The randomized, double-blind, controlled study of 448 patients at 44 international sites is designed to assess the TAXUS moderate-release paclitaxel-eluting coronary stent system in reducing restenosis in high-risk patients, including long de novo lesions with overlapping stents, small vessels and diabetics. Lesion size ranged from 18 - 40 mm in length and 2.5 - 3.75 mm in diameter. TAXUS VI is the first clinical trial to support durability of drug-eluting stents in complex lesions at two years. Clinical follow-up included more than 95 percent of the patients enrolled at two years (428 out of 446).
"The two-year data from TAXUS VI clearly demonstrate the sustained safety and efficacy of the moderate-release TAXUS paclitaxel-eluting stent system in the treatment of patients with long lesions treated with multiple, overlapping stents," said Dr. Grube. "These data indicate that TAXUS stents offer sustained TLR benefits over time."
"The TAXUS VI results demonstrate unparalleled safety in the longest lesions ever studied in a randomized clinical trial," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "This data is consistent with the strong safety and efficacy results seen with the slow-release TAXUS formulation, and illustrates continuing patient benefits over time, attesting to the durability of our technology even among this high-risk patient population."
Continued efficacy
The study's results indicate a continued significant reduction in target lesion revascularization (TLR, or retreatment rate) as compared to the control group at two years. The study reported a 2-year TLR rate of 9.7 percent (21/216) for the TAXUS group, as compared with 21.0 percent (46/219) for the control group (P=0.0013) (only three more interventions were reported between one and two years for the TAXUS group). The rate of patients living free of TLR events was 90.3 percent at two years for the TAXUS group, as compared to 79 percent for the bare-metal stent control group.
Long-term safety
The two-year results for TAXUS VI support long-term safety with the increased levels of paclitaxel in the moderate-release formulation used in the study. Even with an in vitro dosing rate 8-10 times greater than the commercialized slow-release formulation, no compromise in safety was observed. Stent thromboses remained low and comparable to control rates (0.9 percent for both the TAXUS group and the control group).
In May 2004, the Company announced nine-month data from the TAXUS VI study, including TLR. The nine-month TLR rate of 6.8 percent in the TAXUS group was significantly lower than the control group rate of 18.9 percent.
Boston Scientific launched the slow-release formulation TAXUS Express2 paclitaxel-eluting coronary stent system in Europe and other international markets in February 2003 and in the United States in March 2004. The TAXUS Express2 moderate-release paclitaxel-eluting stent is not approved for commercial distribution.
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. 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.