European heart journal · 2025
Heparin administration at first medical contact vs immediately before primary percutaneous coronary intervention: the HELP-PCI trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Chen Jing, Xu Changwu, Qiu Liqiang, Li Bin, Yao Wei, Wu Hui, Hu Longcai, Xu Guang, Zhu Dongmei, Li Zhengzai, Wu Xiaolin, Xiao Chuang, Liu Bo, Shen Xiuzhen, Deng Zhaowu, Zhuo Chaogui, Su Huajun, Yang Keping, Zhang Youen, Zhang Meichun, Li Chang, Lv Xuexiang, Hong Lifeng, Guo Fan, Wu Xingan, Xu Hao, Li Mingjian, He Liqun, Wu Wenjun, Lei Yuhua, Li Dongsheng, Li Huoping, Chen Shaoze, Bao Hong, Xiong Xuguang, Liu Bo, Yang Guokang, Chen Jinke, Lan Xiao, Zheng Qibin, Yang Guanglong, Zhang Mingxi, Yang Jian, Jiang Hong
Аннотация
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.
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.