About PCI
Angiomax® (bivalirudin), Now Recommended in the ACC/AHA/SCAI Practice Guidelines for PCI1
Percutaneous Coronary Intervention (PCI) Vital to Restoration of Coronary Blood Flow
Most acute coronary ischemic events (sudden death, myocardial infarction, myocardial ischemia, vessel occlusion) are triggered by rupture or erosion of atherosclerotic plaque and subsequent occurrence of thrombotic process in a coronary artery.
Disrupted plaques, which can result in decreased coronary blood flow or obstruction, are a fundamental step in the pathogenesis of acute coronary syndromes and underlie 75% of the thrombi responsible for acute coronary syndromes.2,3 The rupture may be spontaneous or iatrogenic, as during balloon inflation.
Patients with unstable angina are routinely treated with aspirin, for its platelet inhibitory effects, and with either heparin, also known as unfractionated heparin (UFH), or low-molecular-weight heparin for their inhibition of thrombin generation and activity.2
Despite such therapy, many of these patients require angioplasty to restore coronary blood flow. UFH has been the foundation anticoagulant since the first angioplasty procedure in 1977.4 However, because of its well-recognized limitations, alternative therapeutic agents have been found for use in combination with, or as a replacement for, heparin.
Anticoagulation Indispensible During PCI
The need for adequate anticoagulation during PCI due to the risk of thrombus formation is well established1. The risk of thrombus formation is related to inflation of an intracoronary balloon, which purposely causes arterial injury. In autopsy studies of patients who die from cardiac or noncardiac causes following PCI, findings of intimal or intimal-medial "tears, cracks, or breaks," as well as the presence of thrombi, are common.
Such arterial injury or disrupted plaques expose thrombogenic components to intraluminal blood, thereby triggering thrombosis through platelet adhesion and activation, as well as activation of other components of the coagulation process. Consequently, anticoagulation is an essential treatment strategy for PCI.
For more information about PCI and the latest in anticoagulants and angioplasty research, visit the Helpful Resources section of this site.
Safety Considerations
ANGIOMAX with provisional use of glycoprotein IIb/IIIa inhibitor is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), and in patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components. The most common (
10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache, and hypotension. 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. Please see complete
prescribing information.
1Smith SC, Feldman TE, Hirshfeld JW, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). American Heart Association Web Site. Available at: http://www.americanheart.org. Accessed November 14, 2005.
2Weitz JI, Bates SM. Beyond heparin and aspirin: new treatments for unstable angina and non-Q-wave myocardial infarction. Arch Intern Med. 2000;160(6):749-758.
3Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995;92(3):657-671.
4Topol EJ, Bonan R, Jewitt D, et al. Use of a direct antihrombin, hirulog, in place of heparin during coronary angioplasty. Circulation. 1993;87(5):1622-1629.