Department of Cardiology, Central Hospital of Xuzhou, Xuzhou Institute of Cardiovascular Disease, Xuzhou City 221009, Jiangsu Province, China.
Department of Cardiology, Central Hospital of Xuzhou, Xuzhou Institute of Cardiovascular Disease, Xuzhou City 221009, Jiangsu Province, China.
Heart Lung Circ. 2019 Jun;28(6):858-865. doi: 10.1016/j.hlc.2018.05.097. Epub 2018 May 22.
To determine whether nicorandil administration distal to the thrombus in the coronary artery during percutaneous coronary intervention (PCI) in acute ST-segment elevation myocardial infarction (STEMI) patients reduced the incidence of no-reflow phenomenon, reperfusion injury, and adverse events.
This randomised controlled trial involved 170 STEMI patients who underwent PCI. All patients underwent thrombectomy and tirofiban injection (10μg/kg) distal to the vascular lesion via a suction catheter, followed by nicorandil (84 patients; 2mg) or saline injection (86 patients; 2mL) at the same site. The primary endpoint (major adverse cardiac events, MACEs) was 6-month cardiovascular mortality or unplanned readmission rate due to worsening congestive heart failure. The secondary endpoints were thrombolysis in myocardial infarction (TIMI) grade, TIMI myocardial perfusion grade (TMPG), resolution of ST-segment elevation (defined as >50% decrease in ST elevation); and ventricular arrhythmias.
Upon Kaplan-Meier analysis, freedom from MACEs was 92.9% in the nicorandil group and 81.4% in the placebo (p=0.026). The numbers of patients achieving TIMI grade 3 (95.24% vs. 86.05%; p=0.040) and TMPG 3 (94.05% vs. 83.72%; p=0.033) were greater in the nicorandil group than in the control group. Resolution of ST-segment elevation occurred in 84.52% and 68.60% patients in the nicorandil and control groups, respectively (p=0.014). Ventricular arrhythmias occurred in 5.95% and 16.28% patients in the nicorandil and control groups, respectively (p=0.032).
Early administration of nicorandil distal to the vascular lesion during PCI in STEMI patients may reduce the incidence of reperfusion injury, and improve short-term clinical outcomes.
NCT02435797.
在急性 ST 段抬高型心肌梗死（STEMI）患者经皮冠状动脉介入治疗（PCI）中，于冠状动脉内血栓远端给予硝酸异山梨酯，以降低无复流现象、再灌注损伤和不良事件的发生率。
本随机对照试验纳入了 170 例接受 PCI 的 STEMI 患者。所有患者均行经抽吸导管血栓切除术和替罗非班（10μg/kg）注射至血管病变远端，随后于同一部位注射硝酸异山梨酯（84 例；2mg）或生理盐水（86 例；2mL）。主要终点（主要不良心脏事件，MACEs）为 6 个月时心血管死亡率或因充血性心力衰竭恶化而再入院率。次要终点为心肌梗死溶栓治疗（TIMI）分级、TIMI 心肌灌注分级（TMPG）、ST 段抬高缓解（定义为 ST 段抬高降低≥50%）；以及室性心律失常。
根据 Kaplan-Meier 分析，硝酸异山梨酯组的 MACEs 无事件生存率为 92.9%，安慰剂组为 81.4%（p=0.026）。硝酸异山梨酯组达到 TIMI 分级 3 级（95.24%比 86.05%；p=0.040）和 TMPG 3 级（94.05%比 83.72%；p=0.033）的患者比例均高于对照组。硝酸异山梨酯组和对照组的 ST 段抬高缓解率分别为 84.52%和 68.60%（p=0.014）。硝酸异山梨酯组和对照组的室性心律失常发生率分别为 5.95%和 16.28%（p=0.032）。
在 STEMI 患者 PCI 中于血管病变远端早期给予硝酸异山梨酯，可能降低再灌注损伤发生率，并改善短期临床结局。
NCT02435797。
