title: Effect of post-primary percutaneous coronary intervention bivalirudin infusion on net adverse clinical events and mortality: A comprehensive pairwise and network meta-analysis of randomized controlled trials.
abstract: OBJECTIVE
  To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality.
  
  
  BACKGROUND
  In primary PCI, lower risk of bleeding with bivalirudin (vs. unfractionated heparin [UFH]) is counterbalanced by an increased risk of acute stent thrombosis (ST). Several randomized clinical trials (RCTs) and a recent meta-analysis suggest that acute ST risk may be eliminated without compromising the bleeding benefit, but only if the full dose, not a low dose, of bivalirudin is continued post-PCI. However, it is not known whether this improved risk leads to lower rates of NACEs and mortality.
  
  
  METHODS
  Scientific databases and Web sites were searched for RCTs. Trials were included if study patients were undergoing primary PCI for acute ST-segment elevation myocardial infarction and were randomly assigned to bivalirudin or UFH treatment. The bivalirudin arm was divided based on post-PCI bivalirudin dosage: The Biv-Full group received 1.75 mg/kg/h, the Biv-Low group, 0.25 mg/kg/h, and the Biv-No group, none.
  
  
  RESULTS
  Six RCTs involving 16,842 patients were found. In pairwise meta-analysis, bivalirudin improved 30-day all-cause mortality by 35% and cardiac mortality by 32%, but did not yield a NACE rate better than that achieved with UFH. Subgroup analysis showed the Biv-Full group had a 46% lower NACE rate and 47% lower all-cause mortality than UFH. These effects were not seen in the other two groups. Network meta-analysis yielded similar results. At treatment ranking, the Biv-Full group yielded the best treatment efficacy.
  
  
  CONCLUSIONS
  In primary PCI, full-dose bivalirudin infusion for 3-4 hr after PCI appeared to improve NACE rates compared to UFH. It also seemed to be the most effective strategy for improving cardiac mortality and all-cause mortality. © 2016 Wiley Periodicals, Inc.
authors.affiliation: School of Medicine, Section of Cardiology, University of Tennessee, Memphis, TN.|Veterans Affairs Medical Center, Memphis, TN.
authors.forename: Rahman
authors.initials: R
authors.lastname: Shah
authors.affiliation: Section of Hematology, Virginia Commonwealth University, Richmond, VA.
authors.forename: Khalid
authors.initials: K
authors.lastname: Matin
authors.affiliation: College of Pharmacy, The University of Tennessee, Memphis, TN.
authors.forename: Kelly C
authors.initials: KC
authors.lastname: Rogers
authors.affiliation: The Duke Clinical Research Institute, Durham, NC.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D000991:Antithrombins / Q000008:administration & dosage* / Q000009:adverse effects; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D016017:Odds Ratio; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; 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 / Q000401:mortality / Q000628:therapy*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: bivalirudin; mortality; primary percutaneous coronary intervention