Under the new Dublin/Academic Research Consortium (ARC) definition of late-stent thrombosis (blood clotting events in stents), which was developed to eliminate variability in the definitions across various drug-eluting stent trials, the late stent thrombosis rate with XIENCE V in the SPIRIT II trial out to one year was zero percent for XIENCE V (0/220 patients treated with XIENCE V) and 1.3 percent for TAXUS (1/76 patients treated with TAXUS). The number of late stent thromboses in the SPIRIT FIRST trial, which compared XIENCE V to the MULTI-LINK VISION® metallic stent, remained zero for patients receiving XIENCE V out to two years of clinical follow-up.

"The statistically significant reduction in major adverse cardiac events that we see in patients treated with XIENCE V in our SPIRIT III U.S. trial is consistent with the reduced MACE rates reported today from our SPIRIT II European trial," said John M. Capek, Ph.D., senior vice president, Abbott Vascular. "Across both of these trials, the risk of cardiac death, heart attack or re-treatment in the diseased artery area in patients was approximately two to three times lower with XIENCE V than with TAXUS."


About XIENCE V

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 expects to submit XIENCE V for U.S. FDA approval in the second quarter of 2007.

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

About the SPIRIT Family of Trials

SPIRIT FIRST was a first-in-man study comparing the XIENCE V Everolimus Eluting Coronary Stent System with the MULTI-LINK VISION bare metallic stent system. SPIRIT FIRST demonstrated positive results with one MACE event at one year and no additional MACE events out to two years. SPIRIT II is a 300-patient randomized, single-blind, prospective clinical trial evaluating XIENCE V versus TAXUS in Europe and Asia Pacific. SPIRIT III is a large-scale pivotal clinical trial comparing XIENCE V to TAXUS in the United States and Japan. SPIRIT IV is currently enrolling patients and will evaluate the safety and efficacy of XIENCE V for the treatment of coronary artery disease in a more complex patient population in the United States. SPIRIT V is an international clinical trial that will provide additional clinical experience with XIENCE V in approximately 3,000 patients at 100 clinical sites throughout Europe, Asia, Canada and Latin America. SPIRIT WOMEN is the world's first drug-eluting stent trial to study only women and will evaluate the characteristics of women undergoing stent implantation as well as the performance of XIENCE V in those patients in Europe, Asia-Pacific, Canada and Latin America.


Back to HCB News

More Industry Headlines