Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction: Results of a randomized trial

E. Magnus Ohman, Frans Van De Werf, Elliott M. Antman, Robert M. Califf, James A de Lemos, C. Michael Gibson, Renee L. Oliverio, Lynn Harrelson, Carolyn McCabe, Peter DiBattiste, Eugene Braunwald

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Abstract

Background: The combination of older reduced-dose fibrinolytic agents and platelet glycoprotein IIb/IIIa inhibitors has shown modest improvements in reperfusion and more striking improvements in ST-segment resolution after acute myocardial infarction. We performed a multicenter dose-ranging study of reduced doses of a newer fibrinolytic (tenecteplase) combined with tirofiban, a glycoprotein IIb/IIIa inhibitor. Methods: The first goal of the trial was to identify a dose or doses of tirofiban that, when combined with reduced-dose tenecteplase, would result in a higher incidence of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow at 60 minutes versus full-dose tenecteplase alone. The second goal was to assess whether the optimum dose(s) from the first stage also would result in greater resolution of ST-segment elevation. Results: In all, 409 patients aged 18 to 75 years with myocardial infarction were enrolled. The incidence of TIMI grade 3 flow at 60 minutes did not differ significantly among dose groups, ranging from 50% to 68%. The corrected TIMI frame count likewise did not differ substantially (range 34-42). More patients given combined therapy had complete resolution of ST-segment elevation at 60 minutes compared with patients given tenecteplase alone. Major bleeding was infrequent, and no strokes occurred. Based on angiographic results of the first stage, the second planned stage of the study was not performed. Conclusions: Although combination therapies were not associated with increased reperfusion compared with full-dose tenecteplase alone, similar TIMI flow grades were achieved despite reductions in tenecteplase doses. ST-segment resolution was more rapid and complete with combination therapy versus full-dose tenecteplase, suggesting enhanced microcirculatory perfusion to the infarct zone in this dose-ranging trial.

Original languageEnglish (US)
Pages (from-to)79-88
Number of pages10
JournalAmerican Heart Journal
Volume150
Issue number1
DOIs
StatePublished - Jul 2005

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tirofiban
Myocardial Infarction
Platelet Glycoprotein GPIIb-IIIa Complex
Reperfusion
Integrin beta3
Fibrinolytic Agents
Incidence
ST Elevation Myocardial Infarction
tenecteplase

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction : Results of a randomized trial. / Ohman, E. Magnus; Van De Werf, Frans; Antman, Elliott M.; Califf, Robert M.; de Lemos, James A; Gibson, C. Michael; Oliverio, Renee L.; Harrelson, Lynn; McCabe, Carolyn; DiBattiste, Peter; Braunwald, Eugene.

In: American Heart Journal, Vol. 150, No. 1, 07.2005, p. 79-88.

Research output: Contribution to journalArticle

Ohman, EM, Van De Werf, F, Antman, EM, Califf, RM, de Lemos, JA, Gibson, CM, Oliverio, RL, Harrelson, L, McCabe, C, DiBattiste, P & Braunwald, E 2005, 'Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction: Results of a randomized trial', American Heart Journal, vol. 150, no. 1, pp. 79-88. https://doi.org/10.1016/j.ahj.2005.01.007
Ohman, E. Magnus ; Van De Werf, Frans ; Antman, Elliott M. ; Califf, Robert M. ; de Lemos, James A ; Gibson, C. Michael ; Oliverio, Renee L. ; Harrelson, Lynn ; McCabe, Carolyn ; DiBattiste, Peter ; Braunwald, Eugene. / Tenecteplase and tirofiban in ST-segment elevation acute myocardial infarction : Results of a randomized trial. In: American Heart Journal. 2005 ; Vol. 150, No. 1. pp. 79-88.
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T2 - Results of a randomized trial

AU - Ohman, E. Magnus

AU - Van De Werf, Frans

AU - Antman, Elliott M.

AU - Califf, Robert M.

AU - de Lemos, James A

AU - Gibson, C. Michael

AU - Oliverio, Renee L.

AU - Harrelson, Lynn

AU - McCabe, Carolyn

AU - DiBattiste, Peter

AU - Braunwald, Eugene

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Y1 - 2005/7

N2 - Background: The combination of older reduced-dose fibrinolytic agents and platelet glycoprotein IIb/IIIa inhibitors has shown modest improvements in reperfusion and more striking improvements in ST-segment resolution after acute myocardial infarction. We performed a multicenter dose-ranging study of reduced doses of a newer fibrinolytic (tenecteplase) combined with tirofiban, a glycoprotein IIb/IIIa inhibitor. Methods: The first goal of the trial was to identify a dose or doses of tirofiban that, when combined with reduced-dose tenecteplase, would result in a higher incidence of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow at 60 minutes versus full-dose tenecteplase alone. The second goal was to assess whether the optimum dose(s) from the first stage also would result in greater resolution of ST-segment elevation. Results: In all, 409 patients aged 18 to 75 years with myocardial infarction were enrolled. The incidence of TIMI grade 3 flow at 60 minutes did not differ significantly among dose groups, ranging from 50% to 68%. The corrected TIMI frame count likewise did not differ substantially (range 34-42). More patients given combined therapy had complete resolution of ST-segment elevation at 60 minutes compared with patients given tenecteplase alone. Major bleeding was infrequent, and no strokes occurred. Based on angiographic results of the first stage, the second planned stage of the study was not performed. Conclusions: Although combination therapies were not associated with increased reperfusion compared with full-dose tenecteplase alone, similar TIMI flow grades were achieved despite reductions in tenecteplase doses. ST-segment resolution was more rapid and complete with combination therapy versus full-dose tenecteplase, suggesting enhanced microcirculatory perfusion to the infarct zone in this dose-ranging trial.

AB - Background: The combination of older reduced-dose fibrinolytic agents and platelet glycoprotein IIb/IIIa inhibitors has shown modest improvements in reperfusion and more striking improvements in ST-segment resolution after acute myocardial infarction. We performed a multicenter dose-ranging study of reduced doses of a newer fibrinolytic (tenecteplase) combined with tirofiban, a glycoprotein IIb/IIIa inhibitor. Methods: The first goal of the trial was to identify a dose or doses of tirofiban that, when combined with reduced-dose tenecteplase, would result in a higher incidence of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow at 60 minutes versus full-dose tenecteplase alone. The second goal was to assess whether the optimum dose(s) from the first stage also would result in greater resolution of ST-segment elevation. Results: In all, 409 patients aged 18 to 75 years with myocardial infarction were enrolled. The incidence of TIMI grade 3 flow at 60 minutes did not differ significantly among dose groups, ranging from 50% to 68%. The corrected TIMI frame count likewise did not differ substantially (range 34-42). More patients given combined therapy had complete resolution of ST-segment elevation at 60 minutes compared with patients given tenecteplase alone. Major bleeding was infrequent, and no strokes occurred. Based on angiographic results of the first stage, the second planned stage of the study was not performed. Conclusions: Although combination therapies were not associated with increased reperfusion compared with full-dose tenecteplase alone, similar TIMI flow grades were achieved despite reductions in tenecteplase doses. ST-segment resolution was more rapid and complete with combination therapy versus full-dose tenecteplase, suggesting enhanced microcirculatory perfusion to the infarct zone in this dose-ranging trial.

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