Switching to ANGIOMAX

REPLACE-2 subanalysis: improved bleeding results in patients switched to Angiomax® (bivalirudin)

  • ANGIOMAX with "provisional" GP IIb/IIIa inhibitor* was associated with decreased major bleeding vs heparin + GP IIb/IIIa inhibitor, regardless of prior heparin use within the preceding 48 hours1
  • Patients switched to ANGIOMAX with "provisional" GP IIb/IIIa inhibitor from any heparin pretreatment experienced a 45% relative risk reduction in mortality rates at 1 year vs patients given heparin + GP IIb/IIIa inhibitor (2.1% vs 3.8%, respectively; P = .07)2,3

* In REPLACE-2: 93% of patients received ANGIOMAX monotherapy.4
§ Pretreatment was defined as receiving the treatment within the previous 48 hours.
† Major bleed: Defined in REPLACE-2 as intracranial or retroperitoneal bleeding; transfusion of 2 or more units of blood/blood products; a fall in hemoglobin of >4 g/dL, whether or not bleeding site was identified; clinically overt blood loss (spontaneous or nonspontaneous) with a fall in hemoglobin of >3 g/dL.4
‡ Minor bleed: Defined in REPLACE-2 as observed bleeding that did not meet the criteria for a major bleed.4

Patients switched to ANGIOMAX with "provisional" GP IIb/IIIa inhibitor experienced a 33%-57% relative risk reduction in mortality at 1 year2,3

* Pretreatment was defined as receiving the treatment within the previous 48 hours.

ACUITY PCI subset analysis confirms switching benefits seen in REPLACE-2

  • Switching from heparin(s)—UFH or enoxaparin—to ANGIOMAX* reduced non-CABG major bleeding† by 48%2,5
  • Mortality rates at 1 year were similar in patients switched from UFH or enoxaparin to ANGIOMAX (n=1,292) vs in patients remaining on heparin(s) + GP IIb/IIIa inhibitor in the consistent arm (n=1,236) [2.7% vs 2.9%, respectively; P = .75]2

* In the ACUITY ANGIOMAX-ALONE group: 91% of PCI patients received ANGIOMAX monotherapy.4
† Major bleed: Defined in REPLACE-2 as intracranial or retroperitoneal bleeding; transfusion of 2 or more units of blood/blood products; a fall in hemoglobin of >4 g/dL, whether or not bleeding site was identified; clinically overt blood loss (spontaneous or nonspontaneous) with a fall in hemoglobin of >3 g/dL.4
‡ Minor bleed: Defined in REPLACE-2 as observed bleeding that did not meet the criteria for a major bleed. 4

The HORIZONS AMI subanalysis further demonstrates that switching to ANGIOMAX reduces major bleeding in patients given heparin before PCI6

  • MACE in the ANGIOMAX* switch arm (with prior UFH) was 4.6% vs 5.6% for patients in the heparin + GP IIb/IIIa inhibitor consistent arm (with prior UFH)6
  • In HORIZONS AMI, 66% of ANGIOMAX patients and 76% of heparin + GP IIb/IIIa inhibitor patients were given heparin as an IV bolus prior to PCI procedure6

* In HORIZONS AMI: 93% of ANGIOMAX patients received ANGIOMAX monotherapy.6

Follow these guidelines for switching patients undergoing percutaneous coronary intervention (PCI) to ANGIOMAX:7

LMWH = low molecular weight heparin

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.

1 Gibson CM, Ten Y, Murphy SA, et al. Association of prerandomization anticoagulant switching with bleeding in the setting of percutaneous coronary intervention (a REPLACE-2 analysis). Am J Cardiol. 2007;99:1687-1690.

2Data on file. The Medicines Company; Parsippany, NJ.

3Lincoff 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.

4Lincoff AM, Bittl JA, Harrington RA, et al. 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;289:853-863.

5White HD, Chew DP, Hoekstra JW, et al. Safety and efficacy of switching from either unfractionated heparin or enoxaparin to bivalirudin in patients with non–ST-elevation acute coronary syndromes managed with an invasive strategy: results from the ACUITY trial. J Am Coll Cardiol. 2008;51:1734-1741.

6Stone 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.

7Reed MD, Bell D. Clinical pharmacology of bivalirudin. Pharmacotherapy. 2002;22:105S-111S.