This study evaluated whether early heparin administration at first medical contact improves STEMI outcomes compared with administration immediately before PCI, informing the timing of antithrombotic therapy in acute MI care pathways.
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.
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.
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.
