Bivalirudin with planned or provisional abciximab versus low-dose heparin and abciximab during percutaneous coronary revascularization: Results of the Comparison of Abciximab Complications with Hirulog for Ischemic Events Trial (CACHET)

• Published in: The American heart journal Vol. 143; no. 5; pp. 847 - 853
• Main Authors: Lincoff, A.Michael, Kleiman, Neal S., Kottke-Marchant, Kandace, Maierson, Elizabeth S., Maresh, Kelly, Wolski, Katherine E., Topol, Eric J.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.05.2002; Elsevier; Elsevier Limited
• Subjects: Abciximab; Aged; Angioplasty; Angioplasty, Balloon, Coronary; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Antithrombins - adverse effects; Antithrombins - therapeutic use; Biological and medical sciences; Blood. Blood coagulation. Reticuloendothelial system; Cardiology; Chemotherapy, Adjuvant; Drug therapy; Drug Therapy, Combination; Feasibility Studies; Female; Heart attacks; Heparin, Low-Molecular-Weight - adverse effects; Heparin, Low-Molecular-Weight - therapeutic use; Hirudin Therapy; Hirudins - adverse effects; Hirudins - analogs & derivatives; Humans; Immunoglobulin Fab Fragments - adverse effects; Immunoglobulin Fab Fragments - therapeutic use; Male; Medical sciences; Middle Aged; Peptide Fragments - adverse effects; Peptide Fragments - therapeutic use; Pharmacology. Drug treatments; Pilot Projects; Platelet Aggregation Inhibitors - adverse effects; Platelet Aggregation Inhibitors - therapeutic use; Platelet Glycoprotein GPIIb-IIIa Complex - antagonists & inhibitors; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Stents; Peptides; Angioplasty; Cardiovascular disease; Anticoagulant; Bivalirudin; Monoclonal antibody; Antithrombin; Stent; Percutaneous route; Ischemia; Complication; Antagonist; Human; Drug combination; Glycoprotein IIbIIIa; Abciximab; Low dose; Treatment efficiency; Coronary artery; Instrumentation therapy; Coronary heart disease; Antiplatelet agent; Chemotherapy; Treatment; Polypeptide; Heparin; Comparative study
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1067/mhj.2002.122173

Background The direct thrombin inhibitor bivalirudin has previously been associated with better efficacy and lower hemorrhage risk than heparin during balloon angioplasty. This agent has not yet been tested with stenting or in combination with platelet glycoprotein IIb/IIIa antagonists. Methods and Results In a pilot trial, 268 patients who underwent coronary intervention were randomized in 3 sequential phases to treatment with bivalirudin (with or without abciximab) or the control regimen of low-dose weight-adjusted heparin with abciximab. Patients in the bivalirudin arms received bivalirudin (1.0 mg/kg bolus, infusion of 2.5 mg/kg/h for 4 hours) plus abciximab in phase A, bivalirudin (0.5 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional (“rescue”) abciximab in phase B, or bivalirudin (0.75 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional abciximab in phase C. Abciximab was necessitated on a provisional basis in 24% of the patients in the bivalirudin arms of phases B and C. A composite clinical endpoint of death, myocardial infarction, repeat revascularization, or major bleeding by 7 days occurred in 3.3%, 5.9%, 0, and 10.6% of the patients in the bivalirudin phase A, bivalirudin phase B, bivalirudin phase C, and heparin plus planned abciximab arms, respectively (P =.018 for the pooled bivalirudin groups versus the heparin group). Conclusion Bivalirudin with planned or provisional abciximab may be at least as safe and effective as low-dose heparin plus abciximab during percutaneous coronary intervention. (Am Heart J 2002;143:847-53.)