Unsurpassed ischemic efficacy throughout the risk spectrum in patients
undergoing Percutaneous Coronary Intervention (PCI)
Angiomax® (bivalirudin) is an anticoagulant currently approved in
the U.S. for use in patients undergoing percutaneous coronary intervention, and
in patients with or at risk for heparin-induced thrombocytopenia and thrombosis
syndrome (HIT/HITTS) undergoing PCI.1
The recent Harmonizing Outcomes with Revasculation and Stents in Acute Myocardial
Infarction Study (HORIZONS AMI) trial findings support the use of ANGIOMAX use in
ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI
and are consistent with those in landmark trials Randomized Evaluation of PCI Linking
ANGIOMAX to Reduced Clinical Events (REPLACE-2) and Acute Catheterization and Urgent
Intervention Triage StrategY (ACUITY)* demonstrating potent efficacy and reductions
in major bleeding versus heparin + glycoprotein (GP) IIb/IIIa inhibitors.1
* The safety and effectiveness of ANGIOMAX have not been established in patients
with acute coronary syndromes (ACS) who are not undergoing PCI.1
- ANGIOMAX with or without GP IIb/IIIa has demonstrated unsurpassed ischemic efficacy
and reduced bleeding vs heparin with or without GP IIb/IIIa inhibitor in patients
undergoing PCI1,5-8
- Is supported by 7 major randomized trials1,7,8
- Patients ranged across an increasing risk of ischemic complications5-8
- More than 1.25 million patients have been treated with ANGIOMAX since 2001.9-11
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.
1ANGIOMAX Prescribing Information. The Medicines Company; Parsippany,
NJ, December 6, 2005.
2Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for
the management of patients with unstable angina/non-ST-elevation myocardial infarction:
executive summary. Circulation. 2007;116:803-877.
3Antman EM, Hand M, Armstrong PW, et al. 2007 focused update of the ACC/AHA
2004 guidelines for the management of patients with ST-elevation myocardial infarction.
Circulation. 2008;117:296-329.
4King SB III, Smith SC Jr, Hirshfeld JW Jr, et al. 2007 focused update
of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention.
Circulation. 2008;117:261-295.
5Lincoff 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.
6Bittl JA, Chaitman BR, Feit F, et al. 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.
7Stone GW, White HD, Ohman EM, 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.
Lancet. 2007;369:907-919.
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.
9Data on file. The Medicines Company; Parsippany, NJ.
10Source® Non-retail Database, 2002-2007. Conshohocken,
Pa: Wolters Kluwer Health.
11ACTracker® Database, 2007. Evanston, Ill: Solucient,
LLC.