Clinical Study Of Fondaparinux In Patients With Non-ST-Segment Elevation Acute Coronary Syndrome

Background and objective: In the past,large randomized controlled trials(RCTs)and real-world studies have shown that compared with enoxapalin,fondaparinux can significantly reduce the risk of nosocomial bleeding in patients with non-ST-segment acute coronary syndrome(NSTACS).Fondaparinux also can reduce the near-term and long-term mortality.However,these studies were completed around 2010,which were included different populations and treatment regimens.In addition,the previous large-scale clinical studies were all conducted in European and American populations.There is no large-scale clinical study in China at present.Therefore,it is very necessary to carry out real world studies on the new anticoagulant therapy strategy and the large sample population in China.This study was from the REFOCAS(Real-word Study of Fondaparinux in Chinese NSTE-ACS Patients).There were 150 participating research centers nationwide.Our hospital and Ganzhou Municipal Hospital were the participating research centers.The study was sponsored by the General Hospital of the Chinese People’s Liberation Army and supported by the China Health Promotion Foundation.A total of 9078 subjects were planned.The study is to evaluate the incidence of ischemia and bleeding events in Chinese patients with non ST segment elevation acute coronary syndroms(NSTACS)treated with different antithrombotic strategies of fondaparinux or low molecular weight heparin(LMWH)in combination with antiplatelet agents(ticagrelor or clopidogrel).Methods: Continuous charge 97 NSTACS patients randomized divided into fondaparinux group(observation group)or LMWH group(control group)of anticoagulant intervention,two groups ratio 2:1.Main study endpoints are death,myocardial infarction again,or nonfatal stroke,bleeding in 30 days and the second study endpoints are all causes death,myocardial infarction again,or nonfatal stroke,major bleeding and minor bleeding in hospital or in six months.Results: There was no significant difference in the major bleeding and minor bleeding between the fondaparinux and LMWH groups(P >0.05);the major bleeding(2% vs 0%,P=0.460);minor bleeding(2% vs 13%,P=0.50)during hospitalization.During the discharge visit period,there was no significant difference in major bleeding and minor bleeding between fondaparinux and low molecular weight heparin group(P>0.05);the rates of minor bleeding between the two groups were(2% vs 0%,P=0.649).There was no significant difference in the outcome variables of non-fatal stroke and minor bleeding between the fondaparinux group and the LMWH group(P>0.05)and minor bleeding(3% vs 0%,P=0.419);non-fatal stroke(2% vs 0%,P=0.649)following up results at 30 days after discharge.The results of 6-month following-up showed that there was no significant difference in the two outcome variables of all-cause death and minor hemorrhage between the fondaparinux group and the LMWH group(P>0.05)),all-cause mortality(2% vs 0%,P=0.46);minor bleeding(5% vs 8%,P=0.812).Chi-square test could not be performed at the end point of the study where the number of positive persons was zero during the visit period,so the sample size should be increased in the later period to compare the effects between the two groups.Conclusion:There was no significant difference between sulfonate and LMWH in minor or major bleeding during hospitalization(P>0.05).There were no statistically significant differences in minor bleeding at discharge visit(P>0.05),minor bleeding and non-fatal stroke at 30 days after discharge(P>0.05),all-cause death and minor bleeding at 6months after discharge(P>0.05).