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)
Andreas W. Bonz, MD*,*,
Björn Lengenfelder*,
J.örg Strotmann, MD*,
Stefanie Held, MD*,
Oliver Turschner, MD*,
Kerstin Harre, MD*,
Christian Wacker, MD*,
Christiane Waller, MD*,
Nikolaus Kochsiek, MD*,
Malte Meesmann, MD*,
Ludwig Neyses, MD*,
Peter Schanzenbächer, MD*,
Georg Ertl, MD* and
Wolfram Voelker, MD*
* 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.
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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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