Myocardial infarction: reteplase and abciximab reduced reinfarction, refractory ischaemia and urgent revascularisation compared with reteplase alone, but caused more bleeding and thrombocytopenia

Clinical bottom line (level 1b)

  1. Patients with an acute myocardial infarction who received reteplase and abciximab compared with reteplase alone were less likely to reinfarct (NNT = 84 at 30 days) or develop refractory ischaemia (NNT = 67 at 30 days) .
  2. Patients on reteplase and abciximab were less likely to require urgent PTCA (NNT = 40 at 7 days) or CABG (NNT = 140 at 7 days) , but more likely to develop severe bleeding (NNH = 180 at 30 days) or thrombocytopenia (NNH = 97 at 30 days) .
  3. There was no clear difference in mortality or thrombocytopenia between the two groups.
GUSTO-V investigators : Lancet 2001; 357 : 1905-1914
Expires April 2004

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: 820 acute hospitals in 20 countries worldwide

16588 patients (aged mean 61, 75% male) with an acute myocardial infarction (persistent chest pain for at least 30 minutes with evolving ST elevation or new left bundle branch block)

Excluded if
  • > 6 hours since onset of symptoms
  • aged < 18
  • planned catheter based reperfusion
  • active bleeding or non-compressible vascular puncture site
  • bp > 180/110 mmHg
  • warfarin therapy
  • stroke within previous 2 years
  • weight > 120 kg
  • platelet count < 100 x 10 9 /l

Control Group: (n = 8260, 8260 analysed): reteplase two 10 unit boluses 30 minutes apart, followed by unfractionated heparin 5000 unit bolus followed by 1000 U/h infusion (or 800 U/h if < 80 kg)
Experimental Group: (n = 8328, 8328 analysed): reteplase two 5 unit boluses 30 minutes apart, and abciximab 0.25 mg/kg bolus and 0.125 microgm/kg per min (maximum 10 microgm/min) for 12 hours, and unfractionated heparin 60 units/kg bolus (maximum 5000 U) followed by an infusion of 7 U/kg per hour
All patients received aspirin 150-325 mg orally or 250-500 mg iv, followed by 75-325 mg daily. Patients on reteplase alone could receive abciximab if revascularisation was planned within 24 hours or on a physician's recommendation thereafter.
98% followed for 30 days
Outcome notes:
  • severe bleeding : causing haemodynamic instability
  • thrombocytopenia : platelet count < 50 x 109/l

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death 30 days 488
(5.91%)		 468
(5.62%)		 5%
(-8% to 16%)		 0.29%
(-0.42% to 1.00%)		 350
(NNT = 240 to infinity;
NNH = 100 to infinity)
reinfarction 30 days 289
(3.50%)		 192
(2.31%)		 34%
(21% to 45%)		 1.19%
(0.68% to 1.70%)		 84
(59 to 150)
refractory ischaemia 30 days 1057
(12.8%)		 941
(11.3%)		 12%
(4% to 19%)		 1.50%
(0.51% to 2.49%)		 67
(40 to 200)
PTCA 7 days 2305
(27.9%)		 2115
(25.4%)		 9%
(4% to 13%)		 2.51%
(1.16% to 3.85%)		 40
(26 to 86)
CABG 7 days 306
(3.70%)		 250
(3.00%)		 19%
(4% to 31%)		 0.70%
(0.16% to 1.25%)		 140
(80 to 650)
intracranial haemorrhage 30 days 49
(0.59%)		 52
(0.62%)		 -5%
(-55% to 29%)		 -0.031%
(-0.27% to 0.21%)		 -3200
(NNT = 370 to infinity;
NNH = 490 to infinity)
severe bleeding 30 days 42
(0.51%)		 90
(1.08%)		 -110%
(-210% to -48%)		 -0.57%
(-0.84% to -0.30%)		 -180
(-330 to -120)
thrombocytopenia 30 days 10
(0.12%)		 96
(1.15%)		 -850%
(-1700% to -400%)		 -1.03%
(-1.27% to -0.79%)		 -97
(-130 to -79)

Citation

  1. GUSTO-V investigators , : reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO-V randomised trial. Lancet 2001; 357 : 1905-1914
Search Terms: from ACP Journal Club
Contributor: Chris Ball, April 2002
Reviewer:

Clinical Question.
Patient myocardial infarction
Intervention or Exposure reteplase and abciximab
Comparison reteplase
Outcome death, reinfarction, refractory ischaemia, revascularisation, bleeding