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择期冠状动脉支架置入术中预防性使用阿昔单抗:一项随机试验的结果

Prophylactic abciximab in elective coronary stenting: results of a randomized trial.

作者信息

Tamburino Corrado, Russo Giovanni, Nicosia Antonino, Galassi Alfredo R, Foti Rosario, Scriffignano V, Kereiakes Dean J, Giuffrida Giuseppe

机构信息

The Lindner Center for Research & Education, 2123 Auburn Avenue, Suite 424, Cincinnati, OH 45219, USA.

出版信息

J Invasive Cardiol. 2002 Feb;14(2):72-9.

Abstract

BACKGROUND

The use of abciximab (c7E3 Fab; ReoPro , Eli Lilly & Company, Indianapolis, Indiana) during percutaneous coronary intervention (PCI) decreases the incidence of early (30-day) and late (6-month to 1 year) adverse cardiac ischemic events. In a high-risk population, abciximab also reduced the need for target lesion revascularization. PCI of lesions with complex morphology, particularly long lesions, is associated with more complicated outcomes. The use of multiple and/or long intracoronary stents to cover long coronary lesions may lower the incidence of acute or subacute occlusion, but is still limited by a high late restenosis rate. We characterized patients undergoing elective implantation of long or multiple overlapping coronary stents and determined the impact of abciximab administration on clinical and angiographic outcomes.

METHODS AND RESULTS

In a prospective, single-center randomized trial, a total of 107 patients undergoing elective implantation of long or multiple overlapping coronary stents were randomly assigned to receive either standard-dose heparin (n = 53) or abciximab plus low-dose heparin (n = 54). The use of abciximab was not associated with an increased incidence of bleeding or vascular complications compared to standard heparin regimen (3.7% versus 3.8%, respectively; p = NS). A 68% reduction in composite in-hospital cardiac events (i.e., death, myocardial infarction, urgent revascularization) was observed in the abciximab group (3.7% versus 11.5%, p = 0.1). At 6-month follow-up, a 48% reduction of target lesion revascularization (11% versus 21%; p = 0.1) and a decrease in binary angiographic restenosis were observed for abciximab-treated patients (17% versus 34%; p < 0.05).

CONCLUSION

The peri-procedural use of abciximab during implantation of long or multiple overlapping coronary stents is safe and effective, as it does not increase bleeding or vascular complications compared to standard heparin anticoagulation and reduces the incidence of in-hospital adverse cardiac events; moreover, abciximab improves 6-month clinical and angiographic outcomes in such a complex setting.

摘要

背景

在经皮冠状动脉介入治疗(PCI)期间使用阿昔单抗(c7E3 Fab;ReoPro,礼来公司,印第安纳波利斯,印第安纳州)可降低早期(30天)和晚期(6个月至1年)心脏缺血性不良事件的发生率。在高危人群中,阿昔单抗还减少了靶病变血管重建的需求。形态复杂的病变,尤其是长病变的PCI,与更复杂的结果相关。使用多个和/或长的冠状动脉内支架覆盖长冠状动脉病变可能会降低急性或亚急性闭塞的发生率,但仍受高晚期再狭窄率的限制。我们对接受长或多个重叠冠状动脉支架择期植入的患者进行了特征分析,并确定了阿昔单抗给药对临床和血管造影结果的影响。

方法与结果

在一项前瞻性、单中心随机试验中,共有107例接受长或多个重叠冠状动脉支架择期植入的患者被随机分配接受标准剂量肝素(n = 53)或阿昔单抗加低剂量肝素(n = 54)。与标准肝素方案相比,使用阿昔单抗与出血或血管并发症发生率增加无关(分别为3.7%和3.8%;p = 无显著性差异)。阿昔单抗组观察到住院期间复合心脏事件(即死亡、心肌梗死、紧急血管重建)减少68%(3.7%对11.5%,p = 0.1)。在6个月的随访中,阿昔单抗治疗的患者靶病变血管重建减少48%(11%对21%;p = 0.1),二元血管造影再狭窄减少(17%对34%;p < 0.05)。

结论

在长或多个重叠冠状动脉支架植入期间围手术期使用阿昔单抗是安全有效的,因为与标准肝素抗凝相比,它不会增加出血或血管并发症,并降低住院期间不良心脏事件的发生率;此外,在这种复杂情况下,阿昔单抗可改善6个月的临床和血管造影结果。

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