Rationale and design of the INFUSE-AMI study: A 2 x 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction

被引:34
作者
Gibson, C. Michael [1 ]
Maehara, Akiko [2 ,3 ]
Lansky, Alexandra J. [2 ,3 ]
Wohrle, Jochen [4 ]
Stuckey, Tom [5 ]
Dave, Rajesh [6 ]
Cox, David [7 ]
Grines, Cindy [8 ]
Dudek, Dariusz [9 ]
Steg, Gabriel [10 ]
Parise, Helen [10 ]
Wolff, Steven D. [2 ,3 ]
Cristea, Ecaterina [2 ,3 ]
Stone, Gregg W. [2 ,3 ]
机构
[1] Harvard Univ, Sch Med, Beth Israel Deaconess Med Ctr, Dept Med,Div Cardiovasc, Boston, MA USA
[2] Columbia Univ, Med Ctr, New York, NY USA
[3] Cardiovasc Res Fdn, New York, NY USA
[4] Univ Ulm, Clin Internal Med 2, Ulm, Germany
[5] UNC Sch Med, LeBauer Cardiovasc Res Fdn, Greensboro, NC USA
[6] Harrisburg Hosp, Harrisburg, PA USA
[7] Lehigh Valley Hosp, Allentown, PA USA
[8] William Beaumont Hosp, Royal Oak, MI 48072 USA
[9] Jagiellonian Univ, Coll Med, Inst Cardiol, Krakow, Poland
[10] Hop Bichat Claude Bernard, Serv Cardiol, F-75877 Paris 18, France
关键词
GLYCOPROTEIN IIB/IIIA INHIBITION; LEUKOCYTE INTEGRIN MAC-1; THROMBUS ASPIRATION; PRIMARY ANGIOPLASTY; DISTAL EMBOLIZATION; STRONG PREDICTOR; FOLLOW-UP; REPERFUSION; IMPROVES; TRIAL;
D O I
10.1016/j.ahj.2010.10.006
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies. Design INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 x 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding. Summary INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin. (Am Heart J 2011;161:478-486.e7.)
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页码:478 / +
页数:16
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