Effect of Post–Primary Percutaneous Coronary Intervention Bivalirudin Infusion on Acute Stent Thrombosis

Meta-Analysis of Randomized Controlled Trials

Rahman Shah, Kelly Rogers, Agha J. Ahmed, Bryan J. King, Sunil V. Rao

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1313-1320
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume9
Issue number13
DOIs
StatePublished - Jul 11 2016

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Percutaneous Coronary Intervention
Stents
Meta-Analysis
Thrombosis
Randomized Controlled Trials
Heparin
Odds Ratio
Confidence Intervals
Hemorrhage
bivalirudin
Databases
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Effect of Post–Primary Percutaneous Coronary Intervention Bivalirudin Infusion on Acute Stent Thrombosis : Meta-Analysis of Randomized Controlled Trials. / Shah, Rahman; Rogers, Kelly; Ahmed, Agha J.; King, Bryan J.; Rao, Sunil V.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 13, 11.07.2016, p. 1313-1320.

Research output: Contribution to journalArticle

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abstract = "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.",
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AB - 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.

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