ANGIOMAX provides data-driven victories in patients from stable to ST-segment Elevation
Myocardial Infarction (STEMI) undergoing Percutaneous Coronary Intervention (PCI).
findings support ANGIOMAX use in STEMI patients undergoing primary PCI
- Patients (N=3,602) were randomized to receive heparin + glycoprotein (GP) IIb/IIIa
inhibitor or ANGIOMAX1*
- Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction
study (HORIZONS AMI) primary results 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)1-3†
To learn more about HORIZONS AMI trial design, please click here.
* ANGIOMAX monotherapy included "provisional" GP IIb/IIIa inhibitor.
† The safety and effectiveness of ANGIOMAX have not been established
in patients with acute coronary syndrome (ACS) who are not undergoing PCI.4
ANGIOMAX significantly reduced NACE* and major bleeding with no difference
in MACE† at 30 days in HORIZONS AMI1‡ —
these results were maintained at 1 year5
* NACE=MACE or major bleeding.1
† MACE=major adverse cardiovascular events: all-cause death, reinfarction,
ischemic target vessel revascularization, or stroke.1
‡ IN HORIZONS AMI, 93% of ANGIOMAX patients received ANGIOMAX
monotherapy, without provisional GP IIb/IIIa inhibitor.1
§ Data from Kaplan-Meier analyses based on log-rank estimates.
|| Non-CABG.
ANGIOMAX resulted in lower rates of overall and cardiac mortality at 30 days1
and
1 year in HORIZONS AMI 5
* IN HORIZONS AMI, 93% of ANGIOMAX patients received ANGIOMAX monotherapy, without
provisional GP IIb/IIIa inhibitor.1
† Data from Kaplan-Meier analyses based on log-rank estimates.
Please see important
safety information and
bleeding definitions.
PCI subset: ANGIOMAX demonstrates unsurpassed ischemic efficacy vs heparin(s) +
GP IIb/IIIa inhibitor6
- Major bleeding† with ANGIOMAX vs heparin(s) + GP IIb/IIIa inhibitor
was 4% vs 7%, respectively (P<.001)6
- Results in the ANGIOMAX + GP IIb/IIIa inhibitor arm (n=2,609) vs heparin(s) + GP
IIb/IIIa inhibitor: net clinical outcome, 14.9% vs 13% respectively (P =
.10); composite ischemia, 9.3% vs 8% (P = .16), major bleeding†;
7.5% vs 7% respectively (P = .32)6
To learn more about ACUITY trial design, please click here.
* In the ACUITY ANGIOMAX-alone group: 91% of PCI patients received ANGIOMAX
monotherapy.6
† Please see important safety information and
bleeding definitions.
ACUITY PCI subset mortality results at 1 year confirm long-term efficacy7
* In the ACUITY ANGIOMAX-alone group: 91% of PCI patients received ANGIOMAX
monotherapy.6
† Mortality rates based on 1-year Kaplan-Meier estimates.6
was one of the largest clinical trials conducted to evaluate antithrombotics in
stable angina and unstable angina patients undergoing PCI (N=6,002)2
- Major bleeding† with ANGIOMAX with "provisional" GP IIb/IIIa inhibitor
vs heparin + GP IIb/IIIa inhibitor was 2.4% vs 4.1%, respectively (P <
.001)2
- Acute coronary syndrome (ACS)‡ was present in 22% of patients
(n=1,330) undergoing PCI in REPLACE-22
To learn more about REPLACE-2 trial design, please click here.
* In REPLACE-2: 93% of ANGIOMAX patients received ANGIOMAX monotherapy.2
† Please see important safety information and
bleeding definitions.
‡ ACS was defined in REPLACE-2 as unstable angina within preceding
48 hours or MI within prior 7 days.2
REPLACE-2 mortality rates at 1 year demostrate long-term efficacy
- In REPLACE-2, postprocedural bleeding was more stongly correlated with 1-year mortality
than was creatine kinase MB elevation8
* In REPLACE-2, 93% of ANGIOMAX patients received ANGIOMAX monotherapy.2
† Mortality rates based on 1-year Kaplan-Meier estimates.8
Consistent efficacy in patients with diabetes in REPLACE-2 and ACUITY PCI subset2,6,9
- Major bleeding‡ in REPLACE-2 for patients receiving ANGIOMAX with
"provisional" GP IIb/IIIa inhibitor patients was 3.0% vs 3.3% (P=.69) for
heparin + GP IIb/IIIa inhibitor 10
- Major bleeding‡ in ACUITY PCI subset for ANGIOMAX patients was
4.6% vs 8.5% (P<.003) for heparin(s) + GP IIb/IIIa inhibitor6,11
* In REPLACE-2: 92% of diabetic patients received ANGIOMAX monotherapy.10
†In the ACUITY ANGIOMAX-alone group, 92% of diabetic patients
undergoing PCI received ANGIOMAX monotherapy.9
‡ Please see important safety information and
bleeding definitions.
Further evidence in patients with diabetes in HORIZONS AMI12
- Major bleeding* in HORIZONS AMI for ANGIOMAX patients with diabetes was 7.8% vs
9.6% for heparin +
GP IIb/IIIa inhibitor (P=NS)12
* Please see
important safety information and
bleeding definitions.
Consistent outcomes in troponin-positive* patients in ACUITY PCI subset6
- Major bleeding‡ in ACUITY PCI subset for troponin-positive patients
was 4.2% vs 7.0% (P<.001) for ANGIOMAX vs heparin(s) + GP IIb/IIIa inhibitor6
* Troponin-positive at baseline.6
† In the ACUITY ANGIOMAX-alone group: 91% of troponin-positive
patients undergoing PCI received ANGIOMAX monotherapy.6
‡ Please see important safety information and
bleeding definitions.
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.
1Stone 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.
2Lincoff 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.
3Stone 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.
4ANGIOMAX Prescribing Information. The Medicines Company; Parsippany,
NJ, December 6, 2005.
5Mehran R; HORIZONS-AMI Trial Investigators. A prospective, randomized
comparison of bivalirudin vs. heparin plus glycoprotein IIb/IIIa inhibitors during
primary angioplasty in acute myocardial infarction—one year results [oral presentation].
Presented at: Transcatheter Cardiovascular Therapeutics (TCT); October 12-17, 2008;
Washington, DC.
6Stone 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.
7White 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.
8Lincoff 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.
9Data on file. The Medicines Company; Parsippany, NJ.
10Gurm HS, Sarembrock IJ, Kereiakes DJ, et al. Use of bivalirudin during
percutaneous coronary intervention in patients with diabetes mellitus: an analysis
from the REPLACE-2 trial. J Am Coll Cardiol. 2005;45:1932-1938.
11White HD, Ohman EM, Lincoff AM, et al. Safety and efficacy of bivalirudin
with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary
syndromes undergoing percutaneous coronary intervention: one year results from the
ACUITY trial. J Am Coll Cardiol. 2008;52;807-814.
12Witzenbichler B, Guagliumi G, Desaga M, et al. Impact of diabetes mellitus
on the safety and effectiveness of bivalirudin in patients with acute myocardial
infarction undergoing primary angioplasty: the HORIZONS AMI Trial. (abstract 2900-192)
J Am Coll Cardiol. 2008;B-67.