Mar 30, 2003
Guidant Announces Preliminary 30-Day Results of Study of Carotid Artery Stenting as Alternative Treatment for High Surgical-Risk Patients

Study Evaluates Potential New Minimally Invasive Treatment for Carotid Artery Disease

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced preliminary 30-day results of the ARCHeR trial, a study designed to evaluate the safety and efficacy of carotid artery stenting as a minimally invasive alternative for treating carotid artery disease in patients ineligible for surgery or at high surgical-risk.

"The ARCHeR clinical is a key study in Guidant's efforts to establish a minimally invasive alternative to the traditional surgical method used to treat patients with carotid artery disease. We are encouraged by the 30-day results of the study," said Beverly Huss, president, Endovascular Solutions, Guidant Corporation.

"We are pleased to report that the 30-day findings of the trial are very promising," said co-principal investigator Mark H. Wholey, M.D., Chairman of the Pittsburgh Vascular Institute in Pittsburgh, Pa. "We hope that when available, the long-term results of the ARCHeR study will establish less-invasive carotid stenting as an important therapy for this large group of patients suffering from carotid artery disease who are not well-treated by standard carotid surgery."

The preliminary 30-day ARCHeR results were presented today at the American College of Cardiology meeting in Chicago and the Society of Interventional Radiology meeting in Salt Lake City. In patients enrolled in the study, the 30-day total major adverse event (MAE) rate - defined as all-cause stroke, death and myocardial infarction - was 7.8 percent. ACCULINK device success, defined as successful deployment of the stent and less than 50 percent residual stenosis, was 97.8 percent. Device success for the ACCUNET - successful delivery, placement and retrieval - was 92.7 percent.

In the ARCHeR trial, all of the patients had at least one risk factor that made them a poor surgical candidate and approximately 45 percent of the patients had two or more of these risk factors. "These early results are an encouraging indicator that we may be able to offer carotid artery stenting as an alternative treatment option to high-risk patients who, because of their co-morbidities or other factors, would have had poor outcomes from traditional surgery," said L. Nelson Hopkins, M.D., Professor and Chairman of Neurosurgery at the State University of New York at Buffalo and co-principal investigator for the ARCHeR clinical trial. Patients with carotid artery disease are at risk for stroke, the third-most common cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association.

The ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk Patients) trial is a prospective, non-randomized, multi-center, single-arm study that enrolled 437 registry patients at 41 sites in North and South America. Patients were implanted with Guidant's investigational ACCULINK(tm) Carotid Stent System, designed specifically for the treatment of atherosclerotic lesions in the internal carotid artery, one of the vessels that distributes blood to the brain. During the latter phase of the trial, 278 patients were treated with the ACCULINK Stent System in combination with Guidant's investigational ACCUNET® Embolic Protection System, which is designed to trap particles of atherosclerotic plaque that might be released during the procedure and may lead to stroke and other complications. The ARCHeR primary endpoints are 1) combined 30-day MAE and ipsilateral stroke between days 31 and 365, and 2) ACCUNET device success. Patient follow-up in the trial is ongoing.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for a 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.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company''s newsroom at www.guidant.com/newsroom.

This release includes forward-looking statements concerning trial results and development of the therapy. The statements are based on assumptions about many important factors, including final trial results, continuing clinical and regulatory developments, and other factors identified on Exhibit 99.1 to the company''s most recent 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements.