Nov 13, 2001
Guidant Completes Enrollment Of First Drug-Eluting Stent Trial Utilizing Actinomycin-D

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced that it has completed enrollment of 360 patients in the international ACTION clinical trial. The trial supports Guidant's internal PHARMA-LINK(tm) Drug Eluting Stent Program utilizing Actinomycin-D. The first 90 patients from the ACTION trial, which were implanted as of Sept. 19, will serve as the basis for the filing of an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration, while the full 360 patient trial will serve as the basis for Guidant's submission for CE Mark approval in Europe.

"Guidant is extremely pleased and impressed with the dedication of the investigators participating in the ACTION trial," said Guido J. Neels, president, Guidant Europe. "Patient enrollment was completed ahead of target, which demonstrates the high interest level of the study participants."

"We are very excited to have fully enrolled the trial sooner than expected and look forward to reporting results in the near future," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "This milestone, coupled with our recent announcement of the start of the DELIVER clinical trial utilizing a paclitaxel-coated stent system, is further evidence of Guidant's rapid progress in bringing this therapy to patients with heart disease."

The ACTION (ACTinomycin-D Eluting Stent Improves Outcomes by Reducing Neointimal Hyperplasia) Trial, is evaluating Guidant's drug-eluting stent system in patients with de novo lesions in native coronary arteries. The trial enrolled the 360 patients at 28 centers in Europe, Australia, New Zealand, and Brazil. Professor Patrick Serruys, M.D., of Erasmus University and Thoraxcentre Hospital in Rotterdam, the Netherlands, is serving as principal investigator for the trial.

"I would like to thank all the investigators for their dedication and hard work, as it is a significant achievement to have 360 randomized patients enrolled in the study in just 96 days," commented Professor Serruys. "I am very impressed with the results I have seen to date and look forward to providing the initial results in six months."

"To date, there have been no reported deaths or subacute thrombosis (SAT) and the Data Safety and Monitoring Board (DSMB) has found no safety concerns," commented Capek.

The drug-eluting stent system utilized in the ACTION trial is one of two Guidant drug-eluting stent platforms currently in clinical trial. The second is the paclitaxel-coated ACHIEVE(tm) Stent System that will be developed and manufactured by Cook Incorporated. Guidant will be the exclusive worldwide distributor of the ACHIEVE Stent System. Other clinical trials have shown drug-eluting stents to be highly effective in preventing restenosis, the re-blocking of arteries following angioplasty and stenting.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.