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急性心肌梗死中冠状动脉支架与传统球囊血管成形术的院内及远期结果(GRAMI试验)。急性心肌梗死中的吉安图尔科-鲁宾支架。

In-hospital and late results of coronary stents versus conventional balloon angioplasty in acute myocardial infarction (GRAMI trial). Gianturco-Roubin in Acute Myocardial Infarction.

作者信息

Rodríguez A, Bernardi V, Fernández M, Mauvecín C, Ayala F, Santaera O, Martínez J, Mele E, Roubin G S, Palacios I, Ambrose J A

机构信息

Cardiac Unit Otamendi/Anchorena Hospital, Buenos Aires, Argentina.

出版信息

Am J Cardiol. 1998 Jun 1;81(11):1286-91. doi: 10.1016/s0002-9149(98)00154-4.

Abstract

One hundred four patients presenting with acute myocardial infarction < 24 hours after onset were randomized to 2 groups: group I (n = 52) was treated with balloon angioplasty followed electively with Gianturco Roubin II stents, and group II was treated with conventional balloon angioplasty alone (n = 52). All lesions were suitable for stenting. Baseline clinical, demographic, and angiographic characteristics were similar in the 2 groups. Procedural success was defined as no laboratory death or emergent coronary bypass, Thrombolysis In Myocardial Infarction (TIMI) trial 2 or 3 flow after the procedure in a culprit vessel, and a residual stenosis < or = 30% for coronary angioplasty and < 20% for stent. Procedural success was 98% in group I versus 94.2% in group II, p = NS. Thirteen patients in group II (25%) had bailout stenting during the initial procedure. Adverse in-hospital events including either death, nonelective coronary bypass, recurrent ischemia, and reinfarction occurred in 3.8% in group I versus 19.2% in group II, p = 0.03. Repeat angiography performed routinely before hospital discharge revealed TIMI 3 flow in the infarct-related artery in 98% in group I versus 83% in group II, p < 0.03. At late follow-up, event-free survival was significantly better in the stent (83%) than in the coronary angioplasty (65%) group (p = 0.002). The procedural in-hospital and late outcomes of this randomized study demonstrate that balloon angioplasty followed electively by coronary stents can be used as the primary modality for patients undergoing coronary interventions for acute myocardial infarction, increasing TIMI 3 flow, reducing in-hospital adverse events, and improving late outcome compared with balloon angioplasty alone.

摘要

104例急性心肌梗死发病后24小时内就诊的患者被随机分为两组:第一组(n = 52)接受球囊血管成形术,随后选择性植入Gianturco Roubin II支架;第二组(n = 52)仅接受传统球囊血管成形术。所有病变均适合植入支架。两组的基线临床、人口统计学和血管造影特征相似。手术成功定义为无实验室死亡或急诊冠状动脉搭桥,罪犯血管术后心肌梗死溶栓(TIMI)试验血流达2级或3级,冠状动脉血管成形术残余狭窄≤30%,支架植入残余狭窄<20%。第一组手术成功率为98%,第二组为94.2%,p =无显著性差异。第二组有13例患者(25%)在初始手术过程中接受了补救性支架植入。住院期间不良事件包括死亡、非选择性冠状动脉搭桥、复发性缺血和再梗死,第一组发生率为3.8%,第二组为19.2%,p = 0.03。出院前常规进行的重复血管造影显示,第一组梗死相关动脉TIMI 3级血流的比例为98%,第二组为83%,p<0.03。在晚期随访中,支架组(83%)无事件生存率显著高于冠状动脉血管成形术组(65%)(p = 0.002)。这项随机研究的住院手术及晚期结果表明,对于接受冠状动脉介入治疗的急性心肌梗死患者,选择性冠状动脉支架植入球囊血管成形术可作为主要治疗方式,与单纯球囊血管成形术相比,可增加TIMI 3级血流,减少住院期间不良事件,并改善晚期预后。

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