Prehospital Heparin Administration in Patients With STEMI Undergoing Primary PCI: HEPARIN-STEMI Randomized Controlled Trial.

We investigated the benefits and safety of pretreatment with unfractionated heparin (UFH) in patients with STEMI referred to primary PCI.

我们研究了在被推荐进行直接PCI的STEMI患者中，使用未分级肝素（UFH）预处理的益处和安全性。

Methods

In HEPARIN-STEMI (Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction)-a single-center, open-label, randomized controlled trial-patients with STEMI with ≤6 hours symptom duration were assigned to receive either a 70- to 100-IE/kg bolus of UFH at first prehospital medical contact plus a supplemental dose before PCI, adjusted to activated clothing time ≥250 seconds, or to a control group receiving standard UFH at the time of PCI.

在HEPARIN-STEMI（ST段抬高型心肌梗死患者使用未分级肝素的预处理）-一项单中心、开放标签、随机对照试验中，将症状持续时间≤6小时的STEMI患者分配到两组：一组在首次院前医疗接触时接受70至100 IU/kg的UFH（未分级肝素）负荷剂量，并在PCI（经皮冠状动脉介入治疗）前给予补充剂量，调整至活化凝血时间≥250秒；另一组为对照组，在PCI时接受标准剂量的UFH。

The primary efficacy end point was TIMI (Thrombolysis in Myocardial Infarction) flow grade 2-3 in the infarct-related artery at initial coronary angiography.

主要疗效终点是初次冠状动脉造影时梗死相关动脉的TIMI（心肌梗死溶栓治疗）血流等级2-3级。

The primary safety end point was BARC (Bleeding Academic Research Consortium) type 3-5 bleeding during the index hospital stay.

主要安全性终点是在指数住院期间发生的BARC（Bleeding Academic Research Consortium）3-5级出血事件。

Results

From March 2022 to February 2025, 298 patients were randomized to UFH pretreatment and 295 to the control group.

从2022年3月到2025年2月，共有298名患者被随机分配到UFH预处理组，295名患者被分配到对照组。

The groups were comparable in age, sex, risk factors, previous cardiovascular events, and median delay from symptoms to coronary angiography (145 versus 150 minutes; P=0.814).

两组在年龄、性别、风险因素、既往心血管事件以及从症状出现到冠状动脉造影的中位延迟时间（145分钟对比150分钟；P=0.814）方面具有可比性。

The median time from UFH pretreatment to coronary angiography was 60 minutes (25th-75th interquartile range, 47-55 minutes).

从UFH预处理到冠状动脉造影的中位时间是60分钟（第25-75百分位数范围，47-55分钟）。

TIMI flow grade 2-3 in the infarct-related artery was documented in 43% of patients with UFH pretreatment and 27% of patients in the control group (relative risk, 1.59 [95% CI, 1.27-1.98]; P<0.001), with no significant difference in BARC type 3-5 bleeding (2.4% versus 2.0%; relative risk, 1.16 [95% CI, 0.39-3.45]; P=0.789).

在使用UFH预处理的患者中，43%的患者记录了梗死相关动脉的TIMI血流2-3级，而在对照组中这一比例为27%（相对风险为1.59 [95%置信区间，1.27-1.98]；P<0.001），在BARC 3-5级出血方面没有显著差异（2.4%对比2.0%；相对风险为1.16 [95%置信区间，0.39-3.45]；P=0.789）。

Conclusions

In patients with STEMI undergoing primary PCI, in a mature STEMI network, pretreatment with UFH at first prehospital medical contact was associated with an absolute 16% increase in infarct-related artery patency without an increased risk of bleeding.

在进行原发性PCI的STEMI患者中，在成熟的STEMI网络中，首次院前医疗接触时使用UFH预处理与梗死相关动脉开通率绝对增加16%相关，而没有增加出血风险。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05247424.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT05247424.