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Prescribing Information

ACUITY: PCI Subanalysis

Additional Clinical Information

About PCI

Bleeding – a Predictor
of Mortality

About HIT/HITTS

Removal of the Femoral
Arterial Catheter

Medical Information

Helpful Resources

ANGIOMAX Key Events at:

Mode of Action Video

See a vivid demonstration of ANGIOMAX in action. Watch ANGIOMAX: Thrombin-Specific Inhibition for Preventing Thrombosis and Thrombin-Mediated Platelet Activation.

Clinical Information

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Evolution of ANGIOMAX

BAT showed a reduction in both ischemic and bleeding events in patients undergoing percutaneous transluminal coronary angioplasty (PTCA)¹
REPLACE-1 and CACHET formed the basis of REPLACE-2, which evaluated patients undergoing contemporary percutaneous coronary intervention (PCI)^2,3
REPLACE-2 demonstrated proven efficacy plus less bleeding which equates to improved outcomes^4,5
ATBAT demonstrated safety and efficacy in patients with heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI⁶
In patients undergoing PCI in ACUITY, Angiomax® (bivalirudin) alone in moderate- and high-risk patients demonstrated proven efficacy plus significantly less bleeding, which equates to improved outcomes.⁷
The future of ANGIOMAX includes clinical trials that evaluate ANGIOMAX in a number of different settings.

Data Across Several Trials Support Efficacy Plus Less Bleeding in PCI

Consistent Results Across Low-, Moderate-, and High-Risk Patients Undergoing PCI

^*Important Bleeding Definitions

To learn more about these studies, visit REPLACE-2 and ACUITY PCI clinical outcomes sections.

In the largest pooled analysis of ANGIOMAX data from 4 PCI trials:¹⁰

ANGIOMAX provided significant reductions in the incidence of death (P = .049), revascularization (P = .02), and major bleeding (P <.001) at 48 hours vs heparin, regardless of glycoprotein (GP) IIb/IIIa use. Rates of MI were not significantly different (P = 0.07).
REPLACE-2 results in high-risk patient subgroups (diabetes, hypertension, renal insufficiency, advanced age) were consistent with overall findings of the pooled analysis

* Defined as: intracranial, intraocular, or retroperitoneal hemorrhage, clinically overt blood loss leading to hemoglobin drop >3 g/dL (or 10% of hematocrit), or transfusion of >2 units whole blood or packed red blood cells.

Bivalirudin Versus Heparin in Percutaneous Coronary Intervention: A Pooled Analysis examined data at 48 hours from 4 randomized, controlled clinical trials in PCI comparing ANGIOMAX with heparin (with or without GP IIb/IIIa): Bivalirudin Angioplasty Trial (BAT) (N = 4,312), Comparison of Abciximab Complications with Hirulog for Ischemic Events Trial (CACHET) (N = 268), and Randomized Evaluation in PCI Linking ANGIOMAX to Reduced Clinical Events (REPLACE) Trial Part 1 (N = 1,056) and Part 2 (N = 6,002). A subgroup analysis of pooled data from these 4 trials compared ANGIOMAX with heparin in patients with diabetes, hypertension, renal insufficiency, and advanced age.

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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, on behalf of the 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 for the REPLACE-2 Investigators. 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, for the ATBAT Investigators. 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 Invasive 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.

⁸Supplement to: Stone 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. Available at: http://content.nejm.org. Accessed December 6, 2006.

⁹Data on file. The Medicines Company, Parsippany, NJ.

¹⁰Ebrahimi R, Lincoff AM , Bittl JA, et al. Bivalirudin vs heparin in percutaneous coronary interventions: a pooled-analysis. J Cardiovasc Pharmacol Ther. 2005;10:209-216.