1. 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)

2. 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:

3. 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 μg/kg infusion for 36 hours].
Bonz AW, et al. J Am Coll Cardiol 2002;40:

4. 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:

5. 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: