Myocardial infarction: tenecteplase was not different than alteplase.

Clinical bottom line (level 1b-)

  1. Patients who had an acute myocardial infarction and were given tenecteplase, had no difference in 30 day all-cause mortality than those given alteplase.
Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators : Lancet 1999; 354: 716-722
Expires March 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 1021 hospitals in 29 countries

16949 patients (aged 12% over 75 years, 77% male) acute myocardial infarction within 6 hours before randomisation

Excluded if
  • hypertension- systolic blood pressure >180 mmHg or diastolic >110 mmHg or both
  • use of abciximab or other glycoprotein IIb/IIIa antagonists within preceding 12 hours
  • biopsy of parenchymal organ
  • substantial trauma within 2 months before admission
  • any major head trauma and any other trauma occurring after onset of the current MI
  • any known history of stroke, transient ischaemic attack or dementia
  • any known structural damage to the central nervous system
  • current therapy with oral anticoagulation, with an international normalised ratio of more than 1.3
  • sustained cardiopulmonary resuscitation (>10 minutes) in the previous 2 weeks
  • pregnancy, lactation or parturition in the previous 30 days
  • active participation in another investigative drug study or device protocol in the previous 30 days
  • previous enrolment in this study
  • any other disorder that the investigator judged would place the patient at increased risk
  • inability to follow protocol and to comply with follow-up requirements


Note:
  • Only 16504 patients received study medication due to various reasons.


Control Group: (n = , analysed): bolus and infusion of alteplase plus bolus of placebo- 15 mg bolus followed by a 0.75 mg/kg infusion over 30 minutes and a 0.50 mg/kg infusion over 60 minutes
Experimental Group: (n = , analysed): adjusted bolus of tenecteplase plus bolus and infusion of placebo- administered over 5-10 seconds in a dose according to bodyweight (between 30 and 50 mg)
All patients received 150-325 mg aspirin orally and intravenous heparin.
100% followed for 30 days

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNH
(95% CI)
all-cause mortality 30 days 522
(6.15%)		 523
(6.18%)		 -1.00%
(-13.0% to 11.0%)		 -0.03%
(-0.76% to 0.69%)		 3180
(NNT = 144 to infinity;
NNH = 132 to infinity)

Comments

  1. This trial excluded a difference of 10% relative risk (a maximum benefit missed of NNT=144).

Citation

  1. Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators , : Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet 1999; 354: 716-722
Contributor: Clare Wotton and Bob Phillips, February 2000
Reviewer:

Clinical Question.
Patient myocardial infarction
Intervention or Exposure tenecteplase
Comparison alteplase
Outcome mortality