Coronary heart disease: c7E3 Fab monoclonal antibody decreased death, MI or unplanned surgery.

Clinical bottom line (level 1b)

  1. Patients undergoing high risk coronary angioplasty who were given a c7E3 Fab bolus plus infusion were less likely to die, have an MI or need unplanned surgery, than those given placebo (NNT = 22 at 30 days) .
  2. Patients given a c7E3 Fab bolus and a placebo infusion had no clear difference in death, MI or unplanned surgery.
The EPIC Investigators : New England Journal of Medicine 1994; 330 (14): 956-961
Expires March 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 56 institutions, USA

2099 patients (aged mean 61 years, 72% male) Scheduled to undergone coronary angioplasty or directional atherectomy and at high risk for vessel closure. High risk was defined as one of: acute evolving MI within12 hours after symptom onset that necessitated 'rescue' percutaneous intervention; early postinfarction angina or unstable angina with at least two episodes at rest associated with ECG changes in the last 24 hours; clinical or angiographic characteristic indicating high risk, according to American Heart Association and American College of Cardiology criteria.

Excluded if
  • high risk of bleeding
  • 80 years old or older
  • known bleeding diathesis
  • major surgery within preceding two years
  • stroke within preceding two years


    • Control Group: (n = 696, 696 analysed): placebo bolus and infusion
    Experimental Group: (n = 695, 695 analysed): c7E3 Fab monoclonal antibody, bolus dose 0.25 mg/kg, followed by placebo infusion
    Experimental Group: (n = 708, 708 analysed): c7E3 Fab monoclonal antibody, bolus dose 0.25 mg/kg, followed by an infusion of 10 microg/minute
    All patients were given oral aspirin (325 mg at least two hours before angioplasty or atherectomy and daily thereafter), and heparin (iv in an initial bolus of 10,000 to 12,000 U followed by incremental bolus doses up to 3,000 U at 15 minute intervals, but no more than 20,000 U during the procedure.
    100% followed for 30 days
    Outcome notes:
    • death, nonfatal MI or unplanned surgery- c7E3 Fab bolus vs placebo : death, nonfatal MI, coronary artery bypass grafting or repeat percutaneous intervention for acute ischaemia and insertion of a coronary endovascular stent because of procedural failure or placement of an intraaortic counterpulsation balloon pump to relieve refractory ischaemia, unplanned repeat angioplasty, urgent coronary surgery or failure of angioplasty.

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death, nonfatal MI or unplanned surgery- c7E3 Fab bolus vs placebo 30 days 89
    (12.8%)    		 79
    (11.4%)    		 11.0%
    (-18.0% to 33.0%)    		 1.42%
    (-2.00% to 4.84%)    		 70
    (NNT = 21 to infinity;
    NNH = 50 to infinity)
    death, MI or unplanned surgery- c7E3 Fab bolus plus infusion vs placebo 30 days 89
    (12.8%)    		 59
    (8.33%)    		 35.0%
    (11.0% to 52.0%)    		 4.45%
    (1.24% to 7.66%)    		 22
    (13 to 80)

    Comments

    1. Adaptations of protocols using abciximab (such as EPILOG) based on patient weight have reduced side-effects.

    Citation

    1. The EPIC Investigators , : Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. New England Journal of Medicine 1994; 330 (14): 956-961
    Contributor: Clare Wotton and Musab Hayatli, January 2000
    Reviewer: Andreas Michaelides

    Clinical Question.
    Patient undergoing high risk coronary angioplasty
    Intervention or Exposure monoclonal antibody, abciximab
    Comparison placebo
    Outcome death, MI or unplanned surgery