PARIS, Dec. 11 /Xinhua-PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) yesterday presented data on its long-term randomized clinical
trials to a special U.S. Food and Drug Administration (FDA) panel, showing
that the TAXUS(TM) paclitaxel-eluting coronary stent is as safe as bare-metal
stents (BMS), and far more effective in keeping arteries open and reducing
the need for repeat procedures.
The data presented by Dr. Donald Baim, Chief Medical and Scientific
Officer for Boston Scientific, were based on a detailed analysis of 2,797
patients from four randomized TAXUS clinical trials who received TAXUS or BMS
for approved indications and were followed closely for four years. The data
showed that the TAXUS stent reduced the need to retreat vessels due to
restenosis by nearly 50 percent compared to BMS.
The very late stent thrombosis rate for the TAXUS stent group is not
statistically different from the BMS control group, according to any of the
available definitions. There is no evidence of any increase in clinical
complications in the TAXUS stent group, and favorable risk-benefit outcomes
were seen in important trial subgroups, including patients with diabetes,
small vessels and multiple stents per vessel.
"When used for approved indications, the TAXUS stent is twice as
effective as BMS in keeping vessels open, helping patients stay healthy, and
avoid restenosis and the need for repeat procedures," said Dr. Baim. "It is
important to understand that restenosis is not benign. Overall, the total
number of deaths in the TAXUS stent group was the same or slightly lower than
the BMS group throughout the four years following the procedure."
"We have continued to be forthcoming and transparent with the clinical
data related to our DES because we believe it is important to help doctors
and patients make the best and most informed decisions," said Dr. Baim.
Dr. Baim said the risk of stent thrombosis is greatest in the first year
following implantation, and drops off to very low levels thereafter for both
BMS and drug-eluting stents (DES), a finding corroborated by other studies.
Boston Scientific is continuing to study stent thrombosis and has agreed to
provide lead financial support for an extension of the independent STENT
registry, which will include the enrollment of an additional 10,000 DES
patients.
Dr. Baim went on to present data indicating that patients have a far
better chance of avoiding blood clots if they take anti-clotting drugs for
six or more months after a stenting procedure. The data is consistent with
current published recommendations from the American Heart Association and
American College of Cardiology Guidelines for these procedures. The adoption
of longer anti-clotting drug therapy following DES is one of the topics the
FDA panel is expected to consider at the conclusion of testimony on Friday.
Boston Scientific also presented data on its 7,000-patient ARRIVE I and
II registries of real-world patients including those with complex lesions.
While the TAXUS randomized clinical trials focused on patients who received a
single stent to relieve a blockage in a single vessel, the patients enrolled
in the ARRIVE registries tended to present much more complex situations
involving very small, very long or multiple vessel blockages that often
required multiple stents. These patients represent up to two-thirds of the
patients who receive TAXUS stents in the real-world practice of
interventional cardiologists.
The data presented by Dr. Baim showed that patients in the ARRIVE
registries with simple blockages had comparable outcomes to those with
similar lesions in the TAXUS clinical trials, confirming the ability of these
registries to accurately track clinical outcomes. As expected, patients with
complex coronary artery disease had slightly higher adverse events compared
to the randomized trials and the simpler cases in the ARRIVE registries.
However, the rates of death and heart attack were equivalent or better than
those for potential alternative treatments such as bypass surgery. The data
on complex cases were also consistent with real-world registries of DES using
either the TAXUS or the CYPHER(TM) stents. These registries showed trends
towards lower rates of death, heart attack, and repeat procedures for TAXUS
stents compared to CYPHER stents, in patients with diabetes mellitus(1).
"The patients treated in ARRIVE had such complex disease that many would
have been poor candidates for BMS or conventional angioplasty," said Dr.
Baim. "They were just too sick and the standard treatment for many of these
patients would have been bypass surgery, yet the patients treated with the
TAXUS stent had similar or lower rates of death, heart attacks and repeat
procedures than historically seen with bypass surgery.
The FDA panel, which will conclude two days of hearings on Friday, first
considered data involving approved uses of DES before moving to uses by
interventional cardiologists for other kinds of cases, many of them involving
complex heart disease or subsets like diabetic patients.
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties. For more information, please visit
http://www.bostonscientific.com .
This press release contains forward-looking statements. Boston Scientific
wishes to caution the reader of this press release that actual results may
differ from those discussed in the forward-looking statements and may be
adversely affected by, among other things, risks associated with new product
development and commercialization, clinical trials, intellectual property,
regulatory approvals, competitive offerings, Boston Scientific’s overall
business strategy, and other factors described in Boston Scientific’s
filings with the Securities and Exchange Commission.
(1) data on file
