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Data Presented to FDA Panel Show TAXUS(TM) Drug-Eluting Stents as Safe as Bare-Metal Stents and Far More Effective in Reducing Repeat Procedures

2006-12-11 09:35 832

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

Source: Boston Scientific Corporation
collection