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TOPSTAR Design

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.

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TOPSTAR Design

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  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;40:662-668

  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 + 0.15- μg/kg infusion for 36 hours]. Bonz AW, et al. J Am Coll Cardiol 2002;40:662-668

  4. 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 Death/MI/TVR Positive Troponin 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

  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;40:662-668

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