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Study Finds Taxus Express2 Paclitaxel-eluting Stent System Has Lower MACE Rate Than Cypher
Data show safety trend in favor of Taxus
NATICK, MA -- August 16, 2005 -- Boston Scientific Corporation today welcomed the results of an independent study demonstrating that Boston Scientific's Taxus(R) Express2(TM) paclitaxel-eluting stent system had lower incidents of major adverse cardiac events (MACE) than Johnson & Johnson's Cypher(R) sirolimus-eluting stent system.
The results of the study were published in the August 1 edition of the American Journal of Cardiology.
The study showed a safety trend in favor of Taxus over Cypher in the cumulative one-year MACE rate, the study's primary endpoint, which was 15.6 percent for Taxus versus 20.4 percent for Cypher.
Of the three MACE components, the results favored Taxus over Cypher in the cumulative rates of target vessel revascularization (TVR, or retreatment rate) (5.9 percent for Taxus versus 10.3 percent for Cypher) and myocardial infarction (10 percent for Taxus versus 14.1 percent for Cypher). For the third MACE component, cumulative mortality, the results were essentially equivalent (7.2 percent for Taxus versus 7.7 percent for Cypher).
"The major finding of this study is that unrestricted use of PESs [paclitaxel-eluting stents] in a universal drug-eluting stent environment is associated with a nonsignificantly lower incidence of major adverse cardiac events at one year compared with SESs [sirolimus-eluting stents]," according to the study.
"We are pleased that this new study reconfirms the strong safety profile of paclitaxel-eluting stent systems we have seen across our broad range of clinical trials as well as in approximately 1.5 million Taxus systems implanted to date," said Hank Kucheman, President of Boston Scientific's Interventional Cardiology business. "It is particularly impressive that the safety results demonstrated a trend in favor of the paclitaxel-eluting system among the challenging diabetic patient population in this study. Our focus on safety is one of the reasons Taxus is the worldwide market leader in drug- eluting stents."
The study, conducted at the Rotterdam Cardiology Hospital in The Netherlands, included 293 patients with diabetes and de novo coronary artery disease who were enrolled in identical sequential registries, one assessing the paclitaxel-eluting stents and one assessing the sirolimus-eluting stents.
SOURCE: Boston Scientific Corporation
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