Sep 30, 2002
Guidant Announces Preliminary Results of Largest Drug Eluting Stent Trial To Date

Early Data from 1,533-Patient Trial Supports Safety of Paclitaxel Eluting Stents In High-Risk Patients

Indianapolis, Ind. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced preliminary results from the first cohort of patients enrolled in the DELIVER II Clinical Trial, a clinical study designed to evaluate the benefit of the paclitaxel-coated ACHIEVE(tm) Drug Eluting Coronary Stent System in patients with lesions at high risk of restenosis. The trial enrolled 1,533 patients, including patients with chronic total occlusions, bifurcations, long lesions, small vessels, diabetes, multi-vessel disease and in-stent restenosis.

The DELIVER II Clinical Trial reported a 30-day major adverse cardiac events (MACE) rate of 3 percent for the first 500 patients enrolled in the trial. The MACE rates include any deaths, myocardial infarctions and target lesion revascularization within the 30-day period.

"In such a high-risk population, 30-day MACE rates between 10 and 20 percent are the norm. Achieving such a low event rate is a tribute to the MULTI-LINK PENTA Stent that provides the platform for the ACHIEVE Stent System''s paclitaxel coating," said Prof. Eberhard Grube from the Herzzentrum Siegburg, principal investigator for the study, who presented the preliminary DELIVER II results at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference on Saturday, September 28, in Washington, D.C. "Preliminary clinical data from the DELIVER II trial supports the benefit of paclitaxel eluting stents in high risk patients."

"As the first and largest trial evaluating a drug eluting stent in a high-risk patient population, DELIVER II presents an opportunity to advance knowledge about the benefit of paclitaxel eluting stents for the treatment of coronary artery disease in the most challenging clinical settings," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "We are pleased with the low MACE results for the first cohort of patients enrolled in the DELIVER II Clinical Trial."

The DELIVER II Clinical Trial is an unblinded, non-randomized trial that will follow patients implanted with the ACHIEVE Stent System for a period of up to three years. The primary endpoint of the study is the target lesion revascularization rate, a measure of long-term clinical success. The study also will report on a number of secondary endpoints including safety, device success and cost effectiveness. The trial completed enrollment in 76 centers outside the United States on September 9, 2002, less then 17 weeks after product was made available to sites.

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 more than 10,000 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.