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The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 65 - 70
1 Jan 2021
Nikolaus OB Rowe T Springer BD Fehring TK Martin JR

Aims. Recent improvements in surgical technique and perioperative blood management after total joint replacement (TJR) have decreased rates of transfusion. However, as many surgeons transition to outpatient TJR, obtaining routine postoperative blood tests becomes more challenging. Therefore, we sought to determine if a preoperative outpatient assessment tool that stratifies patients based on numerous medical comorbidities could predict who required postoperative haemoglobin (Hb) measurement. Methods. We performed a prospective study of consecutive unilateral primary total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) performed at a single institution. Prospectively collected data included preoperative and postoperative Hb levels, need for blood transfusion, length of hospital stay, and Outpatient Arthroplasty Risk Assessment (OARA) score. Results. A total of 504 patients met inclusion criteria. Mean age at time of arthroplasty was 65.3 years (SD 10.2). Of the patients, 216 (42.9%) were THAs and 288 (57.1%) were TKAs. Six patients required a blood transfusion postoperatively (1.19%). Transfusion after surgery was associated with lower postoperative day 1 Hb (median of 8.5 (interquartile range (IQR) 7.9 to 8.6) vs 11.3 (IQR 10.4 to 12.2); p < 0.001), longer length of stay (1 day (IQR 1 to 1) vs 2 days (IQR 2 to 3); p < 0.001), higher OARA score (median of 60.0 (IQR 40 to 75) vs 5.0 (IQR 0-35); p = 0.001), and total hip arthroplasty (p < 0.001). All patients who received a transfusion had an OARA score > 34; however, this did not reach statistical significance as a screening threshold. Conclusion. Risk of blood transfusion after primary TJR was uncommon in our series, with an incidence of 1.19%. Transfusion was associated with OARA scores > 60. The OARA score, not American Society of Anesthesiologists grade, reliably identified patients at risk for postoperative blood transfusion. Selective Hb monitoring may result in substantial cost savings in the era of cost containment. Cite this article: Bone Joint J 2021;103-B(1):65–70


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 2 | Pages 213 - 217
1 Feb 2005
Mundy GM Birtwistle SJ Power RA

We randomised 120 patients who were undergoing either primary total hip or knee arthroplasty to receive either ferrous sulphate or a placebo for three weeks after surgery. The level of haemoglobin and absolute reticulocyte count were measured at one and five days, and three and six weeks after operation. Ninety-nine patients (ferrous sulphate 50, placebo 49) completed the study. The two groups differed only in the treatment administered. Recovery of level of haemoglobin was similar at five days and three weeks and returned to 85% of the pre-operative level, irrespective of the treatment group. A small, albeit greater recovery in the level of haemoglobin was identified at six weeks in the ferrous sulphate group in both men (ferrous sulphate 5%, placebo 1.5%) and women (ferrous sulphate 6%, placebo 3%). The clinical significance of this is questionable and may be outweighed by the high incidence of reported side effects of oral iron and the cost of the medication. Administration of iron supplements after elective total hip or total knee arthroplasty does not appear to be worthwhile


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 935 - 941
1 Sep 2024
Ailaney N Guirguis PG Ginnetti JG Balkissoon R Myers TG Ramirez G Thirukumaran CP Ricciardi BF

Aims. The purpose of this study was to determine the association between prior sleeve gastrectomy in patients undergoing primary total hip and knee arthroplasty, and 90-day complications, incidence of revision arthroplasty, and patient-reported outcome scores at final follow-up. Methods. This is a retrospective, single-centre analysis. Patients undergoing primary hip or knee arthroplasty with a prior sleeve gastrectomy were eligible for inclusion (n = 80 patients). A morbidly obese control group was established from the same institutional registry using a 1:2 match, for cases:controls with arthroplasty based on propensity score using age, sex, pre-sleeve gastrectomy BMI, Current Procedural Terminology code to identify anatomical location, and presurgical haemoglobin A1C. Outcomes included 90-day complications, incidence of revision arthroplasty, and patient-reported outcome scores at final follow-up. Multivariable logistic regressions evaluated associations of underlying preoperative demographic and treatment characteristics with outcomes. Results. Complications within 90 days of surgery were increased in the sleeve gastrectomy group relative to the obese control group after controlling for underlying preoperative demographic characteristics (odds ratio (OR) 4.00 (95% CI 1.14 to 13.9); p = 0.030). Postoperative revisions were similar in the sleeve gastrectomy group relative to the obese control group after controlling for underlying preoperative demographic characteristics (OR 17.8 (95% CI 0.64 to 494.3); p = 0.090). Patient-Reported Outcomes Measurement Information System (PROMIS) depression decreased by a greater amount from pre- to postoperative in the obese controls relative to the sleeve gastrectomy group (OR 4.04 (95% CI 0.06 to 8.02); p = 0.047). PROMIS pain interference and physical function change from pre- to postoperative was not associated with sleeve gastrectomy status. Conclusion. We found a higher rate of complications at 90 days in patients who underwent sleeve gastrectomy prior to primary hip or knee arthroplasty relative to a matched, obese control population. Prosthetic revision rates were similar between the two groups, while improvements in PROMIS depression scores were larger in the obese cohort. This study suggests that sleeve gastrectomy to achieve preoperative weight loss prior to arthroplasty surgery may not mitigate early complication risks in obese patient populations. Cite this article: Bone Joint J 2024;106-B(9):935–941


The Bone & Joint Journal
Vol. 101-B, Issue 9 | Pages 1093 - 1099
1 Sep 2019
Bradley KE Ryan SP Penrose CT Grant SA Wellman SS Attarian DE Green CL Risoli T Bolognesi MP

Aims. Antifibrinolytic agents, including tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), have been shown to be safe and effective for decreasing perioperative blood loss and transfusion following total hip arthroplasty (THA) and total knee arthroplasty (TKA). However, there are few prospective studies that directly compare these agents. The purpose of this study was to compare the benefits of intraoperative intravenous TXA with EACA. Patients and Methods. A total of 235 patients (90 THA and 145 TKA) were enrolled in this prospective, randomized controlled trial at a single tertiary-care referral centre. In the THA cohort, 53.3% of the patients were female with a median age of 59.8 years (interquartile range (IQR) 53.3 to 68.1). In the TKA cohort, 63.4% of the patients were female with a median age of 65.1 years (IQR 59.4 to 69.5). Patients received either TXA (n = 119) or EACA (n = 116) in two doses intraoperatively. The primary outcome measures included change in haemoglobin level and blood volume, postoperative drainage, and rate of transfusion. Secondary outcome measures included postoperative complications, cost, and length of stay (LOS). Results. TKA patients who received EACA had greater drainage (median 320 ml (IQR 185 to 420) vs 158 ml (IQR 110 to 238); p < 0.001), increased loss of blood volume (891 ml (IQR 612 to 1203) vs 661 ml (IQR 514 to 980); p = 0.014), and increased haemoglobin change from the preoperative level (2.1 ml (IQR 1.7 to 2.8) vs 1.9 ml (IQR 1.2 to 2.4); p = 0.016) compared with patients who received TXA. For the THA cohort, no statistically significant differences were observed in any haematological outcome measure. One patient in the EACA group required transfusion. No patient in the TXA group required transfusion. There were no statistically significant differences in number or type of postoperative complications or LOS for either THA or TKA patients regardless of whether they received TXA or EACA. Conclusion. For hip and knee arthroplasty procedures, EACA is associated with increased perioperative blood loss compared with TXA. However, there is no significant difference in transfusion rate. While further prospective studies are needed to compare the efficacy of each agent, we currently recommend orthopaedic surgeons to select their antifibrinolytic based on cost and regional availability. Cite this article: Bone Joint J 2019;101-B:1093–1099


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 8 | Pages 1079 - 1083
1 Aug 2008
Moonen AFCM Thomassen BJW Knoors NT van Os JJ Verburg AD Pilot P

This prospective randomised clinical trial evaluated the effect of alternatives for allogeneic blood transfusions after total hip replacement and total knee replacement in patients with pre-operative haemoglobin levels between 10.0 g/dl and 13.0 g/dl. A total of 100 patients were randomly allocated to the Eprex (pre-operative injections of epoetin) or Bellovac groups (post-operative retransfusion of shed blood). Allogeneic blood transfusions were administered according to hospital policy. In the Eprex group, 4% of the patients (two patients) received at least one allogeneic blood transfusion. In the Bellovac group, where a mean 216 ml (0 to 700) shed blood was retransfused, 28% (14 patients) required the allogeneic transfusion (p = 0.002). When comparing Eprex with Bellovac in total hip replacement, the percentages were 7% (two of 30 patients) and 30% (nine of 30 patients) (p = 0.047) respectively, whereas in total knee replacement, the percentages were 0% (0 of 20 patients) and 25% (five of 20 patients) respectively (p = 0.042). Pre-operative epoetin injections are more effective but more costly in reducing the need for allogeneic blood transfusions in mildly anaemic patients than post-operative retransfusion of autologous blood


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 10 | Pages 1397 - 1401
1 Oct 2005
Walmsley PJ Kelly MB Hill RMF Brenkel I

The routine use of surgical drains in total hip arthroplasty remains controversial. They have not been shown to decrease the rate of wound infection significantly and can provide a retrograde route for it. Their use does not reduce the size or incidence of post-operative wound haematomas. This prospective, randomised study was designed to evaluate the role of drains in routine total hip arthroplasty. We investigated 552 patients (577 hips) undergoing unilateral or bilateral total hip arthroplasty who had been randomised to either having a drain for 24 hours or not having a drain. All patients followed standardised pre-, intra-, and post-operative regimes and were independently assessed using the Harris hip score before operation and at six, 18 and 36 months follow-up. The rate of superficial and deep infection was 2.9% and 0.4%, respectively, in the drained group and 4.8% and 0.7%, respectively in the undrained group. One patient in the undrained group had a haematoma which did not require drainage or transfusion. The rate of transfusion after operation in the drained group was significantly higher than for undrained procedures (p < 0.042). The use of a drain did not influence the post-operative levels of haemoglobin, the revision rates, Harris hip scores, the length of hospital stay or the incidence of thromboembolism. We conclude that drains provide no clear advantage at total hip arthroplasty, represent an additional cost, and expose patients to a higher risk of transfusion


The Bone & Joint Journal
Vol. 96-B, Issue 6 | Pages 765 - 771
1 Jun 2014
Thomassen BJW den Hollander PHC Kaptijn HH Nelissen RGHH Pilot P

We hypothesised there was no clinical value in using an autologous blood transfusion (ABT) drain in either primary total hip (THR) or total knee replacement (TKR) in terms of limiting allogeneic blood transfusions when a modern restrictive blood management regime was followed. A total of 575 patients (65.2% men), with a mean age of 68.9 years (36 to 94) were randomised in this three-arm study to no drainage (group A), or to wound drainage with an ABT drain for either six hours (group B) or 24 hours (group C). The primary outcome was the number of patients receiving allogeneic blood transfusion. Secondary outcomes were post-operative haemoglobin (Hb) levels, length of hospital stay and adverse events. This study identified only 41 transfused patients, with no significant difference in distribution between the three groups (p = 0.857). The mean pre-operative haemoglobin (Hb) value in the transfused group was 12.8 g/dL (9.8 to 15.5) versus 14.3 g/dL (10.6 to 18.0) in the non-transfused group (p < 0.001, 95% confidence interval: 1.08 to 1.86). Post-operatively, the median of re-transfused shed blood in patients with a THR was 280 mL (Interquartile range (IQR) 150 to 400) and in TKR patients 500 mL (IQR 350 to 650) (p <  0.001). ABT drains had no effect on the proportion of transfused patients in primary THR and TKR. The secondary outcomes were also comparable between groups. Cite this article: Bone Joint J 2014;96-B:765–71


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 696 - 702
1 Jun 2022
Kvarda P Puelacher C Clauss M Kuehl R Gerhard H Mueller C Morgenstern M

Aims

Periprosthetic joint infections (PJIs) and fracture-related infections (FRIs) are associated with a significant risk of adverse events. However, there is a paucity of data on cardiac complications following revision surgery for PJI and FRI and how they impact overall mortality. Therefore, this study aimed to investigate the risk of perioperative myocardial injury (PMI) and mortality in this patient cohort.

Methods

We prospectively included consecutive patients at high cardiovascular risk (defined as age ≥ 45 years with pre-existing coronary, peripheral, or cerebrovascular artery disease, or any patient aged ≥ 65 years, plus a postoperative hospital stay of > 24 hours) undergoing septic or aseptic major orthopaedic surgery between July 2014 and October 2016. All patients received a systematic screening to reliably detect PMI, using serial measurements of high-sensitivity cardiac troponin T. All-cause mortality was assessed at one year. Multivariable logistic regression models were applied to compare incidence of PMI and mortality between patients undergoing septic revision surgery for PJI or FRI, and patients receiving aseptic major bone and joint surgery.


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 2 | Pages 265 - 268
1 Mar 1997
Barwell J Anderson G Hassan A Rawlings I

We studied the effects of the timing of tourniquet release in 88 patients randomly allocated for release after wound closure and bandaging (group A), or before the quadriceps layer had been closed allowing control of bleeding before suture (group B). The groups were similar in mean age, weight, gender, preoperative knee score, radiographic grading, and prosthesis implanted. Patients in group B had less postoperative pain, achieved earlier straight-leg raising, and had fewer wound complications. Five patients in group A had to return to theatre, three for manipulation under anaesthesia, one for secondary closure of wound dehiscence, and one for drainage of a haematoma. The last patient later developed a deep infection, which was treated by a two-stage revision. There were no significant differences between the two groups in operating time, or the decrease in haemoglobin concentration at 48 hours postoperatively. Some of the adverse effects of the use of a tourniquet for knee surgery can be significantly reduced by early tourniquet release, with haemostasis before the quadriceps mechanism and the wound are closed


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 689 - 695
1 Apr 2021
Jämsä P Reito A Oksala N Eskelinen A Jämsen E

Aims

To investigate whether chronic kidney disease (CKD) is associated with the risk of all-cause revision or revision due to a periprosthetic joint infection (PJI) after primary hip or knee arthroplasty.

Methods

This retrospective cohort study comprised 18,979 consecutive hip and knee arthroplasties from a single high-volume academic hospital. At a median of 5.6 years (interquartile range (IQR) 3.5 to 8.1), all deaths and revisions were counted. To overcome the competing risk of death, competing risk analysis using the cumulative incidence function (CIF) was applied to analyze the association between different stages of CKD and revisions. Confounding factors such as diabetes and BMI were considered using either a stratified CIF or the Fine and Gray model.


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1512 - 1518
1 Nov 2015
Courtney PM Melnic CM Gutsche J Hume EL Lee G

Older patients with multiple medical co-morbidities are increasingly being offered and undergoing total joint arthroplasty (TJA). These patients are more likely to require intensive care support, following surgery. We prospectively evaluated the need for intensive care admission and intervention in a consecutive series of 738 patients undergoing elective hip and knee arthroplasty procedures. The mean age was 60.6 years (18 to 91; 440 women, 298 men. Risk factors, correlating with the need for critical care intervention, according to published guidelines, were analysed to identify high-risk patients who would benefit from post-operative critical care monitoring. A total of 50 patients (6.7%) in our series required critical care level interventions during their hospital stay. Six independent multivariate clinical predictors were identified (p < 0.001) including a history of congestive heart failure (odds ratio (OR) 24.26, 95% confidence interval (CI) 9.51 to 61.91), estimated blood loss >  1000 mL (OR 17.36, 95% CI 5.36 to 56.19), chronic obstructive pulmonary disease (13.90, 95% CI 4.78 to 40.36), intra-operative use of vasopressors (OR 8.10, 95% CI 3.23 to 20.27), revision hip arthroplasty (OR 2.71, 95% CI 1.04 to 7.04) and body mass index > 35 kg/m2 (OR 2.70, 95% CI 123 to 5.94). The model was then validated against an independent, previously published data set of 1594 consecutive patients. The use of this risk stratification model can be helpful in predicting which high-risk patients would benefit from a higher level of monitoring and care after elective TJA and aid hospitals in allocating precious critical care resources.

Cite this article: Bone Joint J 2015;97-B:1512–18.


The Bone & Joint Journal
Vol. 98-B, Issue 1_Supple_A | Pages 98 - 100
1 Jan 2016
Su EP Su S

During the last ten years, greater attention has been given to the management of peri-operative blood loss after total knee arthroplasty (TKA), as it is a modifiable outcome that has a significant effect on the rate of complications, the recovery, and the economic burden. Blood loss after TKA has been greatly reduced during this time, thereby dramatically reducing the rates of allogeneic transfusion. This has significantly reduced the complications associated with transfusion, such as fluid overload, infection, and increased length of stay.

The greatest advent in lowering peri-operative blood loss after TKA has been the introduction of tranexamic acid, which reduces blood loss without increasing the risk of thromboembolic events.

This paper discusses the ways of reducing blood loss after TKA, for which a multimodal algorithm, with pre-, intra- and post-operative measures, has been adopted at our institution.

Cite this article: Bone Joint J 2016;98-B(1 Suppl A):98–100.


The Bone & Joint Journal
Vol. 96-B, Issue 3 | Pages 395 - 398
1 Mar 2014
Bailey O Torkington MS Anthony I Wells J Blyth M Jones B

The aim of this study was to determine if a change in antibiotic prophylaxis for routine hip and knee replacement was associated with an increased risk of acute renal impairment.

We identified 238 patients (128 knees and 110 hips) who had received a single prophylactic dose of 1.5 g cefuroxime before joint replacement. We compared them with prospectively collected data from 254 patients (117 knees and 137 hips) who received a single prophylactic dose of 2 g flucloxacillin and a height- and gender-determined dose of gentamicin. The primary outcome measure was any new renal impairment as graded by clinically validated criteria.

We identified four patients (1.69%) in the cefuroxime group who developed renal impairment. All four had mild impairment and all renal function was normal by the third post-operative day. The incidence of new-onset renal impairment was significantly higher in the flucloxacillin-and-gentamicin group at 9.45% (24 patients) (p < 0.001). Three of these patients remained with acute renal impairment after a week, although the serum creatinine levels in all subsequently returned to normal.

Cite this article: Bone Joint J 2014;96-B:395–8.


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1556 - 1561
1 Nov 2013
Irwin A Khan SK Jameson SS Tate RC Copeland C Reed MR

In our department we use an enhanced recovery protocol for joint replacement of the lower limb. This incorporates the use of intravenous tranexamic acid (IVTA; 15 mg/kg) at the induction of anaesthesia. Recently there was a national shortage of IVTA for 18 weeks; during this period all patients received an oral preparation of tranexamic acid (OTA; 25 mg/kg). This retrospective study compares the safety (surgical and medical complications) and efficacy (reduction of transfusion requirements) of OTA and IVTA. During the study period a total of 2698 patients received IVTA and 302 received OTA. After adjusting for a range of patient and surgical factors, the odds ratio (OR) of receiving a blood transfusion was significantly higher with IVTA than with OTA (OR 0.48 (95% confidence interval 0.26 to 0.89), p = 0.019), whereas the safety profile was similar, based on length of stay, rate of readmission, return to theatre, deep infection, stroke, gastrointestinal bleeding, myocardial infarction, pneumonia, deep-vein thrombosis and pulmonary embolism. The financial benefit of OTA is £2.04 for a 70 kg patient; this is amplified when the cost saving associated with significantly fewer blood transfusions is considered.

Although the number of patients in the study is modest, this work supports the use of OTA, and we recommend that a randomised trial be undertaken to compare the different methods of administering tranexamic acid.

Cite this article: Bone Joint J 2013;95-B:1556–61.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 6 | Pages 776 - 783
1 Jun 2009
Rajesparan K Biant LC Ahmad M Field RE

Tranexamic acid is a fibrinolytic inhibitor which reduces blood loss in total knee replacement. We examined the effect on blood loss of a standardised intravenous bolus dose of 1 g of tranexamic acid, given at the induction of anaesthesia in patients undergoing total hip replacement and tested the potential prothrombotic effect by undertaking routine venography. In all, 36 patients received 1 g of tranexamic acid, and 37 no tranexamic acid. Blood loss was measured directly per-operatively and indirectly post-operatively.

Tranexamic acid reduced the early post-operative blood loss and total blood loss (p = 0.03 and p = 0.008, respectively) but not the intraoperative blood loss. The tranexamic acid group required fewer transfusions (p = 0.03) and had no increased incidence of deep-vein thrombosis. The reduction in early post-operative blood loss was more marked in women (p = 0.05), in whom this effect was dose-related (r = −0.793).

Our study showed that the administration of a standardised pre-operative bolus of 1 g of tranexamic acid was cost-effective in reducing the blood loss and transfusion requirements after total hip replacement, especially in women.


The Bone & Joint Journal
Vol. 96-B, Issue 4 | Pages 479 - 485
1 Apr 2014
Pedersen AB Mehnert F Sorensen HT Emmeluth C Overgaard S Johnsen SP

We examined the risk of thrombotic and major bleeding events in patients undergoing total hip and knee replacement (THR and TKR) treated with thromboprophylaxis, using nationwide population-based databases. We identified 83 756 primary procedures performed between 1997 and 2011. The outcomes were symptomatic venous thromboembolism (VTE), myocardial infarction (MI), stroke, death and major bleeding requiring hospitalisation within 90 days of surgery.

A total of 1114 (1.3%) and 483 (0.6%) patients experienced VTE and bleeding, respectively. The annual risk of VTE varied between 0.9% and 1.6%, and of bleeding between 0.4% and 0.8%. The risk of VTE and bleeding was unchanged over a 15-year period. A total of 0.7% of patients died within 90 days, with a decrease from 1% in 1997 to 0.6% in 2011 (p < 0.001). A high level of comorbidity and general anaesthesia were strong risk factors for both VTE and bleeding, with no difference between THR and TKR patients. The risk of both MI and stroke was 0.5%, which remained unchanged during the study period.

In this cohort study of patients undergoing THR and TKR patients in routine clinical practice, approximately 3% experienced VTE, MI, stroke or bleeding. These risks did not decline during the 15-year study period, but the risk of dying fell substantially.

Cite this article: Bone Joint J 2014;96-B:479–85.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 5 | Pages 636 - 644
1 May 2009
Eriksson BI Kakkar AK Turpie AGG Gent M Bandel T Homering M Misselwitz F Lassen MR

A once-daily dose of rivaroxaban 10 mg, an oral, direct Factor Xa inhibitor, was compared with enoxaparin 40 mg subcutaneously once daily for prevention of venous thromboembolism in three studies of patients undergoing elective hip and knee replacement (RECORD programme).

A pooled analysis of data from these studies (n = 9581) showed that rivaroxaban was more effective than enoxaparin in reducing the incidence of the composite of symptomatic venous thromboembolism and all-cause mortality at two weeks (0.4% vs 0.8%, respectively, odds ratio 0.44; 95% confidence interval 0.23 to 0.79; p = 0.005), and at the end of the planned medication period (0.5% vs 1.3%, respectively; odds ratio 0.38; 95% confidence interval 0.22 to 0.62; p < 0.001). The rate of major bleeding was similar at two weeks (0.2% for both) and at the end of the planned medication period (0.3% vs 0.2%).

Rivaroxaban started six to eight hours after surgery was more effective than enoxaparin started the previous evening in preventing symptomatic venous thromboembolism and all-cause mortality, without increasing major bleeding.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 2 | Pages 257 - 264
1 Feb 2012
Raskob GE Gallus AS Pineo GF Chen D Ramirez L Wright RT Lassen MR

In order to compare the effect of oral apixaban (a factor Xa inhibitor) with subcutaneous enoxaparin on major venous thromboembolism and major and non-major clinically relevant bleeding after total knee and hip replacement, we conducted a pooled analysis of two previously reported double-blind randomised studies involving 8464 patients. One group received apixaban 2.5 mg twice daily (plus placebo injection) starting 12 to 24 hours after operation, and the other received enoxaparin subcutaneously once daily (and placebo tablets) starting 12 hours (± 3) pre-operatively. Each regimen was continued for 12 days (± 2) after knee and 35 days (± 3) after hip arthroplasty. All outcomes were centrally adjudicated. Major venous thromboembolism occurred in 23 of 3394 (0.7%) evaluable apixaban patients and in 51 of 3394 (1.5%) evaluable enoxaparin patients (risk difference, apixaban minus enoxaparin, -0.8% (95% confidence interval (CI) -1.2 to -0.3); two-sided p = 0.001 for superiority). Major bleeding occurred in 31 of 4174 (0.7%) apixaban patients and 32 of 4167 (0.8%) enoxaparin patients (risk difference -0.02% (95% CI -0.4 to 0.4)). Combined major and clinically relevant non-major bleeding occurred in 182 (4.4%) apixaban patients and 206 (4.9%) enoxaparin patients (risk difference -0.6% (95% CI -1.5 to 0.3)).

Apixaban 2.5 mg twice daily is more effective than enoxaparin 40 mg once daily without increased bleeding.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 251 - 256
1 Feb 2011
Yokote R Matsubara M Hirasawa N Hagio S Ishii K Takata C

Prophylaxis against venous thromboembolism after elective total hip replacement is routinely recommended. Our preference has been to use mechanical prophylaxis without anticoagulant drugs. A randomised controlled trial was performed to evaluate whether the incidence of post-operative venous thromboembolism was reduced by using pharmacological anticoagulation with either fondaparinux or enoxaparin in addition to our prophylactic mechanical regimen. A total of 255 Japanese patients who underwent primary unilateral cementless total hip replacement were randomly assigned to one of three postoperative regimens, namely injection of placebo (saline), fondaparinux or enoxaparin. There were 85 patients in each group. All also received the same mechanical prophylaxis during and after the operation, regardless of their assigned group. The primary measurement of efficacy was the presence of a venous thromboembolic event by day 11, defined as deep-vein thrombosis detected by ultrasonography, documented symptomatic deep-vein thrombosis or documented symptomatic pulmonary embolism. The duration of follow-up was 12 weeks.

The rate of venous thromboembolism was 7.2% with the placebo, 7.1% with fondaparinux and 6.0% with enoxaparin (p = 0.95 for the comparison of all three groups). Our study confirmed the effectiveness and safety of mechanical thromboprophylaxis without the use of anticoagulant drugs after total hip replacement in Japanese patients.