HORIZONS-AMI clinical trial demonstrates efficacy of drug-eluting stent

Lower mortality, bleeding with bivalirudin compared with other anticoagulants

Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors.

Results from "Two-Year Follow-up from a Prospective, Randomized Trial of Heparin Plus Glycoprotein IIb/IIIa Inhibitors vs. Bivalirudin and Paclitaxel-Eluting vs. Bare Stents in STEMI" will be presented at TCT on Friday, September 25.

"The results at two years are more impressive than both the initial 30-day and the one year results that we reported at TCT last year," said Gregg W. Stone, MD, immediate past chairman of CRF, professor of medicine at Columbia University Hospital and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. Dr. Stone is the principal investigator of the HORIZONS-AMI trial.

"The data show that use of bivalirudin alone, as opposed to a combination of heparin and GP IIb/IIIa inhibitors can save lives."

After two years, treatment with bivalirudin alone compared to heparin plus GPIIB/IIIa inhibitors resulted in:

• A significant 36 percent reduction in major bleeding and a significant 25 percent reduction in reinfarction, with comparable rates of stent thrombosis, TVR and stroke.
• A significant 41 percent reduction in cardiac mortality and a 25 percent reduction in all-cause mortality, the latter representing 15 lives saved per 1,000 patients treated.

In addition, at two years, the implantation of a paclitaxel-eluting stent compared to a bare-metal stent resulted in:

• Significant 42 percent and 34 percent reductions in ischemic target lesion revascularization (TLR) and target vessel revascularization (TVR) respectively, with no evidence of late catch-up

• Comparable rates of all-cause and cardiac mortality, reinfarction and stent thrombosis, with no safety concerns apparent

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).