The ACUITY ( Acute Catheterization and Urgent Intervention Triage strategy ) trial has assessed the potential of the injectable anti-clotting medicine Bivalirudin ( Angiomax ) in patients experiencing cardiac emergencies known as acute coronary syndromes ( ACS ).
The results have shown that Bivalirudin, in the Bivalirudin alone treatment group, was effective and reduced the risk of major bleeding, a key risk factor for mortality, by 47% compared to the standard combination of injectable drugs used in ACS patients.
In ACUITY, we tested several different combinations of drug therapies and found that the simplest regimen was the best," said ACUITY's principal investigator, Gregg W. Stone, at Columbia University Medical Center. " Previous ACS trials have added drug on top of drug to achieve better efficacy, sacrificing safety along the way. The ACUITY trial showed that Bivalirudin alone is as effective as more complicated dual drug regimens, and results in significantly less bleeding, which means improved outcomes for patients."
The ACUITY trial is one of the largest ACS clinical trials ever conducted to evaluate anti-clotting therapies administered in the hospital.
Enrolling 13,819 patients in 17 countries, investigators employed an early invasive strategy, starting anticoagulant therapy at arrival to the emergency department and quickly moving patients to the cardiac catheterization laboratory for evaluation and, in most cases, a percutaneous coronary intervention ( PCI ), commonly known as angioplasty.
Anticoagulant treatments were continued during these procedures.
Each year in the United States, 5 million people go to the emergency department with chest pain, of which about 1.4 million are identified with ACS.
Acute coronary syndromes include a range of conditions, such as myocardial infarction.
Currently, when patients go to the emergency department with ACS symptoms, there is a significant risk for heart attack or death. Most often, there are several different drugs given to ACS patients including the standard injectable combination of heparins ( unfractionated or low-molecular weight ) plus GP IIb/IIIa inhibitors, sometimes in combination with each other, to prevent heart attack and death. The use of these drugs, especially when given in combination, can lead to bleeding complications in patients undergoing PCI, which further increases the risk of death for patients.
The ACUITY trial results have demonstrated that, compared to the heparin combination, Bivalirudin provided similar protection from myocardial infarction, death and reocclusion of the diseased coronary artery ( revascularization ), while significantly reducing bleeding in ACS patients.
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action.
In clinical trials, Angiomax has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in ischemic and bleeding complications remain evident even in high-risk patients.
In the U.S., Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty ( PTCA ) and with provisional GP IIb/IIIa inhibition in patients undergoing PCI.
Angiomax is also indicated in patients with, or at risk of heparin-induced thrombocytopenia and thrombosis syndrome ( HIT/HITTS ) undergoing PCI.
Angiomax is intended for use with Aspirin.
The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration.
Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Source: The New England Journal of Medicine, 2006