title: Transradial access mitigates bleeding benefit offered by bivalirudin over heparin in patients undergoing percutaneous coronary intervention: Insights from meta-analysis of randomized and observational studies.
abstract: OBJECTIVE
  Recent randomized control trials (RCTs) showed conflicting efficacy and safety between bivalirudin and heparin during percutaneous coronary intervention (PCI). We aimed to perform an updated meta-analysis, including real-world and trial data to examine the factors affecting their risk-benefit ratio.
  
  
  METHODS
  We searched Medline, the Cochrane library, and meeting abstracts for studies comparing bivalirudin versus heparin during PCI. Random-effect meta-analyses for MACE (major adverse cardiovascular events), stent thrombosis (ST) and major bleeding were performed. p-Value <0.05 was considered statistically significant.
  
  
  RESULTS
  Meta-analysis of 20 RCTs and 31 observation studies (n=165,835) showed that bivalirudin and heparin were similar in the risk of MACE in RCTs (OR 1.05, 95% CI 0.97-1.13) and observational studies (OR 0.94, 95% 0.81-1.10). Major bleeding was lower with bivalirudin in both RCTs (OR 0.60, 95% CI 0.51-0.70) and observational studies (OR 0.56, 95% CI 0.47-0.68). However, in the metaregression analysis, every 10% increase of transradial access decreased the bleeding benefit of bivalirudin by 4.9% (p=0.046, adjusted for GPI and heparin loading dose). ST with bivalirudin was higher with ST-segment elevation myocardial infarction (STEMI) in RCTs (OR 1.51, 95% CI 1.15-1.99) but not in observational studies (p=0.65).
  
  
  CONCLUSIONS
  In this large meta-analysis, bivalirudin is associated with a lower risk of bleeding compared to heparin in both RCTs and observational studies, however, transradial PCI mitigated most of this bleeding benefit. Heparin should be the preferred agent in transradial PCI given its lower cost and comparable outcomes.
authors.affiliation: Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Tilak
authors.initials: T
authors.lastname: Pasala
authors.affiliation: Department of Medicine, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Rama Dilip
authors.initials: RD
authors.lastname: Gajulapalli
authors.affiliation: Center for Health Care Research and Policy, MetroHealth/Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors.forename: Shari
authors.initials: S
authors.lastname: Bolen
authors.affiliation: Department of Cardiovascular Medicine, University of Alabama, Birmingham, AL, USA.
authors.forename: Navkaranbir S
authors.initials: NS
authors.lastname: Bajaj
authors.affiliation: The Heart and Vascular Center, Case Western Reserve University/MetroHealth, Cleveland, OH, USA.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Gandhi
authors.affiliation: Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Anwar
authors.initials: A
authors.lastname: Tandar
authors.affiliation: Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Theophilus
authors.initials: T
authors.lastname: Owan
authors.affiliation: Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: fred.welt@hsc.utah.edu.
authors.forename: Frederick G P
authors.initials: FG
authors.lastname: Welt
mesh_terms: D000925:Anticoagulants / Q000494:pharmacology; D057186:Comparative Effectiveness Research; D054059:Coronary Occlusion / Q000601:surgery*; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006493:Heparin / Q000494:pharmacology*; D006629:Hirudins / Q000494:pharmacology*; D006801:Humans; D010446:Peptide Fragments / Q000494:pharmacology*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods; D011994:Recombinant Proteins / Q000494:pharmacology; D018570:Risk Assessment
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: Bivalirudin; Heparin; Percutaneous coronary intervention; Transradial access