Value of ANGIOMAX
Bleeding can affect cost
- In an evaluation performed by Milkovitch and colleagues, increases in cost for an
occurrence of Thrombolysis in Myocardial Infarction trial (TIMI)—major bleeding,*
transfusion, or a vascular complication—range from $6,897 to $17,807 (in 2007
dollars)1†
* Please see
important safety information and
bleeding definitions.
† Dollar amounts given as 2003 figures (in Milkovitch analysis) adjusted
to reflect 2007 totals using a 4% annual inflation rate.1
In an analysis of REPLACE-2 (n=4,651 US patients), economic outcomes favored ANGIOMAX
- ANGIOMAX with "provisional" GP IIb/IIIa inhibitor reduced procedural cost by $335/patient
and a total resource cost savings both in-hospital ($405/patient) and at 30-day
follow up ($374/patient) vs heparin +
GP IIb/IIIa inhibitor3
In an analysis of ACUITY (n=7,851 US patients), economic outcomes favored ANGIOMAX4
- A prospective economic evaluation of the ACUITY trial in 7,851 US patients compared
in-hospital and 30-day costs of using ANGIOMAX with those of heparin(s) + GP IIb/IIIa
undergoing an early invasive strategy for management of NSTE-ACS
- Cumulative 30-day costs remained lowest with ANGIOMAX monotherapy, and resulted
in significant cost savings of $123 per patient compared with heparin(s) + cath
lab GP IIb/IIIa, and $422 per patient compared with heparin(s) + upstream GP IIb/IIIa.
* Medical care costs were expressed in 2005 US dollars.
† In the ACUITY ANGIOMAX-alone group: 92% of US PCI patients received
ANGIOMAX monotherapy.5
Bleeding affected Length of Stay (LOS) in Acute Catheterization and Urgent Intervention
Triage StrategY (ACUITY) Percutaneous Coronary Intervention (PCI) subset
- In a subanalysis of ACUITY, bleeding events* in patients undergoing PCI were associated
with a 2-day increase in LOS (P<.001) vs those patients without bleeding
events6
* Please see
important safety information and
bleeding definitions.
Angiomax® (bivalirudin) reduced major bleeding throughout landmark
trials
- In REPLACE-2, ANGIOMAX* with "provisional" GP IIb/IIIa inhibitor reduced major bleeding†
by 41% vs heparin + GP IIb/IIIa inhibitor7
- In the ACUITY PCI subset, ANGIOMAX‡ reduced major bleeding* by 49% vs
heparin(s) + GP IIb/IIIa inhibitor5
- In Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction
study (HORIZONS AMI), ANGIOMAX§ reduced major bleeding* by 40% vs heparin
+ GP IIb/IIIa inhibitor8
* IN REPLACE-2: 93% of ANGIOMAX patients received ANGIOMAX monotherapy.7
† Please see important safety information and
bleeding definitions.
‡ In the ACUITY ANGIOMAX-alone group: 91% of PCI patients received ANGIOMAX
monotherapy.5
§ In HORIZONS AMI: 93% of ANGIOMAX patients received ANGIOMAX monotherapy.8
ANGIOMAX was associated with reduced LOS in a retrospective analysis of patients
undergoing PCI
- In 1,075 patients undergoing PCI, treatment with ANGIOMAX (n=539) was associated with
reduced LOS by approximately 1 day vs heparin + GP IIb/IIIa inhibitor (n=536) median
2.8 ± 2.9 days vs 3.5 ± 4.1 days, respectively [P<.001]9
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.
1Milkovitch G, Gibson G. Economic impact of bleeding complications and
the role of antithrombotic therapies in percutaneous coronary intervention. Am J
Health-Syst Pharm. 2003;60(suppl 3):S15-S21.
2Cohen DJ. Economic implications of the use of direct thrombin inhibitors
in percutaneous coronary intervention. Adv Stud Pharm. 2005;2:80-89.
3Cohen DJ, Lincoff AM, Lavelle TA, et al. Economic evaluation of bivalirudin
with provisional glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein
IIb/IIIa inhibition for percutaneous coronary intervention: results from the REPLACE-2
trial. J Am Coll Cardiol. 2004;44:1792-1800.
4Pinto DS, Stone GW, Shi C, et al, on behalf of the ACUITY Investigators.
Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition
versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive
management of acute coronary syndromes. J Am Coll Cardiol. 2008;25:1758-1768.
5Stone GW, McLaurin BT, Cox DA, et al; for the Acute Catheterization
and Urgent Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin
in patients with acute coronary syndromes undergoing percutaneous coronary intervention:
a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage
strategy (ACUITY) trial. Lancet. 2007;369:907-919.
6Data on file. The Medicines Company; Parsippany, NJ.
7Lincoff 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.
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.
9Watson K, Seybert AL, Saul MI, et al. Comparison of patient outcomes
with bivalirudin versus unfractionated heparin in percutaneous coronary intervention.
Pharmacotherapy. 2007;27:647-656.