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经皮腔内冠状动脉成形术与药物治疗对急性心肌梗死单支血管病变稳定存活者的随机对照研究:德国心脏病学会工作小组的一项研究

Randomized comparison of percutaneous transluminal coronary angioplasty and medical therapy in stable survivors of acute myocardial infarction with single vessel disease: a study of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte.

作者信息

Zeymer Uwe, Uebis Rainer, Vogt Albrecht, Glunz Hans-Georg, Vöhringer Hans-Friedrich, Harmjanz Dietrich, Neuhaus Karl-Ludwig

机构信息

Medizinische Klinik II, Klinikum Kassel, Berlin, Germany.

出版信息

Circulation. 2003 Sep 16;108(11):1324-8. doi: 10.1161/01.CIR.0000087605.09362.0E. Epub 2003 Aug 25.

Abstract

BACKGROUND

Percutaneous transluminal coronary angioplasty of the infarct-related artery in stable survivors of acute myocardial infarction is often performed, even in patients without any symptoms or residual ischemia. Despite the lack of randomized studies, it is widely believed that this intervention will improve the clinical outcome of these patients.

METHODS AND RESULTS

Three hundred patients with single vessel disease of the infarct vessel and no or minor angina pectoris in the subacute phase (1 to 6 weeks) after an acute myocardial infarction were randomized to angioplasty (n=149) or medical therapy (n=151). Primary end point was the survival free of reinfarction, (re)intervention, coronary artery bypass surgery, or readmission for severe angina pectoris at 1 year. The event-free survival at 1 year was 82% in the medical group and 90% in the angioplasty group (P=0.06). This difference was mainly driven by the difference in the need for (re)interventions (20 versus 8, P=0.03). At long-term follow-up (mean, 56 months), survival was 89% and 96% (P=0.02). Survival free of reinfarction, (re)intervention, or coronary artery bypass surgery was 66% and 80% in the medically and interventionally treated patients, respectively (P=0.05). The use of nitrates was significantly lower in the angioplasty group, both at 1 year (38% versus 67%, P=0.001) and at long-term follow-up (36% versus 55%, P=0.006).

CONCLUSIONS

Percutaneous revascularization of the infarct-related coronary artery in stable patients with single vessel disease improves clinical outcome at long-term follow-up and reduces the use of nitrates. The results of our study should be reproduced in a confirmatory study with a larger sample size before percutaneous coronary intervention in this low-risk patient subgroup, after myocardial infarction can be recommended as routine treatment in clinical practice.

摘要

背景

在急性心肌梗死稳定的存活患者中,即使是没有任何症状或残余缺血的患者,也常常对梗死相关动脉进行经皮腔内冠状动脉成形术。尽管缺乏随机研究,但人们普遍认为这种干预将改善这些患者的临床结局。

方法与结果

300例在急性心肌梗死后亚急性期(1至6周)患有梗死血管单支病变且无或仅有轻微心绞痛的患者被随机分为血管成形术组(n = 149)或药物治疗组(n = 151)。主要终点是1年时无再梗死、(再)干预、冠状动脉搭桥手术或因严重心绞痛再次入院的生存率。药物治疗组1年时无事件生存率为82%,血管成形术组为90%(P = 0.06)。这种差异主要是由(再)干预需求的差异驱动的(20例对8例,P = 0.03)。在长期随访(平均56个月)中,生存率分别为89%和96%(P = 0.02)。药物治疗组和干预治疗组无再梗死、(再)干预或冠状动脉搭桥手术的生存率分别为66%和80%(P = 0.05)。血管成形术组硝酸盐的使用在1年时(38%对67%,P = 0.001)和长期随访时(36%对55%,P = 0.006)均显著更低。

结论

在患有单支病变的稳定患者中,对梗死相关冠状动脉进行经皮血管重建术可改善长期随访的临床结局并减少硝酸盐的使用。在将心肌梗死后的这一低风险患者亚组的经皮冠状动脉介入治疗推荐为临床实践中的常规治疗之前,我们研究的结果应在一项样本量更大的验证性研究中得到重现。

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