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Self-expanding versus balloon-expandable stents in acute myocardial infarction: Results from the APPOSITION II Study: Self-expanding stents in ST-segment elevation myocardial infarction

机译:自扩张支架与球囊扩张支架在急性心肌梗死中的应用:研究II:自扩张支架在ST段抬高型心肌梗死中的应用

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Objectives: This study sought to investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 3 days after implantation in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Background: Acute myocardial infarction is associated with vasoconstriction and large thrombus burden. Resolution of vasoconstriction and thrombus load during the first hours to days after primary percutaneous coronary intervention may lead to stent undersizing and malapposition, which may subsequently lead to stent thrombosis or restenosis. In addition, aggressive stent deployment may cause distal embolization. Methods: Eighty patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomized to receive a self-expanding stent (STENTYS, STENTYS SA, Paris, France) (n = 43) or a balloon-expandable stent (VISION, Abbott Vascular, Santa Clara, California; or Driver, Medtronic, Minneapolis, Minnesota) (n = 37) at 9 European centers. The primary endpoint was the proportion of stent strut malapposition at 3 days after implantation measured by optical coherence tomography. Secondary endpoints included major adverse cardiac events (cardiac death, recurrent myocardial infarction, emergent bypass surgery, or clinically driven target lesion revascularization). Results: At 3 days after implantation, on a per-strut basis, a lower rate of malapposed stent struts was observed by optical coherence tomography in the self-expanding stent group than in the balloon-expandable group (0.58% vs. 5.46%, p < 0.001). On a per-patient basis, none of the patients in the self-expanding stent group versus 28% in the balloon-expandable group presented ≥5% malapposed struts (p < 0.001). At 6 months, major adverse cardiac events were 2.3% versus 0% in the self-expanding and balloon-expandable groups, respectively (p = NS). Conclusions: Strut malapposition at 3 days is significantly lower in ST-segment elevation myocardial infarction patients allocated to self-expanding stents when than in those allocated to balloon-expandable stents. The impact of this difference on clinical outcome and the risk of late stent thrombosis need to be evaluated further. (Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction [APPOSITION II]; NCT01008085)
机译:目的:本研究旨在探讨在进行初次经皮冠状动脉介入治疗的ST段抬高型心肌梗死患者植入后3天,自扩张支架是否比球囊扩张支架更有效,以减少支架的贴壁不良。背景:急性心肌梗死与血管收缩和大量血栓负担相关。在初次经皮冠状动脉介入治疗后的最初几小时至几天内,血管收缩和血栓负荷的缓解可能导致支架缩小和贴壁不良,继而可能导致支架血栓形成或再狭窄。另外,支架的积极部署可能会导致远端栓塞。方法:将80例行原发性经皮冠状动脉介入治疗的ST段抬高型心肌梗死患者随机分配到自膨胀支架(STENTYS,STENTYS SA,法国巴黎)(n = 43)或球囊膨胀支架(VISION,Abbott)位于美国加利福尼亚州圣克拉拉的Vascular;或位于明尼苏达州明尼阿波利斯的Medtronic驾驶员(n = 37)在9个欧洲中心。主要终点是在植入后第3天通过光学相干断层扫描测量的支架支撑杆错位的比例。次要终点包括主要的不良心脏事件(心脏死亡,复发性心肌梗塞,紧急旁路手术或临床驱动的靶病变血运重建)。结果:在植入后3天,在自支撑支架组中,通过光学相干断层扫描观察到的每个支架的不良率均低于球囊扩张组(0.58%vs. 5.46%, p <0.001)。在每位患者的基础上,自扩张支架组的患者中,没有任何患者出现≥5%的错位撑杆,而球囊扩张组中的这一比例为28%(p <0.001)。在6个月时,自扩张组和球囊扩张组的主要不良心脏事件分别为2.3%和0%(p = NS)。结论:分配给自扩张支架的ST段抬高型心肌梗死患者在3天时支杆错位明显低于分配给球囊扩张支架的患者。这种差异对临床结局和晚期支架内血栓形成风险的影响需要进一步评估。 (在急性心肌梗死中STENTYS自扩张式冠状动脉支架和球囊扩张式支架之间的随机比较[定位II]; NCT01008085)

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