Heparin administration at first medical contact vs immediately before primary percutaneous coronary intervention: the HELP-PCI trial.

Methods

HELP-PCI was an investigator-initiated, randomized controlled trialconducted at 36 clinical centres in China.

HELP-PCI是一项由研究者发起的随机对照试验，该试验在中国的36个临床中心进行。

Patients with STEMI presenting ≤12 h after symptom onset undergoing PPCI were randomly assigned (1:1) to intravenous administration with UFH (100 U/kg) at FMC or in the Cath Lab through a catheter sheath.

在症状发作后≤12小时内接受PPCI的STEMI患者被随机分配（1:1），在FMC时或在导管室通过导管鞘管静脉给予UFH（100 U/kg）治疗。

The primary endpoint was Thrombolysis in Myocardial Infarction flow grade (TFG)-3 of infarct-related artery (IRA) at diagnostic angiography before PPCI.

主要终点是在PPCI前诊断性血管造影中，梗死相关动脉（IRA）的溶栓治疗在心肌梗死中的血流分级（TFG）-3级。

The secondary outcome was complete epicardial and myocardial reperfusion after PPCI and major adverse cardiac and cerebrovascular events (MACCE; defined as the composite of all-cause death, cardiac death, heart failure hospitalizations, re-infarction, stent thrombosis, unplanned revascularization, and stroke) at 12 months.

次要结果是PPCI后的完全心外膜和心肌再灌注以及12个月时的主要不良心脏和脑血管事件（MACCE；定义为全因死亡、心脏死亡、心力衰竭住院、再梗死、支架血栓形成、计划外血运重建和中风的复合结果）

Safety outcome was 30-day Bleeding Academic Research Consortium (BARC) type ≥2 bleeding.

安全性结果是30天内出血学术研究联盟（BARC）类型≥2的出血

Results

A total of 999 patients with STEMI undergoing PPCI were randomly assigned to receive either UFH administration at FMC (n = 505) or in the Cath Lab (n = 494).

共有999名接受PPCI治疗的STEMI患者被随机分配，分别在FMC（n = 505）或导管室（n = 494）接受UFH治疗。

Pre-treated population at FMC showed a higher frequency of TFG-3 of IRA compared with the Cath Lab group (23.6% vs 17.6%; odds ratio, 1.44; 95% confidence interval, 1.06-1.97; P = .02).

在FMC接受预处理的患者中，IRA的TFG-3频率高于导管室组（23.6% vs 17.6%；比值比，1.44；95%置信区间，1.06-1.97；P = .02）。

There were no significant differences in secondary endpoints or in the safety endpoint, including 12-month MACCE, complete epicardial and myocardial reperfusion, and major bleeding.

次要终点或安全性终点（包括12个月的MACCE、完全的冠状动脉和心肌再灌注以及主要出血）之间没有显著差异。

Conclusions

Pre-treatment with loading-dose UFH at FMC was associated with an improvement of spontaneous reperfusion of IRA without increasing the risk of major bleeding.

在FMC使用负荷剂量的普通肝素预处理与IRA自发再灌注的改善相关，而不会增加主要出血的风险。