Combined Use of Bivalirudin and Radial Access in Acute Coronary Syndromes Is Not Superior to the Use of Either One Separately: Meta-Analysis of Randomized Controlled Trials

JACC Cardiovasc Interv. 2016 Aug 8;9(15):1523-31. doi: 10.1016/j.jcin.2016.05.023.

Abstract

Objectives: The aim of this meta-analysis was to study the relation between access site and bivalirudin use on outcomes in patients with acute coronary syndrome (ACS).

Background: Bivalirudin and radial access use are 2 strategies that are increasingly used to lower major bleeding in patients with ACS undergoing invasive approaches. The interaction between these 2 strategies and the benefit of using them in combination are unclear.

Methods: This analysis included randomized controlled trials that compared bivalirudin to heparin with or without glycoprotein IIb/IIIa inhibitors in patients with ACS and reported outcomes stratified by arterial access site. Meta-analyses of outcome data were performed on the basis of access site and anticoagulation regimen. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated from event rates using random-effects models.

Results: Eight trials with a total of 27,491 patients were included. Bivalirudin reduced major bleeding risk in patients with femoral access (OR: 0.51; 95% CI: 0.46 to 0.6; p < 0.001) but not in patients with radial access (OR: 0.75; 95% CI: 0.45 to 1.26; p = 0.28). Moreover, radial access reduced major bleeding risk in patients treated with heparin (OR: 0.57; 95% CI: 0.43 to 0.77; p < 0.001) but not in patients treated with bivalirudin (OR: 0.96; 95% CI: 0.65 to 1.41; p = 0.83). There were no differences in major adverse cardiovascular events or all-cause mortality between bivalirudin and heparin, regardless of access site.

Conclusions: Bivalirudin reduces bleeding risk only with femoral access, and radial access reduces bleeding risk only with heparin anticoagulation. Therefore, there is no additional benefit to the combined use of bivalirudin and radial access strategies in patients with ACS.

Keywords: acute coronary syndrome(s); bivalirudin; femoral access; heparin; radial access.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / mortality
  • Acute Coronary Syndrome / therapy*
  • Aged
  • Anticoagulants / therapeutic use
  • Antithrombins / adverse effects
  • Antithrombins / therapeutic use*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / methods*
  • Catheterization, Peripheral / mortality
  • Female
  • Femoral Artery
  • Hemorrhage / chemically induced
  • Hemorrhage / prevention & control
  • Heparin / therapeutic use
  • Hirudins / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Odds Ratio
  • Peptide Fragments / adverse effects
  • Peptide Fragments / therapeutic use*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Percutaneous Coronary Intervention / mortality
  • Radial Artery*
  • Randomized Controlled Trials as Topic
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Risk Factors
  • Treatment Outcome

Substances

  • Anticoagulants
  • Antithrombins
  • Hirudins
  • Peptide Fragments
  • Recombinant Proteins
  • Heparin
  • bivalirudin