title: Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of randomized trials.
abstract: Chronic kidney disease is associated with an increased risk of ischemic and bleeding events after percutaneous coronary intervention (PCI). The direct thrombin inhibitor bivalirudin reduces these combined events. We sought to assess whether this benefit was influenced by renal function. A meta-analysis of 3 randomized trials (n = 5,035) comparing bivalirudin with heparin during PCI, stratified by estimated creatinine clearance using the Cockcroft-Gault equation (>90 [n = 1,578], 90 to 60 [n = 2,163], 59 to 30 [n = 1,255], and <30 ml/min [n = 39]), was conducted. The composite end points of death, myocardial infarction or revascularization, hemorrhage, and combined ischemic or bleeding events were assessed. A common odds ratio for each creatinine clearance strata was estimated with a random-effects model. The interaction between renal impairment and benefit from bivalirudin was assessed. Adverse ischemic and bleeding events increased with decreasing renal function. The relative benefit of bivalirudin with respect to ischemic and bleeding events was maintained within each stratum. The absolute benefit in terms of ischemic and bleeding complications increased with decreasing creatinine clearance (normal 2.2%, mild 5.8%, moderate 7.7%, severe 14.4%; p trend <0.001, interaction p = 0.044). Renal dysfunction remains a prevalent risk factor for ischemic and bleeding events in patients who undergo PCI. Bivalirudin provides greater absolute benefit in patients with impaired renal function.
authors.affiliation: Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, South Australia, Australia. derek.chew@fmc.sa.gov.au
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: William
authors.initials: W
authors.lastname: Kimball
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Henry
authors.forename: Peter
authors.initials: P
authors.lastname: Berger
authors.forename: Peter A
authors.initials: PA
authors.lastname: McCullough
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: John A
authors.initials: JA
authors.lastname: Bittl
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000628:therapy; D003404:Creatinine / Q000097:blood; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006629:Hirudins / Q000031:analogs & derivatives*; D006801:Humans; D006973:Hypertension / Q000150:complications; D007511:Ischemia / Q000209:etiology / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012307:Risk Factors; D012737:Sex Factors
chemical_list: D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D003404:Creatinine; C074619:bivalirudin