Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial) - 26/08/11
, John A Bittl, MD b, Neal S Kleiman, MD c, Ian J Sarembock, MD d, J.Daniel Jackman, MD e, Sameer Mehta, MD f, Mark A Tannenbaum, MD g, Alan L Niederman, MD h, William B Bachinsky, MD i, J Tift-Mann, MD j, H.Graham Parker, MD k, Dean J Kereiakes, MD l, Robert A Harrington, MD m, Frederick Feit, MD n, Elizabeth S Maierson, BA a, Derek P Chew, MBBS o, Eric J Topol, MD aREPLACE-1 Investigators
Abstract |
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.
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 | This study was supported by The Medicines Company, Cambridge, Massachusetts. |
Vol 93 - N° 9
P. 1092-1096 - mai 2004 Retour au numéro
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