Abbott's XIENCE V Everolimus Eluting Coronary Stent Shows Continued Superiority to Taxus Stent in Reducing Major Adverse Cardiac Events

26/10/07 Data presented from Abbott’s SPIRIT III U.S. pivotal clinical trial demonstrated continued positive, statistically significant clinical results for the XIENCE V Everolimus Eluting Coronary Stent System at one year, 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. The results were presented at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington D.C.

These results follow the data presented earlier this year at the annual American College of Cardiology conference, wherein XIENCE V demonstrated superiority to TAXUS in the SPIRIT III trial 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. (In-segment late loss is a measure of vessel renarrowing).

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 is an important clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).

* In 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. Target Vessel Failure is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack.

* 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 results from XIENCE V represent an important advancement for patients with coronary artery disease,” said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "As a next generation drug eluting stent, XIENCE V continues to demonstrate longer-term safety and consistently superior efficacy results across the SPIRIT trials with the potential to raise the bar for all DES."