OBJECTIVES: To compare the efficacy and safety of aspirin and rivaroxaban in preventing venous thromboembolism (VTE) after total knee arthroplasty (TKA).
METHODS: Thirty-two patients with osteoarthritis of the knee and knee arthroplasty indication were selected. The operated patients were randomized into two groups (A and B). Group A received 300 mg of acetylsalicylic acid (aspirin) and Group B received 10 mg of rivaroxaban daily for 14 days. Follow-up was performed weekly for four weeks and evaluated the presence of signs and symptoms of DVT, the healing of the surgical wound, and possible local complications such as hematoma, and superficial or deep infection that required surgical approach.
RESULTS: It was verified that there were no differences between groups (rivaroxaban and aspirin) regarding gender, age, and (p > 0.05). After using the general linear model (GLM) test, it was found that there was a decrease in Hb and Ht levels, preoperatively and at one, three, seven, and 14 days (Hb: p = 1.334 × 10-30; Ht: p = 1.362 × 10-28). However, they did not differ as to the type of medication (Hb: p = 0.152; Ht: p = 0.661). There were no identifiable differences in local complications, systemic complications, deep vein thrombosis (DVT), readmission to hospital, reoperation, or death (p > 0.05) between groups (rivaroxaban and aspirin).
CONCLUSIONS: Both aspirin and rivaroxaban can be considered useful among drugs available VTE the prevention after TKA.
This study aimed to compare the efficacy and safety of aspirin, rivaroxaban and low-molecular-weight heparin (LMWH) for post total knee arthroplasty (TKA) deep vein thrombosis (DVT) prophylaxis. Between July 2011 and July 2013, a prospective randomized controlled trial was performed on 324 patients with osteoarthritis who underwent primary unilateral TKA. Twelve hours after the surgery, Group A was given oral rivaroxaban at a dose of 10 mg/day. Group B was given subcutaneous LMWH at a dose of 4000 AxaIU (0.4 ml)/day and Group C was given oral aspirin at a dose of 100 mg/day. All three groups were treated for 14 days, and all of the patients were followed for 4 weeks. The incidence of DVT, dominant/hidden blood loss, the incidence of wound complications and the incidence of subcutaneous ecchymosis in the affected extremities were compared between the three groups. The incidence of DVT was lower in Group A compared with the other two groups [3 (2.94%) vs. 14 (12.50%), P = 0.029; 3 (2.94%) vs. 18 (16.36%), P = 0.017]. However, hidden blood loss [1.71 (1.19-2.97) vs. 1.18 (0.77-2.31), P = 0.009; 1.71 (1.19-2.97) vs. 1.30 (0.61-2.43), P = 0.004] and wound complications [5 (4.90) vs. 3 (2.67), P = 0.027; 5 (4.90) vs. 2 (1.82), P = 0.014] were more common in Group A than in the other groups. There were no significant differences between Group B and Group C in the incidence of DVT [14 (12.50%) vs. 18 (16.36%), P = 0.831], hidden blood loss [1.18 (0.77-2.31) vs. 1.30 (0.61-2.43), P = 0.327] or wound complications [3 (2.67) vs. 2 (1.82), P = 0.209]. No significant differences in the incidence of limb swelling were found between the three groups [38 (37.25%) vs. 28 (25.00%) vs. 24 (21.82%), P = 0.247]. Group A had a higher incidence of subcutaneous ecchymosis in the affected extremities than Group C [74 (72.55%) vs. 54 (49.09%), P = 0.039], but there were no significant differences between Groups A and B [74 (72.55%) vs. 62 (55.36%), P = 0.193] or between Groups B and C [62 (55.36%) vs. 54 (49.09%), P = 0.427]. Rivaroxaban has a positive anticoagulation effect but leads to increases in both postoperative blood loss and wound complications in patients. Hence, clinicians using rivaroxaban for anticoagulant therapy should closely monitor the changes in the hemoglobin level and wound healing and promptly supplement blood volume and provide other symptomatic and supportive treatments. No significant difference in post-TKA DVT prophylaxis was found between aspirin and LMWH, and the former can be used as part of a multimodal anticoagulation therapy.
BACKGROUND: Semuloparin is a novel ultra-low-molecular-weight heparin under development for venous thromboembolism (VTE) prevention in patients at increased risk, such as surgical and cancer patients.
OBJECTIVES: Three Phase III studies compared semuloparin and enoxaparin after major orthopedic surgery: elective knee replacement (SAVE-KNEE), elective hip replacement (SAVE-HIP1) and hip fracture surgery (SAVE-HIP2).
PATIENTS/METHODS: All studies were multinational, randomized and double-blind. Semuloparin and enoxaparin were administered for 7-10 days after surgery. Mandatory bilateral venography was to be performed between days 7 and 11. The primary efficacy endpoint was a composite of any deep vein thrombosis, non-fatal pulmonary embolism or all-cause death. Safety outcomes included major bleeding, clinically relevant non-major (CRNM) bleeding, and any clinically relevant bleeding (major bleeding plus CRNM).
RESULTS: In total, 1150, 2326 and 1003 patients were randomized in SAVE-KNEE, SAVE-HIP1 and SAVE-HIP2, respectively. In all studies, the incidences of the primary efficacy endpoint were numerically lower in the semuloparin group vs. the enoxaparin group, but the difference was statistically significant only in SAVE-HIP1. In SAVE-HIP1, clinically relevant bleeding and major bleeding were significantly lower in the semuloparin vs. the enoxaparin group. In SAVE-KNEE and SAVE-HIP2, clinically relevant bleeding tended to be higher in the semuloparin group, but rates of major bleeding were similar in the two groups. Other safety parameters were generally similar between treatment groups.
CONCLUSIONS: Semuloparin was superior to enoxaparin for VTE prevention after hip replacement surgery, but failed to demonstrate superiority after knee replacement surgery and hip fracture surgery. Semuloparin and enoxaparin exhibited generally similar safety profiles.
Publication Thread
ADVANCE(Apixaban for the Prevention of Thrombosis-related Events)
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Publication Thread
RECORD 4(Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 4)
To compare the efficacy and safety of aspirin and rivaroxaban in preventing venous thromboembolism (VTE) after total knee arthroplasty (TKA).
METHODS:
Thirty-two patients with osteoarthritis of the knee and knee arthroplasty indication were selected. The operated patients were randomized into two groups (A and B). Group A received 300 mg of acetylsalicylic acid (aspirin) and Group B received 10 mg of rivaroxaban daily for 14 days. Follow-up was performed weekly for four weeks and evaluated the presence of signs and symptoms of DVT, the healing of the surgical wound, and possible local complications such as hematoma, and superficial or deep infection that required surgical approach.
RESULTS:
It was verified that there were no differences between groups (rivaroxaban and aspirin) regarding gender, age, and (p > 0.05). After using the general linear model (GLM) test, it was found that there was a decrease in Hb and Ht levels, preoperatively and at one, three, seven, and 14 days (Hb: p = 1.334 × 10-30; Ht: p = 1.362 × 10-28). However, they did not differ as to the type of medication (Hb: p = 0.152; Ht: p = 0.661). There were no identifiable differences in local complications, systemic complications, deep vein thrombosis (DVT), readmission to hospital, reoperation, or death (p > 0.05) between groups (rivaroxaban and aspirin).
CONCLUSIONS:
Both aspirin and rivaroxaban can be considered useful among drugs available VTE the prevention after TKA.
