"The diabetic sub-population data reinforce the overall positive findings of the TAXUS V study, which has significantly expanded our understanding of the efficacy of the TAXUS paclitaxel-eluting system in very complex patients," said Dr. Stone. "These results confirm that the TAXUS technology is an effective tool for clinicians to use in treating challenging cases such as diabetics. This data will be welcomed by interventional cardiologists who treat these difficult patients."
"We are pleased that these results reaffirm the performance of the TAXUS system in complex patient populations," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "The strong TAXUS V subset data is consistent with positive results from other TAXUS trials."
The diabetic sub-population analysis demonstrated significant improvements among diabetic patients receiving the TAXUS system versus those in the control group. 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.
The nine-month target lesion revascularization rate (TLR, or retreatment rate) for the medically treated diabetic sub-population of the TAXUS group was 9.6 percent compared with 17.5 percent in the control group (P=0.09). The diabetic sub-population also reported an in-segment binary restenosis rate of 18.2 percent in the TAXUS group compared with 38.4 percent in the control group (P<0.0001). 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 group compared to the control group (0.31 (+/-0.56) mm versus 0.62 (+/-0.61) mm; P<0.0001).
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 previously 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: 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.