| Objective:To provide medication for improved efficacy and prognosis in patients with high bleeding risk in ACS combining NVAF with PCI by assessing the effectiveness and safety of lower doses of dabigatran etexilate or lower doses of rivaroxaban combined clopidogrel.Methods:The prospective open randomized controlled trial method was employed in this project.Specifically,66 participants who met inclusion criteria(CHA2DS2-VASc score≥2 points and HAS-BLED score ≥3 points)and exclusion criteria were randomly assigned to groups A and B.Both groups were given aspirin(Bayer AG 100mg*30 tablets)and clopidogrel(Sanofi 75mg*7 tablets)before surgery,each with a loading dose of 300 mg.The two groups of patients were given dabigatran etexilate(110mg BID Shanghai Boehringer Han AG)or rivaroxaban(15mg QD Bayer AG)+ aspirin(100mg QD)+ clopidogrel(75 mg QD)from the beginning of PCI to 1 week after surgery.After discharge from the hospital,patients in group A received dabigatran etexilate(110mg BID)with clopidogrel(75 mg QD);patients in group B received rivaroxaban(15mg BID)with clopidogrel(75 mg QD).Two groups of patients were collected for 6 months of continuous treatment of adverse events.Result:(1)About 6.06% of patients in Group A or the dabigatran etexilate group had bleeding events(1 case of stool hidden blood,1 case of calf hematoma),and approximately 12.12% of patients in Group B had bleeding events(2 cases of stool hidden blood,1 case of right knee cavity blood accumulation,1 case of nasal haemorrhage),with no statistically significant difference(P =0.627).(2)In the prevention of stroke,systemic embolism,Stent thrombosis,and RE-MI,the effect of 110 mg of Dabigatran Etexilate or 15 mg of rivaroxaban combined clopidogrel antithrombotic is similar(P>0.05).(3)After six months of treatment,the APTT(41.48±3.11)s of Group A was more significantly higher than the APTT(38.48±3.67)s of Group B,with a significant difference(t=3.583,P=0.001).Compared with Group A,the PT(13.93±1.09)s in Group B was increased more significantly,presenting a significant difference(t=3.015,P=0.004).(4)In Group A and Group B,PLT,D-D,and Fib all exhibited a decrease during the 6-month treatment;PLT(t=0.203,P=0.839),D-D(t=0.90,P=0.373),Fib(t=0.321,P=0.749),with no significant difference(P>0.05).(5)After six months of treatment,Group A: ALT was(60.45±15.75)U/L,AST was(52.85±22.85)U/L,Cr was(101.64±22.15)umol/L,Un was(7.11±1.90)mmol/L;Group B: ALT was(60.30±9.81)U/L,AST was(46.67±16.30)U/L,Cr(103.00±18.86)umol/L,UN was(7.14 ± 2.81)mmol/L.As indicated by comparing the results of the two groups,the P value was 0.963,0.210,0.798,and 0.952,respectively,demonstrating no significant difference(P>0.05).Conclusion:(1)Regarding bleeding events defined by BARC,minor drug-related bleeding events occurred less frequently in the dabigatran ester group than in the varoxaban group and may be safer,though the results of follow-up between the two groups were not statistically significant.(2)No significant difference in the antithrombotic efficacy was observed between 110 mg of dabigatranate combined with clopidogrel and15 mg of rivaroxaban combined with clopidogrel. |
PDF Full Text Request