| Objective: To observe the safety of rivaroxaban in anticoagulation therapy for patients with nvaf by prospective study.Methods: The enrolled patients were patients with nvaf requiring anticoagulant therapy,all of whom volunteered to take rivaroxaban for anticoagulant therapy.A total of 143 patients were enrolled,including 7patients who lost follow-up in the middle of the course and 4 patients who entered the terminal event,and132 patients were finally included in the observational study.Before enrollment,patients signed the informed consent to take rivaroxaban voluntarily,which was approved by the ethics committee of our hospital.The anticoagulant compliance questionnaire should be filled out during the enrolling and followup.The general data of the patients were collected at the time of enrollment,and the assessment of stroke and hemorrhage was performed.Two doses of rivaroxaban,15 mg and 20 mg,were used for anticoagulant therapy after evaluation by cardiovascular physicians in our hospital.Patients were monitored at 1,3,6,9and 12 months after taking the medicine,macrobiochemistry,blood routine and blood coagulation indicators were monitored,and follow-up was completed to record the occurrence of adverse events such as bleeding and embolism,data collection,treatment and analysis were carried out,and risk factors related to bleeding were studied.Regular distribution of drugs and collection of empty boxes of drugs every 3months.All data were analyzed and processed by SPSS20.0 software(P<0.05),meaning the difference was statistically significant.3.Analysis of hemagglutination indicators: the monitoring analysis of six hemagglutination indicators(PT,APTT,TT,PR,INR,d-dimer,FIB)in patients showed that the differences of PT,APTT,TT,PR between the bleeding group and the non-bleeding group were statistically significant.ROC curve analysis showed that PT had a significant ability to predict bleeding.Results:1.Basic information: a total of 149 patients were included,including 7 patients who lost follow-up in the middle of the course,4 patients who entered the terminal event,and 132 patients who were finally included in the observational study.Patients with an average age of 70.41±11.28 years old,male,76 cases(57.58%),106 cases(80.30%),being overweight merge history of high blood pressure in 81 cases(61.36%),history of diabetes mellitus 29 cases(21.70%),cerebral infarction merger/TIA history of 36 cases(27.27%),merge history of heart failure in 19(14.39%),merge history of hardening of the arteries of 70 cases(53.03%),25cases(18.94%)with bleeding history.Cha2ds2-vasc score of patients: 19(14.39%)patients with score < 2,and 57(43.18%)patients with score ?2.Among the female patients,there were 5(3.79%)patients with score < 3 and 51(38.64%)patients with score ?3.Patient HAS-BLED scoring: 72 patients(54.55%)had a score < 3 and 60 patients(45.45%)had a score ?3.2.Analysis of adverse events: the number of bleeding patients during medication was 22,the incidence of bleeding was 16.67%,the incidence of new thrombus was 2,and the incidence of thrombus was1.52%.There were 68 cases(51.52%)in the 15 mg QD group,with a bleeding rate of 8.82%(6/68),a new incidence of thrombosis of 1.47%(1/68),and 64 cases(48.48%)in the 20 mg QD group,with a bleeding rate of 25.00%(16/64),and a thrombosis incidence of 1.56%(1/64).The difference of bleeding events between groups was statistically significant(P=0.013),while the difference of embolization events between groups was not statistically significant(P=0.747).The patients were divided into three groups according to their age: < the bleeding rate of patients aged 60 was 7.41%(2/27),the bleeding rate of patients aged 60-80 was 12.99%(10/77),and the bleeding rate of patients aged 80 was 35.71%(10/28).The difference of bleeding incidence in different age groups was statistically significant(P=0.017).Rivaroxaban dose,patient age and bleeding history were statistically significant between the bleeding group and the non-bleeding group.Multiple logistic regression analysis showed that large rivaroxaban dose,old age and bleeding history were risk factors for bleeding.The laboratory indexes of cystatin-C and hemoglobin showed statistically significant differences between the bleeding group and the non-bleeding group.Conclusion:1.For anticoagulation therapy in patients with nvaf,the bleeding rate of 20 mg rivaroxaban was higher than15 mg,and the bleeding rate of patients showed an increasing trend with the increase of age,and the bleeding rate was more likely to be bleeding at the age of > and 80.It was shown that patients with af were safer to take a small dose of Rivaroxaban when anticoagulant therapy was effective.2.The anticoagulation intensity of PT,APTT,TT and PR in rivaroxaban anticoagulation therapy was monitored,which was consistent with the current clinical practice.It was found that the incidence of bleeding increased significantly when PT was greater than 13.8s.3.Old age,history of bleeding and large dose of Rivaroxaban were risk factors for bleeding,which were consistent with current clinical practice.The study further confirmed that hemoglobin is a predictor of bleeding risk in patients,and found that cystatin C can also be used to assess bleeding risk. |
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