Departments of Cardiology (P.C., C.T., W.Z., T.W., X.G., K.L., J.M., Z.D., Chen Li, J. Zong, F.Z., J.H., X.K., Chunjian Li), the First Affiliated Hospital of Nanjing Medical University, China.
Department of Cardiology, Xuzhou Central Hospital, Jiangsu, China (P.C.).
Circ Cardiovasc Interv. 2024 Feb;17(2):e013455. doi: 10.1161/CIRCINTERVENTIONS.123.013455. Epub 2024 Jan 23.
It is uncertain whether adjunctive thrombolysis is beneficial for patients with ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 120 minutes of presentation. This study was to determine whether in patients presenting with ST-segment-elevation myocardial infarction a single bolus recombinant staphylokinase (r-SAK) before timely PCI leads to improved patency of the infarct-related artery and reduces the infarct size.
This is an open-label, prospective, multicenter, randomized study. We enrolled patients aged 18 to 75 years who were within 12 hours of symptom onset of ST-segment-elevation myocardial infarction and expected to undergo PCI within 120 minutes. Patients were administered loading doses of aspirin and ticagrelor and intravenous heparin and were randomized to receive 5 mg bolus of r-SAK or normal saline intravenously before PCI. The primary end point was Thrombolysis in Myocardial Infarction flow grade 2 to 3 or grade 3 in the infarct-related artery 60 minutes after thrombolysis. The infarct size was detected by cardiac magnetic resonance 5 days after randomization. The safety end point was major bleeding (Bleeding Academic Research Consortium ≥3) during 30-day follow-up.
A total of 283 patients were screened from 8 centers and 200 were randomized (median age, 58.5 years; 14% female). The median symptom to thrombolysis time was 252.5 (interquartile range, 142.8-423.8) minutes and thrombolysis to coronary arteriography was 50.0 (interquartile range, 37.0-66.0) minutes. Patients randomized to r-SAK compared with normal saline more often had Thrombolysis in Myocardial Infarction flow grade 2 to 3 (69.0% versus 29.0%; <0.001) and Thrombolysis in Myocardial Infarction flow grade 3 (51.0% versus 18.0%; <0.001) and had smaller infarct size (21.91±10.84% versus 26.85±12.37%; =0.016). There was no increase in major bleeding (r-SAK, 1.0% versus control, 3.0%; =0.616).
A single bolus r-SAK before primary PCI for ST-segment-elevation myocardial infarction improves infarct-related artery patency and reduces infarct size without increasing major bleeding.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05023681.
对于在出现症状 120 分钟内接受经皮冠状动脉介入治疗 (PCI) 的 ST 段抬高型心肌梗死患者，辅助溶栓是否有益尚不确定。本研究旨在确定 ST 段抬高型心肌梗死患者在及时行 PCI 前单次静脉推注重组葡激酶 (r-SAK) 是否能改善梗死相关动脉的通畅性并减少梗死面积。
这是一项开放标签、前瞻性、多中心、随机研究。我们纳入了年龄在 18 至 75 岁之间、症状发作后 12 小时内且预计在 120 分钟内接受 PCI 的 ST 段抬高型心肌梗死患者。患者给予阿司匹林和替格瑞洛负荷剂量，并给予静脉肝素，然后随机静脉推注 5mg r-SAK 或生理盐水。主要终点是溶栓后 60 分钟梗死相关动脉的心肌梗死溶栓血流分级 2-3 级或 3 级。随机分组后 5 天通过心脏磁共振检测梗死面积。安全性终点是 30 天随访期间的主要出血（Bleeding Academic Research Consortium≥3 级）。
从 8 个中心共筛选了 283 例患者，200 例患者被随机分组（中位年龄 58.5 岁，14%为女性）。中位症状到溶栓时间为 252.5（四分位间距，142.8-423.8）分钟，溶栓到冠状动脉造影时间为 50.0（四分位间距，37.0-66.0）分钟。与生理盐水相比，r-SAK 组患者更常出现心肌梗死溶栓血流分级 2-3 级（69.0% vs 29.0%；<0.001）和 3 级（51.0% vs 18.0%；<0.001），梗死面积更小（21.91±10.84% vs 26.85±12.37%；=0.016）。主要出血发生率无增加（r-SAK 组 1.0% vs 对照组 3.0%；=0.616）。
在 ST 段抬高型心肌梗死患者直接 PCI 前单次静脉推注 r-SAK 可改善梗死相关动脉的通畅性，减少梗死面积，且不增加主要出血。
