Efficacy and safety of rivaroxaban versus low-molecular-weight heparin for the prevention of symptomatic in-hospital venous thrombosis following primary total hip and knee arthroplasty: a large-sample, multicenter, retrospective study.

内容摘要

To evaluate the efficacy and safety of rivaroxaban and low molecular weight heparin (LMWH) for the prevention of postoperative venous thrombosis (VTE) following primary unilateral total hip arthroplasty (THA) and total knee arthroplasty (TKA). A total of 11,686 patients who received rivaroxaban and LMWH (6,110 cases of THA and 5,576 cases of TKA) between January 2014 and November 2017 in 26 large teaching hospitals were enrolled. The patients were divided into two groups according to the postoperative use of anticoagulant drugs, including 4,591 cases in the rivaroxaban group (2,288 cases of THA and 2,303 cases of TKA) and 7,095 cases in the LMWH group (3,822 cases of THA and 3,273 cases of TKA). The incidence of deep vein thrombosis (DVT) in the lower extremities, and pulmonary embolism (PE), were analyzed as indicators of efficacy. The incidences of postoperative bleeding events, total blood loss (TBL), and transfusion rate, were considered as safety indicators. The overall incidence of DVT was 0.40% (47/11,686) in patients undergoing primary THA/TKA. The incidence of DVT in the rivaroxaban group was 0.74% (34/4591); this was significantly higher than that in the LMWH group (0.18%; 13/7095) (OR 4.07, 95% CI 2.14-7.71;p&#x2009;<&#x2009;0.001). In the THA subgroup, the incidence of DVT in the rivaroxaban group was 0.52% (12/2288 cases); this was significantly higher than that in the LMWH group 0.10% (0.10%; 4/3822) (p&#x2009;=&#x2009;0.002). In the TKA subgroup, the incidence of DVT was 0.96% (22/2303 cases) in the rivaroxaban group and 0.27% (9/3273 cases) in the LMWH group (p&#x2009;<&#x2009;0.001). Only one patient treated with LMWH after TKA was diagnosed with symptomatic PE in this study. There was no significance difference in terms of safety between rivaroxaban and LMWH (p&#x2009;>&#x2009;0.05) in terms of the incidence of bleeding events and TBL. However, in the TKA subgroup, TBL was significantly higher in the rivaroxaban group than in the LMWH group (915&#x2009;&#xb1;&#x2009;514&#xa0;ml vs. 872&#x2009;&#xb1;&#x2009;487&#xa0;ml, p&#x2009;=&#x2009;0.030). With regards to transfusion rate, patients in the rivaroxaban group had a significantly higher need for blood transfusion than those in the LMWH group (OR 3.30,95% CI 2.88-3.78;p&#x2009;<&#x2009;0.001). Subgroup analysis revealed that the transfusion rates in the THA and TKA sub-groups were both higher in the rivaroxaban group (14.8%, 14.2%) than those in the LMWH group (6.5%, 3.0%) (p&#x2009;<&#x2009;0.001). For patients following primary unilateral THA/TKA, LMWH is superior to rivaroxaban in terms of the prevention of symptomatic in-hospital DVT' and the control of TBL and transfusion rates. However, the efficacy of these drugs for controlling bleeding events was similar when compared between the two groups.