Steffenino Giuseppe, Santoro Giovanni Maria, Maras Patrizia, Mauri Francesco, Ardissino Diego, Violini Roberto, Chiarella Francesco, Lucci Donata, Marini Maurizio, Baldasseroni Samuele, Maggioni Aldo Pietro
Department of Cardiology, S. Croce e Carle Hospital, Cuneo, Italy.
Ital Heart J. 2004 Feb;5(2):136-45.
The aim of this study was to observe the outcomes of high-risk patients with acute myocardial infarction treated with primary angioplasty and intravenous thrombolysis in a community setting.
A prospective study of the in-hospital and 12-month outcomes was conducted in 17 cardiology centers where primary angioplasty was available, and in 30 where it was not. Three thousand seventy-four patients in the first 12 hours of an evolving infarction were recruited; among these, 2227 patients who met one or more pre-defined criteria of increased risk were included in the study.
Thrombolysis and primary angioplasty were respectively performed in 1090 and in 721 patients; 416 patients (18.7%) received no reperfusion treatment. The incidence of the primary combined in-hospital endpoint (death, non-fatal reinfarction and stroke) was similar in patients treated with thrombolysis (9.2%) and with primary angioplasty (10.7%) (odds ratio--OR 1.19, 95% confidence interval--CI 0.86-1.63, p = NS), and was higher (22.6%) in patients receiving no reperfusion treatment as compared to thrombolysis (OR 3.30, 95% CI 2.36-4.63, p < 0.0001). The occurrence of the 12-month endpoint (death, reinfarction, congestive heart failure and recurrent angina) was lower after primary angioplasty than after thrombolysis (26.8 vs 35.0%, OR 0.68, 95% CI 0.55-0.84, p = 0.0003), due to a lower incidence of angina. At multivariate analysis, older age, anterior infarction, Killip class > 1, high heart rate, and low systolic blood pressure on admission were all significantly associated with a higher incidence of both endpoints. The adjusted analysis confirmed that, despite similar in-hospital results after both reperfusion treatments, primary angioplasty was independently associated with better 1-year outcomes (relative risk 0.66, 95% CI 0.56-0.79, p < 0.0001).
In this observation in the community setting, a strategy of primary angioplasty in patients with high-risk myocardial infarction was not better than thrombolysis in terms of mortality or recurrent infarction, but was associated with less angina at 1 year.
本研究旨在观察在社区环境中接受直接血管成形术和静脉溶栓治疗的高危急性心肌梗死患者的治疗结果。
对17个可进行直接血管成形术的心脏病中心和30个不能进行该手术的中心进行了一项关于住院期间和12个月治疗结果的前瞻性研究。纳入了3074例在心肌梗死发病后12小时内的患者；其中，2227例符合一项或多项预先定义的高风险标准的患者被纳入研究。
分别有1090例和721例患者接受了溶栓和直接血管成形术治疗；416例患者（18.7%）未接受再灌注治疗。直接血管成形术治疗组（10.7%）和溶栓治疗组（9.2%）的主要住院联合终点事件（死亡、非致死性再梗死和中风）发生率相似（优势比[OR]为1.19，95%置信区间[CI]为0.86 - 1.63，p = 无显著性差异），未接受再灌注治疗的患者该发生率（22.6%）高于溶栓治疗组（OR为3.30，95%CI为2.36 - 4.63，p < 0.0001）。直接血管成形术治疗后12个月终点事件（死亡、再梗死、充血性心力衰竭和复发性心绞痛）的发生率低于溶栓治疗后（26.8%对35.0%，OR为0.68，95%CI为0.55 - 0.84，p = 0.0003），原因是心绞痛发生率较低。多因素分析显示，年龄较大、前壁梗死、Killip分级>1、心率较快以及入院时收缩压较低均与两个终点事件的较高发生率显著相关。校正分析证实，尽管两种再灌注治疗后的住院结果相似，但直接血管成形术与更好的1年治疗结果独立相关（相对风险为0.66，95%CI为0.56 - 0.79，p < 0.0001）。
在本次社区观察中，高危心肌梗死患者的直接血管成形术策略在死亡率或再梗死方面并不优于溶栓治疗，但与1年时较少的心绞痛发作相关。
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