UPDATE: Big Study Shows Coated Stents Topping Older Versions
28 Mars 2009 - 7:59PM
Dow Jones News
A big study analyzing outcomes for patients with both regular
heart stents and versions coated with medication found patients
with the coated devices had fewer cases of serious
complications.
The data, which covered nearly 263,000 patients treated over
three years, were released Saturday at the American College of
Cardiology's annual conference.
The study lends support to a $4 billion drug-coated stent
business that has been steadily working its way back from worries
about safety problems. Boston Scientific Corp. (BSX), Abbott
Laboratories (ABT), Johnson & Johnson (JNJ) and Medtronic Inc.
(MDT) are the big stent makers.
Coronary stents are tiny devices used to prop open clogged heart
arteries. Older, bare-metal ones can be susceptible to scar tissue
that narrows arteries and sometimes leads to another procedure,
while coated stents use medication to fight this process. They have
proven successful at that task, but worries arose a few years ago
that coated stents were also more likely to trigger potentially
deadly clots.
The connected worry that clots meant coated-stent patients were
more likely to die triggered a major drop in coated-stent usage.
The market hasn't bounced all the way back, but has been steadily
recovering amid data indicating this isn't the case.
The new study, which involved analysis of a major data registry,
furthered that trend by not showing safety issues with coated
devices over 30 months.
"We can say with some confidence that they're not killing
people," said Pamela Douglas, a professor of medicine at Duke
University who presented the study data Saturday, during a press
conference.
While some coated stents may have a slight inclination to allow
clots, patients now take longer and sometimes open-ended courses of
anti-clotting drugs, and doctors will steer patients who can't take
such medication to bare-metal stents.
The latest study - the largest-ever to evaluate real-world stent
patients - involved analysis of data from ACC's National
Cardiovascular Data Registry on patients over the age of 65. It
included 217,675 patients with coated stents and 45,025 with
bare-metal devices.
The study found that patients with coated stents had
significantly lower rates of death and non-fatal heart attacks.
There were slightly fewer cases of repeat procedures with coated
stent patients and stroke rates were similar in both groups,
according to slides from Douglas' presentation.
This study wasn't a randomized and controlled trial reviewing
the two types of stents, which means it doesn't have the highest
possible level of evidence. But randomized trials often include
more basic cases, while this study reviews the kinds of patients
doctors are more likely to see on a day-to-day basis.
The study was funded by the Cardiovascular Consortium of the
Agency for Healthcare Research and Quality, which is part of the
U.S. Department of Health and Human Services. ACC's registry also
provided support.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com