Objective Bivalirudin as a new anticoagulant of can inhibit thrombin directly,and have been widely used in the anticoagulant therapy of percutaneous coronary intervention(PCI)in many domestic and foreign large-scale evidence-based studies.This study was to explore whether non-ST-segment elevation coronary syndrome patients(NSTE-ACS)with PCI perioperative anticoagulation need to delay the application of bivalirudin and select to maintain the delayed application of bivalirudin at full or low dose.Methods 1 125 cases of NSTE-ACS patients with PCI were enrolled in the Department of Cardiology,China Meitan General Hospital.According to the condition of patient's consent,the selected patients were divided into unfractionated heparin group(group A,n =39)and routine group(group B,n = 34),low-dose delayed group(group C,n = 24),highdose delayed group(group D,n = 28).2 Four groups of patients were treated in accordance with coronary heart disease secondary prevention conventional medication.3 Four groups of patients were repeatedly detected ACT(immediately,2 hours,4 hours,6 hours after surgerys)to quantify anticoagulant effect.Bleeding events during hospitalization and 30 days after operation were monitored and recorded(all according to the BARC grading standard)and other safety endpoints and major adverse cardiac events(MACE)and other effective endspoint.Results 1 There was no statistically significant difference in total postoperative bleeding events among four groups(28.2%vs14.7% vs25.0% vs21.4%,P=0.57),the number of bleeding events in group B,C,D was significantly lower in group A,postoperative 1 type bleeding events(12.8%vs8.8%vs16.7%vs14.3%,P=0.83),postoperative 2-5 bleeding events(15.4%vs5.9%vs8.3%vs7.1%,P=0.54),MACE(2.6%vs0.0%vs0.0%vs0.0%,P=0.53),thrombocytopenia,acute stent thrombosis(0.0%vs2.9vs0.0vs0.0%,P=0.45)also were no significant statistical difference.There was 1 MACE case of death due to digestive tract hemorrhage after conventional heparin anticoagulation in group A,group B,group C,group D were no.There was 1 case of acute stent thrombosis with no postoperative delayed use of bivalirudin in routine group,the other groups was no.2 Comparison of incidence of total bleeding events in different risk degrees subgroups of four groups of patients according to GRACE score: low-risk subgroups(P=0.65),middle and high risk subgroups(36.8%vs13.3%vs19.0%vs12.5%,P=0.19),the total bleeding events were no significant statistical difference,but the bleeding cases of middlle and high risk patients in B,C,D groups were significantly lower in group A.And does not increase with drug dose,was proved the advantage of bivalirudin in the bleeding.3 Four groups of patients were repeatedly detected postoperative ACT numerical value: immediate(P=0.00),2 hour(P=0.00),4 hours(P=0.03)and 6 hours(P=0.02)were statistically significant,group B,C,D were significantly higher than that of group A,the rate of decline was significantly greater than the A group.Conclusions 1 In the NSTE-ACS patients treated with PCI,the efficacy of different doses of bivalirudin and heparin were equivalent,and the total bleeding cases decreased,which indirectly reflected the better effect of the prevention of hemorrhage in middle and high risk patients than that in the heparin group.Total clinical benefit was better than heparin group.This was consistent with the previous evidence-based research that the benefits of patients were derived from the reduction in the incidence of bleeding,and there was no significant difference in the prevention of ischemic adverse events.2 In low-riskpatients,the efficacy and safety of different dosage of bivalirudin were comparable,and there were no statistical differences in bleeding and adverse events,considering economic factors,and the ischemia risks were low,so it was recommended that It was also very beneficial to give this kind of people routine bivalirudin.3 For middle and high risk patients,compared with non-delayed group,the efficacy of low-dose delayed bivalirudin was comparable,but the ACT can reach the ideal state which guidelines recommend.and the number of bleeding events does not increase with the increase of the time after PCI.Compared with full-dose delayed group,the efficacy of low-dose delayed bivalirudin was comparable,but there was no statistically significant difference in safety,but the bleeding events decreased,and was mostly 1-2 type minor bleeding.Therefore,it is possible to achieve a better clinical effect for this type of patient by recommending a low-dose delayed bivalirudin in the application of bivalirudin.Because of the lower positive rates of the bleeding and adverse events of bivalirudin,a single center study and less sample size,if undertake multicenter study and enlarge the study sample size,it is more able to verify the advantages of low-dose delayed bivalirudin after PCI.However,the specific prolonged use of doses and methods has yet to be further verified by a large sample of clinical studies. |