title: Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention.
abstract: Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.
authors.affiliation: Quebec Heart-Lung Institute, Quebec, Quebec, Canada.
authors.forename: Alberto E
authors.initials: AE
authors.lastname: Barria Perez
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Sanjit J
authors.initials: SJ
authors.lastname: Jolly
authors.affiliation: The Wright Center for Graduate Medical Education, The Common Wealth Medical College, Scranton, Pennsylvania.
authors.forename: Samir B
authors.initials: SB
authors.lastname: Pancholy
authors.affiliation: Quebec Heart-Lung Institute, Quebec, Quebec, Canada.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Plourde
authors.affiliation: Quebec Heart-Lung Institute, Quebec, Quebec, Canada.
authors.forename: Goran
authors.initials: G
authors.lastname: Rimac
authors.affiliation: Quebec Heart-Lung Institute, Quebec, Quebec, Canada.
authors.forename: Yann
authors.initials: Y
authors.lastname: Poirier
authors.affiliation: Quebec Heart-Lung Institute, Quebec, Quebec, Canada.
authors.forename: Olivier
authors.initials: O
authors.lastname: Costerousse
authors.affiliation: Quebec Heart-Lung Institute, Quebec, Quebec, Canada. Electronic address: olivier.bertrand@criucpq.ulaval.ca.
authors.forename: Olivier F
authors.initials: OF
authors.lastname: Bertrand
mesh_terms: D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use; D014943:Global Health; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D017202:Myocardial Ischemia / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D019106:Postoperative Hemorrhage / Q000139:chemically induced / Q000453:epidemiology*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013927:Thrombosis / Q000517:prevention & control*
chemical_list: D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin