Analysis Of Effectiveness, Safety Assessment And Bleeding Related Factors Of Rivaroxaban In Patients Over 60 Years Old

Objective:The purpose of this study is to explore the efficacy and safety of Rivaroxaban in patients over 60 years old with different doses and age stratification,and to analyze related risk factors for bleeding.Methods:A retrospective analysis of thromboembolic disease and Non-valvular atrial fibrillation patients aged 60 years or older who were admitted to the First Hospital of Jilin University between January 2016 and August 2018 was performed.General data of these patients were collected at admission,including age,gender,daily dose of Rivaroxaban,coagulation routine,platelet,liver function,kidney function and D-dimer test results.The Rivaroxaban-related bleeding and the occurrence of new thrombosis were recorded.The frequencies of bleeding and thrombosis at different doses were compared.The frequencies of bleeding at different age groups was also compared.Then we analyzed related bleeding risk factors.Results:(1)A total of 299 eligible patients were enrolled in this study,of which 46.5% were male(139/299)and 53.5% were female(160/299).The average age was 71.66.The maximum age was 93,while the minimum age was 60.During the treatment,there were 25 patients who suffered from bleeding(2 cases were moderate bleeding and 23 cases were slightly bleeding).In addition,there were two patients who suffered from new thrombosis during treatment.The incidence of bleeding was 8.4%,and the incidence of new thrombosis was 0.7%.(2)According to the daily dose of oral Rivaroxaban,the patients were divided into: 97 cases(32.4%)in the 10 mg QD group,3.1%(3/97)in bleeding rate and 0.0%(0/97)in the new incidence of thrombus;74 cases(24.8%)in the 15 mg QD group,the bleeding rate was 5.4 %(4/74)and the new incidence of thrombus was 1.4%(1/74);78 cases(26.1%)in the 10 mg BID group,the bleeding rate was 10.3%(8/78)and a new incidence of thrombus was 1.3%(1/78);50 cases(16.7%)in the first 15 mg BID after21 days was changed to 20 mg QD group,the bleeding rate was 20.0%(10/50),and the new incidence of thrombus was 0.0%(0/52).The incidence of bleeding events increased with the increase of oral Rivaroxaban doses,and the difference between the groups was statistically significant,(P<0.001).Comparison between first 15 mg BID after 21 days was changed to 20 mg QD group with 10 mg QD group the bleeding rate was statistically significant,(P<0.008).The incidence of embolism between the groups was not statistically significant(P=0.765).(3)Patients were divided into different age groups: 134 cases(44.8 %)aged 60~69 with a bleeding rate of 3.7%(5/134);109 cases(36.5%)aged 70~79 with a bleeding rate of 8.3 %(9/109);Greater than or equal to 80 years old 56 cases(18.7%),bleeding rate 19.6 %(11/56);the incidence of bleeding events increased with age,(P=0.001).Comparison between greater than or equal to 80 years old group with aged 60~69 group the bleeding rate was statistically significant,(P<0.016).(4)According to different types of bleeding,23 cases were classified as mild bleeding,accounting for 7.7%.Minor bleeding occurred in 2 cases,accounting for 0.7%,and no serious bleeding occurred.(5)Comparison of the baseline data between the bleeding group and non-bleeding group demonstrated that age,daily dose of Rivaroxaban and prothrombin activity were risk factors for bleeding events.Multivariate logistic regression analysis indicated that age and daily dose of Rivaroxaban were independent risk factors for bleeding.Conclusion:1.With the increase of daily dose of Rivaroxaban,the bleeding rate gradually increased(P<0.001).There was no statistical difference in the incidence of thrombus(P=0.765),indicating that daily low dose of Rivaroxaban are safer for the elderly in the case when the recommended dose of Rivaroxaban is effective.2.Under different age groups,the bleeding rate increased with age(P=0.001),especially for the people greater than or equal to 80 years old,suggesting that the older patients are more likely to bleeding.The dailydose of Rivaroxaban should be selected the lowest dose within the recommended dose range.3.Comparison of the baseline data between the bleeding group and non-bleeding group showed that age,daily dose of Rivaroxaban and prothrombin activity were statistically significant.Multivariate logistic regression analysis results suggested that age and daily dose of Rivaroxaban are independent risk factors for bleeding.