Effect of Additional Temporary Glycoprotein IIb-IIIa Receptor Inhibition on Troponin Release in Elective Percutaneous Coronary Interventions After Pretreatment With Aspirin and Clopidogrel (TOPSTAR Trial)

TOPSTAR Design Single center, double-blind, randomized, prospective study of ELECTIVE PCI patients Assessed the additive benefit of administering a GP IIb-IIIa inhibitor to the treatment regimen of aspirin, unfractionated heparin, and clopidogrel. This additive benefit was assessed in terms of: Cardiac troponin (TnT) release post-elective PCI; and The incidence of death, MI, and target vessel revascularization (TVR) at 9 months. Bonz AW, et al. J Am Coll Cardiol 2002;40:662-668

TOPSTAR Background Elevated cardiac troponin pre-PCI is associated with a higher risk of mortality. TOPSTAR assessed the association of post PCI troponin with the adjunctive use of GP IIb IIIa inhibitors and clinical outcomes. RESTORE dosing regimen of Tirofiban was used [10-μg/kg bolus + 0.15- μg/kg infusion for 36 hours]. Bonz AW, et al. J Am Coll Cardiol 2002;40:662-668

With and Without GP IIb-IIIa Inhibition n = 109 Elective PCI Patients Reductions in Troponin & Long-term Death/MI/TVR with Aspirin, Heparin & Pretreatment With Clopidogrel With and Without GP IIb-IIIa Inhibition n = 109 Elective PCI Patients P < 0.05 P < 0.05 P < 0.08 P < 0.05 Positive Troponin Death/MI/TVR ASA + UFH + Pretreatment with Clopidogrel (n = 46) ASA + UFH + Clopidogrel + GP IIb-IIIa Inhibitor (n = 50) Bonz AW, et al. J Am Coll Cardiol 2002;40:662-668

TOPSTAR Study Results TOPSTAR demonstrates that aspirin, heparin, and pretreatment with clopidogrel is associated with a 74% rate of turning troponin positive by 48 hours after PCI. The addition of a GP IIb-IIIa inhibitor to pretreatment with clopidogrel reduces troponin release and reduces the risk of death or MI most likely by reducing platelet aggregates and microembolization. Bonz AW, et al. J Am Coll Cardiol 2002;40:662-668