Nov 21, 2002
Landmark Heart Failure Therapy Study Sponsored by Guidant Achieves Primary Endpoint

COMPANION Study Stopped Due to Significant Reduction in Combined All-Cause Mortality and All-Cause Hospitalization Cardiac Resynchronization Therapy Defibrillator Arm Demonstrated Significant Reduction in All-Cause Mortality Guidant to Host Webcast Later Today

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today reported that the COMPANION investigative team announced the termination of a landmark trial called Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION).

COMPANION is a prospective, multi-center, randomized study of patients with advanced heart failure (NYHA Class III or IV). The patients studied in this trial had a poorly functioning left ventricle, the heart's main pumping chamber. The study enrolled more than 1,600 patients at 130 centers in the United States. The COMPANION study used Guidant''s CONTAK TR(tm) cardiac resynchronization therapy (CRT-P) and CONTAK CD® cardiac resynchronization therapy defibrillator (CRT-D) in the device treatment arms.

Michael R. Bristow, M.D., Ph.D., University of Colorado Health Sciences Center, and Arthur M. Feldman M.D., Ph.D., Jefferson Medical College, co-chaired the study.

"Previous trials have demonstrated that cardiac resynchronization therapy (CRT) devices improve exercise performance and quality of life. The COMPANION study demonstrated that the cardiac resynchronization therapies provide a clinically significant reduction in combined mortality and hospitalization," said Dr. Bristow. "Additionally, the cardiac resynchronization defibrillator (CRT-D) arm demonstrated a significant reduction in all-cause mortality. This is the first chronic, long-term implantable device trial to demonstrate these benefits in an advanced heart failure population."

"These extraordinary new findings for such a critical disease should significantly impact the well being and care of patients with heart failure," said Dr. Feldman.

COMPANION was designed with predetermined stopping rules. Termination was recommended by the independent Data and Safety Monitoring Board (DSMB) to the COMPANION investigative team due to achievement of the primary endpoint. The prospectively defined primary endpoint was combined all-cause mortality and all-cause hospitalization. The COMPANION study compared heart failure patients receiving optimal medical treatment to those receiving implantable cardiac resynchronization therapies plus optimal medical treatment.

Guidant plans to submit results of the COMPANION study to the FDA and international regulatory agencies for its implantable cardiac resynchronization devices. Additional indications for use of these devices, if approved, could significantly expand the eligible patient population.

The COMPANION study design can be referenced in the Journal of Cardiac Failure 2000:6:3; 276-285. COMPANION''s investigative team expects to present and publish the study findings in early 2003.

The COMPANION study is sponsored by Guidant Corporation. Guidant has a strong heritage of sponsoring landmark clinical trials designed to answer critical clinical questions about long-term treatment outcomes for cardiovascular disease. Other Guidant sponsored trials include MADIT II, MADIT and CADILLAC.

Webcast

Guidant will conduct a webcast today, November 21, at 4:30 p.m. EST to discuss the COMPANION trial. The webcast will be hosted by Fred McCoy, president, Guidant Cardiac Rhythm Management. The webcast will feature COMPANION co-chairmen Michael Bristow, M.D., Ph.D., and Arthur Feldman, M.D., Ph.D.

Guidant''s live webcast 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. 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 contains forward-looking statements concerning the therapy and the eligible patient population. The statements are based on assumptions about many important factors, including regulatory timelines and approvals, continuing product developments, and other factors identified on Exhibit 99.1 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update it forward-looking statements.

System requirements for the webcast include Internet Explorer 5.0 (or higher) or Netscape Navigator 4.0 (or higher). Users also should have the most recent version of Windows Media Player, which can be downloaded for free at http://www.microsoft.com/windows/windowsmedia/en/download/. Users may experience varying levels of performance based on their connection speed, system capabilities and presence of a corporate firewall. To ensure a connection, users should go to the program five to 15 minutes before its start.