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Pivotal Stent Trial Results Announced

by Barbara Kram, Editor | March 27, 2007
Abbott XIENCE™ V Everolimus
Eluting Coronary Stent

Click to enlarge
Abbott Park, Illinois - Data presented from Abbott's SPIRIT III U.S. pivotal clinical trial at the American College of Cardiology's 56th Annual Scientific Session in New Orleans demonstrated the following key results:

* The randomized SPIRIT III trial of 1,002 patients comparing Abbott's next-generation XIENCE™ V Everolimus Eluting Coronary Stent System with the TAXUS® paclitaxel-eluting coronary stent system met both its primary endpoint and major secondary endpoint.

* In its primary endpoint of in-segment late loss at eight months, XIENCE V demonstrated superiority to TAXUS with a statistically significant 50 percent reduction in late loss compared to TAXUS (0.14 +/- 0.41 mm XIENCE V, 0.28 +/- 0.48 mm TAXUS, p superior =0.004). In-segment late loss is a measure of vessel renarrowing.
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* In its major secondary endpoint of Target Vessel Failure at nine months, XIENCE V demonstrated non-inferiority to TAXUS with an observed 21 percent reduction in Target Vessel Failure for XIENCE V compared to TAXUS (7.2 percent XIENCE V, 9.0 percent TAXUS, p non-inferior <0.0001). Target Vessel Failure is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack.

* Subsequent to SPIRIT III meeting its primary and major secondary endpoints, an analysis of nine-month Major Adverse Cardiac Events (MACE), such as cardiac death, heart attack or target lesion revascularization (artery re-treatment due to lack of blood supply) was undertaken in which XIENCE V demonstrated superiority to TAXUS with a statistically significant 44 percent reduction in MACE at nine months compared to TAXUS (4.6 percent XIENCE V, 8.1 percent TAXUS, p superior =0.028).

"Not only did the SPIRIT III trial meet its primary and major secondary endpoints, but it showed a statistically significant reduction in major adverse cardiac events, favoring XIENCE V," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, principal investigator of the SPIRIT III clinical trial, who presented the results today. "The enhanced freedom from adverse events with XIENCE V, coupled with its low profile, makes the XIENCE V stent an important advance for patients with coronary artery disease."

One-Year SPIRIT II European Clinical Trial Results Demonstrate Continued Safety with XIENCE V; Zero Late Stent Thrombosis in SPIRIT FIRST and SPIRIT II Under New ARC Definition

In the important clinical endpoint of MACE, one-year follow-up results from 300 patients enrolled in Abbott's randomized SPIRIT II European clinical trial demonstrated superiority for XIENCE V compared to TAXUS in an additional analysis with a statistically significant 71 percent reduction in major adverse cardiac events for XIENCE V-treated patients compared to TAXUS-treated patients (2.7 percent XIENCE V, 9.2 percent TAXUS, p superior =0.04). These data are available in an online poster session to registrants of the American College of Cardiology's 56th Annual Scientific Session.