Heparin administration at first medical contact vs immediately before primary percutaneous coronary intervention: the HELP-PCI trial
Jing Chen, Changwu Xu, Liqiang Qiu, Bin Li, Yao Wei, Hui Wu, Liaoliao Hu, Guang Xu, Dongmei Zhu, Zhengzai Li, Xiaolin Wu, Chuang Xiao, Chuang Xiao, Xiuzhen Shen, Xiuzhen Shen, Chao Zhuo, Huajun Su, Keping Yang, Youen Zhang, Meichun Zhang, Chang Li, Xuexiang Lv, Li-Feng Hong, Fan Guo, Xingan Wu, Hao Xu, Minghui Li, Lirong He, Wenjun Wu, Yuhua Lei, Dongsheng Li, Huoping Li, Shaoze Chen, Hong Bao, Hong Bao, Xuguang Xiong, Guokang Yang, Jinke Chen, Jinke Chen, Qibin Zheng, Guanglong Yang, Mingxi Zhang, Jian Yang, Hong Jiang, Jian Yang, Hong Jiang
Abstract
BACKGROUND AND AIMS: The beneficial effect of pre-treatment with unfractionated heparin (UFH) at first medical contact (FMC) before primary percutaneous coronary intervention (PPCI) in all-comers with ST-elevation myocardial infarction (STEMI) remains uncertain. METHODS: HELP-PCI was an investigator-initiated, randomized controlled trial conducted at 36 clinical centres in China. 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. The primary endpoint was Thrombolysis in Myocardial Infarction flow grade (TFG)-3 of infarct-related artery (IRA) at diagnostic angiography before PPCI. 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. Safety outcome was 30-day Bleeding Academic Research Consortium (BARC) type ≥2 bleeding. 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). 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). 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. 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.