title: Efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.
abstract: BACKGROUND
  The efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention (PCI)(1) remains controversial in to date. Our meta-analysis was undertaken to evaluate the efficacy and safety of bivalirudin compared with heparin in patients undergoing PCI.
  
  
  METHODS
  We searched PubMed, Cochrane Library, EMBASE, Clinical Trials.gov databases for randomized controlled trials (RCTs).(2) The primary efficacy endpoint was mortality. Secondary efficacy endpoints were incidence of major adverse cardiovascular events (MACE),(3) myocardial infarction (MI),(4) target vessel revascularization (TVR)(5) and stent thrombosis up to 30days and 1year. The safety endpoint was major bleeding up to 30days. Subgroup analyses were also conducted according to the clinical status of patients and the different use rate of GPI in two groups.
  
  
  RESULTS
  17 RCTs met the including criteria and 40,655 patients were included. No significant difference was observed in mortality (risk ratio [RR](6) 0.90; 95% confidence interval [CI](7) 0.77 to 1.05; p=0.19; I(2)=20%) and the risk of MACE (RR 1.02; 95% CI 0.96 to 1.09; p=0.45; I(2)=37%). Bivalirudin increased the risk of MI (RR 1.10; 95% CI 1.02 to 1.19; p=0.01; I(2)=13%), TVR (RR 1.20; 95% CI 1.04 to 1.38; p=0.01; I(2)=6%) and stent thrombosis (RR 1.32; 95% CI 1.08 to 1.60; p=0.006; I(2)=0%) but decreased the risk of major bleeding (RR 0.54; 95% CI 0.48 to 0.61; p<0.00001; I(2)=0).
  
  
  CONCLUSIONS
  Bivalirudin is associated with higher risk of MI, stent thrombosis and TVR but lower risk of major bleeding compared with heparin. The reduction of major bleeding is associated with the glycoprotein platelet IIb/IIIa inhibitor (GPI)(8) use rate.
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China.
authors.forename: Shuo
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, The 230 Hospital of People's Liberation Army, 19 Shijing Road, Zhenxing District, Dandong 118000, Liaoning Province, China.
authors.forename: Weihua
authors.initials: W
authors.lastname: Gao
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China.
authors.forename: Haixia
authors.initials: H
authors.lastname: Li
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China.
authors.forename: Meijuan
authors.initials: M
authors.lastname: Zou
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China.
authors.forename: Sihao
authors.initials: S
authors.lastname: Sun
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China.
authors.forename: Yijie
authors.initials: Y
authors.lastname: Ba
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China. Electronic address: chenggang63@hotmail.com.
authors.forename: Gang
authors.initials: G
authors.lastname: Cheng
mesh_terms: D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects*; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011183:Postoperative Complications / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: Bivalirudin; Heparin; Meta-analysis; Percutaneous coronary intervention