Efficacy And Safety Of Anticoagulation Therapy After Primary PCI In STEMI Patients

Objective: This study is an open, prospective, randomized, controlled trail evaluating the efficacy and safety of LMWH after primary PCI in patients with acute STEMI. This study will provide important data on whether LMWH is recommend for the management of patients with acute STEMI after primary PCI. Method: From April 2012 to March 2015, complete clinical data of 377 cases with acute STEMI which primary PCI was successfully performed in our hospital were collected. All cases were randomized into the LMWH group or non-LMWH group(control group). Efficacy endpoints were defined as the incidence of major adverse cardiac and cerebrovascular events(MACCE) during in-hospital period and at both 30 days to 6 months of follow-up. Safety endpoints were defined as the incidence of major and minor bleeding events classified by the TIMI and GUSTO criteria. Statistical differences between the incidence of both efficacy and safety endpoints were analyzed by SPSS 16.0. Survival analysis was performed by the Kaplan-Meier method. Then, two specified STEMI groups(one was the elder patients group and the other poor-reperfusion group) were enrolled in the study for the post-PCI using of LMWH. Results:1.1 For STEMI patients in which successful PPCI were performed, there were no statistical differences of the incidence of both in-hospital and follow-up MACCE between two groups.1.2 Total bleeding events were significantly increased in the LMWH group, and statistical significance was found between two groups(P=0.036). Thus, combined use of LMWH with antiplatelet therapies might increase the risk of hemorrhage.2.1 For elder patients, routine used of LMWH after PPCI brought no decreasing of MACCE. Survival analysis also showed no statistical significance of long term survival rate between the two groups2.2 Total bleeding events were increased in the LMWH group without statistical significance. The results showed a certain bleeding risk of LMWH using in the elder patients.3.1 Compared with the control group, LMWH used in poor-perfusion group showed the reduction of both in-hospital and follow-up MACCE. But the difference had no statistical significance yet.3.2 Total bleeding events were slightly increased in the LMWH group with no statistical significance. Conclusions:1. There’s no need for the routine use of LMWH in acute STEMI patients who have obtained well reperfusion after successful PCI procedure.2. It is not encouraged for the routine use of LMWH in elder patients after successful PCI. The dosage and course of treatment should be well adjusted. Careful monitoring of bleeding events is also important.3. LMWH can be considered in STEMI patients with poor-reperfusion in order to reduce the incidence of ischemic events, thus improve clinical prognosis.