Acute coronary syndrome: oral glycoprotein IIb/IIIa inhibitors increase death and major bleeding

Clinical bottom line (level 1a)

  1. Patients with acute coronary syndrome or requiring urgent revascularisation who receive an oral glycoprotein IIb/IIIa inhibitor compared with aspirin are at increased risk of major bleeding (NNH = 59 at 1-10 months) and death (NNH = 210 at 1-10 months) , but are less likely to undergo urgent revascularisation (NNT = 130 at 1-10 months) .
  2. There is no clear difference in the rate of myocardial infarction between the two groups.
Chew et al: Circulation 2001; 103 : 201-206
Expires May 2004

The study

Systematic review of all randomised, double-blind, placebo-controlled trials of
  • Patients: acute coronary syndrome or requiring percutaneous coronary intervention
  • Intervention: oral glycoprotein IIb/IIIa inhibitors (xemilofiban, orbofiban, sibrafiban) compared with aspirin
  • Outcome: death, myocardial infarction, major bleeding, urgent revascularisation

Articles found in English using Medline, 1990 to 2000 (search terms: platelet, oral, random, inhibit or block ) and hand-searching recent cardiology conference proceedings

Selection criteria: see above and below
Appraisal criteria: randomisation, blinding
Articles excluded if:
  • phase II dose-ranging studies
  • < 1000 patients enrolled
  • follow-up < 30 days
4 RCTs found involving 33340 patients followed for 90 to 300 days

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 NNT
(95% CI)
death 1-10 months
(1.3%)
(1.7%)		 -36%
(-66% to -13%)		 -210
(-600 to -120)
major bleeding 1-10 months
(2.4%)
(4.1%)		 -70%
(-95% to -50%)		 -59
(-84 to -44)
myocardial infarction 1-10 months
(2.8%)
(3.6%)		 -4%
(-15% to 7%)
urgent revascularisation 1-10 months -
(3.6%)
(2.8%)		 22%
(13% to 33%)		 130
(84 to 220)

Comments

  1. Though the search strategy was limited, the nature of the field means that important articles were unlikely to have been missed.

Citation

  1. Chew DP, Bhatt DL, Sapp S, et al: increased mortality with oral platelet glycoprotein IIb/IIIa antagonists: a meta-analysis of phase III multicenter randomized trials. Circulation 2001; 103 : 201-206
Search Terms: from ACP Journal Club
Contributor: Chris Ball, May 2002
Reviewer:

Clinical Question.
Patient acute coronary syndrome or requiring urgent revascularisation
Intervention or Exposure oral glycoprotein IIb/IIIa inhibitor
Comparison aspirin
Outcome death, myocardial infarction, major bleeding, urgent revascularisation