Outcome of urgent and elective percutaneous coronary interventions after pharmacologic reperfusion with tenecteplase combined with unfractionated heparin, enoxaparin, or abciximab

J Am Coll Cardiol. 2003 Oct 1;42(7):1178-85. doi: 10.1016/s0735-1097(03)00917-3.

Abstract

Objectives: The aim of this study was to evaluate percutaneous coronary intervention (PCI) in the Assessment of the Safety and Efficacy of New Thrombolytic Regimens (ASSENT-3) trial.

Background: In the ASSENT-3 trial, co-therapy with abciximab (ABC) or enoxaparin (ENOX) reduced ischemic complications after ST-elevation acute myocardial infarction treated with tenecteplase when compared with unfractionated heparin (UFH). The effect of these new co-therapies on the results of PCI is unknown.

Methods: Clinical outcomes in patients who received co-therapy with ABC, ENOX, or UFH and subsequently underwent an elective (n = 1,064) or urgent (n = 716) PCI in the ASSENT-3 trial were compared.

Results: No significant differences in clinical end points were observed in patients who underwent an elective PCI. A non-significant trend toward fewer in-hospital myocardial re-infarctions was seen with ABC and ENOX when compared with UFH (0.5% vs. 0.6% vs. 1.5%, respectively). The incidence of bleeding complications was similar in the three treatment arms. Significantly fewer ABC- and ENOX-treated patients needed urgent PCI compared with UFH (9.1% vs. 11.9% vs. 14.3%; p < 0.0001), but outcomes in these patients were in general less favorable (30-day mortality: 8.2% vs. 5.4% vs. 4.5%; 1-year mortality: 11.0% vs. 8.5% vs. 5.6%; in-hospital re-infarction: 3.9% vs. 2.5% vs. 2.7%; major bleeding complications: 8.8% vs. 7.0% vs. 3.4%). In pairwise comparisons with UFH, the higher one-year mortality and major bleeding rates after ABC were statistically significant (p = 0.045 and p = 0.012, respectively).

Conclusions: Clinical outcomes after elective PCI were similar with the three antithrombotic co-therapies studied in ASSENT-3. Although fewer patients needed urgent PCI with ABC and ENOX, clinical outcomes were less favorable in this selected population, especially with ABC.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Abciximab
  • Alberta
  • Angioplasty, Balloon, Coronary*
  • Antibodies, Monoclonal / administration & dosage
  • Anticoagulants / administration & dosage
  • Belgium
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Elective Surgical Procedures
  • Emergency Treatment
  • Enoxaparin / administration & dosage
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Germany
  • Heparin / administration & dosage
  • Humans
  • Immunoglobulin Fab Fragments / administration & dosage
  • Italy
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Netherlands
  • North Carolina
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Recurrence
  • Spain
  • Survival Analysis
  • Sweden
  • Tenecteplase
  • Tissue Plasminogen Activator / administration & dosage
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Anticoagulants
  • Enoxaparin
  • Fibrinolytic Agents
  • Immunoglobulin Fab Fragments
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Heparin
  • Tissue Plasminogen Activator
  • Tenecteplase
  • Abciximab