Study Shows 2-Year Benefits For Stent-Guiding System
September 23 2009 - 5:23PM
Dow Jones News
After two years, a study examining devices that measure pressure
around heart-artery blockages to help place stent scaffolds showed
using the devices cut the odds of death or heart attacks compared
with a traditional imaging tool.
St. Jude Medical Inc. (STJ) and Volcano Corp. (VOLC) make these
fractional flow reserve, or FFR, measurement tools, which involve a
wire with a pressure sensor that determines the significance of
narrowing in heart arteries. The devices could lead to more
selective use of heart stents, where Abbott Laboratories (ABT),
Boston Scientific Corp. (BSX), Johnson & Johnson (JNJ) and
Medtronic Inc. (MDT) are major manufacturers.
Two-year results from the St. Jude-sponsored "Fame" study were
released Wednesday at the Transcatheter Cardiovascular Therapeutics
conference in San Francisco.
One-year results that also backed the technology were released
at the same conference last October, and later published in the New
England Journal of Medicine. St. Jude bought Radi Medical Systems,
a Swedish company that makes FFR tools, for $250 million in cash
not long after Fame's one-year data were issued.
The study included 1,005 patients with problems in multiple
heart arteries. Their treatment was either guided with FFR or just
an angiogram imaging system.
After two years, there was an 8.4% risk of patients dying or
having a heart attack when treatment was guided with FFR, compared
with a 12.7% rate among patents whose treatment was guided with an
angiogram.
While the rates of these serious complications was lower for the
FFR group, about a third-fewer stents were used among those
patients compared with patients in the angiogram group. That
doesn't mean FFR technology kept many patients from getting stents
- 90% of the patients in that group still got them - but it did
help determine how many stents they received.
"We're not saying stenting is bad," said William Fearon,
associate director of interventional cardiology at Stanford
University Medical Center and the co-principal investigator on the
Fame study. But the message is there is a more efficient and
effective way to do stenting procedures, he said in an
interview.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com