Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial)

• Published in: The American journal of cardiology Vol. 93; no. 9; pp. 1092 - 1096
• Main Authors: Lincoff, A.Michael, Bittl, John A, Kleiman, Neal S, Sarembock, Ian J, Jackman, J.Daniel, Mehta, Sameer, Tannenbaum, Mark A, Niederman, Alan L, Bachinsky, William B, Tift-Mann, J, Parker, H.Graham, Kereiakes, Dean J, Harrington, Robert A, Feit, Frederick, Maierson, Elizabeth S, Chew, Derek P, Topol, Eric J
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.05.2004; Elsevier; Elsevier Limited
• Subjects: Aged; Angioplasty, Balloon, Coronary; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Antithrombins - adverse effects; Antithrombins - therapeutic use; Biological and medical sciences; Cardiology. Vascular system; Dose-Response Relationship, Drug; Drug therapy; Female; Heart; Heart attacks; Heparin - adverse effects; Heparin - therapeutic use; Hirudins - adverse effects; Hirudins - analogs & derivatives; Humans; Intraoperative Care; Male; Medical sciences; Middle Aged; Mortality; Patients; Peptide Fragments - adverse effects; Peptide Fragments - therapeutic use; Pilot Projects; Platelet Glycoprotein GPIIb-IIIa Complex - therapeutic use; Postoperative Complications - etiology; Postoperative Complications - mortality; Postoperative Hemorrhage - chemically induced; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Studies; Treatment Outcome; United States - epidemiology; Whole Blood Coagulation Time; Evaluation; Randomization; Angioplasty; Instrumentation therapy; Clinical trial; Anticoagulant; Bivalirudin; Circulatory system; Heparin; Cardiology; Phlebology; Comparative study
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2004.01.033

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.