title: Impact of baseline hemorrhagic risk on the benefit of bivalirudin versus unfractionated heparin in patients treated with coronary angioplasty: a meta-regression analysis of randomized trials.
abstract: BACKGROUND
  Bivalirudin significantly reduces 30-day major and minor bleeding compared with unfractionated heparin (UFH), while resulting in similar or lower rates of ischemic events in both patients with stable and unstable coronary disease undergoing percutaneous coronary intervention. We performed a meta-analysis of randomized trials to evaluate the impact of bivalirudin compared with UFH, with or without glycoprotein IIb/IIIa receptor inhibitors (GPI), on the rates of mortality, myocardial infarction (MI), and major bleeding.
  
  
  METHODS
  We searched electronic databases for randomized controlled trials with >100 patients comparing bivalirudin (±provisional GPI) with UFH with either routine or provisional GPI in patients undergoing percutaneous coronary intervention. The principal efficacy end points were mortality and MI within 30 day, whereas major bleeding was the principal safety end point. We assessed the benefit of bivalirudin for each efficacy end point relative to the baseline bleeding risk, using the control (UFH) major bleeding rate as proxy for that risk.
  
  
  RESULTS
  A total of 12 randomized trials that enrolled 33,261 patients were included. Overall, there was no significant difference in mortality and MI between bivalirudin monotherapy and UFH (±GPI), whereas major bleeding was significantly lower with bivalirudin. Bivalirudin reduced major and minor bleeding across the entire bleeding risk spectrum.
  
  
  CONCLUSIONS
  Bivalirudin significantly reduces major and minor bleeding regardless of the estimated baseline hemorrhagic risk.
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. Electronic address: giuseppe.tarantini.1@gmail.com.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: Weil Cornell Medical College, NY Methodist Hospital, Brooklyn, NY.
authors.forename: Sorin Jakob
authors.initials: SJ
authors.lastname: Brener
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Barioli
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gratta
authors.affiliation: Department of Cardiology, Careggi Hospital, Florence, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Parodi
authors.affiliation: Department of Cardiology, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Rossini
authors.affiliation: Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Eliano Pio
authors.initials: EP
authors.lastname: Navarese
authors.affiliation: Department of Cardiovascular Medicine, Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Niccoli
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
authors.forename: Anna Chiara
authors.initials: AC
authors.lastname: Frigo
authors.affiliation: Department of Cardiology, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Musumeci
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.
authors.forename: Sabino
authors.initials: S
authors.lastname: Iliceto
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY.
authors.forename: Gregg Whitney
authors.initials: GW
authors.lastname: Stone
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D017202:Myocardial Ischemia / Q000517:prevention & control*; D010446:Peptide Fragments / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin