TAXUS® Express2™
Stent System Shows
Significant Reduction of Restenosis
in Diabetic Patients
in Clinical Trial
TAXUS V data demonstrated increased benefit in insulin-requiring diabetics
NATICK, Mass. and WASHINGTON, Oct. 20 -- Boston Scientific Corporation
(NYSE: BSX - News) today announced nine-month sub-population data from its TAXUS
V clinical trial that further supports the performance of the TAXUS® Express2™
paclitaxel-eluting coronary stent system for the treatment of coronary artery
disease in diabetic patients, particularly higher-risk, insulin-requiring diabetics.
TAXUS V expands on the TAXUS IV pivotal trial by studying the most challenging
lesions and highest-risk patients ever studied in a randomized, controlled clinical
trial in the United States. The Company made the announcement at the annual Transcatheter
Cardiovascular Therapeutics symposium in Washington, D.C.
"The TAXUS V diabetic sub-population data provides impressive results on of the outcome of the TAXUS stent system in treating complex patients, especially insulin-requiring diabetics," said Naim Z. Farhat, M.D., who presented the results at TCT. "Most significantly, the data from this study shows an observed increasing benefit of the TAXUS system in the higher-risk insulin sub-group as compared to control and other diabetic patients."
"The TAXUS V clinical trial studies some of the most complex patients and we are pleased that the TAXUS Express2 stent system performs well in this challenging patient population," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "The strong TAXUS V subset data is consistent with positive outcomes from other TAXUS trials."
The diabetic sub-population analysis demonstrated significant improvements among diabetic patients receiving the TAXUS paclitaxel-eluting system versus those in the bare metal control group, and further improvements among the higher-risk, insulin-requiring diabetic patients. The nine-month target lesion revascularization rate (TLR, or retreatment rate) for the medically- treated diabetic sub-population of the TAXUS stent group was 9.6 percent compared with 17.5 percent in the control group (P=0.04), a reduction comparable to the non-diabetic sub-population (45 percent in both cases). Among insulin-requiring diabetic patients, the TLR rate was 8.3 percent compared to 17.3 percent in the control group (P=0.24), a reduction of 52 percent, which is particularly impressive considering the low rate in the control arm.
The diabetic sub-population also reported an in-segment binary restenosis rate of 18.2 percent in the TAXUS stent group compared with 38.4 percent in the control group (P<0.0001), a reduction of 53 percent. Among insulin- requiring diabetic patients, the restenosis rate was 20.9 percent in the TAXUS stent group compared with 46.7 percent in the control group (P=0.0138), a reduction of 55 percent.
In addition to the improved restenosis rates, marked improvement in in- segment late loss was also seen in the diabetic sub-population of the TAXUS stent group compared to the control group (0.31 (+/-0.56) mm versus 0.62 (+/- 0.61) mm; P<0.0001), a reduction of 50 percent. Among insulin-requiring diabetic patients, the late loss improvement was even better (0.26 (+/-0.58) mm versus 0.59 (+/-0.57); P=0.0085), a reduction of 56 percent.
Diabetic patients represent approximately 31 percent (356 of 1,156) of the overall patient population in the study. Diabetic patients are more likely than non-diabetic patients to experience restenosis following angioplasty and stenting with bare metal stents, and may stand to benefit substantially from drug-eluting stent technology.
TAXUS V is a randomized, double-blinded trial that enrolled 1,172 patients at 66 sites in the United States, assessing the safety and efficacy of a slow- release formulation paclitaxel-eluting coronary stent system in reducing restenosis in de novo lesions 10 - 46 mm in length and 2.25 - 4.0 mm in diameter. The Company announced in March that the trial met its primary endpoint of nine-month target vessel revascularization (symptom-driven repeat revascularization of the target vessel, or TVR), as well as all secondary endpoints.
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. The Company 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 clinical trials, the regulatory approval process, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.
CONTACT:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
Source: Boston Scientific Corporation
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