Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction Via Radial Access Anticoagulated With Bivalirudin Versus Heparin: A Report From the National Cardiovascular Data Registry

JACC Cardiovasc Interv. 2017 Jun 12;10(11):1102-1111. doi: 10.1016/j.jcin.2017.03.021. Epub 2017 May 17.

Abstract

Objectives: The aim of this study was to compare bivalirudin with heparin as anticoagulant agents in patients with ST-segment elevation myocardial infarction treated with radial primary percutaneous coronary intervention (PCI).

Background: Recent studies in which PCI was performed predominantly via radial access did not show bivalirudin to be superior to heparin.

Methods: Outcomes were compared in patients with STEMI included in the National Cardiovascular Data Registry CathPCI database from 2009 to 2015 who underwent primary PCI via radial access and who were anticoagulated with bivalirudin or heparin.

Results: The sample included 67,368 patients, of whom 29,660 received bivalirudin and 37,708 received heparin. The 2 groups of patients did not differ significantly in their mean age or percentage of men. The unadjusted comparison showed no significant difference in the rate of the composite endpoint of death, myocardial infarction, or stroke (4.6% vs. 4.7%; p = 0.47) and a significantly higher rate of acute stent thrombosis (1.00% vs. 0.60%; p < 0.001) with bivalirudin compared with heparin. After adjusting for multiple variables, including a propensity score reflecting the probability of receiving bivalirudin, the odds ratio of the composite endpoint of death, myocardial infarction, or stroke for bivalirudin versus heparin was 0.95 (95% confidence interval: 0.87 to 1.05; p = 0.152), and the odds ratio for acute stent thrombosis was 2.11 (95% confidence interval: 1.73 to 2.57) for bivalirudin versus heparin. Major bleeding rates were not significantly different.

Conclusions: In patients undergoing primary PCI via transradial access anticoagulated with bivalirudin or heparin, there was no difference in the composite endpoint of death, myocardial infarction, or stroke.

Keywords: ST-segment elevation myocardial infarction; anticoagulation; bivalirudin; heparin; percutaneous coronary intervention; transradial.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Chi-Square Distribution
  • Coronary Thrombosis / mortality
  • Female
  • Hemorrhage / chemically induced
  • Heparin / adverse effects
  • Heparin / therapeutic use*
  • Hirudins / adverse effects
  • Hospital Mortality
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Myocardial Infarction / mortality
  • Odds Ratio
  • Peptide Fragments / adverse effects
  • Peptide Fragments / therapeutic use*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Percutaneous Coronary Intervention / mortality
  • Propensity Score
  • Radial Artery* / diagnostic imaging
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • ST Elevation Myocardial Infarction / diagnostic imaging
  • ST Elevation Myocardial Infarction / mortality
  • ST Elevation Myocardial Infarction / therapy*
  • Stroke / mortality
  • Time Factors
  • Treatment Outcome
  • United States

Substances

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