Author + information
- Received January 13, 2016
- Revision received March 16, 2016
- Accepted March 24, 2016
- Published online July 11, 2016.
- Rahman Shah, MDa,b,∗ (, )
- Kelly C. Rogers, PharmDb,c,
- Agha J. Ahmed, MDd,
- Bryan J. King, MDa,b and
- Sunil V. Rao, MDe
- aSection of Cardiology, University of Tennessee, School of Medicine, Memphis, Tennessee
- bVeterans Affairs Medical Center, Memphis, Tennessee
- cUniversity of Tennessee, College of Pharmacy, Memphis, Tennessee
- dHutchinson Clinic, Hutchinson, Kansas
- eThe Duke Clinical Research Institute, Durham, North Carolina
- ↵∗Reprint requests and correspondence:
Dr. Rahman Shah, University of Tennessee, School of Medicine, Section of Cardiovascular Medicine, 1030 Jefferson Avenue, Memphis, Tennessee 38104.
Objectives The aim of this study was to evaluate the efficacy of various doses of post–primary percutaneous coronary intervention (PCI) bivalirudin infusion to prevent acute stent thrombosis (AST).
Background In several recent randomized controlled trials, bivalirudin infusion was continued post-PCI as either a full PCI dose (Biv-Full) or a reduced dose (Biv-Low) to reduce the risk for AST. The results of these trials varied, so the authors performed a meta-analysis of RCTs to determine whether the risk for AST is dose dependent.
Methods Scientific databases and Web sites were searched for RCTs. A traditional meta-analysis was performed using moderator analyses and network meta-analysis using mixed-treatment comparison models to compare the efficacy of various bivalirudin doses in reducing AST.
Results Data from 5 trials including 16,294 patients were analyzed. Compared with heparin, bivalirudin increased AST risk 2-fold, but this was ameliorated by continuing Biv-Full (risk ratio: 0.90, 95% confidence interval: 0.32 to 2.54; p = 0.852). This effect was not seen with Biv-Low. Similarly, in mixed-treatment models, no difference in AST rate was found between heparin and Biv-Full (odds ratio: 0.97; 95% confidence interval: 0.36 to 2.21). After 30 days, bivalirudin decreased the risk for major bleeding by 47% compared with heparin; this benefit persisted even with continued Biv-Full post-PCI (risk ratio: 0.29; 95% confidence interval: 0.16 to 0.53; p < 0.001).
Conclusions Although bivalirudin is associated with a greater risk for AST than heparin post–primary PCI, this limitation may be mitigated by continuing Biv-Full (not Biv-Low) 3 to 4 h post-operatively. The decrease in bleeding risk with bivalirudin compared with heparin is not compromised by this strategy.
Dr. Rao is a consultant for Terumo Interventional Systems, AstraZeneca, Merck, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 13, 2016.
- Revision received March 16, 2016.
- Accepted March 24, 2016.
- American College of Cardiology Foundation