Big Study Shows Coated Stents Outperforming Older Versions
28 Marzo 2009 - 1:00PM
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 three-year data, set for release Saturday at the American
College of Cardiology's annual conference, 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.
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, non-fatal heart attacks and
repeat procedures compared with those who got bare-metal stents.
Rates of stroke and major bleeding were about the same.
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