Oct 19, 2000
New Data Establishes Stenting as an Effective Treatment for Heart Attack Victims

Indianapolis, Ind. and Santa Clara, Calif. - Clinical data from a recent clinical trial sponsored by Guidant Corporation (NYSE and PCX: GDT) demonstrate that coronary stenting is a safe and effective treatment for patients who have recently suffered heart attacks. FDA review and approval is anticipated at a future date. The research was presented today by Gregg W. Stone, M.D., FACC, of the Lenox Hill Hospital in New York, at the 12th annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C.

The study, named CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications), was designed to compare several methods of treatment for heart attack. Patients in the trial were separated into four arms, which compared clinical outcomes of treatment with Guidant''s MULTI-LINK® and MULTI-LINK DUET(tm) Coronary Stent Systems, with and without the anti-clotting drug ReoPro® (abciximab), to treatment with percutaneous transluminal coronary angioplasty (PTCA), with and without ReoPro. The CADILLAC study is the largest interventional trial of angioplasty in acute myocardial infarction (AMI) ever performed.

Results from the study of 2,665 patients at 74 centers around the world determined that when treated within 12 hours of the onset of heart attack symptoms, patients who received treatment with Guidant''s MULTI-LINK or MULTI-LINK DUET stents had a statistically significant lower rate of the primary endpoint of major adverse cardiac event (MACE, a composite of death, stroke, repeat myocardial infarction and ischemia-driven repeat vascularization of the target vessel) at six months than patients treated with PTCA. Additionally, stenting alone resulted in a significantly lower MACE rate than PTCA plus ReoPro at six months.

"The results of CADILLAC clearly establishes stenting as the optimal interventional management strategy for patients with heart attack. Compared to alternative treatments, patients receiving MULTI-LINK or MULTI-LINK DUET stents to treat an evolving heart attack can expect improved event-free survival," said Stone, the principal investigator for the study.

Guidant''s MULTI-LINK and MULTI-LINK DUET stents are tiny metal tubes that function as scaffolding to hold arteries open, restoring natural blood flow to previously blocked arteries. Guidant, which recently announced FDA approval of its MULTI-LINK TETRA(tm) Coronary Stent System, is the global leader in stents and stent delivery systems. More than 1.5 million Guidant stents have been used to successfully treat patients with coronary artery disease since 1997.

"Heart attack is a serious medical problem that touches a large percentage of the population, whether as victims or as family members and friends of victims," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "We are pleased with the encouraging results from the CADILLAC trial. We anticipate that this compelling data will be well-received by physicians around the world and Guidant intends to use these results to pursue the first indication of stenting for the treatment of AMI."

The American Heart Association estimates that death by heart attack accounts for one out of every five deaths each year in the United States. There are over 1 million new and re-occurring cases of heart attack each year, with more than 40 percent resulting in death.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.