Analysis Of Efficacy And Safety Of Rivaroxaban In Elderly Patients Over 80 Years Old

BackgoundChina is in a period of accelerated growth of social aging,and the number of the elderly is gradually increasing.With the increase of age,the incidence rate of thromboembolic disease is increasing,which is the main cause of death or disability of the elderly in the world.Therefore,the anticoagulant therapy for the elderly is particularly important.Compared with traditional anticoagulant drugs,rivaroxaban has the advantages of stable efficacy,rapid effect,good safety,less interaction with food and drug,no need to monitor blood coagulation function and so on.Moreover,EINSTEIN test,ROCKER-AF test and other large-scale clinical studies have confirmed its clinical benefits.At present,it has been widely used in anticoagulant treatment and prevention of thromboembolic diseases,such as deep vein thrombosis(DVT),pulmonary embolism(PTE),nonvalvular atrial fibrillation(NVAF),acute coronary syndrome(ACS)and prevention of venous thrombosis after hip / knee replacement surgery in many countries.It is possible to increase the occurrence of adverse reactions of rivaroxaban,so the risk of using rivaroxaban in the elderly is significantly higher than that in the young.This requires clinicians to evaluate the benefits and risks of rivaroxaban according to the specific conditions of elderly patients.Although the clinical benefits of rivaroxaban have been fully confirmed in young people,there is a lack of relevant clinical trials in elderly patients,and there are only a handful of patients over 80 years old.At present,there is insufficient evidence for the efficacy and safety of different doses of rivaroxaban anticoagulation in elderly patients.Therefore,this study collected all the indexes of the elderly patients over 80 years old who took rivaroxaban regularly for a long time in our hospital,and analyzed the efficacy and safety of anticoagulant therapy with different doses of rivaroxaban in elderly patients,so as to provide more clinical basis for the use of rivaroxaban in elderly patients.ObjectiveTo investigate the efficacy and safety of rivaroxaban anticoagulation in elderly patients(≥ 80 years old)with different doses and indications.MethodsThis study is a retrospective study.Through the electronic medical record management system of our hospital,patients over 80 years old who took rivaroxaban regularly during hospitalization from January 2018 to May 2020 were randomly selected.89 cases were selected through strict selection and exclusion criteria.Collect the basic information of patients: age,gender.The clinical data such as indications,dosage and adverse reactions of rivaroxaban were collected.The laboratory indexes of patients were collected: blood routine test(Hb,PLT),blood coagulation function(APTT,PT),liver function(ALT,AST),renal function(Crea).The related bleeding(including skin hemorrhage,gastrointestinal bleeding,intracranial hemorrhage,etc.)and new stroke were recorded.The incidence of hemorrhagic events was calculated.The relationships between gender,age,different indications,dosage of rivaroxaban and hemorrhagic events and new stroke were analyzed.The changes of blood routine,coagulation function,liver and kidney function before and after treatment with rivaroxaban were compared.The data were analyzed by statistical software SPSS17.0,P<0.05 with statistical significance.Results1.A total of 89 patients were included in this study,male patients accounted for51.7%(46/89),female patients accounted for 48.3%(43/89),the median age(interquartile range)was 85.0(5.0)years old.There was no significant difference in the proportion of male to female and age in different dosage groups of AF,DVT and PE groups(P >0.05).There was no significant difference in the proportion of male to female and age in different dosage groups of 10 mg qd,15 mg qd,20 mg qd or 10 mg bid(P >0.05).2.During the treatment period of this study,the incidence of bleeding in the whole group was 11.2%(10/89),including 3.8% of skin bleeding(3/89),6.7% of gastrointestinal bleeding(6/89),1.1% of intracranial hemorrhage(1/89),and gastrointestinal bleeding accounted for 60% of the total bleeding.The incidence of bleeding was 11.1%(6/54)in AF patients,6.9%(2/29)in DVT patients,33.3%(2/6)in PE patients,P=0.196,and the difference was not statistically significant.According to the daily oral dose of rivarovaban,the patients were divided into three groups: the bleeding rate was 7.0%(5/71)in 10 mg qd group(71 cases),25%(2/8)in 15 mg qd group(8 cases),and 30%(3/10)in 20 mg qd or 10 mg bid group(10 cases).The incidence of bleeding events increased with the increase of oral rivarovaban dose(P<0.05).There was no significant difference in the incidence of bleeding events between the two groups(P>0.05).Among the subjects in this study,the incidence of bleeding in male patients was 13.0%(6/46),while that in female patients was 9.3%(4/43),P=0.741.There was no significant difference between the two groups(P>0.05).The correlation analysis between age and bleeding events,P=0.693,there was no statistical significance.3.The incidence of new stroke in the whole group was 4.5%(4/89).The new stroke rate of AF group was 5.6%(3/54),DVT group was 3.4%(1/29),PE group was0%(0/6),P>0.05.The new stroke rate was 5.6%(4/71)in 10 mg qd group,0%(0/8)in15mg qd group,and 0%(0/10)in 20 mg qd or 10 mg bid group.There was no statistical significance in the incidence of stroke events in each group.There was no significant difference in the incidence of stroke events between the two groups.4.After long-term regular rivaroxaban treatment,Hb,PLT,ALT,AST and Crea of the whole group had no significant difference(P>0.05),but APTT and PT were significant higher than those before treatment(P<0.05).There were no significant differences in APTT,PT,AST,Crea among the three different disease groups before and after treatment(P>0.05).There was no significant difference in Hb,APTT,Pt,ALT,AST and Crea between among 10 mg qd,15 mg qd,20 mg qd or 10 mg bid groups before and after treatment with different doses of rivaroxaban(P<0.05).There was significant difference in PLT after treatment(P<0.05).There was no significant difference in PLT,APTT,ALT,AST and Crea between the bleeding group and the non-bleeding group after treatment(P>0.05).There was significant difference in hemoglobin(Hb)after treatment(P<0.05).Conclusion1.With the increase of dose of rivaroxaban,the incidence of bleeding increased(P<0.05),but there was no significant difference in the incidence of thrombosis(P>0.05),indicating the low dose rivaroxaban may be safer for patients over 80 years old.2.The risk of bleeding and new stroke was similar in the treatment group with different rivaroxaban indications(P>0.05).3.In the elderly patients over 80 years old,gender has nothing to do with the occurrence of bleeding events,but the main bleeding events are gastrointestinal bleeding and skin bleeding.