Jul 14, 2003
New Study Shows Excellent Six-Month Results for Guidant's Market-Leading Small Vessel Stent

European Trial Demonstrates Low Restenosis Rate in Stenting of Small Vessels

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced results from the European Pixel Trial, a study evaluating the performance of the company''s MULTI-LINK PIXEL(tm) Small Vessel Stent System.

The European PIXEL Trial compared the restenosis rates of patients with first-time lesions whose vessels were expanded with a balloon catheter prior to stent implantation (pre-dilatation) versus those who received direct stenting with a MULTI-LINK PIXEL stent (without pre-dilatation). The study demonstrated six-month restenosis (artery re-blockage) rates of 25.0 percent for the patients in the pre-dilatation group, compared to 16.0 percent for those patients who received direct stenting.

Additionally, the major adverse cardiac events (MACE) rate at six months was 6.2 percent for the PIXEL direct-stenting group and the study''s six-month, clinically driven target lesion revascularization rate was 3.4 percent for the PIXEL direct stenting. MACE is a commonly-used, composite measure of safety that accounts for adverse cardiovascular events in clinical trials.

Approximately 20 percent of atherosclerotic lesions (narrowing or blockage of arteries caused by a build-up of fat, or plaque, within the artery wall) occur in small vessels, which can be more difficult to treat due to the location of the lesions and the possibility that abrupt closure may occur. Approximately 375,000 patients worldwide are expected to be treated with small vessel stents this year.

"We are pleased to report these excellent results for the MULTI-LINK PIXEL as they make a very strong case for direct stenting in small vessels," said Eulogio Garcia, M.D., Hospital Gregorio Maranon, Madrid, Spain, and lead investigator of the European PIXEL Trial. "Some physicians have chosen not to implant stents in small vessel cases because of high restenosis rates, choosing balloon angioplasty instead. These compelling results may lead to a change in that strategy."

"The excellent results of this MULTI-LINK PIXEL study clearly demonstrate the importance of innovative stent and delivery system technology designed for specific lesions," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant Corporation. "These results set the stage for our next advance in small vessel stent technology, the thin-strut, cobalt chromium MULTI-LINK MINI VISION(tm) Coronary Stent System, which again leverages the clinically proven MULTI-LINK design."

The European PIXEL study, a randomized trial, enrolled 350 patients with atherosclerotic lesions in vessels with diameters of 2.2 mm to 2.7 mm at 28 hospitals across Europe, South America, India and New Zealand. Results from the study were presented by Dr. Garcia at the Paris Course on Revascularization (EuroPCR) in Paris in May 2003.

In the U.S., the MULTI-LINK PIXEL is indicated for small vessels in patients presenting with abrupt or threatened abrupt closure, and pre-dilatation with a PTCA catheter is required.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 employees, 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.