Boston Scientific (BSC) announced the final, six-month results of its TAXUS II paclitaxel-eluting stent clinical trial. It is BSC''s first large drug-eluting stent trial, and the results convincingly demonstrated both safety and efficacy in reducing coronary restenosis. The results were consistent with those of other TAXUS trials and were in line with expectations, as stated by the company.
The TAXUS II trial consists of two sequential cohorts: a slow-release formulation and moderate-release formulation. For both cohorts, the significant reduction in the primary endpoint - six-month, percent in-stent volume obstruction as assessed by intravascular ultrasound (IVUS) - indicates that polymer-based, local delivery of paclitaxel interrupts the restenotic process. Significant improvements were also shown in clinical and angiographic endpoints.
"This highly anticipated data strongly confirms previous clinical results showing paclitaxel''s ability to safely and effectively reduce restenosis in a large patient population," said William L. Hunter, chairman and CEO of Angiotech. "Today''s positive results proves, unequivocally, paclitaxel''s strength as a prominent competitor in the drug-eluting stent market."
BSC has acquired worldwide co-exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and other vascular and non-vascular products. Paclitaxel, at cytostatic doses, has demonstrated promising results in preclinical and clinical studies for reducing the processes leading to restenosis.
TAXUS II is a 536-patient randomized, double-blind, multi-center, international study designed to assess the safety and efficacy of a paclitaxel- eluting coronary stent in reducing restenosis in de novo lesions up to 12 mm in length and 3.5 mm in diameter.
Data from this trial is being used to support BSC''s submission for a CE Mark for its TAXUS paclitaxel-eluting stent system, which will use an Express stent, BSC''s internally developed stent approved earlier this month by the U.S. Food and Drug Administration and granted CE Mark last year.
The TAXUS program is a series of clinical studies designed to collect data on BSC''s proprietary paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Paclitaxel, the active component of the popular chemotherapeutic agent Taxol, has demonstrated promising results in preclinical and clinical studies for reducing the processes leading to restenosis. BSC initiated the TAXUS program in 1997.
The TAXUS I trial reported zero thrombosis and zero restenosis. Clinical follow-up through 12 months continues to show favorable results with no additional TLR''s and no sub-acute thrombosis six months after termination of Plavix, an anti-platelet therapeutic commonly used following stenting procedures.
The TAXUS III trial studied the treatment of in-stent restenosis and also confirmed safety with no thrombosis. The study reported encouraging efficacy data as well.
The TAXUS IV trial is studying more than 1,200 patients in the United States, assessing the safety and efficacy of the slow-release formulation. This trial is also using the Express stent.
The TAXUS VI trial is an international trial studying more than 400 patients with complex coronary artery disease. It is designed to establish the safety and efficacy of the moderate-release formulation.
The comprehensive TAXUS program positions BSC to launch paclitaxel- eluting stents in Europe this year and in the United States in 2003, as stated by BSC.