title: Meta-analysis comparing bivalirudin versus heparin monotherapy on ischemic and bleeding outcomes after percutaneous coronary intervention.
abstract: With femoral access, bivalirudin decreases risks of major bleeding after percutaneous coronary intervention (PCI) and provides better net clinical benefit compared to unfractionated heparin (UFH) plus planned glycoprotein IIb/IIIa inhibitors. Whether this benefit exists compared to UFH monotherapy is less clear. We performed a systematic review and meta-analysis to compare outcomes in patients undergoing transfemoral PCI with UFH or bivalirudin. Randomized trials (n = 3) and observational studies (n = 13) comparing bivalirudin to UFH monotherapy were reviewed. Primary outcomes were 30-day rates of major adverse cardiovascular events (MACEs) including death, myocardial infarction (MI), urgent revascularization, as well as all-cause mortality, MI, major bleeding, and blood transfusion. We collected data from 16 studies involving 32,492 patients undergoing PCI. Most observational studies were performed in the United States, whereas all randomized trials were done in Europe. Compared to UFH monotherapy, bivalirudin was associated with similar risk of MACEs (odds ratios [OR] 0.92, 95% confidence interval [CI] 0.75 to 1.12), a substantial 45% relative decrease in major bleeding (OR 0.55, 95% CI 0.43 to 0.72), and a trend in the decrease of transfusion (OR 0.87, 95% CI 0.70 to 1.08). A decrease in mortality was seen in observational studies (OR 0.62, 95% CI 0.45 to 0.85) but remained inconclusive in randomized trials (OR 0.63, 95% CI 0.20 to 2.01). MI rate was similar with the 2 anticoagulants. In conclusion, in patients undergoing transfemoral PCI, the benefit of bivalirudin over UFH monotherapy is driven by a significant decrease in major bleeding with similar rates of MACE. As PCI practice moves toward other bleeding-avoidance strategies such as the radial approach, future studies should focus on the interaction between anticoagulant strategy and access-site choice.
authors.affiliation: Quebec Heart-Lung Institute, Quebec City, Quebec, Canada. olivier.bertrand@criucpq.ulaval.ca
authors.forename: Olivier F
authors.initials: OF
authors.lastname: Bertrand
authors.forename: Sanjit S
authors.initials: SS
authors.lastname: Jolly
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Tejas
authors.initials: T
authors.lastname: Patel
authors.forename: Loic
authors.initials: L
authors.lastname: Belle
authors.forename: Ivo
authors.initials: I
authors.lastname: Bernat
authors.forename: Guido
authors.initials: G
authors.lastname: Parodi
authors.forename: Olivier
authors.initials: O
authors.lastname: Costerousse
authors.forename: Tift
authors.initials: T
authors.lastname: Mann
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D000991:Antithrombins / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000401:mortality; D006493:Heparin / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D017202:Myocardial Ischemia / Q000517:prevention & control*; D010446:Peptide Fragments / Q000008:administration & dosage*; D011183:Postoperative Complications; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin