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Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: the integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial.

Publication ,  Journal Article
Brener, SJ; Zeymer, U; Adgey, AAJ; Vrobel, TR; Ellis, SG; Neuhaus, KL; Juran, N; Ivanc, TB; Ohman, EM; Strony, J; Kitt, M; Topol, EJ
Published in: J Am Coll Cardiol
February 6, 2002

OBJECTIVES: This study was designed to test the hypothesis that eptifibatide and reduced-dose tissue plasminogen activator (t-PA) will enhance infarct artery patency at 60 min in patients with acute myocardial infarction (AMI). BACKGROUND: Combination fibrin and platelet lysis improves epicardial and myocardial reperfusion in AMI. METHODS: Patients were enrolled in a dose finding (Phase A, n = 344) followed by a dose confirmation (Phase B, n = 305) protocol. All patients received aspirin and weight-adjusted heparin and underwent angiography at 60 and 90 min. In Phase A, eptifibatide in a single or double bolus (30 min apart) of 180, 180/90 or 180/180 microg/kg followed by an infusion of 1.33 or 2.0 microg/kg per min was sequentially added to 25 or 50 mg of t-PA. In Phase B, patients were randomized to: 1) double-bolus eptifibatide 180/90 (30 min apart) and 1.33 microg/kg per min infusion with 50 mg t-PA (Group I); 2) 180/90 (10 min apart) and 2.0 g/kg per min with 50 mg t-PA (Group II); or 3) full-dose, weight-adjusted t-PA (Group III). RESULTS: In Phase A, the best rate of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 was achieved using 180/90/1.33 microg/kg per min eptifibatide with 50 mg t-PA: 65% and 78% at 60 and 90 min, respectively. In Phase B, the incidence of TIMI flow grade 3 at 60 min was 42%, 56% and 40%, for Groups I through III, respectively (p = 0.04, Group II vs. Group III). The median corrected TIMI frame count was 38, 33 and 50, respectively (p = 0.02). TIMI major bleeding was reported in 8%, 11% and 6%, respectively; intracranial hemorrhage occurred in 1%, 3% and 2% of patients (p > 0.5 for both). The incidences of death (4%, 5% and 7%), reinfarction or revascularization at 30 days were similar among the three treatment groups. CONCLUSIONS: In comparison with standard t-PA regimen, double-bolus eptifibatide (10 min apart) with a 48-h infusion and half-dose t-PA (Group II) is associated with improved quality and speed of reperfusion. The safety profile of this therapy is similar to that of other combination regimens.

Duke Scholars

Published In

J Am Coll Cardiol

DOI

ISSN

0735-1097

Publication Date

February 6, 2002

Volume

39

Issue

3

Start / End Page

377 / 386

Location

United States

Related Subject Headings

  • Vascular Patency
  • Treatment Outcome
  • Tissue Plasminogen Activator
  • Time Factors
  • Thrombocytopenia
  • Survival Analysis
  • South Africa
  • Radiography
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Platelet Aggregation Inhibitors
 

Citation

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Brener, S. J., Zeymer, U., Adgey, A. A. J., Vrobel, T. R., Ellis, S. G., Neuhaus, K. L., … Topol, E. J. (2002). Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: the integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial. J Am Coll Cardiol, 39(3), 377–386. https://doi.org/10.1016/s0735-1097(01)01758-2
Brener, Sorin J., Uwe Zeymer, AA Jennifer Adgey, Thomas R. Vrobel, Stephen G. Ellis, Karl Ludwig Neuhaus, Nadine Juran, et al. “Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: the integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial.J Am Coll Cardiol 39, no. 3 (February 6, 2002): 377–86. https://doi.org/10.1016/s0735-1097(01)01758-2.
Brener SJ, Zeymer U, Adgey AAJ, Vrobel TR, Ellis SG, Neuhaus KL, et al. Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: the integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial. J Am Coll Cardiol. 2002 Feb 6;39(3):377–86.
Brener, Sorin J., et al. “Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: the integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial.J Am Coll Cardiol, vol. 39, no. 3, Feb. 2002, pp. 377–86. Pubmed, doi:10.1016/s0735-1097(01)01758-2.
Brener SJ, Zeymer U, Adgey AAJ, Vrobel TR, Ellis SG, Neuhaus KL, Juran N, Ivanc TB, Ohman EM, Strony J, Kitt M, Topol EJ. Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: the integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial. J Am Coll Cardiol. 2002 Feb 6;39(3):377–386.
Journal cover image

Published In

J Am Coll Cardiol

DOI

ISSN

0735-1097

Publication Date

February 6, 2002

Volume

39

Issue

3

Start / End Page

377 / 386

Location

United States

Related Subject Headings

  • Vascular Patency
  • Treatment Outcome
  • Tissue Plasminogen Activator
  • Time Factors
  • Thrombocytopenia
  • Survival Analysis
  • South Africa
  • Radiography
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Platelet Aggregation Inhibitors