announced positive results from two trials of its coronary stents Tuesday.
The Natick, Mass., company released follow-up safety and efficacy data from its Taxus V and Taxus VI clinical trials of slow-release and moderate-release versions of its drug-eluting stents.
Stents are metal tubes that prop open arteries after surgery. The Taxus Express2 is coated with the drug paclitaxel, which is released to prevent the artery from narrowing. The Taxus V trial of the Express2 expands on the Taxus IV pivotal trial by including higher-risk patients, such as those with small vessels, large vessels and long lesions that require multiple overlapping stents.
The trial involved 1,172 patients at 66 sites in the U.S., assessing the safety and efficacy of a slow-release version of the paclitaxel-eluting stent. In the trial, 13.2% of patients with the Taxus Express2 stent experienced blockage after nine months, compared with 31.8% in the control group.
Boston Scientific's two-year follow-up data from its Taxus VI clinical trial showed that patients given the moderate-release stent saw a lesion revascularization rate of 9.7% compared with 21% for the control group.
Safety and efficacy benefits were maintained at two years, and even with a dosing rate eight to 10 times higher than the slow-release stent, there was no compromise in safety, the company reported.
The Taxus VI trial involved 448 high-risk patients, including patients with long lesions with overlapping stents, small vessels or diabetes.
"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," said Paul LaViolette, COO of Boston Scientific.
Boston Scientific launched the slow-release Taxus Express2 stent in the U.S. in March 2004. The moderate-release version of the stent hasn't been approved for commercial distribution.