Dissolvable Heart Artery Stents Appear Safe in Study

MONDAY, April 16 (HealthDay News) — New long-term research now
suggests that fully biodegradable stents are safe to use in heart
arteries.

Reporting in the April 16 issue of Circulation, Japanese
researchers said a 10-year study has shown the biodegradable Igaki-Tamai
stent, made of a cornstarch-based material, dissolves into the artery
wall, leaving no permanent foreign material in an artery and reducing the
occurrence of an in-stent blood clot.

According to the study, survival rates from all causes was 87
percent and rates of major heart-related complications were similar to
those seen with metal stents.

Stents, the tiny mesh tubes inserted into heart arteries to keep open
and allow blood to flow to the heart, are far from fail-safe. New
blockages can — and do — occur. So scientists have been trying to
develop new stents, including ones coated with blood-thinning medications.
Metal stents, sometimes coated with drugs, remain in the body where they
can reclog.

The Igaki-Tamai stent, developed by Kyoto Medical Planning Co., is used
in nine European Union countries and Turkey to treat peripheral artery
disease, or blocked arteries in the legs. It is not used to treat blocked
heart arteries in any country.

Study author Dr. Kunihiko Kosuga, director of cardiology at Shiga
Medical Center for Adults in Moriyama City, predicted in a journal news
release that “fully biodegradable stents may hold an important position as
the next generation of coronary devices.”

In the study, 50 people received 84 Igaki-Tamai stents between
September 1998 and April 2000. Researchers report that the survival rate
from heart-related death was 98 percent. Half of the individuals
experienced major heart-related complications, which is in line with
studies of metal stents. The stent was totally absorbed in three
years.

“There is a risk of heart attack if a stent does not get incorporated
into the blood vessel wall,” explained Dr. Barry Kaplan, vice chairman of
cardiology at North Shore University Hospital in Manhasset, N.Y., and Long
Island Jewish Medical Center in New Hyde Park, N.Y. Once the metal stent
is absorbed, the risk theoretically should decrease or go away. The
problem is that metal stents are not always absorbed. In theory,
biodegradable stents should be.

“The panacea would be a drug-eluding biodegradable stent where the
drug is released into the vessel wall before the stent gets absorbed,” he
said. “This would lower the re-stenosis or re-blockage rate, yet eliminate
risk of heart attacks or blood clot,” Kaplan said. “From a technical
standpoint, this particular stent is providing a similar risk to a
bare-metal stent.”

The new study is “helping us feeling more comfortable that this is a
good line of research to pursue and that there is no special concern about
hidden dark sides with this biodegradable stent,” added Dr. Kirk Garratt,
clinical director of interventional cardiovascular research at Lenox Hill
Hospital in New York City.

More information

What is a stent? Learn more from the U.S. National Heart, Lung, and Blood
Institute
.

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