Lincoff A M, Tcheng J E, Califf R M, Bass T, Popma J J, Teirstein P S, Kleiman N S, Hattel L J, Anderson H V, Ferguson J J, Cabot C F, Anderson K M, Berdan L G, Musco M H, Weisman H F, Topol E J
Cleveland Clinic Foundation, Ohio 44195, USA.
Am J Cardiol. 1997 Feb 1;79(3):286-91. doi: 10.1016/s0002-9149(96)00749-7.
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.
在冠状动脉介入治疗期间，使用阿昔单抗（c7E3 Fab）阻断血小板糖蛋白IIb/IIIa受体可降低缺血性并发症的发生率，但却使出血并发症的风险增加了一倍。本初步研究调查了调整肝素剂量和/或早期拔除鞘管是否会减少与阿昔单抗相关的出血并发症。103例接受冠状动脉介入治疗的患者接受了阿昔单抗（0.25mg/kg静脉推注，10μg/min输注12小时）和阿司匹林治疗，并通过2×2析因设计随机分为2种体重调整肝素剂量中的1种，以及2种肝素停用和血管鞘管拔除策略中的1种。在“标准剂量肝素”组中，给予100U/kg的初始推注剂量以达到术中活化凝血时间（ACT）≥300秒；在“低剂量肝素”组中，给予70U/kg的初始推注剂量，不根据ACT进行调整。在“延迟拔除鞘管”组中，在阿昔单抗输注的12小时期间持续输注肝素，随后拔除鞘管；在“早期拔除鞘管”组中，介入操作后停止输注肝素，并在阿昔单抗输注期间拔除鞘管。在随机分配到不同治疗组的患者中，缺血性终点事件的发生没有明显差异。低剂量肝素和早期拔除鞘管可降低出血和输血发生率，当两种策略联合使用时发生率最低。在冠状动脉介入治疗期间，使用阿昔单抗抑制血小板的情况下，减少肝素剂量并进行体重调整以及早期拔除鞘管，可能有助于减少出血并发症的发生率，而不损失临床疗效。
