Analysis of influential factors for rivaroxaban-induced bleeding events in patients with non-valvular atrial fibril‐ lation complicated with coronary heart disease
- VernacularTitle:利伐沙班致非瓣膜性心房颤动合并冠心病患者相关出血事件的影响因素分析
- Author:
Mingyu CHEN
1
,
2
;
Min CHEN
2
;
Jinzhu DENG
2
;
Qiang DAI
1
;
Hongjin GAO
1
Author Information
1. Dept. of Pharmacy,Provincial Clinical College of Fujian Medical University/Fuzhou University Affiliated Provincial Hospital,Fuzhou 350001,China
2. School of Pharmacy,Fujian Medical University,Fuzhou 350122,China
- Publication Type:Journal Article
- Keywords:
rivaroxaban;
non-valvular atrial fibrillation;
coronary heart disease;
bleeding events;
prothrombin time;
dose-
- From:
China Pharmacy
2024;35(18):2272-2277
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To analyze the influential factors for rivaroxaban-induced bleeding events in patients with non- valvular atrial fibrillation (NVAF) and coronary heart disease. METHODS A total of 64 hospitalized patients with NVAF complicated with coronary heart disease who were treated with rivaroxaban and admitted to the Fuzhou University Affiliated Provincial Hospital from November 2021 to May 2023 were included in this retrospective study. The demographic data, laboratory test indexes and other general clinical data, and steady-state trough concentration of rivaroxaban were collected, and the dose- adjusted trough concentration was calculated. The occurrence of bleeding events within 6 months after discharge was recorded. The univariate analysis and binary Logistic regression analysis were adopted to determine the independent risk factors of rivaroxaban- related bleeding events. The binary Logistic regression equation was constructed to predict the probability of bleeding events. The area under the receiver operator characteristic (ROC) curve (AUC) was used to analyze the predictive value of the regression equation. RESULTS Among 64 patients, 19 patients had 24 case-times bleeding events, most of which were mild bleeding (19 case-times, 79.2%), and mainly gastrointestinal bleeding (17 case-times, 70.8%). After symptomatic treatment and adjustment of the anticoagulant regimen, most of them were improved or cured. In the univariate analysis, the proportion of patients with a history of anemia, platelet count, urea nitrogen content, steady-state trough concentration of rivaroxaban, dose-adjusted trough concentration and coagulation indexes [international normalized ratio, prothrombin time (PT), activated partial thromboplastin time] in bleeding group were significantly more or higher than those in non-bleeding group, while the albumin level was significantly lower than that in non-bleeding group (P<0.05). In binary Logistics regression analysis, high PT level (odds ratio=1.473, 95% confidence interval=1.103-1.967, P= 0.009) and high rivaroxaban dose-adjusted trough concentration (odds ratio=1.174, 95% confidence interval=1.018-1.355, P= 0.027) were independent risk factors for rivaroxaban-related bleeding events. The binary Logistic regression equation of bleeding event prediction probability (P) was LogitP=-6.975+0.387×PT level+0.161×dose-adjusted trough concentration, and the AUC of the ROC curve was 0.825 (95% confidence interval was 0.708-0.909, P<0.001). CONCLUSIONS The risk factors of rivaroxaban-related bleeding events in patients with NVAF and coronary heart disease include previous anemia history, high platelet count, high urea nitrogen content, high rivaroxaban steady-state trough concentration, high dose-adjusted trough concentration, high coagulation indexes and low albumin level. High PT level and high dose-adjusted trough concentration are independent risk factors that can be used to predict the risk of rivaroxaban-induced bleeding events. The regression equation has good predictive value.