Guidant's Carotid Artery Stenting Trials Demonstrate Positive Outcomes in High-Risk Patients as Alternative to Surgery to Reduce the Risk of Stroke

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Guidant's Carotid Artery Stenting Trials Demonstrate Positive Outcomes in High-Risk Patients as Alternative to Surgery to Reduce the Risk of Stroke
Results Presented Today at American College of Cardiology Conference in New Orleans

Indianapolis, Ind., and Santa Clara, Calif., March 7, 2004 — Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced positive results in the ARCHeR (ACCULINK for Revascularization of Carotids in High Risk Patients) series of clinical trials. The ARCHeR trials were designed to evaluate the safety and efficacy of carotid artery stenting as a minimally invasive alternative for treating carotid artery disease and reducing the risk of stroke in patients either ineligible or at high risk for surgery.

“We are pleased that the ARCHeR trials demonstrated that high-risk patients benefited from being treated with carotid artery stenting. We see this therapy as an alternative to the traditional invasive surgical treatment,” said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. “High-risk patients in these trials had a low rate of stroke, death and myocardial infarction. Guidant is committed to reducing the risk of stroke, which has serious health and economic consequences for the nearly 2 million people worldwide who suffer a stroke each year.”

Final one-year results for ARCHeR 1 and ARCHeR 2, and final 30-day results for ARCHeR 3 were presented today at the American College of Cardiology (ACC) Scientific Sessions 2004 meeting in New Orleans by William Gray, M.D., director of Endovascular Care at the Swedish Medical Center in Seattle, Wash., and an Executive Committee member overseeing the ARCHeR trials.

“Results from the ARCHeR trials point to the potential of carotid artery stenting as an effective therapy for the thousands of patients with carotid artery disease who, because of their risk and co-morbidity factors, are not well-treated by standard carotid surgery,” said Dr. Gray. “Carotid stenting appears poised to become a realistic treatment option for these high-risk patients.”

The ARCHeR Trials
These three trials treated high-risk patients and featured Guidant’s ACCULINK™ Carotid Stent Systems and ACCUNET™ Embolic Protection Systems, devices designed specifically for use in the carotid artery. The prospective, nonrandomized, single-arm trials enrolled 581 registry patients at 48 sites in North America, Europe and Argentina. The trials enrolled symptomatic patients with occlusions of 50 percent or greater and asymptomatic patients with occlusions of 80 percent or greater. All the patients had at least one risk factor that made them either ineligible for surgery or a high-risk surgical candidate, and approximately 42 percent of the patients had two or more of these risk factors.

Results of the trials:

ARCHeR 1 and 2: The trials enrolled 158 and 278 high-risk patients, respectively. Patients in ARCHeR 1 were treated with the over-the-wire ACCULINK Carotid Stent System. Patients in ARCHeR 2 received the over-the-wire ACCULINK Carotid Stent System and the over-the-wire ACCUNET Embolic Protection System, which is designed to trap particles of atherosclerotic plaque. The 12-month composite primary endpoint of all death, stroke and myocardial infarction (MI) in the first 30 days, plus any ipsilateral stroke (strokes in the same territory of the lesion) between 31 days and one year was 8.3 percent in ARCHeR 1 and 10.2 percent in ARCHeR 2. By comparison, the data associated with the high-risk surgical historical control group indicated a rate of incidence of these events of 14.5 percent.
ARCHeR 3: This trial enrolled 145 high-risk patients and was designed to show equivalence in the safety and performance of the next-generation rapid exchange (RX) versions of ACCULINK and ACCUNET with the first-generation over-the-wire devices used in ARCHeR 2. The combined death, stroke and myocardial infarction rate at 30 days was 8.3 percent, establishing equivalence with the devices used in ARCHeR 2.
Major Stroke or Death: An important safety parameter in any stroke prevention trial is the rate of major stroke and death. At 30 days, the rate of major stroke and death across ARCHeR 1, 2 and 3 was 3.8 percent, 2.5 percent, and 2.8 percent, respectively. From 31 days to one year, there were no major ipsilateral strokes in ARCHeR 1, and only one in ARCHeR 2.

CREST Trial for Lower-Risk Carotid Artery Disease Patients
In addition to the ARCHeR trials, Guidant is participating in the CREST (Carotid Revascularization Endarterectomy vs. Stent Trial) study of carotid artery stenting versus surgery in a patient population at lower risk than those studied in the ARCHeR trials. Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institutes of Health (NIH), CREST is a randomized clinical trial to evaluate the efficacy of carotid artery stenting as compared to carotid endarterectomy surgery in preventing stroke, myocardial infarction and death in the 30-day period immediately following the procedure, and ipsilateral stroke during a multi-year follow-up. Guidant supports CREST by supplying ACCULINK and ACCUNET devices that are used to treat patients enrolled in the trial. The University of Medicine and Dentistry of New Jersey is responsible for the IDE sponsorship, management of trial sites and all FDA submissions for CREST. Current Treatment Requires Incision in Neck

Carotid endarterectomy is currently the standard surgical method for restoring blood flow within the carotid arteries. It requires an incision in the patient's neck and artery to remove plaque and debris from inside the vessel wall, thereby reducing the incidence of an embolic stroke. Approximately 167,000 carotid endarterectomies are performed each year in the United States. About Carotid Artery Disease and Stroke

Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Approximately 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. An ischemic stroke can occur when carotid arteries become narrowed and when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the bloodstream and block vessels in the brain. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die. The lifetime cost of stroke exceeds $90,000 per patient in the United States. For more information, please visit www.guidant.com/carotidmediakit.

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 12,000 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.

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 to the company’s most recent 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements.

Guidant Corporation

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