Post–PCI Bivalirudin Infusion and Acute Stent Thrombosis
What is the efficacy of various doses of post–primary percutaneous coronary intervention (PCI) bivalirudin infusion to prevent acute stent thrombosis?
Scientific databases and websites were searched for randomized controlled trials. The investigators performed a traditional meta-analysis using moderator analyses and network meta-analysis using mixed-treatment comparison models to compare the efficacy of various bivalirudin doses in reducing acute stent thrombosis (AST). In those trials, one of two dosage rates of bivalirudin (1.75 mg/kg/h or 0.25 mg/kg/h, termed Biv-Full and Biv-Low, respectively) was used for post-PCI infusion. Bayesian network meta-analysis was performed using random-effects models.
Data from five trials including 16,294 patients were analyzed. Compared to heparin, bivalirudin increased AST risk twofold, but this was ameliorated by continuing Biv-Full (risk ratio [RR], 0.90; 95% confidence interval [CI], 0.32-2.54; 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 [OR], 0.97; 95% CI, 0.36-2.21). After 30 days, bivalirudin decreased the risk of major bleeding by 47% compared with heparin; this benefit persisted even with continued Biv-Full post-PCI (RR, 0.29; 95% CI, 0.16-0.53; p < 0.001).
The authors concluded that while bivalirudin is associated with a greater risk of AST than heparin post–primary PCI, this limitation may be mitigated by continuing Biv-Full (not Biv-Low) 3–4 hours postoperatively.
This meta-analysis reports that a bivalirudin-based regimen significantly decreased the 30-day risk of major bleeding by 47% at the expense of a twofold increased risk for AST. However, the increased risk of AST may be mitigated by continuing Biv-Full for 3-4 hours postoperatively, but not if the Biv-Low dose was used. Furthermore, the decreased bleeding risk with bivalirudin compared to heparin does not appear to be attenuated by continuing Biv-Full infusion for 3-4 hours post-intervention. Since in the majority of these trials, the patients were not randomized to receive a post-procedure PCI bivalirudin infusion, these findings should be interpreted cautiously and additional randomized controlled trials are needed to confirm these findings.
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