title: Reduction in vascular access site bleeding in sequential abciximab coronary intervention trials.
abstract: We analyzed vascular access site bleeding from the EPIC, EPILOG, and EPISTENT trials to quantify the decrease in vascular bleeding complications in these three trials, especially those attributable to abciximab. The incidence of combined major and minor vascular access site bleeding in nonabciximab (heparin plus placebo) patients progressively decreased from EPIC (8.2%) to EPILOG (2.9%) to EPISTENT (1.7%; P < 0.001). Combined major and minor vascular access site bleeding in abciximab (heparin plus abciximab) patients decreased from EPIC (20%) to EPILOG (5.8%) to EPISTENT (2.2%; P < 0.001). There were more major vascular access site bleeds with abciximab compared to placebo in EPIC (odds ration 3.2; P < 0.001) but not in EPILOG or EPISTENT. Modified abciximab and heparin dosing and improved vascular access site management strategies have decreased the risk of vascular access bleeding during coronary intervention and have essentially eliminated the excess access site bleeding associated with abciximab.
authors.affiliation: Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania 17822, USA. jblankenship@geisinger.edu
authors.forename: James C
authors.initials: JC
authors.lastname: Blankenship
authors.forename: Craig
authors.initials: C
authors.lastname: Balog
authors.forename: Shelly K
authors.initials: SK
authors.lastname: Sapp
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: James E
authors.initials: JE
authors.lastname: Tcheng
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects*; D001780:Blood Coagulation Tests; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D002408:Catheters, Indwelling / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology* / Q000517:prevention & control*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015607:Stents / Q000009:adverse effects*
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab