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.
| Discipline Area | Score |
|---|---|
| Internal Medicine |  |
| Cardiology |  |
A little anticoagulant should help "spontaneous" clot lysis.
This an interesting and well-designed trial. However, it would be more interesting having enough statistical power to figure out whether the benefits in terms of myocardial reperfusion translates into favourable clinical outcomes. Furthermore, an international and multicenter approach would enable the trial to ascertain whether the potential benefits are applied to western patients.
I think that number of randomized participants was a little small (about 1000) for 36 hospitals. Consequently, the incidence of events was small, which might have led to negative results. However, there was a significance in the MACCE rate at 30 days between the two groups due to heart failure hospitalization. I wonder why this difference was not found at 6 and 12 months. Comprehensive cardiac rehabilitation might improve this result.