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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 84 - 84
1 Jan 2016
Tanavalee A Ngarmukos S Tanasubsinn N Boonyanuwat W Wangroongsub Y
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Introduction. Rivaroxaban, an oral factor Xa inhibitor, has been approved by USFDA for prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in hip and knee arthroplasties. Its indication in hip fracture surgery has been recently recommended in Asian venous thromboembolism (VTE) guidelines. Phase II dose-ranging study demonstrated that 5 mg rivaroxaban is as effective as enoxaparin for VTE prophylaxis with lower incidence of bleeding complication than the recommended 10 mg dose. Rivaroxaban is recommended to be given 6–8 hours after operation. However, many surgeons are hesitated to follow this guideline since it might increase post-operative blood loss and wound complication. Elderly patients, such as hip fracture patients, are generally at more risk of bleeding and wound complications. These patients may benefit from using the delayed and reduced-dose regimen. Methods. Since July 2011, all eligible hip fracture patients treated by single group of surgeons were given 5mg daily dose of rivaroxaban for VTE prophylaxis. Initial dose of rivaroxaban was given after drain had been removed (24–36 hours post-operatively) and continued for 14 days. Inclusion criteria are femoral neck fracture or intertrochanteric fracture in patients age 60 and over. Exclusion criteria are pathologic fracture, reoperation for failed fixation, chronic anticoagulant therapy, and allergy to rivaroxaban. Criteria by Aniwan and Rojnackarin were used for clinical diagnosis of DVT and PE. Suspected case of DVT and PE were sent for confirmation with Doppler U/S and Pulmonary Artery CT scan, respectively. All bleeding and wound complications were recorded. Numbers of blood transfusion were also recorded. Patients were followed for at least 6 weeks, all complications were recorded. Results. There were 79 hip fracture patients matching our criteria. They were composed of 54 femoral neck fractures and 25 intertrochanteric fractures. Mean age of patients was 76.3 years. All femoral neck fractures were treated with bipolar hemiarthroplasty and intertrochanteric fractures were treated with short cephalomedullary nail. Two patients (2.6%) were compatible with clinical criteria of DVT. However, Doppler ultrasound examinations do not demonstrate thrombus or intraluminal filling defect. There was no suspected case of PE. There was no major hemorrhagic wound complication requiring reoperation. Minor wound complications include 7 (8.9%) cases of prolong serous oozing and 1 (1.3%) superficial wound infection. Extrasurgical site bleeding includes 1 (1.3%) upper GI bleeding and 2 (2.5%) hematuria. None of the patients received more than 2 units of blood transfusion. Discussion and Conclusion. Delayed and reduced-dose regimen of rivaroxaban is effective for VTE prophylaxis in hip fracture patients. There is no major hemorrhagic wound complication. Nonetheless, extrasurgical site bleeding is frequent. Further randomized comparative study with larger number of patients should be performed to demonstrate whether the benefits of the modified regimen existed or not


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 31 - 31
1 Jan 2016
Mazza E Calori G Colombo M Malagoli E Mazzola S
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Introduction. Our department is responsible specifically for complex cases resulting from trauma. Our experience does not want to add what has been clearly demonstrated by multicenter studies on the efficacy of rivaroxaban but aims to demonstrate how the use of this molecule was effective also in mega-prosthesis and how it has proven to be flexible and safe in dealing with difficulties and surgical complications more common in such difficult cases. Materials and Methods. From January 2010 to date DVT prophylaxis in THR / TKR and revision was routinely performed with rivaroxaban. To date, in addition to first implant/revision in THR/TKR we treated over 30 cases of large segments replacements (large segments+mega-prosthesis) and we have not highlighted complications attributable to rivaroxaban. Discussion. We present in particular the medical and surgical management of three cases with a high risk of bleeding: a case of revision of total femur due to recurrent dislocation, one case of revision for early infection of a TKR and a case of traumatic acetabular revision for pelvicbreakthrough during rehabilitation. Conclusion. The major practical advantages found are: 1) the ability to choose when to start prophylaxis in relation to intraoperative bleeding Vs therapy that begins the previous day, 2) seeking the best prophylaxis for primary prosthetic and complex cases, the single-dose and pharmaco-kinetics/dynamic of rivaroxaban guarantee to be able to easily switch to a traditional prophylaxis in case of a need for further surgey Vs multi-dose of other oral drugs


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 72 - 72
1 Mar 2017
Park S Kang H Yang T
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Introduction. Embolism in total arthroplasty or hip fractures, coagulation disorders, such as a variety of ways for the prevention of complications of anticoagulation therapy with medication is being done well. The purpose of this study, a representative of the anticoagulation therapy with enoxaparin and drug rivaroxaban of coagulation tests performed in patients between the two groups was to determine whether statistically significant differences. Methods. 47 patients who underwent arthroscopic surgery were randomly divided into two groups to rivaroxaban and enoxaparin group, and we performed coagulation tests before and 5 days after arthroscopic surgery to two drugs groups in order to investigate about the difference in clotting capacity. Results. Preoperative coagulation tests coagulation tests before the item was not significantly different between the two groups. (p=0.584) 5 days after surgery, the coagulation tests coagulation tests performed on all items, rivaroxaban showed an increase in the anticoagulation activity Between the two groups showed statistically significant difference (p=0.001),. Discussion and Conclusion. Our results indicate that orthopaedic surgery can induce a lot of bleeding will be careful for use of rivaroxaban. Rivaroxaban(Xarelto®) showed more bleeding tendency than Enoxaparin(Clexane®). So we should take more attentions in postoperative care after Total Joint Arthroplasty


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 89 - 89
1 Sep 2012
Marlow W Adam R Walker J Musthyala S
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Aims. This phase II safety study aimed to investigate the bleeding side effect profile in patients treated with Rivaroxaban as a new agent for venous thromboembolism (VTE) prophylaxis following hip or knee arthroplasty. Methods. A retrospective study of complications was conducted in 88 consecutive patients undergoing hip and knee arthroplasty at one centre. Patients received chemical and/or mechanical VTE prophylaxis according to local guidelines. Data was collected from notes and evaluated using Fisher's exact test and t-Test. Significance was determined if p< =0.05. The primary end-point was local wound site oozing or bleeding. Secondary end-points were drop in haemoglobin, drain output and infection. Results. 55 patients were treated with Rivaroxaban, 18 with mechanical prophylaxis only, 10 with Enoxaparin and 5 with aspirin, clopidogrel or warfarin. The Rivaroxaban cohort demonstrated a statistically significant amount of increased major bleeding (24% vs. 0% p=0.03) and wound oozing (27% vs. 0% p=0.02) when compared to patients treated with Enoxaparin. Compared to those treated with other methods of VTE prophylaxis, Rivaroxaban also significantly increased major bleeding (24% vs. 6% p=0.01) and wound oozing (27% vs. 12% p=0.03). The Rivaroxaban cohort demonstrated a significantly larger drop in haemoglobin compared to the combined non-Rivaroxaban group (3.0 vs. 2.4 g/dL p=0.04). There was no significant difference in drain volume or rate of infection between groups. Conclusions. Rivaroxaban appears to cause increased wound site bleeding in comparison to Enoxaparin and other methods of thromboembolism prophylaxis. Further use of Rivaroxaban at this centre was therefore discontinued; however, the small group sizes and retrospective non-randomised design of this study introduce bias and limit the reliability of its findings. Prospective randomised controlled trial focused on wound complications is required to eliminate selection and reporter biases


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 184 - 184
1 May 2012
G. NS P. W D. M K. JM
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Background. Current treatments for the prevention of thromboembolism include heparin and low-molecular weight heparins (LMWHs). A number of studies have suggested that long term administration of these drugs may adversely affect osteoblasts and therefore, bone metabolism. Xarelto(tm) (Rivaroxaban) is a new anti-thrombotic drug for the prevention of venous thromboembolism in adult patients undergoing elective hip and knee replacement surgery. The aim of this in vitro study was to investigate the possible effects of rivaroxaban on osteoblast proliferation, function, matrix mineralisation and gene expression compared to enoxaparin, a commonly used LMWH. Methods. Primary human osteoblast cultures were treated with varying concentrations of rivaroxaban (0.013, 0.13, 1.3 and 13 μg/ml) or enoxaparin (0.1, 1.0 and 10 international units/ml). The effect of each drug on osteoblast function and matrix mineralisation was evaluated by measuring alkaline phosphatase activity and calcium deposition, respectively. The MTS assay was used to assess the effect of drug treatments on cell proliferation. Changes in osteocalcin, Runx2 and BMP-2 messenger RNA (mRNA) expression following drug treatments were measured by real-time polymerase chain reaction (PCR). Results. Rivaroxaban and enoxaparin treatment did not adversely affect osteoblast proliferation. However, both drugs caused a significant reduction in osteoblast function, as measured by alkaline phosphatase activity, with a moderate reduction in calcium deposition also observed. This reduction in osteoblast function was associated with a reduction in the mRNA expression of the bone marker, osteocalcin, the transcription factor, Runx2, and the osteogenic factor, BMP-2. Conclusion. These data show that rivaroxaban treatment may negatively affect bone through a reduction in osteoblast function. The increased duration of recommended Rivaroxaban therapy (2 and 5 weeks) post-arthroplasty compared to Enoxaparin therapy (average one week) may have a more pronounced effect on bone homeostasis


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 185 - 185
1 May 2012
W. DF M. RL B. IE S. DB F. M T. JB M. H T. W A. KK A. GGT
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Hypothesis. Pre-specified pooling of data from the four phase III RECORD studies was conducted to determine whether rivaroxaban significantly reduced the less-frequent clinical endpoint of symptomatic venous thromboembolism (VTE) and all-cause mortality after total hip or knee arthroplasty (THA or TKA, respectively), compared with standard North American and European enoxaparin regimens. Methods and analysis. Patients (n=12,729) received rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily (RECORD1-3) or 30 mg 12-hourly (RECORD4). Thromboprophylaxis was administered for 31-39 days (RECORD1; THA) or 10-14 days (RECORD3 and 4; TKA). RECORD2 (THA) compared 31-39 days' rivaroxaban with 10-14 days' enoxaparin followed by placebo. The pre-specified primary efficacy endpoint in the pooled analysis (composite of symptomatic VTE and all-cause mortality) and adjudicated bleeding events were analysed in the day 12±2 active treatment pool, when all patients had received active drug, and total treatment duration pool, where subgroup analyses were performed. Results. In the day 12±2 active treatment pool, the primary efficacy endpoint occurred in 0.5% of patients receiving rivaroxaban versus 1.0% of patients receiving enoxaparin (p=0.001). Major bleeding occurred in 0.3% versus 0.2% patients respectively (p=0.18) and major plus clinically relevant non-major bleeding occurred in 2.9% versus 2.5% patients respectively (p=0.19). In the total treatment duration pool, rivaroxaban significantly reduced the primary efficacy endpoint compared with enoxaparin regimens 0.6% versus 1.3% patients (p< 0.001) with similar rates of major bleeding. Over the total treatment period, rivaroxaban consistently reduced the primary efficacy endpoint across the pre-specified subgroups (age, gender, body weight, creatinine clearance). Conclusion. Rivaroxaban significantly reduced the composite of clinically important symptomatic VTE and all-cause mortality after THA or TKA compared with subcutaneous enoxaparin regimens in the direct comparison day 12±2 active treatment pool, with no significant differences in bleeding events. These results suggest a positive benefit-risk profile for oral, once-daily rivaroxaban


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 197 - 197
1 Sep 2012
Jensen C Morrell R Steval A Partington P Reed M Muller S
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Introduction. Rivaroxaban has been recommended for routine use as a thromboprophylactic agent in patients undergoing lower limb arthroplasty. Trials supporting its use have not fully evaluated the risks of wound complications related to rivaroxaban. Method. A retrospective cohort analysis of 1558 consecutive patients who underwent total hip or knee replacements within the same hospital during a 19 month period (2009–2010) was performed. The first 489 patients (Group 1) were given tinzaparin postoperatively as per NICE guidance. The following 559 patients (Group 2) were given rivaroxaban. Concerns regarding wound complications prompted a change back to tinzaparin for the next 510 patients (Group 3.) Other than the thromboprophylactic agent used there were no other differences in the pre and postoperative treatments of all these patients. Results. Nine of the 489 patients in Group 1 (tinzaparin) (1.8%, 95% CI 0.9–3.5%) returned to theatre with wound complications within 30 days compared with 22 out of 559 patients in Group 2 (rivaroxaban) (3.94%, 95% CI 2.6–5.9%.) This increase in RTT rate was statistically significant (p=0.046.) After reverting back to tinzaparin 8 out of 510 patients in Group 3 (tinzaparin) (1.6% 95% CI 0.74–3.1%) returned to theatre. This reduction in RTT rate was statistically significant (p=0.02.) Combining the tinzaparin groups (1 and 3) and comparing with the rivaroxaban group (2) further increases the significance of our observations. Tinzaparin RTT was 1.7% (95% CI 1.0–2.7%) compared with rivaroxaban RTT of 3.94% (95% CI 2.6–5.9%) (p=0.01.). Discussion. We observed a significant rise in wound complication necessitating further surgery after a change in thromboprophylactic agent from tinzaparin to rivaroxaban, followed by a significant reduction after reverting back to tinzaparin. We call for further independent randomised controlled clinical trials examining wound related complications with respect to new pharmacological treatments


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XIX | Pages 1 - 1
1 May 2012
Kassianos A Jeavons L L Kincaid R
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Rivaroxaban was introduced for thromboprophylaxis at the Royal Cornwall Hospital for hip and knee arthroplasty surgery in October 2009. We identified 140 patients from theatre logbooks who underwent elective joint replacement between October 2009 and March 2010. Patient notes, computer and DVT clinic records and WebPacs data were collected to determine the uptake of the new drug and the incidence of wound problems, DVTs and any other post-operative complications. In our sample 55.7% [78/140] patients received rivaroxaban. 10.3% [8/78] of patients on rivaroxaban suffered wound complications compared with 6.6% [4/62] of patients on alternative anticoagulation. Three patients suffered DVT's, 1 of whom was taking rivaroxaban. There were a further 6 patients, 4 on rivaroxaban, with leg swelling severe enough to merit investigation, all of whom had negative doppler scans. Bleeding events included 4 patients with postoperative haematemesis of which 2 were taking rivaroxaban. Five patients, all under different surgical operators of which 3 had taken rivaroxaban, developed stiff total knee replacements and were offered MUA or physiotherapy


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 15 - 15
1 Sep 2012
Hoffman R Naylor J Adie S Dave J
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Rivaroxaban is an oral anticoagulant which has the potential to replace subcutaneous Clexane in post operative prophylaxis of venous thromboembolism following knee replacement. Rivaroxaban has been shown to be at least equivalent to Enoxaparin in the prevention of deep venous thrombosis and pulmonary embolism with a similar rate of major bleeding. However, the morbidity associated with the new product has yet to be fully examined. Our own anecdotal evidence suggests that Rivaroxaban may be associated with poorer knee range of motion, and greater bruising and haemarthrosis. This pilot study aimed to compare these outcomes as well as knee pain and length of hospital stay in patients receiving Rivaroxaban and Enoxaparin following total knee replacement. A controlled before and after study with single blinding was performed. Patients in the ‘Before’ group were given Rivaroxaban (our current protocol). Patients treated in the “After’ group were subjected to our previous protocol (Enoxaparin). Patients were followed up to 6-weeks post surgery. Blinded assessors reviewed range of motion and wound outcomes using a photographic method. Swelling was measured using a standardized technique. Bleeding, pain and length of stay were prospectively recorded. Data analysis is due to be completed in April 2011. Complete results will be available after this time. Discussion: Rivaroxaban was introduced to lessen patient burden as oral administration is presumed to be more acceptable than self-injection of Enoxaparin. It is yet to be determined comprehensively whether the benefits of oral administration outweigh any associated risks. Surgeons must carefully consider the risks and benefits of their choice of venous thrombosis prophylaxis following total knee replacement


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 198 - 198
1 Sep 2012
Rymaszewska M Jameson S James P Serrano-Pedraza I Muller S Hui A Reed M
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Background. The National Institute for Health and Clinical Effectiveness recommends both low molecular weight heparin (LMWH) and Rivaroxaban for venous thromboembolic (VTE) prophylaxis following lower limb arthroplasty. Despite evidence in the literature that suggests Rivaroxaban reduces VTE events, there are emerging concerns from the orthopaedic community regarding an increase in wound complications following its use. Methods. Through the orthopaedic clinical directors forum, Trusts replacing LMWH with Rivaroxaban for lower limb arthroplasty thromboprophylaxis during 2009 were identified. Prospectively collected Hospital episode statistics (HES) data was then analysed for these units so as to determine rates of 90-day symptomatic deep venous thrombosis (DVT), pulmonary embolism (PE), major bleed (cerebrovascular accident or gastrointestinal haemorrhage), all-cause mortality, and 30-day wound infection and readmission rates before and after the change to Rivaroxaban. 2752 patients prescribed Rivaroxaban following TKR or THR were compared to 10358 patients prescribed LMWH. Data was analysed using odds ratios (OR). Results. There were significantly more wound infections in the Rivaroxaban group (3.85% vs. 2.81%, OR=0.72; 95% CI 0.58–0.90). There were no significant differences between the two groups for PE (OR=1.52; 0.77–2.97), major bleed (OR=0.73; 0.48–1.12), all-cause mortality (OR=0.93; 0.46–1.87) and re-admission rate (OR=1.21; 0.88–1.67). There were significantly fewer symptomatic DVTs in the Rivaroxaban group (0.91% vs. 0.36%, OR=2.51; 1.30–4.82). Discussion. This study is the first to describe the real impact of the use of Rivaroxaban in the NHS. When compared with LMWH in lower limb arthroplasty patients, there were fewer DVTs in the Rivaroxaban group. However, wound infection rates were significantly higher following Rivaroxaban use whilst providing no reduction in symptomatic PE or all-cause mortality


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 221 - 221
1 Jun 2012
Rose B Sindali K Soueid H Jeer C Saran D
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Introduction. Rivaroxaban is the first licensed oral direct inhibitor of factor Xa. Recent studies from the RECORD trials suggest rivaroxaban has superior efficacy compared to enoxaparin in preventing venous thromboembolism (VTE) with no significant increase in the major bleeding risk. Concerns remain regarding the incidence of minor bleeding, consequent delayed wound healing and subsequent risk of infection. The aim of this observational study was to assess the incidence of post-operative complications in patients receiving either rivaroxaban or enoxaparin thromboprophylaxis following elective hip and knee arthroplasty. Methods. 258 patients undergoing elective total hip or knee arthroplasty within one NHS Trust were included. 202 subjects (mean age 70.7 years ± 10.0, 43% male) received a daily dose of 10mg of oral rivaroxaban and 56 (mean age 70.9 years ± 9.8, 39% male) had a daily subcutaneous injection of 40 mg of enoxaparin as thromboprophylaxis. Endpoints included VTE (deep vein thrombosis and pulmonary embolism), haemorrhagic wound complications, hospital re-admission, requirement for blood transfusion, minor and major bleeding and death. Results. There were no significant differences in the incidence of deep vein thrombosis, requirement for blood transfusion and readmission rate between rivaroxaban and enoxaparin-treated patients. However, the incidence of minor bleeding (2.0% versus 0%) and haemorrhagic wound complications (4.9% versus 1.8%) were non-significantly higher in the rivaroxaban-treated group. There were no cases of pulmonary embolism, major bleeding or death in either group. Conclusion. Our experience with rivaroxaban in elective hip and knee arthroplasty showed no significant difference in the incidence of VTE or major bleeding. There was, however, a tendency to greater risk of minor bleeding and consequent delayed wound healing affecting both morbidity and delaying discharge. These may predispose patients to a higher risk of wound infection, and thus these issues require further large scale evaluation


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 60 - 60
1 Dec 2013
Frisch N Charters M Wessell N Sikora-Klak J Dobson C Yu S Silverton C Laker M Les C
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Purpose:. Starting February 2012, our institution changed from enoxaparin (Lovenox) to the Factor Xa inhibitor, rivaroxaban (Xarelto) for venous thromboembolism prophylaxis after primary total hip (THA) and total knee arthroplasty (TKA). The purpose of our study was to compare rates of venous thromboembolism and rates of major bleeding between these two medications when used for venous thromboembolism prophylaxis after primary THA and TKA. Methods:. A retrospective review was performed on 1795 patients who underwent THA or TKA at our institution between January 1, 2011 and December 31, 2012. Patients were excluded if they had a bilateral procedure, partial arthroplasty (hip hemiarthroplasty, unicompartmental knee arthroplasty), revision surgery, and cases designated as complex. Patients were excluded if they were on other anticoagulants (dabigatran, aspirin, clopidogrel, warfarin, heparin, fondaparinux), or if pre-operative creatinine was 1.2 or greater. After excluding these patients, there were 1089 patients included in the study. Chart review recorded demographics (age, gender), comorbidities (BMI, ASA, creatinine), surgery performed (primary THA or TKA), length of stay (LOS), venous thromboembolic events (deep venous thrombosis [DVT], pulmonary embolus [PE]), post-operative infections, and major bleeding events (stroke, post-operative bleeding requiring transfusion). Periprosthetic infection rates are also currently being reviewed. T-tests were used to compare continuous variables between treatment groups, and Chi-square tests were used to compare categorical variables between treatment groups (α = 0.05). Results:. There were 779 patients (71.5%) who received enoxaparin and 310 patients (28.5%) who received rivaroxaban during the study period. Demographics of the patients are presented in Table 1. A comparison of venous thromboembolism rates. Pre-operative creatinine was higher in the enoxaparin group (0.81 ± 0.19 vs. 0.72 ± 0.18, p < 0.001). With the numbers available for study, there were no demonstrable differences in DVT (p = 0.400, power = 0.125), PE (p = 0.679, power = 0.066), cerebrovascular events (p = 0.913, power = 0.049), or transfusion rates (p = 0.412, power = 0.121). Conclusion:. To our knowledge this is one of, if not the largest non-industry funded studies comparing these two medications. There were no statistically demonstrable differences between the enoxaparin and rivaroxaban groups in terms of venous thromboembolism or major bleeding complications


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_18 | Pages 1 - 1
1 Dec 2014
Luke C Kamalanathan S Doorgakant A Sanger R
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In recent years, many changes have taken place regarding agents used for chemical thromboprophylaxis in elective joint replacement. Enoxaparin, Rivaroxaban, Dabigatran and Apixaban are all now recommended in NICE CG92 and their use varies nationally. Whilst data exists comparing oral anticoagulants to Enoxaparin, there is little data on the comparative efficacy of the individual oral anticoagulants. This study analyses data from Warrington Hospital, where each of the above oral anticoagulants was used trustwide in 3 successive years following hip and knee arthroplasty. We analysed similar 4–5 month periods in 2010(Rivaroxiban), 2011(Dabigatran) and 2012(Apixaban). The study was done prospectively and data was collected contemporaneously. The total sample size was 475 patients. Data was collected through electronic hospital patient records. Patients were excluded if data was incomplete. We defined our primary outcome as any complication requiring the drug to be omitted or stopped. We found that for Rivaroxaban, 7 of 129 patients had the drug omitted or stopped (5.4%, 95% confidence interval 1.0–9.8), for Dabigatran 19 of 150 patients, (12.7%, 95% confidence interval 6.4–19.0) and for Apixaban 10 of 196 patients (5.1%, 95% confidence interval 0.9–9.3). For Rivaroxaban and Apixaban, there were no confirmed thromboembolic events; however, for Dabigatran, there were six VTEs. All three had bleeding complications, which were well below the figures published for Enoxaparin. Apixaban registered the lowest rate in our study (5.1%). This data suggests that Apixaban is a safe oral anticoagulant in elective total knee and hip replacement


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 196 - 196
1 Sep 2012
Akram T Templeton-Ward O Yousaf S Hargrove R
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Following the outcomes of the RECORD trials the protocol of extended thromboprophylaxis in patients undergoing elective primary total hip or knee arthroplasty has been changed in our institution. Between June 2008 and May 2009 patients were offered extended thromboprophylaxis with 150mg of aspirin daily, commencing preoperatively on admission and continuing for a total of six weeks. From June 2009 onwards patients were treated with 10mg of rivaroxaban once daily for two weeks following total knee and five weeks following total hip arthroplasty commencing 4 to 6 hours postoperatively. Our cohorts were 700 patients before and after the introduction of the new regimen. The two groups were matched for age, sex and type of operation. All patients with no contraindication to treatment with aspirin or rivaroxaban respectively undergoing elective primary total hip or knee arthroplasty were included in the study. Patients receiving warfarin on admission were treated with warfarin postoperatively and were excluded. We have compared the two treatment protocols in terms of safety and efficacy. Results focus on 4 safety outcome measures including mortality, haemorrhagic complications, transfusion requirements and infection rates and 2 efficacy outcome measures including thromboembolic complications and length of inpatient stay. Rates of DVT were equal in the two cohorts (P< 0.005) as were the mortality rates. Transfusion requirements post-operatively were not affected by the introduction of the new regimen however there was a significant increase in both return to theatre rates and prolonged wound ooze (P< 0.005). Infection rates were slightly higher in the cohort treated with rivaroxaban but this was not statistically significant. We conclude that further trials need to be done to confirm the suitability of routine use of rivaroxiban


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_27 | Pages 3 - 3
1 Jul 2013
Kamalanathan S Luke C Doorgakant A Sanger R
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In recent years, many changes have taken place regarding agents used for chemical thromboprophylaxis in elective joint replacement. Enoxaparin, Rivaroxaban, Dabigatran and Apixaban are all now recommended in NICE CG92 and their use varies nationally. While data exist comparing oral anticoagulants to Enoxaparin, there is little data on the comparative efficacy of the individual oral anticoagulants. This study analyses data from Warrington Hospital, where each of the above oral anticoagulants was used trustwide in 3 successive years following hip and knee arthroplasty. We analysed similar 4–5 month periods in 2010 (Rivaroxiban), 2011 (Dabigatran) and 2012 (Apixaban). The study was done prospectively and data was collected contemporaneously. The total sample size was 475 patients. Data was collected through electronic hospital patient records. Patients were excluded if data was incomplete. We defined our primary outcome as any complication requiring the drug to be omitted or stopped. We found that for Rivaroxaban, 7 of 129 patients had the drug omitted or stopped (5.4%, 95% confidence interval 1.0–9.8), for Dabigatran 19 of 150 patients, (12.7%, 95% confidence interval 6.4–19.0) and for Apixaban 10 of 196 patients (5.1%, 95% confidence interval 0.9–9.3). For Rivaroxaban and Apixaban, there were no confirmed thromboembolic events; however, for Dabigatran, there were six VTEs. All three had bleeding complications, which were well below the figures published for Enoxaparin. Apixaban registered the lowest rate in our study (5.1%). This data suggests that Apixaban is a safe oral anticoagulant in elective total knee and hip replacement


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_29 | Pages 64 - 64
1 Aug 2013
Sabnis B Maheshwari R Walmsley P Brenkel I
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Blood loss following total hip replacement is a major contributor to increase morbidity and length of stay. Various techniques have been described to reduce its occurrence. We now follow a set protocol, combining rivaroxaban for thrombo-prophylaxis and tranexamic acid to reduce immediate postoperative bleeding. Patients and methods:. Using data collected prospectively we looked at 2 groups of consecutive patients undergoing THR. The protocol was the only factor changed during the period studied. Initially we used subcutaneous dalteparin injections and continued use of aspirin in peri-operative period following total hip replacements (Group I–317 patients). A new protocol was introduced involving rivaroxaban for thrombo-prophylaxis with its first dose at least 8 hours from skin closure and stopping aspirin at least 7 days before operation. In addition tranexamic acid was given in a dose of 500 mg (or 1 gm in obese patients) intravenously just prior to incision (Group II–348 patients). We compared these two groups regards Hb drop at 24 hours and blood transfusion requirement. Results:. The average Hb drop at 24 hours postop in group I was 3.08 gm/dl compared to 2.31 in group II. (p<0.001). 62 (19.6%) patients in group I required blood transfusion compared to 11 (3.2%) in group II. (p = 0.001) Perioperative blood loss and length of stay reduction was also significantly different. There was no increase in number of DVT/PE, but the sample size was too small to assess this statistically. Conclusion:. This protocol drastically reduces requirement of postoperative blood transfusion requirement helping in reducing the length of stay following hip replacements


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 16 - 16
1 Sep 2012
Smith R Wood A Keenan A Sabnis B Walmsley P Brenkel I
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The risk of venous thrombo-embolism (VTE) is high in orthopedics. Oral direct factor Xa inhibitors have been introduced to help reduce the incidence of VTE. To reduce post-operative bleeding antifibrinolytics are used. We aimed to ascertain the effect of two drugs on post operative bleeding and transfusion requirements. We prospectively recorded patient demographics, operative details, complications, transfusion incidence and VTE incidence in TKR patients. We also sent out questionnaires to patients asking about wound bleeding and VTE. All patients were given 10mg Rivaroxaban 8 hours post operatively and then OD for 14 or 35 days. Patients given tranexamic acid were given 500mg IV, 5 minutes prior to wound closure at the discretion of the surgeon. VTE was Deep Vein Thrombus or Pulmonary Embolism confirmed by Doppler or CTPA. Minor bleed was categorized as dressing soakage or reported wound leakage, major bleed as hematoma requiring revision within 30 days. 509 patients underwent TKR: 200 (39%) received Rivaroxaban only (Group 1), 296 (58%) also received tranexamic acid (Group 2). 13 (3%) patients had no data available. Five patients had a VTE: 4 (2%) in Group 1, 1 (0.3%) in Group 2 [P<0.05]. 39 patients had a minor bleed: 17 (8.5%) in Group 1, 22 (7.4%) in Group 2 [P=0.5]. 2 patients had major bleeds: 1(0.5%) in Group 1 and 1(0.33%) in Group 2 [P=0.69]. There were 30 blood transfusions: 21 (10.5%) in Group 1, 9 (3%) in Group 2 [P<0.0001]. We have demonstrated a reduced requirement for blood transfusions in the tranexamic acid group. However our results, whilst they show a trend towards decreased minor and major bleeding rates, are not significant and require larger studies looking at wound bleeding and leakage


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXII | Pages 32 - 32
1 Jul 2012
Wood A Smith R Keenan A Sabnis B Walmsley P Brenkel I
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The risk of venous thrombo-embolism (VTE) is high in orthopaedics. Oral direct factor Xa inhibitors have been introduced to help reduce the incidence of VTE. To reduce post-operative bleeding antifibrinolytics are used. We aimed to ascertain the effect of two drugs on post-operative bleeding and transfusion requirements. We prospectively recorded patient demographics, operative details, complications, transfusion incidence and VTE incidence in TKR patients. We also sent out a questionnaire to patients asking about wound bleeding and VTE. All patients were given 10mg Rivaroxaban 8 hours post operatively and then once a day for 14 days. Patients given tranexamic acid were given 500mg IV, 5 minutes prior to wound closure at the discretion of the surgeon. VTE was confirmed by Doppler or CTPA as Deep Vein Thrombus or Pulmonary Embolism. Minor bleed was categorised as dressing soakage or reported wound leakage, major bleed as haematoma requiring revision within 30 days. 509 patients underwent TKR: 200(39%) only received Rivaroxaban (Group 1), 296(58%) also received tranexamic acid (Group 2). 13(3%) of patients had no data available. 5 patients had a VTE: 4 (2%) Group 1, 1 (0.3%) Group 2 (P<0.05). 39 patients had a minor bleed: 17 (8.5%) Group 1, 22 (7.4%) Group 2 (P=0.5). 2 patients had major bleeds: 1 (0.5%) Group 1, 1 (0.33%) Group 2 (P=0.69). Blood transfusions 21: (10.5%)Group 1, 9 (3%) Group 2 (P<0.0001). We have demonstrated a reduced requirement for blood transfusions in the tranexamic acid group. However our results whilst they show a trend towards decrease bleeding rates in both the minor and major bleeds are not significant, requiring larger studies looking at wound bleeding and leakage


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 166 - 166
1 Jan 2013
Buddhdev P Basu D Davies N Waters T
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Introduction

Rivaroxiban is a direct inhibitor of factor Xa, a licensed oral thromboprophylactic agent that is increasingly being adopted for lower limb arthroplasty. Rivaroxiban has been NICE-approved for use in primary hip and knee arthroplasty following the RECORD 4 trials; proving it more effective in preventing venous thrombo-embolic (VTE) events compared to enoxaparin. Enhanced Recovery Programmes (ERP) are designed to enable patients to recover quickly and return home safely within a few days.

Methods

We prospectively studied 1223 patients (age- and sex-matched) who underwent lower-limb arthroplasty enrolled in our ERP between March 2010 and December 2011; 454 patients (Group 1) received enoxaparin, 769 patients (Group 2) received rivaroxiban. Patients wore thrombo-embolic stockings for six weeks post surgery. Patients were monitored for thrombo-embolic events and wound-related complications for 42 days post-operatively.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_20 | Pages 24 - 24
1 Apr 2013
Haughton BA Kadakia A Watkins C Moran K Booty L Shetty A Lateef A
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Introduction. Recent UK national guidelines advocate using a combination of mechanical and pharmacological VTE prophylaxis in patients undergoing lower limb arthroplasty. We compared the results from our two series of patients: one treated with clexane and the other treated with rivaroxaban. Methods. Both groups received mechanical prophylaxis. In the first group 89 patients were given 40 mg subcutaneous clexane once daily from the day prior to surgery until they were independently mobile. The second group comprised 99 patients who were given 10 mg of oral rivaroxaban. Results. The mean length of stay was 5 days in the clexane group and 5.5 days in the rivaroxaban group. 24 patients stayed in hospital for 5 days or more because of wound leakage in the rivaroxaban group compared to 10 in the clexane group. 5 patients were readmitted in the clexane group: 3 for pulmonary embolism (PE), 1 for dislocation and 1 for periprosthetic fracture. 5 patients were also readmitted from the rivaroxaban group: 4 for infection and 1 for PE. No patients in the clexane group required re-operations. 2 patients in the rivaroxaban group went back to theatre: 1 for haematoma evacuation and 1 for haematoma evacuation and subsequent revision knee arthroplasty. Conclusion. This study raises concern regarding the rates of postoperative complications with rivaroxaban prophylaxis