Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of randomized trials

• Published in: The American journal of cardiology Vol. 92; no. 8; pp. 919 - 923
• Main Authors: Chew, Derek P, Bhatt, Deepak L, Kimball, William, Henry, Timothy D, Berger, Peter, McCullough, Peter A, Feit, Frederick, Bittl, John A, Lincoff, A.Michael
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 15.10.2003; Elsevier Limited
• Subjects: Adult; Age Factors; Aged; Aged, 80 and over; Analysis; Angioplasty, Balloon, Coronary; Clinical trials; Coronary Artery Disease - therapy; Creatinine - blood; Female; Fibrinolytic Agents - therapeutic use; Hirudins - analogs & derivatives; Humans; Hypertension - complications; Ischemia - etiology; Ischemia - prevention & control; Kidney Failure, Chronic - blood; Kidney Failure, Chronic - complications; Kidneys; Male; Metadata; Middle Aged; Peptide Fragments - therapeutic use; Postoperative Hemorrhage - etiology; Postoperative Hemorrhage - prevention & control; Randomized Controlled Trials as Topic; Recombinant Proteins - therapeutic use; Risk Factors; Sex Factors
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/S0002-9149(03)00970-6

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.