The aim of this study was to evaluate the healthcare costs and benefits of enoxaparin compared to aspirin in the prevention of symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) using data from the CRISTAL trial. This trial-based economic analysis reports value for money as incremental cost per quality-adjusted life-year (QALY) gained in 2022 Australian dollars, compared to a single threshold value of AUD$70,000 per QALY. Event costs were estimated based on occurrence of VTEs and bleeds, and on published guidelines for treatment. Unit costs were taken from Australian sources. QALYs were estimated using CRISTAL six-month follow-up data. Sensitivity analyses are presented that vary the cost of VTE treatment, and extend the analyses to two years.Aims
Methods
Aims. There is uncertainty regarding the optimal means of thromboprophylaxis
following total hip and knee arthroplasty (THA, TKA). This systematic
review presents the evidence for acetylsalicylic acid (aspirin)
as a thromboprophylactic agent in THA and TKA and compares it with
other chemoprophylactic agents. Materials and Methods. A search of literature published between 2004 and 2014 was performed
in accordance with Preferred Reporting Items for Systematic Reviews
and Meta-Analyses guidelines. A total of 13 studies were eligible
for inclusion. Results. Evidence from one good quality randomised controlled trial (RCT)
showed no difference in rates of venous thrombo-embolism (VTE) in
patients given aspirin or low molecular weight heparin (LMWH) following
TKA. There was insufficient evidence from trials with moderate to
severe risk of bias being present to suggest aspirin is more or
less effective than
The aim of this study was to present data on 11 459 patients
who underwent total hip (THA), total knee (TKA) or unicompartmental
knee arthroplasty (UKA) between November 2002 and April 2014 with
aspirin as the primary agent for pharmacological thromboprophylaxis. We analysed the incidence of deep vein thrombosis (DVT) and pulmonary
embolism (PE) then compared the 90-day all-cause mortality with
the corresponding data in the National Joint Registry for England
and Wales (NJR). Aims
Patients and Methods
Since the introduction of the National Institute
for Health and Care Excellence (NICE) guidelines on thromboprophylaxis
and the use of extended thromboprophylaxis with new oral agents,
there have been reports of complications arising as a result of
their use. We have looked at the incidence of wound complications
after the introduction of dabigatran for thromboprophylaxis in our
unit. We investigated the rate of venous thromboembolism and wound
leakage in 1728 patients undergoing primary joint replacement, both
before and after the introduction of dabigatran, and following its
subsequent withdrawal from our unit. We found that the use of dabigatran led to a significant increase
in post-operative wound leakage (20% with dabigatran, 5% with a
multimodal regimen; p <
0.001), which also resulted in an increased
duration of hospital stay. The rate of thromboembolism in patients
receiving dabigatran was higher (1.3%) than in those receiving the multimodal
thromboprophylaxis regimen, including low molecular weight heparin
as an inpatient and the extended use of aspirin (0.3%, p = 0.047).
We have ceased the use of dabigatran for thromboprophylaxis in these
patients. Cite this article:
Post-operative complications after total hip
or knee replacement can delay recovery, prolong hospitalisation, increase
rates of re-admission and, in the most severe cases, lead to long-term
disability or even death. In this analysis of pooled data from four
large, randomised, phase III clinical trials that compared the oral,
direct Factor Xa inhibitor rivaroxaban with subcutaneous enoxaparin
for the prevention of venous thromboembolism after total hip or
knee replacement (n = 12 729), the incidence of complications, including
bleeding and adverse events related to surgery (such as wound infection,
wound dehiscence and haemarthrosis) are reported. Interventions
and procedures relating to surgery are also compared between the
groups. Bleeding events, including excessive wound haematoma and
surgical-site bleeding, occurred at similar rates in the rivaroxaban
and enoxaparin groups. Over the total study duration, adverse surgical
events occurred at a similar rate in the rivaroxaban group compared
with the enoxaparin group after total knee replacement (2.26% This analysis shows that the incidence of adverse surgical events
with rivaroxaban was similar to enoxaparin.
We performed a meta-analysis of modern total
joint replacement (TJR) to determine the post-operative mortality and
the cause of death using different thromboprophylactic regimens
as follows: 1) no routine chemothromboprophylaxis (NRC); 2) Potent
anticoagulation (PA) (unfractionated or low-molecular-weight heparin, ximelagatran,
fondaparinux or rivaroxaban); 3) Potent anticoagulation combined
(PAC) with regional anaesthesia and/or pneumatic compression devices
(PCDs); 4) Warfarin (W); 5) Warfarin combined (WAC) with regional anaesthesia
and/or PCD; and 6) Multimodal (MM) prophylaxis, including regional
anaesthesia, PCDs and aspirin in low-risk patients. Cause of death
was classified as autopsy proven, clinically certain or unknown.
Deaths were grouped into cardiopulmonary excluding pulmonary embolism
(PE), PE, bleeding-related, gastrointestinal, central nervous system,
and others (miscellaneous). Meta-analysis based on fixed effects
or random effects models was used for pooling incidence data. In all, 70 studies were included (99 441 patients; 373 deaths).
The mortality was lowest in the MM (0.2%) and WC (0.2%) groups.
The most frequent cause of death was cardiopulmonary (47.9%), followed
by PE (25.4%) and bleeding (8.9%). The proportion of deaths due
to PE was not significantly affected by the thromboprophylaxis regimen (PA, 35.5%;
PAC, 28%; MM, 23.2%; and NRC, 16.3%). Fatal bleeding was higher
in groups relying on the use of anticoagulation (W, 33.8%; PA, 9.4%;
PAC, 10.8%) but the differences were not statistically significant. Our study demonstrated that the routine use of PA does not reduce
the overall mortality or the proportion of deaths due to PE.
The National Institute for Clinical Excellence (NICE) produces recommendations on appropriate treatment within the National Health Service (NHS) in England and Wales. The NICE guidelines on prophylaxis for venous thromboembolism in orthopaedic surgery recommend that all patients be offered a low molecular weight heparin (LMWH). The linked hospital episode statistics of 219 602 patients were examined to determine the rates of complications following lower limb arthroplasty for the 12-month periods prior to and following the publication of these guidelines. These were compared with data from the National Joint Registry (England and Wales) regarding the use of
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.
We studied 4253 patients undergoing primary joint replacement between November 2002 and November 2007, of whom 4060 received aspirin only as chemical prophylaxis; 46 were mistakenly given low molecular weight heparin initially, which was stopped and changed to aspirin; 136 received no chemoprophylaxis and 11 patients received warfarin because of a previous history of pulmonary embolism. We identified the rate of clinical thromboembolism before and after discharge, and the mortality from pulmonary embolism at 90 days. The overall death rate was 0.31% (13 of 4253) and the rate of fatal pulmonary embolism was 0.07% (3 of 4253). Our data suggest that fatal pulmonary embolism is not common following elective primary joint replacement, and with modern surgical practice elective hip and knee replacement should no longer be considered high-risk procedures.
Patients who have undergone total hip or knee replacement (THR and TKR, respectively) are at high risk of venous thromboembolism. We aimed to determine the time courses of both the incidence of venous thromboembolism and effective prophylaxis. Patients with elective primary THR and TKR were enrolled in the multi-national Global Orthopaedic Registry. Data on the incidence of venous thromboembolism and prophylaxis were collected from 6639 THR and 8326 TKR patients. The cumulative incidence of venous thromboembolism within three months of surgery was 1.7% in the THR and 2.3% in the TKR patients. The mean times to venous thromboembolism were 21.5 days ( The risk of venous thromboembolism extends beyond the usual period of hospitalisation, while the duration of prophylaxis is often shorter than this. Practices should be re-assessed to ensure that patients receive appropriate durations of prophylaxis.
After total hip (THR) or knee replacement (TKR), there is still an appreciable risk of developing deep-vein thrombosis despite prophylaxis with low-molecular-weight heparin (LMWH). In a prospective, randomised study we examined the efficacy of
