HORIZONS AMI will help set guidelines for drug and stent therapy

October 16, 2008

The HORIZONS AMI clinical trial measuring the safety and efficacy of the use of the medication bivalirudin compared to standard drug therapy - heparin and glycoprotein IIb/IIIa inhibitors -- in heart attack patients who receive angioplasty, found that after 1 year, use of bivalirudin resulted in significantly lower rates of all-cause death, death from cardiac causes, and major bleeding.

Late-breaking data presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), show that the use of the anticoagulant bivalirudin reduced net adverse clinical events (NACE) by 16% compared to the standard treatment. In addition, use of bivalirudin significantly reduced the major bleeding that occurs after angioplasty by 39% one year after the angioplasty was performed.

The use of bivalirudin also resulted in a significant 31% reduction in the 1-year rate of all cause mortality and a 43% reduction in the 1-year rate of cardiac mortality, with non-significant differences in the rate of repeat heart attack, stent thrombosis, stroke and target vessel revascularization (TVR) at 1 year.

"These 1-year results, which are even more impressive than the 30-day data reported at TCT one year ago, ensure that HORIZONS AMI will have a dramatic and lasting impact on the way that heart attack patients are treated during percutaneous coronary intervention," said Gregg W. Stone, M.D., CRF Chairman, Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center, and Principal Investigator of the HORIZONS-AMI trial. "The use of bivalirudin rather than heparin plus glycoprotein IIb/IIIa inhibitors reduced the rate of death and cardiac death by 1.4% and 1.7% respectively, which potentially could result in thousands of lives saved per year on a global basis."

"HORIZONS has demonstrated that the prevention of hemorrhagic complications after primary percutaneous coronary intervention in heart attack patients results in improved early and late survival," said Roxana Mehran, M.D., Joint Chief Scientific Officer of the Clinical Trials Center at CRF and Director of Outcomes Research, Data Coordination and Analysis at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. She and her team conducted the study under an Investigational Device Exemption (IDE) from the Food and Drug Administration.

"Optimal drug selection and technique to minimize bleeding are essential to enhance outcomes for patients undergoing interventional therapies," Dr. Mehran said.

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 most dangerous form of heart attack (ST-elevation myocardial infarction).

Cardiovascular Research Foundation

Economic Impact of Switching to Bivalirudin for a Primary Percutaneous Coronary Intervention in a US Hospital (Hospital Practice)
by JTE Multimedia

The addition of glycoprotein IIb/IIIa inhibitors (GPIs) to heparin in percutaneous coronary intervention (PCI) procedures has been demonstrated to reduce ischemic complications; however, GPI use is known to increase the risk of bleeding events, which are linked to increased mortality, longer hospital length of stay, greater medical resource utilization, and increased costs. New antithrombotic therapies have the potential to improve clinical outcomes and decrease costs. The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) study of bivalirudin demonstrated significantly reduced clinical event rates (mortality and bleeding) compared with an unfractionated heparin (UFH) + GPI regimen. Objective The potential clinical and economic value of...

Bivalirudin surpasses heparin on post-PCI transfusion rate.(Cardiovascular Medicine): An article from: Internal Medicine News
by Mitchel L. Zoler (Author)

This digital document is an article from Internal Medicine News, published by Thomson Gale on July 1, 2005. The length of the article is 544 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Bivalirudin surpasses heparin on post-PCI transfusion rate.(Cardiovascular Medicine)
Author: Mitchel L. Zoler
Publication: Internal Medicine News (Magazine/Journal)
Date: July 1, 2005
Publisher: Thomson Gale
Volume: 38 Issue: 13 Page: 56(1)

Distributed by Thomson...

Bivalirudin may reduce need to use IIb/IIIa agents in ACS.(Acute coronary syndrome): An article from: Internal Medicine News
by Mitchel L. Zoler (Author)

This digital document is an article from Internal Medicine News, published by Thomson Gale on May 1, 2006. The length of the article is 974 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Bivalirudin may reduce need to use IIb/IIIa agents in ACS.(Acute coronary syndrome)
Author: Mitchel L. Zoler
Publication: Internal Medicine News (Magazine/Journal)
Date: May 1, 2006
Publisher: Thomson Gale
Volume: 39 Issue: 9 Page: 44(1)

Distributed by Thomson...

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The 6th Edition of the indispensable Textbook of Interventional Cardiology, by Drs. Eric Topol and Paul S. Teirstein, offers you comprehensive, seasoned clinical advice on all aspects of this rapidly evolving subspecialty. You'll find balanced, expert perspectives on the scientific and clinical advances established over the last few decades so you can better decide which procedures deliver optimal results in any given situation. You'll also get an updated look at promising new techniques like transcatheter aortic valve implantation; new interventional approaches for left mainstem disease and thrombus-containing lesions; transradial intervention; and optical coherence tomography (OCT). At www.expertconsult.com you can access the complete contents of the book, plus additional case...