Interventional device developer Boston Scientific of Natick, MA, presented the nine-month results of its Taxus IV paclitaxel-eluting stent clinical trial at the Transcatheter Cardiovascular Therapeutics symposium in Washington, DC.
The randomized, double-blind trial is designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent system in reducing restenosis in de novo lesions 10 mm-28 mm in length and 2.5 mm-3.75 mm in diameter using the firm’s Taxus Express coronary stent system.
The company reported a target-lesion revascularization rate of 3% in the Taxus group compared with 11.3% in the control group, which used an Express bare-metal stent. The target-vessel revascularization rate was said to be 4.7% compared with 12% in the control group.
The study reported an in-segment binary restenosis rate of 7.9% in the Taxus group compared with 26.6% in the control group and an in-stent binary restenosis rate of 5.5% in the Taxus group compared with 24.4% in the control group. The firm said that diabetic patients in the Taxus group had an in-segment binary restenosis rate (6.4%) similar to that of the Taxus group in the overall population (7.9%).
Boston Scientific said that its results supported safety as demonstrated by low rates of major adverse cardiac events (MACE), which include death, myocardial infarction, and target-vessel revascularization. The study reported an 8.5% MACE rate at nine months in the Taxus group compared with 15% in the control group.
By AuntMinnie.com staff writersSeptember 16, 2003
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