Dr. Doğan Şen

Name of the study:
Early Administration of Heparin at First Medical Contact Versus in the Cath Lab for STEMI Patients Undergoing Primary Percutaneous Coronary Intervention (HELP-PCI): A Multicenter, Randomized Trial

Published in Congress: TCT 2024

Link: https://www.tctmd.com/slide/early-administration-heparin-first-medical-contact-versus-cathlab-stemi-patients-undergoing

Background:
The effect of pretreatment with unfractionated heparin (UFH) at first medical contact (FMC) before primary percutaneous coronary intervention (PCI) on patients with ST-segment elevation myocardial infarction (STEMI) remains uncertain.

Methods:
HELP-PCI was an investigator-initiated, randomized controlled trial conducted at 36 clinical centers in 14 cities in China. Patients with STEMI 18 to 80 years of age presenting <12 h after symptom onset undergoing primary PCI were randomly assigned (1:1) to intravenous administration with UFH (100 U/kg) at FMC or in the catheterization laboratory through catheter sheath. The primary endpoint was the TIMI 3 flow of infarct-related artery (IRA) at diagnostic angiography before primer PCI assessedvon the full-analysis set of all participants with angiography. Secondary outcome was defined as 180-day MACE, consisting of death, cardiac death, heart failure hospitalizations, reinfarction, stent thrombosis, unplanned revascularization, and stroke at 180 days. Safety outcome was Bleeding Academic Research Consortium (BARC) types ³ 2 bleeding at 180 days. This trial is registered with ClinicalTrials.gov (NCTO5329155), and is ongoing.

Results:
Between July 20, 2022, and August 20, 2023, in the FAS, a total of 999 patients were randomly assigned to receive either UHF administration at FMC (n = 505) or in catheterization laboratory (n = 494). One hundred eighty-day-day follow-up was completed in 994 (99.9%) patients. Pretreated population at FMC showed and higher frequency of TIMI 3 flow of IRA compared with no pretreated population in the catheterization laboratory (23.8% vs 18.0%; OR: 0.67; 95% CI: 0.47-0.94; P = 0.02). The 180-day MACE occurred in 21 patients in UHF administration at FMC group and 32 patients in the catheterization laboratory group (Kaplan-Meier rate 4.18% vs 6.50%; HR: 0.64 [95% CI: 0.37-1.09]; P = 0.102), There were no significant differences in the frequency of the individual components of the combined endpoint as well. BARC type ³ 2 bleeding was similar in both groups (UFH administration at FMC vs in catheterization laboratory, 1.22% vs 0.80%; P = 0.543).

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

Comment:
This study underlines the importance of the use of UFH at first medical contact (FMC) in STEMI patients and demonstrates the advantages of its use. The results obtained showed that the use of UFH at FMC resulted in a significant increase in the TIMI 3 flow rate at IRA compared to the population without pretreatment in the catheterisation laboratory, supporting patients to experience a better reperfusion. On the other hand, 180-day MACE rates were similar. No significant difference was observed when bleeding rates in both groups were compared. However, further research on the generalisability of the results and their effects in different populations is important. Such studies will contribute to the development of optimal approaches in the treatment of STEMI.