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Investigators Report COSTAR II Pivotal Drug-Eluting Stent Trial,Results at EuroPCR 2007

BARCELONA, Spain, May 22, 2007 /PRNewswire/ -- Principal investigators for the COSTAR II (CObalt Chromium STent with Antiproliferative for Restenosis) trial, the pivotal study for the CoStar(R) cobalt chromium paclitaxel-eluting coronary stent, presented today the clinical trial results of the study at EuroPCR 2007. The investigators confirmed that the study failed to meet its primary endpoint. Conor previously announced this conclusion in a press release on Monday, May 7, 2007.

The COSTAR II trial compared the CoStar(R) stent with the Taxus Express(2) paclitaxel drug-eluting stent, and was designed to demonstrate non-inferiority at eight-month follow-up with respect to major adverse cardiac events (MACE) in patients with multi-vessel or single-vessel disease. In this trial, MACE was defined as a composite of clinically driven target vessel revascularization (re-treatment), new myocardial infarction (heart attack or MI) related to the target vessel and cardiac death related to an intervened vessel.

At eight-month follow-up, the CoStar(R) stent had significantly higher MACE rate than the Taxus stent (11.0 percent vs. 6.9 percent; p=0.005). This difference was largely due to a significantly higher incidence of clinically driven target vessel revascularization (8.1 percent vs. 4.3 percent; p=0.002). No significant differences were found in terms of cardiac death (0.5 percent for the CoStar(R) stent vs. 0.7 percent for the Taxus stent; p=0.541) or new MI (3.4 percent vs. 2.4 percent; p=0.242).

The investigators also reported that the protocol-defined stent thrombosis rates at nine-month were similar between both arms of the study. The total stent thrombosis rate for the CoStar(R) stent was 0.6 percent vs. 0.1 percent for the Taxus stent (p=0.252).

"Comparably higher re-intervention rates are largely responsible for the outcome of this trial," said Mitchell W. Krucoff, M.D., from Duke Cli
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