Post–PCI Bivalirudin Infusion and Acute Stent Thrombosis

Study Questions:

What is the efficacy of various doses of post–primary percutaneous coronary intervention (PCI) bivalirudin infusion to prevent acute stent thrombosis?

Methods:

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.

Results:

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).

Conclusions:

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.

Perspective:

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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