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在随机双盲ADMIRAL研究中,接受支架治疗急性心肌梗死的患者使用阿昔单抗三年的获益情况。

Three-year duration of benefit from abciximab in patients receiving stents for acute myocardial infarction in the randomized double-blind ADMIRAL study.

出版信息

Eur Heart J. 2005 Dec;26(23):2520-3. doi: 10.1093/eurheartj/ehi620. Epub 2005 Oct 25.

Abstract

AIMS

The Abciximab Before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-term Follow-up (ADMIRAL) study demonstrated that early inhibition of the platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor with abciximab led to improved coronary patency, left ventricular function, and clinical outcomes. The current long-term follow-up study evaluated the durability of the positive outcomes.

METHODS AND RESULTS

The randomized double-blind ADMIRAL trial enrolled 300 patients who received either abciximab plus stenting or placebo plus stenting for the treatment of ST-elevation myocardial infarction (STEMI). Abciximab (bolus of 0.25 mg/kg body weight, followed by 12 h infusion of 0.125 microg/kg per min) was administered to 149 patients, whereas 151 patients received placebo. Long-term follow-up was conducted in a blinded manner by either patient chart review or telephone interview. Long-term follow-up data were obtained on 288 patients (96%). After 3 years, using an intent-to-treat analysis, the outcome of all-cause mortality occurred in 9.1% of abciximab-treated patients when compared with 12.2% of placebo patients, absolute and relative risk reductions of 3.1 and 25%, respectively (P=0.36). Parallel Kaplan-Meier curves were observed for the cumulative incidence of death or re-infarction, which was reduced from 16.9% in the placebo group to 11.8% in the abciximab group, absolute and relative risk reductions of 5.1 and 30%, respectively (P=0.20). Rates of recurrent ischaemia were significantly reduced from 21.7 to 11.5% (P=0.05).

CONCLUSION

Adjunctive abciximab to primary stenting for STEMI elicits favourable clinical outcomes with the same absolute risk reductions of hard clinical outcomes from 30 days up to 3 years of follow-up.

摘要

目的

急性心肌梗死直接血管成形术和支架置入术前使用阿昔单抗的急性和长期随访(ADMIRAL)研究表明,早期使用阿昔单抗抑制血小板糖蛋白IIb/IIIa(GP IIb/IIIa)受体可改善冠状动脉通畅情况、左心室功能及临床结局。当前的长期随访研究评估了这些阳性结果的持续性。

方法与结果

随机双盲ADMIRAL试验纳入了300例接受阿昔单抗加支架置入或安慰剂加支架置入治疗ST段抬高型心肌梗死(STEMI)的患者。149例患者接受阿昔单抗治疗(静脉推注0.25 mg/kg体重,随后以0.125 μg/kg每分钟的速度输注12小时),151例患者接受安慰剂治疗。通过查阅患者病历或电话访谈以盲法进行长期随访。获得了288例患者(96%)的长期随访数据。3年后,采用意向性分析,阿昔单抗治疗组全因死亡率为9.1%,而安慰剂组为12.2%,绝对风险降低3.1%,相对风险降低25%(P=0.36)。观察到死亡或再梗死累积发生率的平行Kaplan-Meier曲线,从安慰剂组的16.9%降至阿昔单抗组的11.8%,绝对风险降低5.1%,相对风险降低30%(P=0.20)。复发性缺血发生率从21.7%显著降至11.5%(P=0.05)。

结论

STEMI初次支架置入术辅助使用阿昔单抗可产生良好的临床结局,从30天直至3年的随访期内,严重临床结局的绝对风险降低程度相同。

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