HORIZONS AMI data will likely lead to wider bivalirudin usage in acute MI
WASHINGTON—After one year, use of bivalirudin in MI patients, who receive angioplasty, resulted in significantly lower rates of all-cause death, death from cardiac causes, and major bleeding, compared to the standard drug therapy of heparin and glycoprotein IIb/IIIa inhibitors, according to the HORIZONS AMI trial presented Wednesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The HORIZONS AMI [Harmonizing Outcomes with RevascularIZatiON and Stents in Acute MI], researchers which more than 120 interventional cardiologist centers globally, enrolled 3,602 patients with STEMI with symptom onset less than 12 hours in 11 countries. The patients were randomized either Boston Scientific’s Taxus paclitaxel-eluting stent (2,257) or Boston Scientific’s Express bare-metal stent.
The use of the anticoagulant bivalirudin (Angiomax from the Medicines Company) reduced net adverse clinical events (NACE) by 16 percent compared to the standard treatment. In addition, use of bivalirudin significantly reduced the major bleeding that occurs after angioplasty by 39 percent one year after the angioplasty was performed, according to presenter Roxana Mehran, MD, and director of outcomes research, data coordination and analysis at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City.
She and her colleagues conducted the study under an investigational device exemption (IDE) from the FDA.
Mehran reported that the use of bivalirudin also resulted in a significant 31 percent reduction in the one-year rate of all cause mortality and a 43 percent reduction in the one-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 one year.
Deepak Bhatt, MD, chief of cardiology in the VA Boston Healthcare System and director of the integrated cardiovascular intervention program at Brigham and Women's Hospital and the VA system, who evaluated the study, said that the HORIZONS AMI is much larger, adequately powered study, compared to previous trials. He added that the “results are quite striking, and define a new standard of care”
“HORIZONS has demonstrated that the prevention of hemorrhagic complications after primary PCI in heart attack patients results in improved early and late survival,” Mehran added.
She also said that while mortality was not a primary endpoint, the one-year mortality rates for cardiac death was 3.8 percent in the standard care arm, and 2.1 percent in the bivalirudin arm—a statistically significant difference. Overall, they found a significant 31 percent reduction in all-cause mortality and 43 percent reduction in cardiac mortality at one year.
“Optimal drug selection and technique to minimize bleeding are essential to enhance outcomes for patients undergoing interventional therapies," she said.
“I can’t imagine that after these data are released, that it won’t change the way acute MI pharmacology is performed in the U.S. and outside the U.S.”
Several of the panel members at the presentation noted that this is the largest study to focus on the appropriate use of anticoagulation medications and drug-eluting stents in patients experiencing STEMI.
The HORIZONS AMI trial was sponsored by the Cardiovascular Research Foundation (CRF), which sponsors TCT, and with research grant support from Boston Scientific and the Medicines Company.
The HORIZONS AMI [Harmonizing Outcomes with RevascularIZatiON and Stents in Acute MI], researchers which more than 120 interventional cardiologist centers globally, enrolled 3,602 patients with STEMI with symptom onset less than 12 hours in 11 countries. The patients were randomized either Boston Scientific’s Taxus paclitaxel-eluting stent (2,257) or Boston Scientific’s Express bare-metal stent.
The use of the anticoagulant bivalirudin (Angiomax from the Medicines Company) reduced net adverse clinical events (NACE) by 16 percent compared to the standard treatment. In addition, use of bivalirudin significantly reduced the major bleeding that occurs after angioplasty by 39 percent one year after the angioplasty was performed, according to presenter Roxana Mehran, MD, and director of outcomes research, data coordination and analysis at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City.
She and her colleagues conducted the study under an investigational device exemption (IDE) from the FDA.
Mehran reported that the use of bivalirudin also resulted in a significant 31 percent reduction in the one-year rate of all cause mortality and a 43 percent reduction in the one-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 one year.
Deepak Bhatt, MD, chief of cardiology in the VA Boston Healthcare System and director of the integrated cardiovascular intervention program at Brigham and Women's Hospital and the VA system, who evaluated the study, said that the HORIZONS AMI is much larger, adequately powered study, compared to previous trials. He added that the “results are quite striking, and define a new standard of care”
“HORIZONS has demonstrated that the prevention of hemorrhagic complications after primary PCI in heart attack patients results in improved early and late survival,” Mehran added.
She also said that while mortality was not a primary endpoint, the one-year mortality rates for cardiac death was 3.8 percent in the standard care arm, and 2.1 percent in the bivalirudin arm—a statistically significant difference. Overall, they found a significant 31 percent reduction in all-cause mortality and 43 percent reduction in cardiac mortality at one year.
“Optimal drug selection and technique to minimize bleeding are essential to enhance outcomes for patients undergoing interventional therapies," she said.
“I can’t imagine that after these data are released, that it won’t change the way acute MI pharmacology is performed in the U.S. and outside the U.S.”
Several of the panel members at the presentation noted that this is the largest study to focus on the appropriate use of anticoagulation medications and drug-eluting stents in patients experiencing STEMI.
The HORIZONS AMI trial was sponsored by the Cardiovascular Research Foundation (CRF), which sponsors TCT, and with research grant support from Boston Scientific and the Medicines Company.