Myocardial infarct artery patency and reocclusion rates after treatment with duteplase at the dose used in the International Study of Infarct Survival-3. Burroughs Wellcome Study Group.

Abstract

Duteplase, 98% double-chain recombinant tissue-type plasminogen activator, was administered intravenously in 488 patients with acute myocardial infarction in a multicenter, open, safety and patency study. Duteplase dosing was based on body weight. Duteplase was administered as a bolus of 0.04 MIU/kg of thrombolytic activity followed by 0.36 MIU/kg over 1 hour and 0.067 MIU/kg/hour for 3 additional hours. The patency rate of the infarct-related artery at 90 minutes was 69% (330 of 478). The reocclusion rate at 3 to 48 hours was 6% (18 of 301). Reinfarction occurred in 7.6% of patients (37 of 488), but 12 reinfarctions occurred after coronary angioplasty. Serious bleeding occurred in 7.6% of patients (37 of 488), predominantly at the catheterization entry site. There were 3 instances of central nervous system bleeding, 1 fatal. Fibrinogen levels declined to 83% of baseline at 24 hours. Weight-based dosing may explain the low incidence of serious bleeding in this study. The in-hospital mortality was 6.6% (32 of 488). This study documents that the dose of duteplase used in the International Study of Infarct Survival-3 results in a 90-minute coronary artery patency rate and safety profile comparable to those reported in published studies on the approved dose of alteplase.

• Authors: J M Kalbfleisch, P B Kurnik, U Thadani, M A DeWood, R Kent, R D Magorien, A C Jain, L J Spaccavento, D L Morris, G J Taylor
• Journal: The American journal of cardiology (Am J Cardiol) Vol. 71 Issue 5 Pg. 386-92 (Feb 15 1993) ISSN: 0002-9149 [Print] United States
• PMID: 8430624 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Tissue Plasminogen Activator
• duteplase

Topics

• Coronary Angiography
• Coronary Vessels (drug effects)
• Female
• Follow-Up Studies
• Hospital Mortality
• Humans
• Male
• Middle Aged
• Myocardial Infarction (diagnostic imaging, drug therapy, mortality)
• Recombinant Proteins (administration & dosage, therapeutic use)
• Recurrence
• Time Factors
• Tissue Plasminogen Activator (administration & dosage, therapeutic use)
• Vascular Patency (drug effects)