Objective To assess efficacy and safety of Fondaparinux during thrombolytic therapy in acute ST-elevation myocardial infarction patients.
Methods From November 2011 to April 2012, patients with acute ST-elevation myocardial infarction and pain to hospital time within 6 hours were received thrombolytic therapy by recombinant tissue-type plasminogen activator (rt-PA). Before thrombolytic therapy, patients were randomly assigned to Fondaparinux group (2.5mg, n = 30) or standard heparin group (60U/kg, maximum 4000U, n = 32). Coronary angiography or PCI were performed at 90min after initiating study drugs. Primary endpoints of the trial were the rate of TIMI grade 3 flow at 90minutes. other endpoints included incidence of all cause mortality at in-hospital, 30 days and 6 months, major bleeding and minor bleeding at in-hospital, 30d and 6 months.
Results (1) There were no difference of primary endpoints (Fondaparinux group vs heparin group, 64.6% vs 62.5%, p = 0.158). (2) PCI procedure: Successful rate of immediate post-procedure was 100%. The average number of stents per patient was 1.1 ± 0.4 and the average diameter and length of stent were (3.0 ± 0.7) and (21.2 ± 3.1) mm. (3) Safety: No significant difference existed between fondaparinux group and heparin group in major bleeding (in-hospital, 30d and 6 months, p > 0.05). However, the fondaparinux group had a lower prevalence of mild bleeding than heparin group (in-hospital and 30d, p ± 2.1months. ➀ Fondaparinux group had a lower mortality of in-hospital but has no statistical difference (p > 0.05). ➁ Mortality at 30d and 6 months were all similar in Fondaparinux treated patients compared to heparin treated patients (p > 0.05).
Conclusions Fondaparinux, which can reduce the time of reperfusion with decreasing mortality and mild haemorrhage, is feasible and safe for the patients with STEMI during thrombolysis therapy.