Coronary heart disease: eptifibatide decreased death or nonfatal MI.

Clinical bottom line (level 1b)

  1. Patients with acute coronary syndromes who are given eptifibatide as well as conventional therapy were less likely to die or have a nonfatal MI, than those given conventional therapy alone (NNT = 67 at 30 days) .
  2. Patients who were given eptifibatide were more likely to have a severe bleed than those given conventional therapy alone (NNH = 166 at 30 days)
The PURSUIT Trial Investigators : New England Journal of Medicine 1998; 339 (7): 436-443
Expires March 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 726 hospitals in 28 countries

9461 patients (aged median 64 years, 64% male) ischaemic chest pain at rest, lasting 10 minutes or more within the previous 24 hours, with transient ST elevation of >0.5 mm, transient or persistent ST segment depression of >0.5 mm, T-wave inversion of >1 mm within 12 hours before or after chest pain, or a serum concentration of creatine kinase-MB above the upper limit of normal.

Excluded if
  • persistent ST elevation of > 1 mm
  • active bleeding or a history of bleeding diathesis
  • gastrointestinal or genitourinary bleeding within 30 days before enrolment
  • systolic blood pressure >200 mmHg or diastolic >110 mmHg
  • history of major surgery within the last 6 weeks
  • history of non-haemorrhagic stroke within the previous 30 days or any history of haemorrhagic stroke
  • renal failure
  • pregnancy
  • planned administration of a platelet glycoprotein IIb/IIIa receptor inhibitor or thrombolytic agent
  • receipt of thrombolytic therapy within the previous 24 hours


  • Control Group: (n = 4739, 4739 analysed): placebo
    Experimental Group: (n = 4722, 4722 analysed): eptifibatide (bolus dose of 180 µ g/kg body weight, followed by an infusion of 1.3 µ g/kg/minute, or a bolus of 180 µ g/kg followed by an infusion of 2.0 µ g/kg/minute) to provide plasma concentrations 1.5 to 2.0 times the plasma concentration needed to reach inhibit 80% of platelets ex-vivo, and infusion was continued until discharge or 72 hours (whichever was the shorter)
    All patients were given standard therapy.
    100% followed for 30 days
    Outcome notes:
    • severe bleeding : defined using GUSTO classification- intracranial haemorrhage or bleeding that caused haemodynamic compromise and required intervention

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)
    ARR
    (95% CI)
    NNT
    (95% CI)
    death or nonfatal MI 30 days 744
    (15.7%)
    671
    (14.2%)
    9.00%
    (0.00% to 18.0%)
    1.49%
    (0.05% to 2.93%)
    67
    (34 to 1900)
    severe bleeding 30 days 42
    (0.89%)
    70
    (1.50%)
    -67.0%
    (-145% to -14.0%)
    -0.60%
    (-1.04% to -0.16%)
    -166
    (-618 to -96)

    Comments

    1. Patients who were given the lower dose of test drug were not included in the analysis.

    Citation

    1. The PURSUIT Trial Investigators , : Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. New England Journal of Medicine 1998; 339 (7): 436-443
    Contributor: Clare Wotton and Bob Phillips, January 2000
    Reviewer:

    Clinical Question.
    Patient coronary artery disease
    Intervention or Exposure eptifibatide
    Comparison placebo
    Outcome death and nonfatal MI