May 23, 2002
Guidant Announces Excellent Preliminary Results of Paclitaxel Eluting Stent Trial

DELIVER and ELUTES Data Continue to Support Benefit of Paclitaxel Eluting Stents

Indianapolis, Ind. and Paris - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced preliminary results from the DELIVER Clinical Trial, a single-blinded, randomized study comparing the paclitaxel-coated ACHIEVE(tm) Drug Eluting Coronary Stent to an uncoated bare-metal control stent.

The DELIVER Clinical Trial reported a 30-day major adverse cardiac events (MACE) rate of 0.8 percent, consistent with MACE rates previously observed in Guidant's family of stents. Group A, enrolling 524 patients, reported a 1.2 percent MACE rate at 30 days; Group B, enrolling 519 patients, reported a MACE rate of 0.4 percent. The MACE rates include any deaths, myocardial infarctions and target lesion revascularization within the 30-day period. Additionally, Guidant reported a sub-acute thrombosis rate of 0.2 percent in both arms, also within 30 days. Because the study is blinded, it is not known at this time which group received the ACHIEVE Stent System and which group received the control stent.

"The excellent 30-day MACE data from the DELIVER study are encouraging, and we look forward to reporting eight-month angiographic and nine-month clinical follow-up," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "As we've seen from the data recently reported at EuroPCR, stent and delivery system technology will be important in determining the overall performance of drug eluting stents. As this breakthrough technology evolves, we anticipate that drug eluting stents that leverage state-of-the-art stent design and delivery system technology will provide opportunities for significant improvements in clinical performance."

William Knopf, M.D., of St. Joseph's Hospital in Atlanta, Ga., co-principal investigator of the trial, presented the DELIVER results today at EuroPCR (Paris Course on Revascularization), the leading annual international meeting of interventional cardiologists that takes place through May 24, 2002.

"These promising preliminary results add to the growing repository of clinical data demonstrating the potential benefit of paclitaxel eluting stents for treating coronary artery disease," said Dr. Knopf.

The 12-month results from Cook's ELUTES Clinical Study reported today continue to support the benefit of paclitaxel in drug eluting stents utilizing Cook's proprietary drug coating technology. The study reported no late thrombosis, death or Q-wave myocardial infarctions. Additionally, 12-month target lesion revascularization was reported as 5 percent in the 2.7 µg/mm2 arm of the study, compared to 16 percent in the control arm.

The DELIVER Clinical Trial is designed to serve as the basis for Guidant's submission for U.S. Food and Drug Administration (FDA) approval of the ACHIEVE Stent System on behalf of Cook Incorporated. The new ACHIEVE Drug Eluting Coronary Stent System is manufactured by Cook Incorporated and will be distributed worldwide exclusively by Guidant. Enrollment of 1,043 patients in the study was completed in early March, in less than four months.

Guidant will host an investor briefing at EuroPCR tomorrow, Friday, May 24, at 11:00 a.m. Paris time/5:00 a.m. EDT. The briefing will be hosted by Guido Neels, president, Europe, Middle East, Africa and Canada, Guidant, and John Capek. Also in attendance will be a panel of interventional cardiologists including Tony Gershlick, M.D. (Leicester, Britain) and Dr. Knopf. A live webcast of Guidant's conference call will be accessible through Guidant's website at www.guidant.com/webcast or at CCBN's individual investor center at www.companyboardroom.com. The webcast will be archived on both websites for future on-demand replay.

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.

Top