Highlights
- •Bivalirudin is associated with higher risk of MI, stent thrombosis and TVR but lower risk of major bleeding versus heparin.
- •For NSTE-ACS patients, there is no significant difference between bivalirudin and heparin on efficacy analysis.
- •The glycoprotein platelet IIb/IIIa inhibitor (GPI) use rate will influence the risk of major bleeding.
Abstract
Background
The efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous
coronary intervention (PCI)
1PCI: percutaneous coronary intervention.
remains controversial in to date. Our meta-analysis was undertaken to evaluate the
efficacy and safety of bivalirudin compared with heparin in patients undergoing PCI.Methods
We searched PubMed, Cochrane Library, EMBASE, Clinical Trials.gov databases for randomized controlled trials (RCTs).
2RCTs: randomized controlled trials.
The primary efficacy endpoint was mortality. Secondary efficacy endpoints were incidence
of major adverse cardiovascular events (MACE),
3MACE: major adverse cardiovascular events.
myocardial infarction (MI),
4MI: myocardial infarction.
target vessel revascularization (TVR)
5TVR: target vessel revascularization.
and stent thrombosis up to 30 days and 1 year. The safety endpoint was major bleeding up to 30 days. Subgroup analyses were also conducted according to the clinical status of patients
and the different use rate of GPI in two groups.Results
17 RCTs met the including criteria and 40,655 patients were included. No significant
difference was observed in mortality (risk ratio [RR]
6RR: risk ratio.
0.90; 95% confidence interval [CI]
7CI: confidence interval.
0.77 to 1.05; p = 0.19; I2 = 20%) and the risk of MACE (RR 1.02; 95% CI 0.96 to 1.09; p = 0.45; I2 = 37%). Bivalirudin increased the risk of MI (RR 1.10; 95% CI 1.02 to 1.19; p = 0.01; I2 = 13%), TVR (RR 1.20; 95% CI 1.04 to 1.38; p = 0.01; I2 = 6%) and stent thrombosis (RR 1.32; 95% CI 1.08 to 1.60; p = 0.006; I2 = 0%) but decreased the risk of major bleeding (RR 0.54; 95% CI 0.48 to 0.61; p < 0.00001; I2 = 0).Conclusion
Bivalirudin is associated with higher risk of MI, stent thrombosis and TVR but lower
risk of major bleeding compared with heparin. The reduction of major bleeding is associated
with the glycoprotein platelet IIb/IIIa inhibitor (GPI)
8GPI: glycoprotein platelet IIb/IIIa inhibitor.
use rate.Keywords
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Article info
Publication history
Published online: January 25, 2016
Accepted:
January 22,
2016
Received in revised form:
January 15,
2016
Received:
November 18,
2015
Identification
Copyright
© 2016 Published by Elsevier Inc.
