Topol E J, Ferguson J J, Weisman H F, Tcheng J E, Ellis S G, Kleiman N S, Ivanhoe R J, Wang A L, Miller D P, Anderson K M, Califf R M
Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195, USA.
JAMA. 1997 Aug 13;278(6):479-84. doi: 10.1001/jama.278.6.479.
Abciximab, a monoclonal antibody fragment against the platelet receptor alphaIIb beta3 integrin, prevents platelet aggregation. A randomized, placebo-controlled study showed that abciximab improves outcomes for patients undergoing percutaneous coronary angioplasty at 30 days and at 6 months.
To determine whether abciximab improves outcomes 3 years after coronary angioplasty.
Double-blind, placebo-controlled, randomized trial.
A total of 56 academic and community hospitals in the United States.
A total of 2099 high-risk patients undergoing coronary angioplasty were randomized. Sufficient time elapsed for 2.5 years of follow-up among 2001 patients and for 3 years of follow-up among 1599 patients.
Abciximab bolus of 0.25 mg/kg followed by infusion at 10 microg/min for 12 hours; abciximab bolus of 0.25 mg/kg followed by placebo infusion; or placebo bolus followed by placebo infusion.
The primary outcome was the composite of death, myocardial infarction, or coronary revascularization. Secondary outcomes were death, myocardial infarction, or coronary revascularization individually. Subgroups having refractory unstable angina or evolving myocardial infarction and having different elevations of creatine kinase during initial angioplasty were analyzed.
At 3 years, composite end points occurred in 41.1% of those receiving abciximab bolus plus infusion; 47.4% of those receiving abciximab bolus only; and 47.2% of those receiving placebo only (for abciximab bolus plus infusion vs placebo, P=.009). Death occurred in 6.8%, 8.0%, and 8.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.20); myocardial infarction in 10.7%, 12.2%, and 13.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.08); and revascularization in 34.8%, 38.6%, and 40.1%, respectively (for abciximab bolus plus infusion vs placebo, P=.02). Among those with refractory unstable angina or evolving myocardial infarction, death occurred in 5.1%, 9.2%, and 12.7%, respectively (for abciximab bolus plus infusion vs placebo, P=.01). Death rates increased as periprocedural creatine kinase levels increased.
Abciximab bolus with infusion given at the time of coronary angioplasty improves outcomes as long as 3 years after the procedure.
阿昔单抗是一种针对血小板受体αIIbβ3整合素的单克隆抗体片段，可防止血小板聚集。一项随机、安慰剂对照研究表明，阿昔单抗可改善接受经皮冠状动脉成形术患者在30天时和6个月时的预后。
确定阿昔单抗是否能改善冠状动脉成形术后3年的预后。
双盲、安慰剂对照、随机试验。
美国共56家学术和社区医院。
共2099例接受冠状动脉成形术的高危患者被随机分组。2001例患者有足够时间进行2.5年随访，1599例患者有足够时间进行3年随访。
阿昔单抗按0.25mg/kg静脉推注，随后以10μg/min输注12小时；阿昔单抗按0.25mg/kg静脉推注，随后输注安慰剂；或安慰剂静脉推注，随后输注安慰剂。
主要结局为死亡、心肌梗死或冠状动脉血运重建的复合终点。次要结局分别为死亡、心肌梗死或冠状动脉血运重建。对难治性不稳定型心绞痛或进展性心肌梗死以及初始成形术期间肌酸激酶水平不同升高的亚组进行了分析。
3年时，接受阿昔单抗静脉推注加输注的患者中41.1%出现复合终点；仅接受阿昔单抗静脉推注的患者中47.4%出现复合终点；仅接受安慰剂的患者中47.2%出现复合终点（阿昔单抗静脉推注加输注与安慰剂相比，P = 0.009）。死亡率分别为6.8%、8.0%和8.6%（阿昔单抗静脉推注加输注与安慰剂相比，P = 0.20）；心肌梗死发生率分别为10.7%、12.2%和13.6%（阿昔单抗静脉推注加输注与安慰剂相比，P = 0.08）；血运重建率分别为34.8%、38.6%和40.1%（阿昔单抗静脉推注加输注与安慰剂相比，P = 0.02）。在难治性不稳定型心绞痛或进展性心肌梗死患者中，死亡率分别为5.1%、9.2%和12.7%（阿昔单抗静脉推注加输注与安慰剂相比，P = 0.01）。死亡率随着围手术期肌酸激酶水平的升高而增加。
冠状动脉成形术时给予阿昔单抗静脉推注加输注可改善术后长达3年的预后。
