Nov 15, 2005
Guidant Reports Excellent 12-Month Results from SPIRIT FIRST Everolimus Eluting Coronary Stent Clinical Trial

Results Demonstrate Sustained Benefit of the XIENCE V Everolimus Eluting Coronary Stent System

Indianapolis, Ind., and Dallas, Texas - Guidant Corporation (NYSE: GDT) today announced 12-month adjudicated results from the company''s SPIRIT FIRST clinical trial. SPIRIT FIRST is a prospective, randomized, single-blind trial evaluating Guidant''s rapid-exchange XIENCE(tm) V Everolimus Eluting Coronary Stent System versus an uncoated MULTI-LINK VISION® Coronary Stent System control in de novo (previously untreated) lesions.

"The trial''s impressive results demonstrate the sustained efficacy of the XIENCE V Everolimus Eluting Coronary Stent System," said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, who serves as the study''s principal investigator. "The benefit of an everolimus drug eluting stent, with only one device-related MACE event and no thrombotic events, combined with the highly deliverable rapid-exchange VISION stent and stent delivery system, holds great promise for the treatment of patients with cardiovascular disease."

The one-year data from SPIRIT FIRST continued to demonstrate a preservation of the treatment effect of the XIENCE V Everolimus Eluting Coronary Stent System, with a highly statistically significant reduction of cell proliferation compared to the uncoated control. At one year, the XIENCE V arm demonstrated an angiographic in-stent late loss of 0.23 mm and an in-segment late loss of 0.13 mm, which were 72 percent and 78 percent less, respectively, than the values of the uncoated control (0.81 mm and 0.59 mm). The percent volume obstruction as determined by intravascular ultrasound at one year was 10.7 percent, which was 60 percent less than the control value (26.9 percent).

There were no acute or late stent thromboses reported through the one-year follow-up period. The rate of major adverse cardiac events (MACE) was 15.4 percent (4/26) at one year, compared with 21.4 percent (6/28) for the control. Three of the four MACE events in the treatment arm were not directly related to the XIENCE V Stent, resulting in a device-related MACE rate of 3.8 percent, compared with 21.4 percent for the control. Results were presented today at the American Heart Association Scientific Sessions in Dallas by Prof. Jan J. Piek, M.D. of the Academic Medical Center, Department of Cardiology, University of Amsterdam.

"Everolimus has clearly proven its effectiveness in reducing tissue proliferation in the coronary vessels following stent implantation. We are excited about combining this unique drug with the proven MULTI-LINK VISION, our most advanced coronary stent system, which is available on the rapid-exchange platform physicians prefer," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "We look forward to additional data on this exciting product coming from both SPIRIT II and SPIRIT III. SPIRIT II completed enrollment of 300 patients ahead of schedule last week, and enrollment is proceeding nicely in SPIRIT III as well, with more than 400 patients enrolled to date."

SPIRIT II and SPIRIT III are large-scale pivotal clinical trials evaluating the safety and efficacy of Guidant''s drug eluting stent system for the treatment of coronary artery disease. These prospective, randomized, single-blind trials compare XIENCE V, an everolimus eluting coronary stent system utilizing Guidant''s cobalt chromium MULTI-LINK VISION Coronary Stent System platform, versus the TAXUS® Express 2(tm) Paclitaxel Eluting Coronary Stent System.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.