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CLINICAL STUDY: ADJUNCTIVE THERAPY AND PCI

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)

^* Department of Cardiology, University of Würzburg, Würzburg, Germany

Manuscript received October 16, 2001; revised manuscript received April 16, 2002, accepted May 15, 2002.

^* Reprint requests and correspondence: Dr. Andreas W. Bonz, Medizinische Universitätsklinik, Josef Schneider Strasse 2, 97080 Würzburg, Germany.
a.bonz{at}medizin.uni-wuerzburg.de

OBJECTIVES: The Troponin in Planned PTCA/Stent Implantation With or Without Administration of the Glycoprotein IIb/IIIa Receptor Antagonist Tirofiban (TOPSTAR) trial investigated: 1) the amount of troponin T (TnT) release after nonacute, elective percutaneous coronary intervention (PCI) in patients pretreated with aspirin and clopidogrel; and 2) the effect of additional glycoprotein (GP) IIb/IIIa receptor inhibiton on postinterventional TnT release.

BACKGROUND: No data are available yet as to whether additional administration of a GP IIb/IIIa receptor antagonist might be beneficial in patients undergoing elective PCI already pretreated with aspirin and clopidogrel.

METHODS: After bolus application of the study medication (tirofiban [T] or placebo [P]), PCI was performed followed by an 18-h continuous infusion of T/P. Primary end point of the study was incidence and amount of TnT release after elective PCI after 24 h.

RESULTS: A total of 12 h after PCI troponin release was detected in 63% of the patients receiving P and in 40% of the patients receiving T (p < 0.05), after 24 h in 69% (P) and 48% (T) (p < 0.05) and after 48 h in 74% (P) versus 58% (T) (p < 0.08) of the patients. No differences were observed regarding major bleeding, intracranial bleeding or nonhemorrhagic strokes. After nine months a reduction of combined death/myocardial infarction/target vessel revascularization could be observed in the tirofiban group ([T] 2.3% vs. [P] 13.04%, p < 0.05).

CONCLUSIONS: Troponin T release occurs after successful intervention in 74% of the patients undergoing elective PCI after 48 h even after pretreatment with aspirin and clopidogrel. The GP IIb/IIIa receptor antagonist tirofiban is able to decrease the incidence of troponin release significantly in this patient population.

Abbreviations and Acronyms   ACT   activated clotting time   CK   creatine kinase   GP   glycoprotein   MI   myocardial infarction   P   placebo group   PAU   platelet aggregation units   PCI   percutaneous coronary intervention   PTCA   percutaneous transluminal coronary angioplasty   RPFA   rapid platelet function assay   T   tirofiban group   TnT   troponin T   TOPSTAR   Troponin in Elective PTCA/STent Implantation With or Without Administration of the Glycoprotein IIb/IIIa Receptor Antagonist Tirofiban   TVR   target vessel revascularization

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