TARGET: Do Tirofiban And ReoPro Give Similar Efficacy Trial?
There is considerable debate about the choice of intravenous platelet glycoprotein IIb/IIIa inhibitors for percutaneous coronary intervention, after a meta-analysis of 7 trials and 16,770 patients has shown a 38% reduction in death or non-fatal MI 30 days after the index procedure. At 149 hospitals in 18 countries throughout North America, Europe and Australia, 4810 patients were randomized between 12/30/99 and 8/25/00 and treated with either tirofiban or abciximab on a double-blind, double dummy basis. Clopidogrel and aspirin were administered pre-procedurally, along with a 70 U/kg intravenous heparin bolus. The dose of tirofiban was 10 mcg/kg bolus and 0.15 mcg/kg/min infusion for 18–24 hrs; for abciximab it was 0.25 mcg/kg bolus and 0.125 mcg/kg/min (max 10 mcg/min) infusion. Patients qualified by having suitable anatomy for “intent-to-stent” lesions addressed by percutaneous revascularization, and were not with evolving ST-elevation MI or with serum creatinine >2.5 mg/dl. The primary endpoint is 30 death or non-fatal MI and the trial has >80% power to determine non-inferiority for tirofiban with an expected event rate in the control (abciximab) group of 5.3% based on the EPISTENT trial. The primary endpoint data will be presented along with the key subgroups such as diabetics. Follow-up data for the trial to 1 year will also be performed.
- Copyright © 2000 by American Heart Association