Efficiency and safety of bivalirudin in patients undergoing emergency percutaneous coronary intervention via radial access: A subgroup analysis from the bivalirudin in acute myocardial infarction versus heparin and GPI plus heparin trial

Catheter Cardiovasc Interv. 2017 Jun 1;89(7):1157-1165. doi: 10.1002/ccd.26804. Epub 2016 Sep 28.

Abstract

Objectives: To explore the efficiency and safety of bivalirudin in patients undergoing emergency percutaneous coronary intervention via radial access.

Background: Bivalirudin reduces bleeding risks over heparin in patients undergoing PCI. However, bleeding advantages of bivalirudin in patients undergoing transradial intervention is uncertain.

Methods: In the BRIGHT trial, 1,723 patients underwent emergency PCI via radial access, with 576 patients in the bivalirudin arm, 576 in the heparin arm and 571 in the heparin plus tirofiban arm. The primary outcome was 30-day net adverse clinical event (NACE), defined as a composite of major cardiac and cerebral events or any bleeding.

Results: 30-day NACE occurred in 5.7% with bivalirudin, 7.8% with heparin alone (vs. bivalirudin, P = 0.159), and 10.3% with heparin plus tifofiban (vs. bivalirudin, P = 0.004). The 30-day bleeding rate was 0.9% for bivalirudin, 2.3% for heparin (vs. bivalirudin, P = 0.057), and 5.8% for heparin plus tirofiban (vs. bivalirudin, P < 0.001). Major cardiac and cerebral events (4.9 vs. 5.7 vs. 4.6%, P = 0.899), stent thrombosis (0.5 vs. 0.5 vs. 0.7%, P = 0.899) and acquired thrombocytopenia (0.2 vs. 0.5 vs. 0.9%, P = 0.257) at 30 days were similar among three arms. The interaction test for PCI access and randomized treatment showed no significance on all bleeding (P > 0.05).

Conclusions: The bleeding benefit of bivalirudin was independent of artery access. Bivalirudin lead to statistical reduction on bleeding risks in comparison to heparin plus tirofiban, and only small numerical difference in comparison to heparin, with comparable risks of ischemic events and stent thrombosis in patients with acute myocardial infarction (AMI) undergoing emergency transradial PCI. © 2016 Wiley Periodicals, Inc.

Keywords: acute myocardial infarction; bivalirudin; transradial intervention.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects
  • Antithrombins / administration & dosage*
  • Antithrombins / adverse effects
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Cardiac Catheterization / mortality
  • China
  • Emergencies
  • Female
  • Hemorrhage / chemically induced
  • Hirudins / administration & dosage*
  • Hirudins / adverse effects
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Non-ST Elevated Myocardial Infarction / diagnosis
  • Non-ST Elevated Myocardial Infarction / mortality
  • Non-ST Elevated Myocardial Infarction / therapy*
  • Peptide Fragments / administration & dosage*
  • Peptide Fragments / adverse effects
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Percutaneous Coronary Intervention / mortality
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Aggregation Inhibitors / adverse effects
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Radial Artery* / diagnostic imaging
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Risk Assessment
  • Risk Factors
  • ST Elevation Myocardial Infarction / diagnosis
  • ST Elevation Myocardial Infarction / mortality
  • ST Elevation Myocardial Infarction / therapy*
  • Time Factors
  • Tirofiban
  • Treatment Outcome
  • Tyrosine / administration & dosage
  • Tyrosine / adverse effects
  • Tyrosine / analogs & derivatives*
  • Warfarin / administration & dosage*
  • Warfarin / adverse effects
  • Young Adult

Substances

  • Anticoagulants
  • Antithrombins
  • Hirudins
  • Peptide Fragments
  • Platelet Aggregation Inhibitors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Recombinant Proteins
  • Tyrosine
  • Warfarin
  • Tirofiban
  • bivalirudin