Angioplasty: stenting: eptifibatide reduced death and myocardial infarction but increased major bleeding

Clinical bottom line (level 1b)

  1. Patients undergoing stenting during angioplasty, who received eptifibatide compared with placebo were less likely to die, have a myocardial infarction or require urgent revascularisation (NNT = 28 at 30 days) .
  2. Patients receiving eptifibatide were more likely to have a major bleed (NNH = 120 at 30 days) .
the ESPRIT investigators : Lancet 2000; 356 : 2037-2044
Expires March 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 92 acute hospitals, USA and Canada

2064 patients (aged 54 to 71; median 62, 73% male) with coronary artery disease undergoing angioplasty with stent insertion

Excluded if
  • major surgery within 6 weeks
  • uncontrolled hypertension (> 200/110 mmHg)
  • documented thrombocytopenia (platelet < 100 x 10 9 /l
  • serum creatinine > 350 micromol/l
  • myocardial infarction in previous 24 hours
  • continuing chest pain requiring urgent angioplasty
  • angioplasty within previous 90 days, or staged angioplasty within next 30 days planned
  • previous stent implantation at target lesion within 30 days
  • treatment with glycoprotein IIb/IIIa inhibitor or thienopyridine within 30 days
  • stroke or TIA within previous 30 days; or history of haemorrhagic stroke
  • history of bleeding diathesis or evidence of abnormal bleeding within 30 days

Control Group: (n = 1024, 1024 analysed): placebo
Experimental Group: (n = 1040, 1040 analysed): eptifibatide bolus 180 microg/kg immediately, followed by 2.0 microg/kg/min continusou infusion for 18-24 hours. A second bolus of 180 microg/kg was given 10 minutes after the first.
All patients received aspirin and ticlopidine or clopidogrel on the day of randomisation. A heparin infusion was given adjusted to acheive a an activated clotting time of 200 to 300s
99.9% followed for 30 days

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death, myocardial infarction, urgent target vessel revascularisation 30 days 107
(10.5%)		 71
(6.83%)		 35%
(13% to 51%)		 3.62%
(1.20% to 6.04%)		 28
(17 to 83)
major bleeding 30 days 4
(0.39%)		 13
(1.25%)		 -220%
(-880% to -5%)		 -0.86%
(-1.64% to -0.084%)		 -120
(-1200 to -61)

Citation

  1. the ESPRIT investigators , : novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial. Lancet 2000; 356 : 2037-2044
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, March 2002
Reviewer:

Clinical Question.
Patient angioplasty receiving stent
Intervention or Exposure eptifibatide
Comparison placebo
Outcome death, myocardial infarction, urgent revascularisation