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When Aggrastat® (tirofiban) may be the right choice

Aggrastat® may be the right choice for your NSTE-ACS PCI patients who are:

  • Not adequately pretreated
  • At high risk for repeat PCI
  • Renally impaired
  • Urgent repeat procedures
  • With large thrombus burden
  • Considered high-risk

Aggrastat® High-Dose Bolus treatment is supported by ACC/AHA/SCAI guidelines:

Patients who are not adequately pretreated.1,2

Class: I Level of Evidence A
In patients with NSTE-ACS and high-risk features (e.g. elevated troponin) who are not adequately pretreated with clopidogrel or ticagrelor, it is useful to administer a GP IIb/IIIa inhibitor at the time of PCI.

Patients who are adequately pretreated.1,2

Class: II Level of Evidence A
In patients with NSTE-ACS and high-risk features (e.g. elevated troponin) treated with UFH and adequately pretreated with clopidogrel, it is reasonable to administer a GP IIb/IIIa inhibitor at the time of PCI.

Patients treated with an early invasive strategy.1

Class: II Level of Evidence B
In patients treated with an early invasive strategy and DAPT with intermediate/high-risk features (e.g. positive troponin), a GP IIb/IIIa inhibitor may be considered as part of initial antiplatelet therapy.


Patient Case Profiles

The following profiles are not actual patients. Individual examination is required to determine the best course of treatment.
Please see Important Safety Information and Full Prescribing Information.

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NSTE-ACS patients not adequately pretreated

Symptoms

  • While at home watching TV, 62-year-old male patient developed chest tightness, sweating and neck pain.
  • Patient taken to ED via EMS.
  • In ED, patient continued to experience chest pain despite nitroglycerin and aspirin.
  • >No P2Y12 was administered in ED.

Medical History

  • Hypertension
  • Eats out daily; drinks two beers daily

Medications

  • No medications
  • Home monitoring of blood pressure
  • Recommended low sodium diet

Physical Examination and Lab Results

  • Height 5’11, weight 116 kg, BMI 36
  • Pulse 85 bpm, blood pressure 148/95 mmHg
  • Serum Cr 0.9 mg/dL, Platelets 330, Troponin I 1.0 ng/mL
  • ECG shows ST-segment depression in leads V5-V6
  • Angiography shows total occlusion of the distal RCA

Action:

  • Immediate PCI on RCA
  • Aggrastat® at time of PCI: Single bolus (25 mcg/kg) + maintenance infusion (0.15 mg/kg/min)
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NSTE-ACS patients with renal impairment

Symptoms

  • While walking her dog, 52-year-old female patient experienced discomfort in chest and left shoulder; sweating, and jaw pain.
  • Waited 1 hour to go to ED.

Medical History

  • Hypertension
  • Obstructive sleep apnea
  • End-stage renal disease with dialysis 3 times per week

Home Medications

  • Aspirin 81 mg daily
  • Norvasc® 10 mg daily
  • Lisinopril 10 mg daily
  • Nephrocaps® 1 tablet daily

Concomitant use of Aggrastat with fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding.

Physical Examination and Lab Results

  • Height 5’8, weight 110 kg, BMI 37
  • Pulse 95 bpm, blood pressure 125/60 mmHg
  • Platelets 405, Troponin I 1.47 ng/mL
  • Chest radiograph: mild pulmonary edema
  • ECG shows normal sinus rhythm with anterior ST-segment depression and T-wave inversion
  • Angiography shows 99% mid LAD with clot

Action

  • Transferred to cath lab for PCI on LAD
  • Aggrastat® at time of PCI: Single bolus (25 mcg/kg) + renal-adjusted maintenance infusion (0.075 mg/kg/min)

For renally impairment patients with creatinine clearance ≤60 mL/min a dose adjustment for Aggrastat is required. Renally impaired patients should receive a single bolus (25 mcg/kg within 5 minutes), and a maintenance infusion of 0.075 mcg/kg/min for up to 18 hours.

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NSTE-ACS – Urgent repeat procedure

Symptoms

  • 68-year-old male patient developed severe chest pain and shortness of breath 6-hours following procedure

Medical History

  • Hypertension
  • Hypothyroidism
  • CAD (post myocardial infarction)
  • PCI performed 6-hours prior
  • Smoker; regular alcohol consumption

Aggrastat is contraindicated in patients with active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month.

Home Medications

  • Metoprolol 25 mg twice daily
  • Simvastatin 80 mg daily
  • Levothyroxine 125 mcg daily
  • Aspirin 325 mg daily
  • Clopidogrel 75 mg daily

Concomitant use of Aggrastat with fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding.

Physical Examination and Lab Results

  • Height 5’10, weight 95 kg, BMI 30
  • Pulse 78 bpm, blood pressure 114/68 mmHg
  • Serum Cr 1.2 mg/dL, Platelets 405, Troponin I 1.47 ng/mL
  • Chest radiograph: pulmonary vascular congestion, moderate right-sided pleural effusion
  • ECG shows moderate decrease in left ventricle systolic function with an estimated LVEF of 20-25% and anteroapical hypokinesis
  • Angiography shows LAD stent thrombosis following prior procedure

Action

  • Additional PCI with PTCA and DES placement
  • Aggrastat® at time of PCI: Single bolus (25 mcg/kg) + maintenance infusion (0.15 mg/kg/min)
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NSTE-ACS – High risk cases

Symptoms

  • While grocery shopping, 71-year-old male patient experienced chest tightness
  • Proceeded to ED
  • Symptoms relieved after medications given in ED
  • Symptoms reoccurred after one hour

Medical History

  • Insulin-dependent type II diabetes
  • Hypertension
  • Hypercholesterolemia
  • Smoker

Home Medications

  • Aspirin 81 mg daily
  • Atorvastatin 20 mg daily
  • Insulin

Concomitant use of Aggrastat with fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding.

Physical Examination and Lab Results

  • Height 5’8, weight 111 kg, BMI 37
  • Pulse 72 bpm, blood pressure 149/82 mmHg
  • Heart: regular, no murmurs or gallops
  • Serum Cr 0.87 mg/dL, Platelets 250, Troponin I 1.9 ng/mL, Glc 121 mg/dL, Cholesterol 238 mg/dL
  • ECG shows T-wave inversions in leads V3, V4, and V5
  • Angiography shows total occlusion of obtuse marginal

Action

  • Immediate PCI on obtuse marginal
  • Aggrastat® at time of PCI: Single bolus (25 mcg/kg) + maintenance infusion (0.15 mg/kg/min)

REFERENCES

  1. Amsterdam EA et al. J Am Coll Cardiol. 2014;64:2645-2687
  2. Levine GN et al. J Am Coll Cardiol. 2011;58:e44-e122
  3. Holte E et al. Cardiovasc Ultrasound. 2007 Oct 1;5:33. This work is licensed under the Creative Commons Attribution 2.0 Generic License.
  4. Perez, IE et al. Case Rep Med. 2015;2015:390642 This work is licensed under the Creative Commons Attribution License.
  5. Konishi T et al. Thromb J. 2015 Jul 23;13:25. This work is licensed under the Creative Commons Attribution License. Changes from original: arrow and label removed.
  6. Arcenas RF and Ali MI 2013. Case Rep Cardiol. 2013;2013:407935. This work is licensed under the Creative Commons Attribution License.
Important Safety Information

Indication:

Aggrastat® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Contraindications:

  • Known hypersensitivity to any component of Aggrastat®.
  • History of thrombocytopenia with prior exposure to Aggrastat®.
  • Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month.

Warnings and Precautions:

  • Aggrastat® can cause serious bleeding. Most bleeding associated with Aggrastat® occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic or potentially traumatic procedures such as arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. If bleeding cannot be controlled, discontinue Aggrastat®.
  • Thrombocytopenia: discontinue Aggrastat® and heparin.

Adverse Reactions:

  • Bleeding is the most commonly reported adverse reaction.

For additional information, refer to the full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch
or call 1-800-FDA-1088.