急性心肌梗死合并多支病变患者急诊经皮冠状动脉介入治疗后不同血运重建策略的疗效和经济学评估

Evaluation of different revascularization strategies for patients with acute myocardial infarction with lesions of multiple coronary arteries after primary percutaneous coronary intervention and its economic evaluation

目的：观察急性心肌梗死（AMI）合并冠状动脉多支病变（MVD）患者不同血运重建策略对预后的影响，并评估其经济学效益。方法采用前瞻性随机对照临床研究方法（RCT），选择秦皇岛市第一医院2009年1月至2012年6月收治的成功行急诊经皮冠状动脉介入治疗（PCI）的AMI合并MVD患者。在成功行急诊PCI治疗后，按随机数字表法分为两组：A组于发病后7～10 d行预防性PCI干预非梗死相关血管（non-IRA）病变；B组则根据患者的缺血相关证据对non-IRA行PCI治疗。两组患者均根据指南施行最优化药物治疗，严格随访24个月，随访期间随时调整药物。随访期间记录两组患者主要心脏不良事件〔MACE，包括再发心肌梗死（心梗）、心因性死亡〕；同时记录心因性再住院、再发心绞痛、心力衰竭、再次PCI情况以及植入支架数、总住院时间和总医疗费用。结果428例患者完成24个月的随访，A组215例患者均行non-IRA介入治疗；B组213例中62例行缺血相关的PCI治疗，51例行non-IRA治疗。A组与B组MACE发生率差异无统计学意义〔8.4%（18/215）比10.8%（23/213），χ2＝0.727，P＝0.394〕；其中心因性死亡（5.1%比6.6%）、再发心梗（4.2%比6.6%）、心力衰竭（4.2%比7.0%）的发生率差异无统计学意义（均P＞0.05），但A组再发心绞痛（14.4%比32.9%）、心因性再住院（14.4%比33.8%）和再次支架治疗（12.6%比29.1%）的发生率明显低于B组（均P＜0.01），靶血管血运重建率高于B组（10.7%比5.2%，P＜0.05）。A组患者植入支架总数多于B组（枚：610比366），平均植入支架数也多于B组（枚/例：2.83±0.91比1.72±0.91，t＝12.725，P＝0.000），平均总医疗费用明显高于B组（万元：6.37±1.26比5.15±1.23，t＝10.107，P＝0.000），但总住院时间明显短于B组（d：8.21±2.45比9.89±3.23， t＝6.071，P＝0.000）。由于B组non-IRA血运重建率较低，故B组随访24个月时β受体阻滞剂和硝酸酯类药物使用率明显高于A组〔59.2%（126/213）比47.0%（101/215，χ2＝6.371，P＝0.012；52.6%（112/213）比16.7%（36/215），χ2＝60.748，P＝0.000〕。结论 AMI合并MVD患者在成功行急诊干预IRA后，近期预防性干预non-IRA，尽管可明显降低再发心绞痛、心因性再住院的风险，但并不能降低再发心梗和心因性死亡的风险，同时明显增加了支架植入数和总医疗费用。

ObjectiveTo investigate the effect and medical cost of different revascularization strategies for acute myocardial infarction （AMI） patients with multi-vessel disease （MVD）.Methods A prospective randomized controlled trial （RCT） was conducted. From January 2009 to June 2012, patients with AMI and MVD undergoing primary percutaneous coronary intervention （PCI） were enrolled. They were randomly assigned to group A [staged PCI for non-infarction related artery （non-IRA） within 7-10 days after AMI] and group B （subsequent PCI for non-IRA recommended only for those with evidence of ischemia）. All of patients were given optimized medical therapy according to clinical guideline, and they were followed up for 24 months at regular intervals. Major adverse cardiovascular events（MACE） including recurrence of myocardial infarction and death due to cardiac ailments were recorded. Meanwhile, re-hospitalization from cardiac causes, recurrence of angina, heart failure, and re-PCI, number of stents, total hospital stay days, and total medical expenditure were recorded.Results A total of 428 patients accomplished the 24-month follow up. All the patients underwgennt PCI for non-IRA in group A （215 patients）, while 62 patients in group B （213 patients） undergone PCI for myocardial ischemia, and 51 patients received non-IRA treatment. There was no significant difference in MACE incidence between group A and group B [8.4% （18/215） vs. 10.8% （23/213）,χ2= 0.727,P = 0.394]. The difference of death rate due to cardiac causes （5.1% vs. 6.6%）, recurrence of myocardial infarction （4.2% vs. 6.6%）, and heart failure （4.2% vs. 7.0%） were not significantly different between groups A and B （allP〉 0.05）. The rate of recurrence of angina （14.4 % vs. 32.9%）, re-hospitalization from cardiac causes （14.4% vs. 33.8%）, and re-treatment of implanting stents （12.6% vs. 29.1%） were significantly lower in group A than group B （allP〈 0.01）, and the rate of revascularization was significantly higher in group A than group B （10.7% vs. 5.2%,P〈 0.05）. The total number of stents （610 vs. 366）, mean number of stents per patient （2.83 ±.91 vs. 1.72 ±.91,t = 12.725,P = 0.000）, and total cost per patient （kRMB： 63.7 ±2.6 vs. 51.5 ±2.3,t = 10.107,P = 0.000） in group A were significantly higher than those in group B. Total hospital stay days in group A was significantly less than group B （days： 8.21 ±.45 vs. 9.89 ±.23, t = 6.071,P = 0.000）. Because non-IRA-vascular reconstruction rate was low in group B, the rate of usingβ-blocker and anti-anginal agents during the 24-month follow up in group B was significantly higher than group A [59.2% （126/213） vs. 47.0% （101/215）,χ2= 6.371,P = 0.012; 56.3% （112/213） vs. 17.6% （36/215）,χ2 = 64.704,P = 0.000]. Conclusions In patients with AMI and MVD undergone emergency PCI, staged PCI within 7-10 days for non-IRA cannot decrease the incidence of myocardial infarction and death due to cardiac causes, recurrence of angina and rehospitalization for cardiac causes was diminished, and it may increase the number of stents and medical cost significantly.