The Lancet publishes final 3-year data from landmark HORIZONS-AMI clinical trial

Jun 14 2011

Trial shows that use of bivalirudin alone improves survival in heart-attack patients compared to heparin and a glycoprotein IIb/IIIa inhibitor; drug-eluting stents are also shown to be more effective than bare-metal stents, with equivalent safety

Data from the landmark HORIZONS-AMI clinical trial demonstrated that the administration of the anticoagulant medication bivalirudin enhanced survival compared to the use of heparin plus a glycoprotein (GP) IIb/IIIa inhibitor in heart attack patients undergoing angioplasty after 3 years. Use of a drug-eluting stent (paclitaxel) was also shown to be more effective than a bare-metal stent, with equivalent safety. Final 3-year results of the trial were published in the June 13, 2011, issue of The Lancet.

After 3 years, treatment with bivalirudin alone compared to heparin plus a GP IIb/IIIa inhibitor resulted in significantly reduced rates of all-cause mortality (5.9% vs. 7.7%), cardiac mortality (2.9% vs. 5.1%), reinfarction (6.2% vs. 8.2%) and major bleeding not related to bypass graft surgery (6.9% vs. 10.5%). There were no significant differences in the incidence of ischemia-driven target vessel revascularization, stent thrombosis, stroke, or composite adverse events.

In addition, at 3 years, the implantation of a paclitaxel-eluting stent compared to a bare-metal stent resulted in significantly lower rates of ischemia-driven target lesion revascularization (9.4% vs. 15.1%) with no significant differences in the rates of death, reinfarction, stroke, or stent thrombosis.

"The results at 3 years demonstrate that use of bivalirudin alone, as opposed to a combination of heparin and a GP IIb/IIIa inhibitor, can save lives. The reported reduction in all-cause mortality seen in the trial equates to 18 lives saved per 1,000 patients treated with bivalirudin," said Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation (CRF). Dr. Stone is the principal investigator of the HORIZONS-AMI trial.

"Additionally, results of the trial showed that patients who received a paclitaxel-eluting stent had a 40% reduction in risk of ischemia-driven target lesion revascularization after 3 years compared with those patients given a bare-metal stent," Dr. Stone said.

Source: Cardiovascular Research Foundation