A Randomized Trial of Late Reperfusion Therapy for Acute Myocardial Infarction

A Randomized Trial of Late Reperfusion Therapy for Acute Myocardial Infarction
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急性心肌梗死晚期再灌注治疗的随机试验

DOI:
10.1161/01.cir.85.6.2090
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发表时间:
1992
期刊:
影响因子:
37.8
通讯作者:
S. Ellis
S. Ellis
中科院分区:
医学1区
文献类型:
--
作者:
E. Topol;R. Califf;M. Vandormael;C. Grines;B. George;Mark L. Sanz;T. Wall;M. O'Brien;M. Schwaiger;F. Aguirre;S. Young;J. Popma;K. Sigmon;Kerry L Lee;S. Ellis

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急性冠状动脉闭塞的实验和观察性临床研究表明,晚期再灌注可阻止梗死扩大并促进心肌愈合。本试验的目的是评估晚期患者是否可以实现梗死血管通畅,如果有的话,可以证明有什么益处。方法与结果采用双盲方法,197例出现症状6 ~ 24小时且心电图ST段抬高的患者随机分配到组织型纤溶酶原激活剂组(100mg / 2小时)或安慰剂组。24小时内进行冠状动脉造影以确定梗死血管的通畅状态。有梗死相关动脉闭塞的患者随后有资格进入第二次随机分组:血管成形术(34例)或不血管成形术(37例)。1个月时通过门控血池闪烁显像重新评估心室功能和腔体大小,6个月时通过重复心导管插管重新评估。纤溶酶原激活剂组的主要终点梗死血管通畅率为65%,而安慰剂组为27% (p<0.0001)。在1个月或6个月时,两组之间的射血分数或梗死区区域壁面运动没有差异。6个月时,两组梗死血管通畅率均为59%。在安慰剂组中,在6个月的随访中,舒张末期容积从急性期的127毫升显著增加到159毫升(p=0.006),但纤溶酶原激活剂组患者的腔大小没有增加。冠状动脉血管成形术与初始81%的再通成功率和1个月后心室功能的改善相关,但在后期随访中没有发现该手术的优势,在未进行血管成形术的患者中,自发再通率为38%。结论:该研究表明,无论是溶栓治疗还是血管成形术,大多数晚期患者都有可能实现梗死血管再通。溶栓干预对预防腔体扩张和左室重构有良好的效果,但对溶栓或冠状动脉成形术后的收缩功能没有后期益处。关于应用晚期再灌注治疗的总体潜在益处的结论需要来自旨在评估死亡率降低的大规模试验的数据。
BackgroundExperimental and observational clinical studies of acute coronary occlusion have suggested that late reperfusion prevents infarct expansion and facilitates myocardial healing. The purpose of this trial was to assess whether infarct vessel patency could be achieved in late-entry patients and what benefit, if any, can be demonstrated. Methods and ResultsIn a double-blind fashion, 197 patients with 6 to 24 hours of symptoms and ECG ST elevation were randomly assigned to tissue-type plasminogen activator (100 mg over 2 hours) or placebo. Coronary angiography within 24 hours was used to determine infarct vessel patency status. Patients with infarct-related occluded arteries were then eligible for a second randomization to either angioplasty (34 patients) or no angioplasty (37 patients). Ventricular function and cavity size were reassessed at 1 month by gated blood pool scintigraphy and at 6 months by repeat cardiac catheterization. The primary end point, infarct vessel patency, was 65% for plasminogen activator patients compared with 27% in the placebo group (p<0.0001). There were no differences between these groups in ejection fraction or infarct zone regional wall motion at 1 or 6 months. At 6 months, infarct vessel patency was 59% in both groups. In the placebo group, there was a significant increase in end-diastolic volume from acute phase of 127 ml to 159 ml at 6-month follow-up (p=0.006) but no increase in cavity size for the plasminogen activator group patients. Coronary angioplasty was associated with an initial 81% recanalization success and improved ventricular function at 1 month, but by late follow-up no advantage could be demonstrated for this procedure, and there was a 38% spontaneous recanalization rate in the patients assigned to no angioplasty. ConclusionsThe study demonstrates that it is possible to achieve infarct vessel recanalization in the majority of late-entry patients with either thrombolytic therapy or angioplasty. Thrombolytic intervention had a favorable effect on prevention of cavity dilatation and left ventricular remodeling, but there are no late benefits on systolic function after thrombolysis or coronary angioplasty. The conclusions concerning overall potential benefit of applying late reperfusion therapy will require data from large-scale trials designed to assess mortality reduction.
静脉注射组织纤溶酶原激活剂和早期静脉注射肝素治疗急性心肌梗死的随机对照试验。
DOI: 10.1161/01.cir.79.2.281
发表时间: 1989
期刊: Circulation
影响因子: 37.8
作者:
Topol,EJ;George,BS;Kereiakes,DJ;Stump,DC;Candela,RJ;Abbottsmith,CW;Aronson,L;Pickel,A;Boswick,JM;Lee,KL
通讯作者: Lee,KL
DOI: 10.1016/0735-1097(89)90458-0
发表时间: 1989-10
影响因子: 24
作者:
E. Topol;S. Ellis;R. Califf;B. George;D. C. Stump;Eric R. Bates;E. Nabel;J. Walton;R. Candela;Kerry L. Lee;E. Kline;B. Pitt
通讯作者: E. Topol;S. Ellis;R. Califf;B. George;D. C. Stump;Eric R. Bates;E. Nabel;J. Walton;R. Candela;Kerry L. Lee;E. Kline;B. Pitt
急性心肌梗死紧急冠状动脉成形术后第一年的生存率和心脏事件率。
DOI: 10.1016/0735-1097(88)90274-4
发表时间: 1988
影响因子: 24
作者:
Stack,RS;Califf,RM;Hinohara,T;Phillips,HR;Pryor,DB;Simonton,CA;Carlson,EB;Morris,KG;Behar,VS;Kong,Y
通讯作者: Kong,Y