N

%

N

%

Prior to Procedures

773

0.3

797

0.1

Following Angiography

697

1.3

708

0.7

Following PTCA

239

2.5

236

2.2
The incidence rates of TIMI major bleeding in patients undergoing coronary artery bypass graft surgery (CABG) in PRISM-PLUS within one day of discontinuation of AGGRASTAT were 17% on AGGRASTAT plus heparin (N=29) and 35% on heparin alone (N=31).
Recommended (“High-Dose Bolus”) Regimen
Rates of major bleeds (including any intracranial, intraocular or retroperitoneal hemorrhage, clinically overt signs of hemorrhage associated with a drop in hemoglobin of >3 g/dL or any drop in hemoglobin by 4g/dL, bleeding requiring transfusion of ≥2U blood products, bleeding directly resulting in death within 7 days or hemodynamic compromise requiring intervention) were consistent with the rates observed in subjects administered the PRISM-PLUS regimen of AGGRASTAT. There was a trend toward greater bleeding in ST segment elevation myocardial infarction (STEMI) patients treated with fibrinolytics prior to administration of AGGRASTAT using the recommended regimen during rescue PCI.
Non-Bleeding
The incidences of non-bleeding adverse events that occurred at an incidence of >1% and numerically higher than control, regardless of drug relationship, are shown below:
Table 4 Non-bleeding Adverse Reactions in PRISM-PLUS
AGGRASTAT + Heparin
(N=1953)

%

Heparin alone

(N=1887)

%

Body as a Whole

    Edema/swelling

2

1

    Pain, pelvic

6

5

    Reaction, vasovagal

2

1

Cardiovascular System

    Bradycardia

4

3

    Dissection, coronary artery

5

4

Musculoskeletal System

    Pain, leg

3

2

Nervous System/Psychiatric

    Dizziness

3

2

Skin and Skin Appendage

    Sweating

2

1

Thrombocytopenia
Patients treated with AGGRASTAT plus heparin, were more likely to experience decreases in platelet counts than were those on heparin alone. These decreases were reversible upon discontinuation of AGGRASTAT. The percentage of patients with a decrease of platelets to <90,000/mm3 was 1.5%, compared with 0.6% in the patients who received heparin alone. The percentage of patients with a decrease of platelets to <50,000/mm3 was 0.3%, compared with 0.1% of the patients who received heparin alone.
6.2 Post-Marketing Experience
The following additional adverse reactions have been identified during post-approval use of AGGRASTAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure.
Hypersensitivity: Severe allergic reactions including anaphylactic reactions have occurred during the first day of AGGRASTAT infusion, during initial treatment, and during readministration of AGGRASTAT. Some cases have been associated with severe thrombocytopenia (platelet counts <10,000/mm3)