The safety and efficacy of subcutaneous enoxaparin versus intravenous unfractionated heparin and tirofiban versus placebo in the treatment of acute ST-segment elevation myocardial infarction patients ineligible for reperfusion (TETAMI): a randomized trial
Topic: Anticoagulation in acute coronary syndrome (Gp2a/3b inhibitors)
- Enoxaparin is superior to unfractionated heparin and that tirofiban is better than placebo in patients with acute STEMI ineligible for acute reperfusion.
- Prospective, multi-centered, double blinded, randomized clinical trial
- Enoxaparin (30 mg IV bolus, then 1 mg/kg subcutaneously every 12 hours).
- Enoxaparin (dose noted above) plus tirofiban (10 ug/kg IV bolus, then continuous infusion 0.1 ug/kg/min)
- Unfractionated heparin (UFH; 70 U/kg IV bolus, then continuous infusion 15 U/kg/hr) plus tirofiban (dose noted above).
- 1,216 patients
- > 18 years with STEMI and deemed unsuitable for treatment with thrombolytic or primary PCI
- Contraindication to anticoagulation
- Cardiogenic shock
- Renal insufficiency (not defined)
- Recent use of anticoagulation
- 6 months
- Composite of all death, reinfarction, or recurrent angina at 30 days
- Incidence of the composite triple end point at 48 h and 8 days
- Incidence of the composite double end point of death and reinfarction at 48 h, 8 and 30 days
- Rates of cardiac catheterization, PTCA, or coronary artery bypass grafting (CABG) at 30 days
- All outcomes at 6-month follow-up
- Mean age 63, 72% were men.
- Main reason for not reperfusion these patients with thrombolytic or PCI was late arrival >12 hours.
- Majority of patients received their first dose of study medication more than 12 h after symptom onset.
- Incidence of primary end point occurred in 95 patients (15.7%) in the enoxaparin group and 107 patients (17.3%) in the UFH group (RR 0.89; CI 0.66-1.21).
- Incidence of secondary end point occurred in 52 patients (8.6%) in the enoxaparin group and 53 patients (8.5%) in the UFH group (RR 1.01; CI 0.68-1.50).
TAKE AWAY: Enoxaparin alone or with tirofiban did not reduce incidence of primary or secondary end points when compared to UFH with tirofiban in patients with STEMI ineligible for acute revascularization.
Reference: Cohen M, Gensini GF, Maritz F, et al. The safety and efficacy of subcutaneous enoxaparin versus intravenous unfractionated heparin and tirofiban versus placebo in the treatment of acute ST-segment elevation myocardial infarction patients ineligible for reperfusion (TETAMI): a randomized trial. J Am Coll Cardiol. 2003;42(8):1348-56.