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

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.

• Authors: A Michael Lincoff, John A Bittl, Neal S Kleiman, Ian J Sarembock, J Daniel Jackman, Sameer Mehta, Mark A Tannenbaum, Alan L Niederman, William B Bachinsky, J Tift-Mann 3rd, H Graham Parker, Dean J Kereiakes, Robert A Harrington, Frederick Feit, Elizabeth S Maierson, Derek P Chew, Eric J Topol, REPLACE-1 Investigators
• Journal: The American journal of cardiology (Am J Cardiol) Vol. 93 Issue 9 Pg. 1092-6 (May 01 2004) ISSN: 0002-9149 [Print] United States
• PMID: 15110198 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Antithrombins
• Hirudins
• Peptide Fragments
• Platelet Glycoprotein GPIIb-IIIa Complex
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Aged
• Angioplasty, Balloon, Coronary
• Anticoagulants (adverse effects, therapeutic use)
• Antithrombins (adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Female
• Heparin (adverse effects, therapeutic use)
• Hirudins (adverse effects, analogs & derivatives)
• Humans
• Intraoperative Care
• Male
• Middle Aged
• Peptide Fragments (adverse effects, therapeutic use)
• Pilot Projects
• Platelet Glycoprotein GPIIb-IIIa Complex (therapeutic use)
• Postoperative Complications (etiology, mortality)
• Postoperative Hemorrhage (chemically induced)
• Recombinant Proteins (adverse effects, therapeutic use)
• Treatment Outcome
• United States (epidemiology)
• Whole Blood Coagulation Time