title: Standard versus low-dose weight-adjusted heparin in patients treated with the platelet glycoprotein IIb/IIIa receptor antibody fragment abciximab (c7E3 Fab) during percutaneous coronary revascularization. PROLOG Investigators.
abstract: Blockade of the platelet glycoprotein IIb/IIIa receptor by abciximab (c7E3 Fab) during coronary intervention reduces the incidence of ischemic complications, but has been associated with a doubling of the risk for bleeding complications. The present pilot study investigated whether modification of heparin dosing and/or early sheath removal would reduce the hemorrhagic complications associated with abciximab. One hundred three patients undergoing coronary intervention received abciximab (0.25 mg/kg bolus, 10 microg/min infusion for 12 hours) and aspirin and were randomized by a 2 x 2 factorial design to 1 of 2 weight-adjusted heparin doses and to 1 of 2 strategies for heparin discontinuation and vascular sheath removal. In the "standard-dose heparin" group, an initial bolus of 100 U/kg was administered to achieve a procedural activated clotting time (ACT) > or = 300 seconds; in the "low-dose heparin" group, an initial bolus of 70 U/kg was administered without adjustment for ACT. In the "late sheath removal" arm, heparin infusion was continued for the 12-hour duration of abciximab infusion, followed by sheath removal; in the "early sheath removal" group, heparin was stopped after the interventional procedure and sheaths were removed during the abciximab infusion. There were no apparent differences between patients randomized to the different treatment groups with regard to the occurrence of ischemic end points. Rates of bleeding and blood transfusion were reduced by low-dose heparin and early sheath removal and were lowest when both strategies were combined. Reduction and weight adjustment of heparin dose and early sheath removal in the setting of platelet inhibition with abciximab during coronary intervention may be useful in diminishing the incidence of hemorrhagic complications without loss of clinical efficacy.
authors.affiliation: Cleveland Clinic Foundation, Ohio 44195, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Lincoff
authors.forename: J E
authors.initials: JE
authors.lastname: Tcheng
authors.forename: R M
authors.initials: RM
authors.lastname: Califf
authors.forename: T
authors.initials: T
authors.lastname: Bass
authors.forename: J J
authors.initials: JJ
authors.lastname: Popma
authors.forename: P S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: N S
authors.initials: NS
authors.lastname: Kleiman
authors.forename: L J
authors.initials: LJ
authors.lastname: Hattel
authors.forename: H V
authors.initials: HV
authors.lastname: Anderson
authors.forename: J J
authors.initials: JJ
authors.lastname: Ferguson
authors.forename: C F
authors.initials: CF
authors.lastname: Cabot
authors.forename: K M
authors.initials: KM
authors.lastname: Anderson
authors.forename: L G
authors.initials: LG
authors.lastname: Berdan
authors.forename: M H
authors.initials: MH
authors.lastname: Musco
authors.forename: H F
authors.initials: HF
authors.lastname: Weisman
authors.forename: E J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000077284:Abciximab; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D003327:Coronary Disease / Q000188:drug therapy* / Q000628:therapy; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin; D000077284:Abciximab