The results presented are among the most comprehensive intravascular ultrasound (IVUS) follow-up data of any drug-eluting stent randomized clinical trial. IVUS technology provides views from inside a patient's blood vessels, offering the most accurate visual confirmation of stent deployment and vessel condition.
"The lesions studied in TAXUS V are some of the most difficult we confront in interventional cardiology," said Dr. Weissman. "The TAXUS V IVUS data provides an especially rich source of information on the excellent performance of the TAXUS system. The uniform neointimal suppression across both single stents and multiple overlapping stents attests to the efficacy of TAXUS across a wide range of lesion lengths."
"Boston Scientific is committed to studying the most complex patients and lesions," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "The TAXUS V results presented today are consistent with the extensive body of data we've seen across other TAXUS trials. We are pleased that our IVUS outcomes data continues to support excellent safety and efficacy for the most challenging patients."
The IVUS data confirmed the consistent performance of the TAXUS system in high-risk patients and complex lesions. Patients in the TAXUS group exhibited consistent neointimal suppression out to nine-months across the entire length of the lesions, resulting in stable late loss with sustained clinical benefit over the control group. Quantitative IVUS measurements revealed significant improvements for percent in-stent net volume obstruction (13.2 percent in the TAXUS group versus 31.8 percent in the control group; P<0.0001). Consistency of outcomes was maintained regardless of lesion length or single versus multiple stenting, and a detailed millimeter by millimeter analysis demonstrated consistent neointimal suppression along the total length of the stent.
Efficacy and safety results remained consistent with findings from other ongoing TAXUS clinical trials, including TAXUS II, IV and VI. TAXUS V represents the longest lesions ever studied with IVUS data in a clinical trial for drug-eluting stents.
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. 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, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.