Ischaemic heart disease: angioplasty: abciximab improved survival.

Clinical bottom line (level 1b)

  1. Patients with ischaemic heart disease having PTCA who received abciximab during stent insertion were less likely to die, have an MI or emergency revascularisation than patients who did not (NNT = 18 at 30 days) . There was no clear increase in major bleeding.
  2. Patients who received abciximab rather than stent insertion also were less likely to die, have an MI or emergency revascularisation (NNT = 26 at 30 days) . There was no clear increase in major bleeding.
  3. There was no clear difference in event rate between patients given abciximab who received a stent and those who did not.
EPISTENT investigators : Lancet 1998; 352: 87-92
Expires July 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 63 hospitals, USA and Canada

2399 patients (aged mean 59 years, 75% male) ischaemic heart disease and scheduled to undergo elective or urgent percutaneous coronary angioplasty

Excluded if
  • 60% or less stenosis amenable to angioplasty or stenting
  • unprotected left-mainstem stenosis
  • bleeding diathesis
  • intracranial neoplasm
  • history of stroke within two years
  • uncontrolled hypertension (>180/100)
  • recent surgery or percutaneous coronary intervention within previous three months
  • concurrent warfarin therapy or INR >1.5


    • Control Group: (n = 809, 809 analysed): stent and placebo
    Experimental Group: (n = 794, 794 analysed): stent and abciximab 0.25 mg/kg up to 60 min before procedure, followed by an infusion of 0.125 µ /kg/min for 12 hours (maximum 10 µ /min)
    Experimental Group: (n = 796, 796 analysed): balloon angioplasty and abciximab
    All patients had 325 mg aspirin po once daily; ticlodipine 250 mg po twice daily was given at the discretion of the investigator. All patients had heparin. Those on abciximab had 70 U/kg (maximum 7000 U) with additional boluses as required to achieve activated clotting time >200 s. Patients on placebo had 100 U/kg (maximum 10000 U) with additional boluses as required to achieve activated clotting time >300 s.
    98% followed for 30 days

    The evidence

    stent and placebo vs stent and abciximab
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death, MI, urgent revascularisation 30 days 87
    (10.8%)    		 42
    (5.29%)    		 51%
    (30% to 66%)    		 5.46%
    (2.82% to 8.11%)    		 18
    (12 to 35)
    death or MI 30 days 63
    (7.79%)    		 24
    (3.02%)    		 61%
    (39% to 75%)    		 4.76%
    (2.57% to 6.96%)    		 21
    (14 to 39)
    major bleeding 30 days 18
    (2.22%)    		 12
    (1.51%)    		 32%
    (-40% to 67%)    		 0.71%
    (-0.61% to 2.04%)    		 140
    (NNT = 49 to infinity;
    NNH = 164 to infinity)

    stent and placebo vs no stent and abciximab
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death, MI, urgent revascularisation 30 days 87
    (10.8%)    		 55
    (6.91%)    		 36%
    (11% to 53%)    		 3.84%
    (1.08% to 6.61%)    		 26
    (15 to 93)
    death or MI 30 days 63
    (7.79%)    		 37
    (4.65%)    		 40%
    (11% to 60%)    		 3.14%
    (0.78% to 5.49%)    		 32
    (18 to 130)
    major bleeding 30 days 18
    (2.22%)    		 11
    (1.38%)    		 38%
    (-31% to 70%)    		 0.84%
    (-0.46% to 2.14%)    		 119
    (NNT = 47 to infinity;
    NNH = 219 to infinity)

    no stent and abciximab vs stent and abciximab
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death, MI, urgent revascularisation 30 days 55
    (6.91%)    		 42
    (5.29%)    		 23%
    (-13% to 48%)    		 1.62%
    (-0.73% to 3.97%)    		 62
    (NNT = 25 to infinity;
    NNH = 137 to infinity)
    death or MI 30 days 37
    (4.65%)    		 24
    (3.02%)    		 35%
    (-8% to 61%)    		 1.63%
    (-0.26% to 3.51%)    		 62
    (NNT = 28 to infinity;
    NNH = 384 to infinity)
    major bleeding 30 days 11
    (1.38%)    		 12
    (1.51%)    		 -9%
    (-146% to 51%)    		 -0.13%
    (-1.30% to 1.04%)    		 -773
    (NNT = 96 to infinity;
    NNH = 77 to infinity)

    Comments

    1. Abciximab is a platelet glycoprotein-IIb/IIIa antagonists and acts to prevent platelet aggregation during clotting.
    2. The study is not large enough to show any small differences abciximab with or without stenting. Any differences may not be clinically significant which suggests abciximab may be a useful alternative to stenting.

    Citation

    1. EPISTENT investigators , : Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet 1998; 352: 87-92
    Search Terms: hand search
    Contributor: Chris Ball and Clare Wotton, July 2000
    Reviewer:

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