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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 564 - 564
1 Sep 2012
Kassianos A Jeavons L Kincaid R
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Rivaroxaban, an oral direct factor Xa inhibitor was introduced for thromboprophylaxis at the Royal Cornwall Hospital for hip and knee arthroplasty surgery in October 2009. Our aim was to investigate how safely Rivaroxaban could be implemented and how quickly its regular use was established. We identified 140 patients from theatre logbooks who underwent elective total hip and knee joint replacements between October 2009 and March 2010. Patient notes, computer and DVT clinic records data were collected to determine the uptake of the new drug and the incidence of post-operative complications. We compared our chemical thromboprophylactic rates to those recorded at discharge in a 4-month period prior to our study in 2009. In addition we quantified the time needed before a newly introduced drug becomes established in clinical practice. Patients were divided into two groups. Those who received Rivaroxaban were in group A (n=78, 55.7%) and those who received alternative or no chemical thromboprophylaxis constituted group B (n=62, 44.3%). All patients were prescribed TEDs stockings. 10.3% [8/78] of patients in group A suffered wound complications compared with 6.6% [4/62] of group B patients. Within group A we found that 41.1% (n=7) of the documented wound complications were wound ooze. DVTs occurred in both groups, 1 in group A and 2 in group B. 4 patients had postoperative haematemesis, 2 in each group. Group A had 17 (22%) documented complications. A similar number (n=15, 24%) of patients in group B had recorded complications. Our complication rates compared favourably to the RECORD 1–3 pooled study. From January to April 2009, prior to introduction of Rivaroxaban, 51% of all elective hip and knee replacement surgery patients were receiving any chemical thromboprophylaxis on discharge. This increased to 83% following introduction of Rivaroxaban. During the first month of introduction of Rivaroxaban at our hospital, following NICE guideline, 28% of patients who qualified to receive the drug did. This improved to 95% by the time it had been in use by 3 months. The data shows that there is no statistical significance in complications in thromboprophylaxis in elective total hip and knee replacement surgery between Group A and Group B (P-value 0.8941). This shows similar complication rates to the RECORD clinical study and concludes a safe introduction of the drug to our District General Hospital. Patients in Group A had a reduced occurrence of thrombotic events, but an increase in cases of wound ooze when compared to group B. Following the introduction of Rivaroxaban, it took 3 months for 95% of eligible patients for the drug to be NICE compliant. This demonstrated a 3 month run in time for the implementation of this new treatment regime in our hospital


Background. Thromboembolic disease is a common complication of total hip replacement (THR). The administration of postoperative anticoagulants is therefore highly recommended. The purpose of this study was to compare rivaroxaban with fondaparinux with regards to their safety and effectiveness for the prevention of venous thromboembolic events (VTE) after THR. Methods. We conducted an independent prospective study comparing VTE prevention strategies in two successive series of patients (Groups A and B) undergoing elective unilateral THR. Group A (n=253) received fondaparinux daily 2.5 mg for 10 days, followed by tinzaparin 4500 IU daily for one month. Group B (n=229) received 10 mg rivaroxaban daily for 40 days without platelet monitoring. All surgeries were performed by a single surgeon under general anesthesia using an active blood transfusion-sparing plan. In the absence of contraindications, patients received intra-operative administration of tranexamic acid to reduce postoperative bleeding. Preoperative and postoperative hemoglobin levels were recorded at regular intervals. Bleeding events were documented. The bleeding index was calculated by adding the number of red blood cell units and the difference in the hemoglobin level (in g/dL) between the first morning after the day of surgery and the seventh postoperative day (POD 7). After 5 to 10 days, all patients underwent bilateral lower-extremity duplex ultrasonography to screen for deep venous thrombi. Any clinical symptoms of pulmonary embolism were evaluated with spiral computed tomography lung scans. Clinical evaluation to look for evidence of deep venous thrombi and pulmonary emboli was performed at eight weeks postoperatively. Results. Baseline characteristics between the two groups were comparable. The rate of major bleeding events, proximal deep venous thrombi, and pulmonary emboli was nil in each group. The incidence of blood transfusion was 0.8% in Group A (2 of 253 hips) and 0.4% (1 of 229 hips) in Group B (p=1.0). The bleeding index analysis excluded 8 hips for which the hemoglobin value at POD 7 was not measured. The bleeding index was 1.03 (standard deviation, 0.88) in Group A and 0.8 (standard deviation, 0.80) in Group B (p<0.001). The incidence of bleeding index >2 was 10.5% (27 of 247 hips) in Group A and 3% (7 of 227 hips) in Group B (p<0.001). Discussion. We compared two series of patients treated with THR undertaken with postoperative anticoagulation to prevent VTE. The high level of success these anticoagulant treatments had at preventing VTE in our series could be attributed at least partially to the combination of an active blood-sparing transfusion plan with the use of anticoagulant molecules reported in the literature to be quite potent. Conclusions. This prospective study comparing two anticoagulant regimens in patients treated with THR did not detect any difference with regards to the efficacy of the treatments, although there was significantly less bleeding index in patients who received rivaroxaban


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_12 | Pages 5 - 5
1 Jun 2016
Nicoll K Downie S Hilley A Breusch S Clift B
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British national guidelines recommend agents which antagonise factor Xa or warfarin as prophylaxis of venous thromboembolism (VTE) in lower limb arthroplasty. However, they discourage the use of aspirin prophylaxis. We conducted a prospective, multi-centre audit between two national centres, Ninewells Hospital in Dundee and the Royal Infirmary in Edinburgh to compare bleeding and VTE risk. Only Edinburgh routinely uses aspirin as VTE prophylaxis. The study comprises a number of cycles from 2013 to 2015. Consecutive groups of patients were identified prospectively using elective theatre data and information extracted from their case-notes on type of VTE prophylaxis, VTE occurrence, wound complications and length of hospital stay for a period of nine weeks post-operatively. 262 Edinburgh patients and 92 Dundee patients were included. Most Edinburgh patients were prescribed aspirin in hospital and on discharge (188/262, 71.8%), in line with local protocol. In Dundee, dalteparin was most commonly prescribed in hospital (68/92, 73.9%) and rivaroxaban on discharge (57/92, 62.0%). The Edinburgh group had a 1.5% incidence of pulmonary embolus (PE) and a 1% rate of deep venous thrombosis (DVT), 2% had problems with wound haematoma and one patient (0.4%) required a transfusion; no wound washouts were required. In Dundee there was 0% PE, 2% DVT, 5% had problems with haematoma, 3% required transfusion and 2% required washout. There was no difference in length of hospital stay, with a mode of 4 days for both centres. Non-fatal PE was prevented in Dundee patients but possibly at the cost of greater incidence of wound complications