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TAXUS(R) Stent Demonstrates Similar Outcomes In Diabetic Patients Compared To Non Diabetics In Pooled Analysis Of TAXUS IV And V Trials
Boston Scientific Corporation (NYSE: BSX) announced results from a
pooled analysis of patients from its TAXUS IV and TAXUS V randomized
clinical trials. The analysis compared the safety and efficacy of the
TAXUS(R) Express(TM) Paclitaxel-Eluting Coronary Stent System in diabetic
versus non-diabetic patients. Results demonstrated that despite the known
increased rates of mortality and restenosis for diabetics versus
non-diabetics in patients with cardiovascular disease(1), the TAXUS Stent
had comparable levels of late loss and target lesion revascularization
(TLR) across these patient populations. The study also showed no
significant differences in target vessel revascularization (TVR), stent
thrombosis, or myocardial infarction (MI), after adjustments were made for
differences in other baseline characteristics between patients with or
without diabetes. Analysis of the data was presented by Gregg W. Stone,
M.D., of the Columbia University Medical Center in New York, at the SCAI
Annual Scientific Sessions in Partnership with the ACC/i2 Summit in
Chicago.
"The TAXUS IV/V diabetic subset data indicated that the TAXUS Stent
mitigated the impact of diabetes as a risk factor for restenosis following
stenting procedures in the patients studied," said Dr. Stone. "Diabetic
patients treated with TAXUS Stents compared to bare-metal stents had
significantly improved event-free survival, particularly important in
high-risk patients with diabetes."
The pooled analysis included angiographic outcomes at nine months and
clinical outcomes at three years among 338 diabetic patients and 901
non-diabetic patients treated with the TAXUS Stent from the TAXUS IV and V
clinical trials. Nine-month angiographic outcomes showed equivalent
in-segment late loss (0.27mm vs. 0.31mm, p=0.28) and binary restenosis
(14.3% vs. 15.1%, p=0.83) in diabetics and non-diabetics, respectively.
At three years, TLR was similar for diabetic and non-diabetic patients
(12.4% vs. 10.1%, p=0.25), despite significant baseline differences and
increased comorbidity risk in diabetic patients. TVR was higher in
diabetics (21.4% vs. 15.7%, p=0.017), due to an increase in remote TVR
events (outside the stented segment), which is an indicator of the more
aggressive background disease progression in diabetics. Three-year rates of
stent thrombosis under Protocol definition (0.9% vs. 1.3%, p=0.63) and ARC
Definite/Probable (1.6% vs. 1.9%, p=0.73) were similar, even without
multivariate adjustment.
The TAXUS IV/V analysis also compared 338 diabetic patients treated
with the TAXUS Stent versus 336 diabetic patients treated with bare-metal
stents (BMS). Three-year rates of TVR and TLR were reduced by roughly 50
percent in diabetic patients treated with the TAXUS Stent compared to BMS,
consistent with results seen in other high-risk patient groups. The TAXUS
Stent showed comparable safety to BMS in diabetics, with no significant
differences in death (7.3% vs. 7.1%, p=0.91), cardiac death (4.6% vs. 2.7%,
p=0.23), MI (6.5% vs. 6.6%, p=0.83) or ARC Definite/Probable stent
thrombosis (1.6% vs. 1.5%, p=1.00) in TAXUS and BMS, respectively.
"We are pleased to see that TLR in TAXUS patients -- an important
indicator of TAXUS efficacy -- showed no significant difference between
diabetic and non-diabetic patients in these studies," said Paul LaViolette,
Chief Operating Officer at Boston Scientific. "This analysis is consistent
with data we recently announced from our ARRIVE 1 and 2 real-world
registries, showing that the TAXUS Stent effectively neutralized the impact
of diabetes as a risk factor for restenosis in the patients studied."
The growing diabetic subset accounts for more than one-quarter of all
coronary interventional procedures in the United States. Diabetes is
generally associated with an increased risk of cardiovascular events and
patients with diabetes are more likely than non-diabetic patients to
require repeat procedures due to a higher incidence of restenosis following
angioplasty and stenting.
The safety and effectiveness of the TAXUS Express Stent has not been
established in patients with diabetes in the United States.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like "anticipate,"
"expect," "project," "believe," "plan," "estimate," "intend" and similar
words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the time and
are not intended to be guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding clinical trials, regulatory approvals, competitive offerings,
product performance and our market position. If our underlying assumptions
turn out to be incorrect, or if certain risks or uncertainties materialize,
actual results could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These factors, in
some cases, have affected and in the future (together with other factors)
could affect our ability to implement our business strategy and may cause
actual results to differ materially from those contemplated by the
statements expressed in this press release. As a result, readers are
cautioned not to place undue reliance on any of our forward-looking
statements.
Factors that may cause such differences include, among other things:
future economic, competitive, reimbursement and regulatory conditions; new
product introductions; demographic trends; intellectual property;
litigation; financial market conditions; and, future business decisions
made by us and our competitors. All of these factors are difficult or
impossible to predict accurately and many of them are beyond our control.
For a further list and description of these and other important risks and
uncertainties that may affect our future operations, see Part I, Item 1A -
Risk Factors in our most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission, which we may update in Part II, Item 1A
- Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file
thereafter. We disclaim any intention or obligation to publicly update or
revise any forward-looking statements to reflect any change in our
expectations or in events, conditions, or circumstances on which those
expectations may be based, or that may affect the likelihood that actual
results will differ from those contained in the forward-looking statements.
This cautionary statement is applicable to all forward-looking statements
contained in this document.
References
(1) Rosamond W, Flegal K, Furie K, et al., "Heart disease and stroke
statistics--2008 update: a report from the American Heart Association
Statistics Committee and Stroke Statistics Subcommittee." Circulation.
2008;117(4):e25-146.
Boston Scientific Corporation
http://www.bostonscientific.com
Taxus (R) stent demonstreazã similare Rezultatele La pacienþii diabetici, comparativ cu non diabetici În analizã centralizatã a Taxus IV ºi V Procesele - TAXUS(R) Stent Demonstrates Similar Outcomes In Diabetic Patients Compared To Non Diabetics In Pooled Analysis Of TAXUS IV And V Trials - articole medicale engleza - startsanatate