Clinical Information

Evolution of ANGIOMAX

Bivalirudin Angioplasty Trial (BAT) showed a reduction in both ischemic and bleeding events in unstable angina (UA) patients undergoing percutaneous transluminal coronary angioplasty (PTCA)¹
Randomized Evaluation of PCI Linking ANGIOMAX to Reduced Clinical Events part 1 (REPLACE-1) and Comparison of Abciximab Complications With Hirulog for Ischemic Events Trial (CACHET) formed the basis of Randomized Evaluation of PCI Linking ANGIOMAX to Reduced Clinical Events (REPLACE-2), which evaluated patients undergoing contemporary percutaneous coronary intervention (PCI)^2,3
REPLACE-2 demonstrated potent efficacy in suppressing ischemic events plus less bleeding versus heparin + glycoprotein (GP) IIb/IIIa inhibitor in UA patients undergoing elective or urgent PCI^4,5
Anticoagulant Therapy With Bivalirudin to Assist in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (ATBAT) demonstrated safety and efficacy in patients with heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI⁶
In the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) PCI subset, Angiomax alone in UA and Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) patients demonstrated unsurpassed efficacy in suppressing ischemic events plus less bleeding versus unfractionated heparin (UFH) or enoxaparin + GP IIb/IIIa inhibitor.⁷
In Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Study (HORIZONS AMI), findings support Angiomax use in STEMI patients undergoing primary PCI demonstrating significantly reduced net adverse clinical events (NACE) with no difference in Major adverse cardiovascular events (MACE) and resulted in lower rates of cardiac mortality versus UFH + GP IIb/IIIa inhibitor⁸

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.

¹Bittl JA, Chaitman BR, Feit F, Kimball W, Topol EJ. Bivalirudin Angioplasty Study Investigators. Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: final report reanalysis of the Bivalirudin Angioplasty Study. Am Heart J. 2001;142:952-959.

²Lincoff AM, Bittl JA, Kleiman NS, et al; for the REPLACE-1 Investigators. Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial). Am J Cardiol. 2004;93:1092-1096.

³Lincoff AM, Kleiman NS, Kottke-Marchant K, et al. Bivalirudin with planned or provisional abciximab versus low-dose heparin and abciximab during percutaneous coronary revascularization: results of the Comparison of Abciximab Complications with Hirulog for Ischemic Events Trial (CACHET). Am Heart J. 2002;143:847-853.

⁴Lincoff AM, Bittl JA, Harrington RA, et al; for the REPLACE-2 Investigators. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003;289:853-63. Erratum in: JAMA. 2003;289:1638.

⁵Lincoff AM, Kleiman NS, Kereiakes DJ, et al. Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial. JAMA. 2004;292:696-703.

⁶Mahaffey KW, Lewis BE, Wildermann NM, et al. The Anticoagulant Therapy with Bivalirudin to Assist in the performance of percutaneous coronary intervention in patients with heparin-induced Thrombocytopenia (ATBAT) study: main results. J Invas Cardiol. 2003;15:611-616.

⁷Stone GW, McLaurin BT, Cox DA, et al; for the ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203-2216.

⁸Stone GW, Witzenbichler B, Guagliumi G, et al; for the HORIZONS AMI trial investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218-2230.

ANGIOMAX - Potent Efficacy. Proven Outcomes.

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Clinical Information

Evolution of ANGIOMAX