Key result
Bivalirudin with post-procedure infusion reduced the risk of early definite stent thrombosis compared with heparin monotherapy (RR 0.45; 95% CI 0.23-0.85; P=0.015).
Why the study?
Early trials showed bivalirudin stopped at the end of primary PCI increased stent thrombosis risk compared with heparin plus routine GPIs, but continuing post-procedure bivalirudin infusion might eliminate this risk compared with heparin monotherapy.
Does bivalirudin with a post-procedure infusion reduce the risk of early definite stent thrombosis compared with heparin monotherapy in patients undergoing primary PCI?
Meta-Analysis (n=13,505)
Does bivalirudin with a post-procedure infusion reduce the risk of early definite stent thrombosis compared with heparin monotherapy in patients undergoing primary PCI?
In primary PCI, continuing bivalirudin infusion post-procedure significantly reduces the risk of early definite stent thrombosis compared to heparin monotherapy.
Reduces early definite ST risk 55% vs heparin monotherapy; confirms benefit of post-PCI full-dose bivalirudin in primary PCI.
OBJECTIVES: To evaluate the efficacy of post-primary percutaneous coronary intervention (PCI) bivalirudin infusion (at full PCI dose) to prevent stent thrombosis (ST) compared with heparin monotherapy. BACKGROUND: Early randomized controlled trials (RCTs) have shown that compared with heparin use, bivalirudin use during primary PCI is associated with an increased risk of ST. However, bivalirudin was stopped in those trials at the end of the procedure and glycoprotein IIb/IIIa inhibitors (GPIs) were routinely used with heparin. The increased risk of ST may be eliminated by continuing bivalirudin infusion post-procedure for few hours. Indeed, in most recent trials, a trend of lower ST risk has been observed with a post-procedure infusion of bivalirudin compared with heparin monotherapy (without the routine use of GPI). METHODS: Relevant RCTs were included and risk ratios (RRs) were calculated using random effect models. The primary outcome of interest was the risk of early definite ST. RESULTS: Four RCTs involving 13,505 patients were included in this meta-analysis. Compared with heparin monotherapy, bivalirudin (with a post-procedure infusion) was associated with a 55% decrease in the risk of early definite ST (RR: 0.45, 95% confidence interval: 0.23-0.85; P = 0.015). There was no difference in the risk of early ST between bivalirudin (with a post-procedure infusion) and heparin with GPI. CONCLUSIONS: For primary PCI, a bivalirudin-based anticoagulant strategy (with post procedure infusion) is associated with a lower risk of early definite ST compared with treatment with heparin monotherapy (without GPI).
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Shah et al. (2019) conducted a meta-analysis in primary percutaneous coronary intervention (PCI) (n=13,505). Bivalirudin with a post-procedure infusion vs. heparin monotherapy was evaluated on risk of early definite ST (RR 0.45, 95% CI 0.23-0.85, p=0.015). Bivalirudin with post-procedure infusion reduced the risk of early definite stent thrombosis compared with heparin monotherapy (RR 0.45; 95% CI 0.23-0.85; P=0.015).
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