Clinical Guidelines

For STEMI Patients Undergoing PCI, Effient Is Recommended as a Treatment Choice in the 2009 ACC*/AHA† STEMI Guidelines Update

Class I recommendations1,2

  • A loading dose of thienopyridine is recommended for STEMI patients for whom PCI is planned
    • Effient® (prasugrel) 60 mg should be given as soon as possible for primary PCI (Level of Evidence: B)
  • For STEMI patients undergoing nonprimary PCI, if the patient did not receive fibrinolytic therapy, once the coronary anatomy is known and PCI is planned, a loading dose of 60 mg of Effient should be given promptly and no later than 1 hour after the PCI (Level of Evidence: B)
  • In patients receiving a stent (bare-metal or drug-eluting) during PCI for ACS, Effient 10 mg daily (Level of Evidence: B) should be given for at least 12 months
    • If the risk of morbidity because of bleeding outweighs the anticipated benefit afforded by thienopyridine therapy, earlier discontinuation should be considered (Level of Evidence: C)
  • In patients taking a thienopyridine in whom CABG is planned and can be delayed, it is recommended that Effient be discontinued for at least 7 days to allow for dissipation of the antiplatelet effect (Level of Evidence: C), unless the need for revascularization and/or the net benefit of the thienopyridine outweighs the potential risks of excess bleeding (Level of Evidence: C)

Class IIb recommendation1,2

  • Continuation of Effient beyond 15 months may be considered in patients undergoing drug-eluting stent placement (Level of Evidence: C)

Class III recommendation1,2

  • In STEMI patients with a prior history of stroke or transient ischemic attack for whom primary PCI is planned, Effient is not recommended as part of a dual-antiplatelet therapy regimen (Level of Evidence: C)

For UA/NSTEMI Patients Undergoing PCI, Effient Is Recommended as a Treatment Choice in the 2009 ACC/AHA/SCAI‡ PCI Guidelines Update

PCI Guidelines1,2

Class I recommendation

  • Patients with definite or likely UA/NSTEMI selected for an invasive approach should receive dual-antiplatelet therapy (Level of Evidence: A). Aspirin should be initiated on presentation (Level of Evidence: A). Effient (at the time of PCI) (Level of Evidence: B) is recommended as a second antiplatelet agent

For UA/NSTEMI Patients Managed With PCI, Effient Is Recommended as a Treatment Choice in the 2011 ACCF§/AHA UA/NSTEMI Guidelines Update

Class I recommendations3,4

  • Patients with definite UA/NSTEMI at medium or high risk and in whom an initial invasive strategy is selected should receive dual-antiplatelet therapy on presentation (Level of Evidence: A)
    • Aspirin (ASA) should be initiated upon presentation (Level of Evidence: A)
    • The choice of a second antiplatelet therapy to be added to ASA on presentation includes Effient at the time of PCI (Level of Evidence: B)
  • An LD of thienopyridine is recommended for UA/NSTEMI patients for whom PCI is planned
    • Effient 60 mg should be given promptly and no later than 1 hour after PCI once coronary anatomy is defined and a decision is made to proceed with PCI (Level of Evidence: B)
  • The duration and maintenance dose of thienopyridine therapy should be as follows:
    • In UA/NSTEMI patients undergoing PCI, Effient 10 mg daily should be given for at least 12 months (Level of Evidence: B)
    • If the risk of morbidity from bleeding outweighs the anticipated benefits afforded by thienopyridine therapy, earlier discontinuation should be considered (Level of Evidence: C)
  • In patients taking a thienopyridine in whom CABG is planned and can be delayed, it is recommended that the drug be discontinued to allow for dissipation of the antiplatelet effect (Level of Evidence: B)
    • The period of withdrawal should be at least 7 days in patients receiving Effient (Level of Evidence: C) unless the need for revascularization and/or the net benefit of the thienopyridine outweighs the potential risks of excess bleeding (Level of Evidence: C)

Class IIb recommendations3,4

  • Effient 60 mg may be considered for administration promptly upon presentation in patients with UA/NSTEMI for whom PCI is planned, before definition of coronary anatomy if both the risk for bleeding is low and the need for CABG is considered unlikely (Level of Evidence: C)
  • Continuation of Effient beyond 15 months may be considered in patients following drug-eluting stent (DES) placement (Level of Evidence: C)

Class III (Harm) recommendation3,4

  • In UA/NSTEMI patients with a prior history of stroke and/or TIA for whom PCI is planned, Effient is potentially harmful as part of a dual-antiplatelet therapy regimen (Level of Evidence: B)

*American College of Cardiology.
†American Heart Association.
‡Society for Cardiovascular Angiography and Interventions.
§American College of Cardiology Foundation

SELECTED SAFETY: SIGNIFICANT BLEEDING RISK

Effient can cause significant, sometimes fatal, bleeding. In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (diabetes or prior MI) where its effect appears to be greater and its use may be considered. Click here for Safety Information and Boxed Warning.

References:
  1. Kushner FG, Hand M, Smith SC Jr, et al. Circulation. 2009;120:2271-2306.
  2. Kushner FG, Hand M, Smith SC Jr, et al. J Am Coll Cardiol. 2009;54:2205-2241.
  3. Wright RS, Anderson JL, Adams CD, et al. Circulation. 2011;123:2022-2060.
  4. Wright RS, Anderson JL, Adams CD, et al. J Am Coll Cardiol. 2011;57:1920-1959.

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