October 17, 2008 - The Medicines Company’s Angiomax (bivalirudin) significantly reduced cardiac-related death, improved overall survival and reduced major bleeding compared to conventional therapy (heparin plus a platelet glycoprotein IIb/IIIa inhibitor) in patients undergoing angioplasty for up to one year, according to data released at TCT this week from the HORIZONS-AMI study.
This is the first trial of a pharmacologic therapy to demonstrate a mortality benefit in STEMI patients undergoing primary PCI. Experts believe this strategy could save thousands of lives each year if incorporated globally into routine practice.
The trial demonstrated that Angiomax significantly reduced cardiac-related death by 43 percent (p=0.005), improved overall survival by 31 percent and reduced major bleeding complications by 39 percent compared to heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing angioplasty. Angiomax showed an absolute reduction of 1.7 percent in cardiac-related death and 1.4 percent in all-cause death at one year. The findings were presented at a late-breaking session of the 20th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
“The findings from this large landmark trial represent a giant step forward in the treatment of heart attacks by demonstrating that this drug and device regimen produces a significant reduction in the risk of cardiac mortality, improves overall survival and reduces major bleeding complications,” said the study’s principal investigator Gregg W. Stone, M.D., Cardiovascular Research Foundation chairman, professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. “These data again demonstrate that bivalirudin is a better treatment option than conventional therapy for STEMI patients undergoing primary PCI. This strategy could save thousands of lives each year if incorporated globally into routine practice.”
The HORIZONS-AMI trial compared Angiomax to heparin plus a platelet GPI in 3,602 patients presenting with the most severe form of heart attack, known as ST-elevation myocardial infarction (STEMI) undergoing a primary PCI strategy. Of patients in the Angiomax arm, the majority (93 percent) received Angiomax monotherapy.
“The one-year mortality data from HORIZONS-AMI underscore the importance of the reduction of bleeding and its ability to improve both short- and long-term outcomes, including mortality,” said Roxana Mehran, M.D., associate professor of medicine, Columbia University, 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 New York-Presbyterian Hospital/Columbia University Medical Center.
Results at one year showed Angiomax significantly reduced all-cause death by 31 percent, significantly reduced the incidence of net adverse clinical events, a composite of major adverse cardiac events or major bleeding, by 16 percent, and significantly reduced rates of major bleeding by 39 percent. The data demonstrated no difference in rates of major adverse cardiac event.
“These impressive results underscore the importance of bivalirudin therapy, which could become the worldwide standard of care in treating STEMI patients undergoing PCI,” said Bernhard Witzenbichler, M.D., professor of cardiology and pneumology at the University of Berlin and the top enroller in the HORIZONS-AMI trial.
These data also support results of previous studies showing an association between reduced major bleeding in angioplasty patients with greater long-term survival. Nearly 25,000 patients have been studied in Angiomax clinical trials to date. Angiomax has been shown to result in less bleeding and similar rates of composite ischemia compared to heparin plus GPI in patients undergoing angioplasty for stable angina, unstable angina and non-ST-elevation myocardial infarction (NSTEMI).
The HORIZONS-AMI trial is co-funded by a grant from The Medicines Company. It is the largest study to focus on the appropriate use of anticoagulation medications and stents in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI), commonly known as angioplasty. The landmark trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax with provisional use of GPI or heparin plus GPI. Patients enrolled in the HORIZONS-AMI trial also were assigned randomly to receive either drug-eluting stents or a bare-metal stent.
The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, re-infarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days.
For more information: www.angiomax.com, www.themedicinescompany.com