtually disappeared. Abrupt closure, which
led to emergency CABG 3-5% of the time, was reduced
by a factor of 20. And while stents reduced restenosis,
these devices produced their own
unique brand of complications. |
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Scaffolding
in Artery |
Unlike their construction counterpart, scaffolding inside the artery cannot
be removed when the job is finished. Metal stents are permanent.
They (hopefully) get covered over by endothelial cells and are incorporated
into the lining of the artery, but cell growth can occur inside the
stent, reblocking the blood flow (in-stent restenosis) or in the
case of drug-eluting stents, the endothelial healing can be delayed,
causing platelets to aggregate around the bare metal structure, causing
a blood clot and possible heart attack (late stent thrombosis).
These complications are small in number (very small
in the case of late stent thrombosis) but they complicate what should
be a simple
task. Fix the arterial wall until it heals and then "Take Down The
Scaffolding!"
There's also the issue of the "straight-jacket", as
Dr. Charles Simonton of Abbott calls it. A metal stent must, by its
presence, restrict
the normal natural flexibility of the coronary artery (which is beating
and moving all the time). Certainly the newer stents with thinner
struts are better, but patients with 7, 8 or more stents can get
into the realm of what's called a "full-metal jacket". And too much
metal can compromise future therapy as well -- bypass surgery, for
example.
Enter (or exit!) the bioabsorbable stent. As recent
results have shown, the stent, having done its job, disappears after
two years. Normal motion is restored to the artery which, in many
ways, acts like it did before the stent was placed, except that the
blockage is gone.
These are, of course, hopes. The early trial was only
30 patients. Abbott announced a second phase today which will bring
the total to 110. All agree that larger trials with more patients
and more complex anatomy must be done. All also agree that this technology,
if it proves as safe and effective as the small trial, could revolutionize
the treatment of coronary artery disease yet again.
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