NSTEMI Patients

Non-ST Elevation — Acute Coronary Syndrome

Even though it is difficult to identify patients with NSTE-ACS (Non-ST elevation – Acute Coronary Syndrome) presenting with thrombus, thrombus is present 35-37% of these patients when they arrive in the cath lab. These NSTE-ACS patients are at increased risk of adverse outcomes. ReoPro helps manage thrombus and reduces ischemic complications in these NSTE-ACS patients undergoing PCI. Those patients presenting with a Non ST-segment elevation (NSTEMI) myocardial infarction are at the highest risk of this group.

NSTEMI Patient Identification

The major differentiation of NSTEMI from unstable angina (UA) is having prolonged ischemia and subsequent myocardial necrosis as a result of vessel obstruction being prolonged in duration. Evidence of myocardial necrosis is found by increased levels of biomarkers such as troponin (I or T) and/or CK-MB. A patient will be diagnosed with NSTEMI when presenting with typical symptoms of ischemia with or with out ECG changes but has positive enzymes.

Cardiac enzyme elevation may be a surrogate marker for an active thrombus.

"High serum levels of troponin T or troponin I...reflect an active thrombotic process, with distal embolization of platelet thrombi originating from the culprit lesion."1

NSTEMI patients are at increased risk for adverse outcomes.

Unadjusted In-Hospital Clinical Outcomes2

Outcome

NSTEMI, %
(n=132,551)

Death

12.5

Reinfarction

1.4

Recurrent ischemia

7.6

Congestive heart failure

24.3

Cardiogenic shock

3.4

Stroke

1.4

VT/VF arrest

3.8

New atrial fibrillation

9.3

Bleeding†

13.4

NSTEMI = non-ST-segment elevation myocardial infarction; VF = ventricular fibrillation; VT = ventricular tachycardia.

† Bleeding requiring an intervention such as red blood cell transfusion or surgery.

ReoPro helps manage thrombus and reduces ischemic complications in NSTEMI patients undergoing PCI.

Evidence-Based Results

Click on image to enlarge

The primary endpoint of the EPIC trial was death, MI, or urgent intervention at 30 days (placebo 12.8% [n=696], ReoPro 8.3% [n=708], P=0.008, relative reduction 35%).10
The primary endpoint of the EPILOG trial was death, MI, or urgent revascularization at 30 days (placebo + standard-dose heparin 11.7% [n=939], ReoPro + low-dose heparin 5.2% [n=935], P<0.001 vs placebo + standard-dose heparin, relative reduction 56%; ReoPro + standard-dose heparin 5.4% [n=918], P<0.001 vs placebo + standard-dose heparin, relative reduction 54%).11
The primary endpoint of the CAPTURE trial was death, MI, or an urgent intervention within 30 days (placebo 15.9% [n=635] vs. ReoPro 11.3% [n=630], P=0.012). THe troponin data above are from patients without an MI within 14 days prior to randomization.12
The primary endpoint of the EPISTENT trial was death, MI or an urgent intervention within 30 days (placebo+stent 10.8% [n=809] vs. ReoPro+stent 5.3% [n=794], P<0.001). The troponin data above are from patients with an evaluable troponin T at baseline.13
The primary endpoint in TARGET was death, MI, or an urgent intervention within 30 days (tirofiban 7.6% [n=2398] vs. ReoPro+stent 6.0% [n=2411], P=0.038)14. The troponin data above are from patients with a recent MI.9

2002 ACC/AHA NSTEMI Guidelines

The 2002 ACC/AHA UA/NSTEMI guidelines recognize thrombus as a significant factor in UA/NSTEMI and recommends ReoPro in PCI for UA/NSTEMI patients. "Intravenous platelet GP IIb/IIIa inhibitor in UA/NSTEMI patients undergoing PCI."

For definitions of class and level of evidence, see: 'http://www.acc.org/qualityandscience/clinical/statements.htm'

Page references

  1. Hamm CW, Heeschen C, Goldmann B, et al. N Engl J Med. 1999;340:1623-1629.
  2. Roe M, Parson L, Pollack C, et al. Arch Intern Med. 2005;165;1630-1636.
  3. Lincoff AM, Califf RM, Anderson KM, et al. for the EPIC investigators. J Am Coll Cardiol. 1997;30:149-156.
  4. Data on file. Lilly Research Laboratories.
  5. Data on file. Lilly Research Laboratories.
  6. Stone GW, Moliterno DJ, Bertrand M, et al. Circulation. 2002;105:2347-2354.
  7. Hamm CW, Heeschen C, Goldman B, et al. N Engl J Med. 1999;340:1623-1629.
  8. Data on file. Lilly Research Laboratories.
  9. Stone GW, Moliterno DJ, Bertrand M, et al. Circulation. 2002;105:2347-2354.
  10. The EPIC Investigators. N Engl J Med. 1994;330:956-961.
  11. The EPILOG Investigators. N Engl J Med. 1997;336:1689-1696.
  12. The CAPTURE Investigators. Lancet. 1997;349:1429-1435.
  13. The EPISTENT Investigators. Lancet. 1998;352:87-92.
  14. Topol EJ, Moliterno DJ, Herrmann HC, et al. for the TARGET Investigators. N Engl J Med. 2001;344:1888-1894.

Please see Important Safety Information contained on this website.

Centocor Logo