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经皮冠状动脉介入治疗前降支 ST 段抬高型心肌梗死患者冠状动脉内应用前尿激酶原联合低压球囊预扩张的疗效及安全性。

Efficacy and safety of intracoronary pro-urokinase combined with low-pressure balloon pre-dilatation during percutaneous coronary intervention in patients with anterior ST-segment elevation myocardial infarction.

机构信息

Department of Cardiology, Lu'an Hospital of Anhui Medical University, Lu'an, Anhui, 237000, People's Republic of China.

Graduate School of Bengbu Medical College, Bengbu, Anhui, 233004, People's Republic of China.

出版信息

J Cardiothorac Surg. 2024 Apr 5;19(1):180. doi: 10.1186/s13019-024-02699-7.

Abstract

BACKGROUND

The efficacy and safety of low-pressure balloon pre-dilatation before intracoronary pro-urokinase (pro-UK) in preventing no-reflow during percutaneous coronary intervention (PCI) remains unknown. This study aimed to evaluate the clinical outcomes of intracoronary pro-UK combined with low-pressure balloon pre-dilatation in patients with anterior ST-segment-elevation myocardial infarction (STEMI).

METHODS

This was a randomized, single-blind, investigator-initiated trial that included 179 patients diagnosed with acute anterior STEMI. All patients were eligible for PCI and were randomized into two groups: intracoronary pro-UK combined with (ICPpD group, n = 90) or without (ICP group, n = 89) low-pressure balloon pre-dilatation. The main efficacy endpoint was complete epicardial and myocardial reperfusion. The safety endpoints were major adverse cardiovascular events (MACEs), which were analyzed at 12 months follow-up.

RESULTS

Patients in the ICPpD group presented significantly higher TIMI myocardial perfusion grade 3 (TMPG3) compared to those in the ICP group (77.78% versus 68.54%, P = 0.013), and STR ≥ 70% after PCI 30 min (34.44% versus 26.97%, P = 0.047) or after PCI 90 min (40.0% versus 31.46%, P = 0.044). MACEs occurred in 23 patients (25.56%) in the ICPpD group and in 32 patients (35.96%) in the ICP group. There was no difference in hemorrhagic complications during hospitalization between the groups.

CONCLUSION

Patients with acute anterior STEMI presented more complete epicardial and myocardial reperfusion with adjunctive low-pressure balloon pre-dilatation before intracoronary pro-UK during PCI.

TRIAL REGISTRATION

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摘要

背景

在经皮冠状动脉介入治疗(PCI)中,在使用组织型纤溶酶原激活剂(pro-UK)前进行低压球囊预扩张以预防无复流的疗效和安全性尚不清楚。本研究旨在评估在急性前壁 ST 段抬高型心肌梗死(STEMI)患者中应用冠状动脉内 pro-UK 联合低压球囊预扩张的临床疗效。

方法

这是一项随机、单盲、研究者发起的试验,纳入了 179 例急性前壁 STEMI 患者。所有患者均符合 PCI 适应证,并随机分为两组:冠状动脉内 pro-UK 联合(ICPpD 组,n=90)或不联合(ICP 组,n=89)低压球囊预扩张。主要疗效终点为完全心外膜和心肌再灌注。安全性终点为主要不良心血管事件(MACEs),在 12 个月随访时进行分析。

结果

ICPpD 组患者 TIMI 心肌灌注分级 3(TMPG3)显著高于 ICP 组(77.78%比 68.54%,P=0.013),PCI 后 30 分钟 STR≥70%(34.44%比 26.97%,P=0.047)或 PCI 后 90 分钟 STR≥70%(40.0%比 31.46%,P=0.044)的患者比例更高。ICPpD 组有 23 例(25.56%)患者和 ICP 组有 32 例(35.96%)患者发生 MACEs。两组患者住院期间出血并发症无差异。

结论

在 PCI 中,急性前壁 STEMI 患者应用冠状动脉内 pro-UK 前进行低压球囊预扩张可获得更完全的心外膜和心肌再灌注。

临床试验注册

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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b445/10996115/a24991316b7e/13019_2024_2699_Fig1_HTML.jpg

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