Myocardial infarction: reteplase was as effective as alteplase.

Clinical bottom line (level 1b)

  1. Patients with a myocardial infarction who received reteplase compared with alteplase were not more likely to die.
  2. There was no clear difference in the rate of stroke.
GUSTO-III Investigators : New England Journal of Medicine 1997; 337 ( 16 ): 1118-1123
Topol et al: Circulation 2000; 102 : 1761-1765
Expires March 2004

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 807 acute hospitals in 27 countries in North America, Europe, Africa and Oceania

15059 patients (aged median 63, 73% male) with 30 minutes of continuous chest pain, and ST elevation > 1 mm in 2 or more limb leads or > 2 mm in the precordial leads or bundle branch block on a 12-lead ECG.

Excluded if
  • active bleeding
  • history of stroke or central nervous system damage
  • recent major surgery
  • systolic blood pressure > 200 mmHg or diastolic > 110 mmHg
  • recent non-compressible vascular puncture
  • concomitant use of an oral anticoagulant and INR > 2.0
  • > 6 hours since onset of pain

Note:
  • Patients were randomised 2:1 in favour of reteplase.

Control Group: (n = 4921, 4921 analysed): alteplase (tPA) bolus of 15 mg followed by an infusion of 0.75 mg/kg over 30 minutes, followed by 0.5 mg/kg over 60 minutes
Experimental Group: (n = 10138, 10138 analysed): reteplase 2 bolus dose of 10 MU given 30 minutes apart
All patients received aspirin and a heparin infusion. Other medications including beta-blockers and nitrates were given at the investigators' discretion.
97% followed for 12 months

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death 30 days 356
(7.23%)		 757
(7.47%)		 -3%
(-17% to 9%)		 -0.23%
(-1.12% to 0.65%)		 -430
(NNT = 150 to infinity;
NNH = 89 to infinity)
haemorrhagic stroke 30 days 88
(1.79%)		 166
(1.64%)		 8%
(-18% to 29%)		 0.15%
(-0.29% to 0.60%)		 660
(NNT = 170 to infinity;
NNH = 340 to infinity)
death 12 months 544
(11.1%)		 1135
(11.2%)		 -1%
(-12% to 8%)		 -0.14%
(-1.21% to 0.93%)		 -710
(NNT = 110 to infinity;
NNH = 83 to infinity)

Citation

  1. GUSTO-III Investigators , : A comparison of reteplase with alteplase for acute myocardial infarction. New England Journal of Medicine 1997; 337 ( 16 ): 1118-1123
  2. Topol EJ, Phman M, Armstrong PW, et al: survival outcomes 1 year after reperfusion therapy with either alteplase or reteplase for acute myocardial infarction: results from the global utilization of streptokinase and t-PA for occluded coronary arteries (GUSTO) III trial. Circulation 2000; 102 : 1761-1765
Search Terms: from ACP Journal Club
Contributor: Chris Ball and Clare Wotton, March 2002
Reviewer:

Clinical Question.
Patient myocardial infarction
Intervention or Exposure reteplase
Comparison alteplase
Outcome death