Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.
Department of Cardiology, Handan Central Hospital, Handan, 056000, China.
BMC Cardiovasc Disord. 2020 Jun 26;20(1):308. doi: 10.1186/s12872-020-01584-0.
Prourokinase is a single-chain plasminogen activator presenting with fewer hemorrhagic complications and reduced reocclusion rate compared with the conventional fibrinolytic agents in patients with coronary artery disease. However, prourokinase intracoronary injection during PCI for treating patients with ST-segment elevation myocardial infarction (STEMI) is rarely investigated. Therefore, this study aimed to evaluate the efficacy and safety of intracoronary prourokinase during the percutaneous coronary intervention (PCI) in treating STEMI patients.
Fifty STEMI patients who underwent primary PCI were consecutively enrolled and randomly assigned to intracoronary prourokinase group (N = 25) or control group (N = 25). During the primary PCI procedure, patients in the intracoronary prourokinase group received 10 ml prourokinase injection, while patients in control group received 10 ml saline injection as control. The primary endpoints were coronary physiological indexes, the secondary endpoints were angiographic assessments, myocardial infarct size/reperfusion assessment, cardiac function evaluations, major adverse coronary events (MACEs) and hemorrhagic complications. All patients were followed up for 3 months.
Post PCI, the index of microcirculatory resistance (IMR) was decreased in intracoronary prourokinase group than that in control group (34.56 ± 7.48 vs. 49.00 ± 8.98, P < 0.001), while no difference of coronary flow reserve (CFR) (2.01 ± 0.32 vs. 1.88 ± 0.23, P = 0.267) or fractional flow reserve (FFR) (0.89 ± 0.05 vs. 0.87 ± 0.04, P = 0.121) was found between the two groups. The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin I (cTnI) (P = 0.032) and complete ST-segment resolution (STR) (P = 0.005) were better in intracoronary prourokinase group compared with control group. At 3-months post PCI, left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) were higher, while left ventricular end-diastolic diameter (LVEDd) was lower in intracoronary prourokinase group compared with control group (all P < 0.05). There was no difference in hemorrhagic complication or total MACE between the two groups.
Intracoronary prourokinase during PCI is more efficient and equally tolerant compared with PCI alone in treating STEMI patients.
Chinese Clinical Trial Registry ChiCTR1800016207 . Prospectively registered.
普佑兰酶是一种单链纤维蛋白溶酶原激活物，与传统的纤维蛋白溶解剂相比，在冠状动脉疾病患者中具有较少的出血并发症和降低的再闭塞率。然而，普佑兰酶在经皮冠状动脉介入治疗（PCI）中用于治疗 ST 段抬高型心肌梗死（STEMI）患者的冠状动脉内注射很少被研究。因此，本研究旨在评估经皮冠状动脉介入治疗（PCI）中冠状动脉内普佑兰酶治疗 STEMI 患者的疗效和安全性。
连续纳入 50 例接受直接 PCI 的 STEMI 患者，并随机分为冠状动脉内普佑兰酶组（n=25）或对照组（n=25）。在直接 PCI 过程中，冠状动脉内普佑兰酶组患者接受 10ml 普佑兰酶注射，对照组患者接受 10ml 生理盐水注射作为对照。主要终点是冠状动脉生理指标，次要终点是血管造影评估、心肌梗死面积/再灌注评估、心功能评估、主要不良心血管事件（MACE）和出血并发症。所有患者均随访 3 个月。
PCI 后，冠状动脉内普佑兰酶组的微血管阻力指数（IMR）低于对照组（34.56±7.48比 49.00±8.98，P<0.001），而冠状动脉血流储备（CFR）（2.01±0.32比 1.88±0.23，P=0.267）或血流储备分数（FFR）（0.89±0.05比 0.87±0.04，P=0.121）差异无统计学意义。冠状动脉内普佑兰酶组心肌梗死溶栓治疗血流分级（TMPG）（P=0.024）、肌酸激酶峰值（CK）（P=0.028）、肌酸激酶同工酶-MB（CK-MB）（P=0.016）、心肌肌钙蛋白 I（cTnI）（P=0.032）和完全 ST 段缓解（STR）（P=0.005）均优于对照组。PCI 后 3 个月，冠状动脉内普佑兰酶组左心室射血分数（LVEF）和室壁运动评分指数（WMSI）较高，左心室舒张末期直径（LVEDd）较低（均 P<0.05）。两组出血并发症和总 MACE 发生率差异无统计学意义。
与单纯 PCI 相比，PCI 中冠状动脉内普佑兰酶治疗 STEMI 患者更有效且同样耐受。
中国临床试验注册中心 ChiCTR1800016207. 前瞻性注册。
