Jiang Chao, Dou Jie, Yang Huihui, Guo Ruoling, Gao Jie, Liu Bo, Shu Hongjun, Hou Yanchun, Zhao Lili, Guo Jingtao, Luo Donglei
School of Medicine, Chengde Medical University, Chengde, Hebei, China.
Department of Cardiology, Chengde Central Hospital, Second Clinical College of Chengde Medical University, Chengde, Hebei, China.
Anatol J Cardiol. 2025 Mar 4;29(4):164-72. doi: 10.14744/AnatolJCardiol.2025.4879.
Primary percutaneous coronary intervention (PPCI) is preferred as the reperfusion option for patients with ST-segment elevation myocardial infarction (STEMI).
This study conducted the pharmacoinvasive strategy with half-dose recombinant human prourokinase (PHDP) trial to evaluate whether the PHPD encompassing early fibrinolysis coupled with timely catheterization, provides efficacy and safety similar to that of PPCI in STEMI patients. We randomly assigned patients with STEMI aged 18-80 years who presented within 24 h of their symptoms to receive either PHDP or PPCI.
There was no significant difference in the 2 arms for the primary endpoints, which were defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, TIMI myocardial perfusion grade 3, and ST-segment resolution ≥70% 1 hour after percutaneous coronary intervention. The secondary endpoints, including slow flow/no-reflow (P < .001), malignant arrhythmia (P < .001), and hypotension (P < .001), occurred more frequently in the PPCI arm than in the PHDP arm. The combined 30-day follow-up outcomes occurred more often in the PPCI group than in the PHDP group (P = .032). There were no reported cases of in-hospital intracranial hemorrhage or major bleeding events; the rates of minor bleeding events were similar (P = .157).
Among patients with STEMI presenting ≤24 hours after symptom onset who received the PHDP, the efficacy of complete epicardial and myocardial reperfusion was similar to that among patients who received the PPCI. In addition, PHDP was associated with a decreased risk of procedure-related complications. Conducting clinical efficacy and safety trials with the pharmacoinvasive strategy and the half-dose of fibrinolytic drug is warranted.
对于ST段抬高型心肌梗死(STEMI)患者,首选直接经皮冠状动脉介入治疗(PPCI)作为再灌注治疗方案。
本研究开展了半剂量重组人尿激酶原(PHDP)药物介入策略试验,以评估早期溶栓联合及时导管插入术的PHDP在STEMI患者中是否能提供与PPCI相似的疗效和安全性。我们将年龄在18至80岁、症状出现后24小时内就诊的STEMI患者随机分配接受PHDP或PPCI治疗。
两组的主要终点无显著差异,主要终点定义为心肌梗死溶栓(TIMI)血流3级、TIMI心肌灌注3级以及经皮冠状动脉介入治疗后1小时ST段回落≥70%。次要终点,包括慢血流/无复流(P <.001)、恶性心律失常(P <.001)和低血压(P <.001),在PPCI组比在PHDP组更频繁出现。30天联合随访结果在PPCI组比在PHDP组更常出现(P =.032)。未报告院内颅内出血或重大出血事件;轻微出血事件发生率相似(P =.157)。
在症状发作后≤24小时接受PHDP治疗的STEMI患者中,完全的心外膜和心肌再灌注疗效与接受PPCI治疗的患者相似。此外,PHDP与手术相关并发症风险降低相关。开展药物介入策略和半剂量溶栓药物的临床疗效和安全性试验是有必要的。