Comparison of Bivalirudin versus heparin during percutaneous coronary intervention (the randomized evaluation of PCI linking angiomax to reduced clinical events [REPLACE]-1 trial) AMERICAN JOURNAL OF CARDIOLOGY Lincoff, A. M., Bittl, J. A., Kleiman, N. S., Sarembock, I. J., Jackman, J. D., Mehta, S., Tannenbaum, M. A., Niederman, A. L., Bachinsky, W. B., Tift-Mann, J., Parker, H. G., Kereiakes, D. J., Harrington, R. A., Feit, F., Maierson, E. S., Chew, D. P., Topol, E. J. 2004; 93 (9): 1092-1096


To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach.

View details for DOI 10.1016/j.amjcard.2004.01.033

View details for Web of Science ID 000221140100003

View details for PubMedID 15110198