Dai Jing, Lyu Shu-Zheng, Chen Yun-Dai, Song Xian-Tao, Zhang Min, Li Wei-Min, Zheng Yang, Wen Shang-Yu, Nie Shao-Ping, Zeng Yu-Jie, Gao Hai, Ma Yi-Tong, Zhang Shu-Yang, Guo Li-Jun, Zhang Zheng
Department of Cardiology, Capital Medical University Affiliated Beijing Anzhen Hospital, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.
Department of Cardiology, Chinese PLA General Hospital, Beijing, China.
J Geriatr Cardiol. 2017 Feb;14(2):108-117. doi: 10.11909/j.issn.1671-5411.2017.02.005.
The benefit/risk ratio of stenting in acute ST-segment elevation myocardial infarction (STEMI) patients with single vessel intermediate stenosis culprit lesions merits further study, therefore the subject of the present study.
It was a prospective, multicenter, randomized controlled trial. Between April 2012 and July 2015, 399 acute STEMI patients with single vessel disease and intermediate (40%-70%) stenosis of the culprit lesion before or after aspiration thrombectomy and/or intracoronary tirofiban (15 µg/kg) were enrolled and were randomly assigned (1: 1) to stenting group ( = 201) and non-stenting group ( = 198). In stenting group, patients received pharmacologic therapy plus standard percutaneous coronary intervention (PCI) with stent implantation. In non-stenting group, patients received pharmacologic therapy and PCI (thrombectomy), but without dilatation or stenting. Primary endpoint was 12-month rate of major adverse cardiac and cerebrovascular events (MACCE), a composite of cardiac death, non-fatal myocardial infarction (MI), repeat revascularization and stroke. Secondary endpoints were 12-month rates of all cause death, ischemia driven admission and bleeding complication. Median follow-up time was 12.4 ± 3.1 months. At 12 months, MACCE occurred in 8.0% of the patients in stenting group, as compared with 15.2% in the non-stenting group (adjusted HR: 0.42, 95% CI: 0.19-0.89, = 0.02). The stenting group had lower non-fatal MI rate than non-stenting group, (1.5% 5.5%, = 0.03). The two groups shared similar cardiac death, repeat revascularization, stroke, all cause death, ischemia driven readmission and bleeding rates at 12 months.
Stent implantation had better efficacy and safety in reducing MACCE risks among acute STEMI patients with single vessel intermediate stenosis culprit lesions.
在患有单支血管中度狭窄罪犯病变的急性ST段抬高型心肌梗死（STEMI）患者中，支架置入的获益/风险比值得进一步研究，因此开展了本研究。
这是一项前瞻性、多中心、随机对照试验。在2012年4月至2015年7月期间，纳入了399例患有单支血管病变且罪犯病变在血栓抽吸术和/或冠状动脉内替罗非班（15μg/kg）治疗前后存在中度（40%-70%）狭窄的急性STEMI患者，并将其随机（1:1）分为支架置入组（n = 201）和非支架置入组（n = 198）。在支架置入组，患者接受药物治疗加标准经皮冠状动脉介入治疗（PCI）并植入支架。在非支架置入组，患者接受药物治疗和PCI（血栓切除术），但不进行扩张或支架置入。主要终点是12个月时主要不良心脑血管事件（MACCE）发生率，MACCE是心脏死亡、非致命性心肌梗死（MI）、再次血运重建和中风的综合指标。次要终点是12个月时全因死亡、缺血驱动住院和出血并发症的发生率。中位随访时间为12.4±3.1个月。12个月时，支架置入组8.0%的患者发生MACCE，而非支架置入组为15.2%（校正风险比：0.42，95%置信区间：0.19-0.89，P = 0.02）。支架置入组的非致命性MI发生率低于非支架置入组（1.5%对5.5%，P = 0.03）。两组在12个月时的心脏死亡、再次血运重建、中风、全因死亡、缺血驱动再入院和出血发生率相似。
对于患有单支血管中度狭窄罪犯病变的急性STEMI患者，支架植入在降低MACCE风险方面具有更好的疗效和安全性。
