Landmark stent trial to be presented at TCT 2007

Oct 16 2007

The Cardiovascular Research Foundation (CRF) will release results of its landmark research study, HORIZONS AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) at the nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

The study is designed to examine the safety and effectiveness of stents and anticoagulants in heart attack patients undergoing angioplasty.

The HORIZONS AMI trial data will be presented at a press conference on Wednesday, October 24 at 8:40 am. The results will be presented as a late breaking trial on Wednesday, October 24 at 10:50 am.

“This is a landmark trial, which will help set guidelines for drug and stent therapy during primary angioplasty in patients with heart attacks for many years to come,” said Gregg W. Stone, MD, Chairman of the Cardiovascular Research Foundation and Professor of Medicine, Columbia University Medical Center.

While previous studies of drug-eluting stents have often focused on their use in patients with stable or unstable chest pain, this is the largest study to focus on the appropriate use of anticoagulation medications and drug-eluting stents in patients experiencing the highest risk form of heart attack (ST-elevation myocardial infarction).

“Usually, angioplasty is associated with an excess of bleeding in heart attack patients,” Dr. Stone said. “However, using the anticoagulant bivalirudin with angioplasty in patients with stable coronary artery disease instead of heparin and glycoprotein IIb/IIIa inhibitors reduces bleeding, which has been associated with greater long-term survival. In the HORIZONS AMI trial, we have sought to determine whether using bivalirudin in patients with a heart attack, who undergo angioplasty, provides the same benefit.”

“This study should determine if bivalirudin use is as efficacious as the standard anticoagulant therapy, without causing excess bleeding in these acutely ill patients with a heart attack undergoing angioplasty,” Dr. Mehran, Medical Director of the Data Coordinating and Analysis Center at CRF stated. She and her team conducted this study under an Investigational Device Exemption (IDE) from the Food and Drug Administration.

The HORIZONS AMI trial enrolled over 3600 patients presenting to hospitals in 11 countries with a heart attack. More than 120 national and international interventional cardiology centers are participating in the trial. Patients undergoing angioplasty were randomly assigned to receive either the standard anticoagulant unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. The patients are to be followed for five years.

Thirty-day outcome data will be presented, the primary endpoint of the study.

Comparison of Drug-Eluting Stents to Bare-Metal Stents Underway Patients enrolled in the HORIZONS AMI trial were also randomly assigned to receive either Taxus drug-eluting stents or a bare-metal stent. Data on this portion of the study – also a landmark comparison of drug-eluting stents to bare-metal stents – will be available next year.