Effect of Post-Primary Percutaneous Coronary Intervention Bivalirudin Infusion on Acute Stent Thrombosis: Meta-Analysis of Randomized Controlled Trials.
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).



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.



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.



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).



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.
Section of Cardiology, University of Tennessee, School of Medicine, Memphis, Tennessee; Veterans Affairs Medical Center, Memphis, Tennessee. Electronic address: shahcardiology@yahoo.com.
Rahman
R
Shah
Veterans Affairs Medical Center, Memphis, Tennessee; University of Tennessee, College of Pharmacy, Memphis, Tennessee.
Kelly C
KC
Rogers
Hutchinson Clinic, Hutchinson, Kansas.
Agha J
AJ
Ahmed
Section of Cardiology, University of Tennessee, School of Medicine, Memphis, Tennessee; Veterans Affairs Medical Center, Memphis, Tennessee.
Bryan J
BJ
King
The Duke Clinical Research Institute, Durham, North Carolina.
Sunil V
SV
Rao
D006801:Humans; D000208:Acute Disease; D000925:Anticoagulants / Q000009:adverse effects; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D019317:Evidence-Based Medicine; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects; D016017:Odds Ratio; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants; D000991:Antithrombins; C074619:bivalirudin; D006493:Heparin; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins
acute stent thrombosis; bivalirudin; primary percutaneous coronary intervention