XIENCE V One Year Data Presented at TCT 2007

You don't need to be Editor-In-Chief to add or edit content to WikiDoc. You can begin to add to or edit text on this WikiDoc page by clicking on the edit button at the top of this page. Next enter or edit the information that you would like to appear here. Once you are done editing, scroll down and click the Save page button at the bottom of the page.

C. Michael Gibson, M.S., M.D. October 22, 2007

WASHINGTON, D.C.: Data presented today from the SPIRIT III trial demonstrate sustained one year benefits for the XIENCE(TM) V Everolimus Eluting Coronary Stent System, including continued clinical superiority in major adverse cardiac events (MACE) and continued non- inferior rates of target vessel failure (TVF) with XIENCE V compared to the TAXUS® paclitaxel-eluting coronary stent system.

These results build upon angiographic data presented earlier this year at the annual American College of Cardiology conference. At that time, the XIENCE V demonstrated superiority to TAXUS in the SPIRIT III trial with respect to the study's primary endpoint of in-segment late loss at eight months with a statistically significant 50 percent reduction in late loss compared to TAXUS.

The SPIRIT III clinical trial of 1,002 patients demonstrated the following key results for XIENCE V at one year:

• In an analysis of major adverse cardiac events (MACE), XIENCE V demonstrated clinical superiority to TAXUS with a statistically significant 43 percent reduction in MACE compared to TAXUS at one year. * These MACE results are consistent with the clinically superior 44 percent reduction in MACE observed for XIENCE V at nine months. MACE was defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization.
• With respect to the major secondary endpoint of Target Vessel Failure (TVF), XIENCE V continued to demonstrate statistical non-inferiority to TAXUS with an observed 23 percent reduction in Target Vessel Failure for XIENCE V compared to TAXUS (8.3 percent XIENCE V, 10.8 percent TAXUS) at one year.
• There was no evidence of a difference in either acute (30 day) or late thrombosis rates between XIENCE V and TAXUS out to one year.

"To date, XIENCE V is the only drug-eluting stent system that has demonstrated a statistically significant improvement in event-free survival compared to another FDA approved drug-eluting stent in a pivotal randomized clinical trial," 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. "In SPIRIT III, the risk for patients on the important clinical endpoint of MACE -- cardiac death, heart attack or retreatment in the diseased artery area -- was approximately 43 percent lower with XIENCE V than TAXUS at 1 year. A reduction in MACE with Xience V compared to TAXUS was also present at 1 year in the smaller SPIRIT II trial, demonstrating that this is a robust, reproducible difference."

There was no evidence of a statistical difference between rates of stent thrombosis for XIENCE V or TAXUS out to one year in the SPIRIT III trial. Rates of late stent thrombosis at one year per protocol were 0.3 percent for XIENCE V and 0.6 percent for TAXUS. Rates of definite/probable late stent thrombosis at one year under ARC definition were 0.5 percent for XIENCE V and 0.6 percent for TAXUS.

A variety of SPIRIT III subgroup analyses showed additional observational evidence of favorable clinical and angiographic results for XIENCE V; however, the trial was not designed to analyze statistical differences in any of the sub-groups, including diabetic patients.

The XIENCE V system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION coronary stent platform.

XIENCE V was launched in Europe and Asia Pacific in 2006. XIENCE V is currently an investigational device in the United States and Japan. Results from the SPIRIT III trial are intended to support U.S. Food and Drug Administration (FDA) approval of the XIENCE V Stent System and Ministry of Health and Welfare approval in Japan. Abbott anticipates receiving XIENCE V U.S. FDA approval in the first half of 2008.

Abbott supplies a private-label version of XIENCE V, called the PROMUS(TM) Everolimus-Eluting Coronary Stent System, to Boston Scientific as part of a distribution agreement established between the two companies last year.

SPIRIT FIRST was a first-in-man study comparing the XIENCE V Everolimus Eluting Coronary Stent System with the MULTI-LINK VISION metallic stent system. SPIRIT FIRST demonstrated positive results with one MACE event at one year and no additional MACE events out to three years. In addition, the number of late stent thromboses in the XIENCE V arm of the SPIRIT FIRST trial was zero out to three years of clinical follow-up.

SPIRIT II was a 300-patient randomized, single-blind, prospective clinical trial evaluating XIENCE V versus TAXUS in Europe and Asia Pacific, in which XIENCE V demonstrated superiority in the primary endpoint of in-stent late loss at 6 months, and clinical superiority on MACE with a 71 percent reduction compared to TAXUS at one year.

SPIRIT III is a large-scale pivotal clinical trial comparing XIENCE V to TAXUS in the United States and Japan that demonstrated superiority to TAXUS in the on the study's primary endpoint of in-segment late loss at eight months with a statistically significant 50 percent reduction in late loss compared to TAXUS.

Source:

Abbott Press Release

Acknowledgement and Attribution Regarding Sources of Content

Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .