[Analysis of the safety and effectiveness of antithrombotic prophylaxis after elective total knee and hip arthroplasty: a prospective single-center real-world study].

Abstract

Aim: To evaluate the safety and effectiveness of various antithrombotic prophylaxis regimens after elective total knee arthroplasty (TKA) and elective total hip arthroplasty (THA).

Materials and methods: Medical history, information about concomitant diseases and previously prescribed drug therapy was recorded in all participants. Subsequently, a prospective observation was performed to record specific antithrombotic drugs and the duration of their use after surgery, patient compliance with the rehabilitation regimen, all cases of thrombosis and bleeding; all patients were contacted by phone 1 and 3 months after surgery.

Results: The study population included 271 males (34.7%) and 511 females (65.3%). 332 (42.5%) patients underwent THA and 450 (57.5%) patients underwent TKA. In the perioperative period, 769 patients (98.3%) received fraxiparine monotherapy as antithrombotic prophylaxis, and 13 (1.7%) patients received fraxiparine in combination with an antiplatelet agent due to previous percutaneous coronary intervention or very high cardiac risk. Within 1 month after surgery, 31 (4.0%) patients did not take any anticoagulants despite the prescriptions, 20 (2.6%) patients used aspirin instead of the prescribed anticoagulants. Other patients received direct oral anticoagulants (dabigatran, rivaroxaban, or apixaban) or warfarin as prescribed; among them 73 (9.3%) patients received concomitant antiplatelet agents. Seven (0.9%) patients used three anticoagulants concomitantly. During the first month after surgery, 9 cases (1.2%) of deep vein thrombosis were recorded (5 patients took no anticoagulants, another 4 participants were not compliant with the rehabilitation regimen). 5 (0.6%) cases of epistaxis, 4 (0.5%) cases of hemorrhoidal bleeding and 2 (0.2%) cases of hematoma in the surgical area were reported. All cases of thrombosis and bleeding were mild and resolved spontaneously. No statistically significant differences in the incidence of adverse events were found between different anticoagulant therapy regimens.

Conclusion: In a cohort of real-world patients undergoing elective TKA or THA, the differences between the effectiveness and safety of various anticoagulant prophylaxis regimens were not statistically significant. The incidence of thrombosis was low, and these complications were mainly reported in non-compliant patients. The incidence of bleeding in patients taking anticoagulants with antiplatelet agents was not elevated, however, the size of this subpopulation is small and does not allow to perform a significant assessment of the safety of this treatment regimen. Based on the findings, it is reasonable to develop additional methods to improve patient compliance in order to reduce the frequency of medication errors and decrease the incidence of possible complications.