BRUCEFINAL2

Running head: PREVENTION OF VENOUS THROMBOEMBOLISM 1
Prevention of Venous Thromboembolism After Hip or Knee Replacement
Molly P. Bruce
Georgetown University School of Nursing and Health Studies
NURO540

PREVENTION OF VENOUS THROMBOEMBOLISM 2
Prevention of Venous Thromboembolism After Hip or Knee Replacement
Total hip and knee replacements are surgical procedures that are frequently performed in
healthcare. According to the Centers for Disease Control and Prevention (2014), there are
approximately 719,000 total knee replacements and 332,000 total hip replacements performed in
the United States each year. Hip and knee replacements are performed for various reasons
including development of osteoarthritis, rheumatoid arthritis, osteonecrosis, or fractures, among
many other factors (National Institute of Arthritis and Musculoskeletal and Skin Diseases, 2010).
Patients undergoing these procedures are at an increased risk for the development of venous
thromboembolisms (VTE), which is a potentially fatal complication occurring after major
orthopedic surgeries. Therefore, it is standard practice to place patients on prophylactic
anticoagulants for a minimum of ten days, though extended use of up to five weeks has been
found to be most effective (Eriksson et al., 2008).
Two anticoagulant agents currently available for the prevention of VTE include
rivaroxaban (Xarelto) and enoxaparin (Lovenox). Rivaroxaban is the newest oral anticoagulant
agent introduced for the purpose of reducing the risk of VTE in patients with atrial fibrillation or
patients who have just had knee or hip replacement surgery. Enoxaparin is a low molecular
weight heparin (LMWH) given subcutaneously and has been the standard of care in recent years
for treating hip and knee replacement patients prophylactically (Westendorf et al., 2013). Some
studies have shown rivaroxaban to be as effective as enoxaparin in the prevention of VTE, which
could be useful for prescribing physicians to consider since rivaroxaban may be more preferred
by patients due to administration route.
The purpose of this paper is to present a summary of existing literature comparing the
effectiveness of rivaroxaban to enoxaparin in the prevention of VTE. This will be done by
completing a critical appraisal of the literature including a conceptualization the problem, review
of findings, methodological rigor, strengths and limitations, and an appraisal of the strength of
evidence from included studies in order to develop an evidence-based solution to the below
PICOT question.
PICOT Question
The PICOT question being appraised is, “In adult patients who have undergone hip or
knee replacement, is rivaroxaban more effective than enoxaparin for the prevention of VTE, over

the course of a month?” The population under investigation has undergone either hip or knee
replacement, also known as arthroplasty, and has started rivaroxaban or enoxaparin either prior
to or shortly after the completion of surgery. The age of adults included ranges from 19 to 65.
The intervention under study is the use of oral rivaroxaban and it is being compared to
subcutaneous enoxaparin. Both rivaroxaban and enoxaparin are medications used to prevent the
patient from developing a VTE, or blood clot. Other terms used to describe these medications
are blood thinners or anticoagulants. Specifically, rivaroxaban is a direct factor Xa inhibitor that
interrupts intrinsic and extrinsic pathways during the coagulation cascade, thereby blocking the
formation of blood clots (U.S. National Library of Medicine, 2014). Enoxaparin is a LWMH
that binds to antithrombin III, which inactivates factor Xa and thrombin, inhibiting clot
formation (U.S. National Library of Medicine, 2014). The outcome under study includes
prevention of VTE. Venous thromboembolism includes the development of a deep vein
thrombosis (DVT) or pulmonary embolism (PE). Key words used for VTE might include blood
clot, DVT, pulmonary embolism (PE), or thromboembolism. The timing component of the
PICOT question is over the course of one month.
Significance of the Problem
Venous thromboembolisms occur in approximately 85% of patients who have undergone
major orthopedic surgery without the use of post-pharmacological prophylaxis (Westendorf et
al., 2013). Despite evidence provided in several meta-analysis studies indicating the need for
pharmacological prophylaxis after hip and knee replacement, nearly 50% of patients do not
receive extended prophylaxis after discharge (Kakkar et al., 2008). It is important for patients to
receive prophylactic anticoagulant medications to lessen the risk of VTE development, since this
is a potentially fatal complication. Without VTE prophylaxis after hip and knee replacement,
length of stay, readmission, and mortality will be negatively impacted and financial implications
will result due to the severity of VTE.
Enoxaparin and rivaroxaban are both options that have been explored for prophylaxis in
past years. While enoxaparin has been around longer, rivaroxaban has been receiving more
attention due to its route of administration and potential to be more effective at preventing VTEs.
The required length of time to take prophylactic anticoagulants most always extends past the
patient’s discharge date, given that the minimum recommended length for prophylaxis after hip
or knee replacement is ten days. Therefore, when patients are prescribed daily subcutaneous

enoxaparin, an additional responsibility is put on the patient and family to understand the
importance of administering subcutaneous enoxaparin correctly and consistently. Though it is
important for patient’s to approach rivaroxaban in the same manner, the route of administration
is by mouth, thereby not necessitating family cooperation.
Among other considerations, a study conducted by Duran et al. (2012) found rivaroxaban
to be more cost efficient than enoxaparin. According to Duran et al. (2012), rivaroxaban has a
cost savings of $511.93 per patient when compared to enoxaparin. In addition to being cost
efficient, a study completed by Lassen et al. (2008) found that gastrointestinal side effects were
mostly experienced by patients on these medications and that similar occurrence rates were
found between enoxaparin and rivaroxaban, with the greatest being 13% in patient’s taking
enoxaparin and 12% in those taking rivaroxaban (Lassen et. al, 2008). However, side effects
such as bleeding were found to be greater in rivaroxaban. Given these statistics and the
possibility of rivaroxaban being more efficacious at preventing VTEs than enoxaparin, it is
important for physicians to highly consider rivaroxaban over enoxaparin, while also taking into
consideration risks versus benefits when prescribing prophylaxis for these patients.
Search Strategy and Results
The databases used to search for articles related to the topic included CINAHL and
PubMed. Search terms used included hip or knee arthroplasty or replacement and enoxaparin
and rivaroxaban. The terms hip or knee arthroplasty or replacement were used before adding
another Boolean operator, AND, between enoxaparin and rivaroxaban to further narrow results.
Inclusion criteria included adults, English language, humans, within ten years, aged 19-65+,
rivaroxaban and enoxaparin or LMWH had to be included, and studies had to be done on patients
who underwent hip or knee replacement. Studies were excluded if inclusion criteria were not
met.
After entering appropriate keywords, Boolean operators, and inclusion/exclusion criteria,
there were 26 results on PubMed and four results on CINAHL (Figure 1). Of these results, each
article was screened for overall appropriateness and relativeness to the topic, and a total of
eleven were utilized for this article. These articles consist of eight randomized controlled trials
(RCTs) of which four were pooled-analyses, two cohort studies, and one meta-analysis. Articles

were evaluated and graded using the Rating system for the Hierarchy of Evidence for
Intervention/Treatment Questions (Figure 2).
Critical Appraisal of the Literature
Conceptualization of the Problem
The conceptual framework of the literature that was reviewed for the PICOT question
consisted of making a determination as to whether enoxaparin or rivaroxaban is more effective at
preventing VTE in hip and knee replacement patients. For these studies, each concept was
appropriately and consistently defined by detailing the differences between enoxaparin and
rivaroxaban. The doses of medications used in the studies varied in milligrams (mg) and
frequency of administration. Enoxaparin was administered in either 40mg daily or 30mg twice a
day. Rivaroxaban doses varied from 5-60mg, with the majority of studies administering 10mg
daily. The length of administration time also varied between studies, from ten to 35 days. In
addition to differentiating rivaroxaban from enoxaparin, each study also clearly defined the
concept of VTE.
It is important to note that while concepts were consistent across the majority of studies,
two of these only examined LMWH as a group, instead of enoxaparin alone. The author of one
of these studies explained that they utilized various LMWHs because hospital recommendations
were altered during the study period based on national prophylaxis guidelines for hip or knee
replacement patients (Westendorf et al., 2013). The second study included all LMWH so that
physicians could prescribe based on their preference instead of being limited to one option
(Turpie et al., 2013).
Findings
Findings from the eleven research articles that were utilized were all consistent. There
were no conflicting findings reported on development of VTE. All studies provided statistically
significant results that reported subcutaneous enoxaparin, or LMWH in general, to be associated
with higher rates of VTE when compared to oral rivaroxaban. This stayed true at varying doses
and frequencies of administration (Appendix A).
In addition to researching VTE rates with the administration of rivaroxaban and
enoxaparin, it is relevant to mention that all of the included studies also looked at safety, and
specifically rates of bleeding, for each drug. All but one of these studies reported a minimal to
moderate increase in bleeding with rivaroxaban than with enoxaparin. Fisher et al. (2007) found

that there was a dose-dependent response for bleeding with rivaroxaban (p<0.001), by showing
that in a population of 1,317 patients, bleeding occurred in “0.9%, 1.3%, 2.1%, 3.9%, and 7.0%
of patients receiving rivaroxaban total daily doses of 5, 10, 20, 40, and 60mg, respectively,
versus 1.7% of patients receiving enoxaparin (p. 931).” Westendorf et al. (2013) was the only
study that found rivaroxaban (10mg) to have a lower risk of bleeding when compared with
LMWH, 2.9% versus 7.0% (p<0.001) for 2,538 patients.
Methodological Rigor
Both experimental and nonexperimental research designs were utilized in the appraised
studies. The experimental studies consisted of eight RCTs of which four were pooled analyses,
while the two nonexperimental studies were cohort studies. In addition, a meta-analysis was
included. Of the studies included, the majority of samples were obtained internationally. The
research samples also included all appropriate candidates undergoing hip or knee replacement
being treating prophylactically for VTE, increasing representativeness and external validity of
the population under study.
A factor found in many of the research studies that negatively affected the measurement
of study variables, was the recurring incidence of inadequate venograms obtained to assess for
the development of VTE. To resolve this issue, most of the studies were able to increase the
recruitment of patients to meet the statistical power of their trials. All but two studies were
randomized and blinded, minimizing confounding variables and increasing internal validity. The
two studies that were not randomized were cohort studies, which could have negatively impacted
the internal validity of results obtained.
Strengths and Limitations
The strengths of the overall body of evidence include similarity in study populations,
inclusion of RCTs, and the utilization of ethical guidelines. The PICOT question under appraisal
specifically targets an adult population who has undergone either hip or knee replacement
surgery. These inclusion criteria were all met in the appraised research articles, which increased
the chances of determining an appropriate answer to the PICOT question. In addition, the
majority of studies included were either RCTs or pooled analyses of multiple RCTs. These
studies were not only randomized, but also double-blinded lessening the chances of bias. The
RCTs included also had large sample sizes, with the majority meeting their calculated power
analysis, increasing generalizability. Lastly, the majority of included studies mentioned

appropriate ethical considerations including the obtainment of informed consent and approval
from ethics committees.
The limitations of the body of evidence include the utilization of multiple doses and
frequencies of administration for each drug, use of LMWH instead of enoxaparin in two studies,
the inclusion of two cohort studies, and risks of bias due to connections to sponsors. The studies
under investigation included a variety of drug dosages and frequencies in administration. As
mentioned earlier, enoxaparin dosages ranged from 40mg daily to 30mg twice a day, while
rivaroxaban dosages varied from 5-60mg, with the majority of studies administering 10mg daily.
There was also not a consistent timeframe for the length of administration, ranging from ten to
35 days. These factors combined could lead to inconsistent results that are difficult to compare
to studies with varying dosages, frequencies, and timeframes. In addition, two of the studies
examined LMWH as a group instead of enoxaparin alone, which could also alter the comparison
of findings. Another limitation of the obtained body of evidence includes the utilization of two
cohort studies. Without randomization and blinding, the risk of bias is increased. Lastly, in one
of these cohort studies, Bayer Pharmaceuticals was a sponsor, and this company manufactures
rivaroxaban (Turpie et al., 2013). Many of the involved researchers had connections with Bayer
including employment, stockholders, consultants, and some obtained grants from the company,
further increasing the risk of bias in the included study. This was the same case for the meta-
analysis conducted by Nieto, Espada, Merino, and Gonzalez (2012).
Summary Statement Regarding Strength of the Evidence
After reviewing the body of existing literature, it was found that oral rivaroxaban is
superior to subcutaneous enoxaparin for preventing VTE after total hip or knee replacement. In
order to support this statement, it is important to note that the eleven studies incorporated in this
literature review each included quality, quantity, and consistency of varying degrees. The
majority of the included studies were of high quality, minimizing biases and increasing internal
validity through randomization and blinding. However, two studies were cohort studies and
were not randomized, thereby affecting quality. In addition, the majority of included studies had
a level II rating with the Rating system for the Hierarchy of Evidence for Intervention/Treatment
Questions. Quantity was appropriately addressed in each study since all studies had large sample
sizes with strong magnitude of effects. Power analyses were conducted in the majority of studies
and most of these met their calculated analysis, with the exception of the study conducted by

Kakkar et al. (2008). Relative risk and odds ratios were utilized in the majority of the studies.
Lastly, all studies were consistent since they yielded statistically significant results showing
evidence that rivaroxaban was more efficacious at preventing VTE after total hip or knee
replacement when compared with enoxaparin.
The Rating system for the Hierarchy of Evidence for Intervention/Treatment Questions
(Figure 2) was used to rate evidence obtained from the included research studies. Of these
studies, one was rated a level one, eight were rated a level two, and two were rated as a level
four. Levels are ranked from highest evidence as level one to lowest evidence as level seven.
The average grade of all studies included combined is a level two, suggesting a fairly high level
of evidence, collectively.
Based on the review of literature and overall soundness of evidence obtained, it is
suggested that physicians consider prescribing low-dose rivaroxaban over enoxaparin for
prevention of VTE after total hip or knee replacement based on the patient and their overall risk
factors. However, it is of upmost importance that other considerations not included in the
proposed PICOT question be considered before prescribing rivaroxaban over enoxaparin due to
greater risks of bleeding while on rivaroxaban, especially with higher doses. Fisher et al. (2007)
concluded that daily doses of 5-20mg of rivaroxaban was found to be most effective at
preventing VTE and had a favorable safety balance, relative to enoxaparin. At a dose of 10mg of
rivaroxaban, Huisman et al. (2010) found that bleeding risks were 2.5% compared to 3.1% in
enoxaparin, but there was a 2-fold higher risk of developing VTE with enoxaparin compared
with rivaroxaban. Given the comparison of the nearly similar risks of bleeding to the benefit of
greater protection from VTE with low-dose rivaroxaban, it might be realistic to prescribe low-
dose rivaroxaban over enoxaparin when applicable. Regardless of the provider’s decision to
prescribe rivaroxaban over enoxaparin, patient risks versus benefits must always be taken into
consideration so that the patient can obtain the best results with the least adverse effects possible.
Clinical Recommendations
As mentioned above, it is recommended that low-dose rivaroxaban be prescribed over
enoxaparin for the prevention of venous thromboembolism after hip or knee replacement.
Venous thromboembolism development was shown to be less likely with rivaroxaban than with
enoxaparin. However, it is important to weigh patient risks versus benefits before prescribing

low-dose rivaroxaban due to higher risks of bleeding, especially with higher doses. Due to
theses risks of bleeding, certain factors should be taken into consideration before prescribing
rivaroxaban over enoxaparin. One of these considerations would be to determine whether or not
the patient has had a history of bleeding. For these patients, it might be best to prescribe
enoxaparin rather than low-dose rivaroxaban, even though the bleeding risks were shown to be
only slightly more elevated in rivaroxaban than enoxaparin. Other factors taken into
consideration should include patient preference, likeliness of compliance, and probabilities of
VTE development.
Prescription for Change
The change model used to implement the above clinical recommendations for
organizational change is the ACE Star Model of Knowledge Transformation. This model was
chosen since it includes the utilization of both old and new concepts for improving patient care.
It also is a continuous model, suggesting that knowledge transformation is a constant, endless
process (Stevens, 2004). Medications for VTE prevention are continually developed and
studied, and practice guidelines will always be evolving based on evidence-based practice, just
as the ACE Star Model suggests. This model also incorporate clinical practice guidelines that
disclose risks and benefits of different evidence-based options, which would be beneficial for the
evidence obtained in this paper. The steps applied in this model include discovering a research
question, summarizing the evidence, translating findings, integrating findings into practice, and
evaluating the overall outcomes.
Discovering Research
As mentioned previously, this topic was thoroughly researched using two databases,
PubMed and CINAHL, in order to generate knowledge on the proposed PICOT question.
Articles with various research designs including RCTs, cohort studies, and a meta-analysis were
incorporated in the search to gather evidence on the topic. This stage of discovering existing
research is necessary in order to rectify the need for change in current clinical practice (Stevens,
2004).
Summarizing the Evidence
Stevens (2004) mentions that summarizing the evidence is the first step in evidenced-
based practice, since it encompasses research findings into one meaningful statement. By

combining findings from various studies, the risk of overall findings occurring based on chance
diminishes, and reliability and reproducibility of findings is increased (Stevens, 2004). The
evidence obtained on the proposed PICOT question in this paper, suggested that VTE rates were
lessened with rivaroxaban than with enoxaparin prophylaxis. This held true for every study that
was included.
Translation of Evidence
After a summary of existing evidence is developed, it is important to translate this into a
clinical practice guideline (CPG) so that providers can easily become informed on the overall
body of evidence (Stevens, 2004). Clinical practice guidelines help assist providers in
determining the best clinical decisions for their patients by including risks, benefits, and costs.
These guidelines also clearly explain clinical recommendations and link these recommendations
to evidence obtained during research (Stevens, 2004). The CPG for the evidence obtained on the
proposed PICOT question in this review, will include the recommendation to prescribe low-dose
rivaroxaban over enoxaparin for VTE prevention. It also will include the findings of higher
bleeding rates with rivaroxaban and the importance to weigh risks versus benefits for each
patient.
Integration of Evidence into Practice
In order to integrate evidence into practice, it is important to identify key stakeholders,
barriers, and facilitators for change. Key stakeholders included in this recommendation of
implementing low-dose rivaroxaban over enoxaparin for VTE prevention in hip and knee
replacement patients, encompasses the surgeons who are completing the surgery, nurses
providing care after the procedures, and the patients and outpatient providers after discharge.
These are the main individuals who will be affected by the change, and therefore need to be
involved in the decision making process. A major barrier to change for the recommendations
made would be non-adherence to change by these providers and noncompliance by the patient.
Providers may be most comfortable with their previous standard of practice and become resistant
to change. In addition, patients may not be compliant with medication administration, and in the
case of prescribing enoxaparin, may not be adequately administering their medication as
prescribed. Lastly, the major facilitators of change would be the inpatient and outpatient

providers caring for these patients, since they have authoritative privileges for prescribing these
medications.
It is also important to have a strategy for implementing change. Lewin’s Model of
Change incorporates three steps to implement change including unfreezing, changing, and
refreezing. In the first step, the stakeholders will be recognized and pursued. A summary of the
obtained evidence will be presented to them in order to increase motivation for change. At this
time, it is important to address all questions and concerns so that the stakeholders are well
informed on the new evidence. The next step is incorporating the change itself by facilitating
and integrating the developed CPGs into practice. Lastly, the change is made permanent and
overall health outcomes, efficacy, and patient and provider satisfaction are evaluated.
Evaluating Outcomes
The last step in the ACE Star Model of Knowledge Transformation is evaluating
outcomes. To evaluate patient outcomes for VTE prevention after hip or knee replacement, both
formative and summative criteria will be included. The formative criteria to be evaluated
include medication compliance and appropriate administration by nurses and patients, number of
providers who adopt the change, and overall feasibility of recommendations made. Summative
criteria will include the occurrence of VTE with rivaroxaban as compared to enoxaparin,
bleeding rates with each drug, a cost summary, and unintended consequences. Time points for
these evaluations will take place on the day of medication course completion and subsequently
one month after this date. Venous thromboembolism development will be evaluated with
venograms. Evaluation results will be disseminated to the aforementioned key stakeholders so
that the clinical practice change can be reevaluated for effectiveness.
Conclusion
The intention of this paper was to determine a solution to the proposed PICOT question
regarding the effectiveness of rivaroxaban compared to enoxaparin for the prevention of VTE
after total hip or knee replacement surgery. This was achieved by reviewing multiple studies
completed on the topic with overall high levels of evidence. This paper included an explanation
of the PICOT question, significance of the problem, search strategy and results, critical appraisal
of the literature, conceptualization of the problem including findings, methodological rigor,
strengths and limitations, and a summary statement regarding strength of evidence from the

articles included in this review. By evaluating these criterions, it was concluded that rivaroxaban
is superior in preventing VTE after hip or knee replacement when compared with enoxaparin,
suggesting that prescribing providers should closely consider their options based on the patient
and their risk factors when interacting with this patient population.

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Appendix A
Summary of Primary Sources of Evidence
Citation of Evidence Eriksson, B.I., Borris, L.C., Friedman, R.J., Haas, S., Huisman,
M.V., Kakkar, A.K.,… Bandel, T.J. (2008).
Study Question or Hypothesis Null hypothesis: “The efficacy of rivaroxaban is inferior to that
of enoxaparin in the per-protocol population.”
Study Design RCT; double-blinded; between February 2006-March 2007
Sample Setting  Sample size: 4,541
 Setting: None given
 Location: 27 countries worldwide
Interventions & Outcomes
 Independent variables: Rivaroxaban 10mg once daily
PO or Enoxaparin 40mg once daily SC in addition to
either a PO or SC placebo
 Dependent variable: development of VTE
Data Collection & Analysis  Data collection methods: bilateral venography done at
last dose of study drug & at 36 days to screen for VTE;
laboratory tests
 Data analysis methods: Analysis of variance with two-
sided P values, with a type I error of 5%; Mantel-
Haenszel weighting with corresponding asymptotic
two-sided 95% CI used to estimate difference between
incidence rates in rivaroxaban group and enoxaparin
group that was estimated by stratification according to
country
Findings & Conclusions  VTE occurred in 4/1696 (0.2%) in those taking
Rivaroxaban and in 33/1678 (2.0%) in the Enoxaparin
group (absolute risk reduction, 1.7%; 95% CI, 1.0 to
2.5; P<0.001) (p. 2768)
Strengths & Limitations  Strengths: Trial performed under Declaration of
Helsinki; protocol approved by institutional review
board; informed consent obtained from patients; power
analysis; adequate follow-up (only 1 patient withdrew)
 Limitations: Number of valid venograms was lower
than expected- more patients recruited than planned
for; no information given on setting of drug
administration
Implications for Practice &
Research
Taking Rivaroxaban 10mg daily PO was significantly more
effective than Enoxaparin 40mg SC daily for the prevention of
VTE after hip arthroplasty.
Level of Evidence Level II, Rating System for the Hierarchy of Evidence for
Intervention/Treatment Questions (Melnyk & Fineout-
Overholt, 2011)
Citation of Evidence Fisher, W.D., Eriksson, B.I., Bauer, K.A., Borris, L., Dahl,
O.E. Gent, M.,… Haas, S. (2007).

Study Question or Hypothesis Is Rivaroxaban as effective as enoxaparin at preventing VTE
in patients undergoing knee or hip replacement?
Study Design Pool-analysis of 2 RCTs that were both double-blinded
Sample Setting  Sample size: Hip study 722; Knee study 621
 Setting: Not given
 Location: Hip study in Europe; Knee study in North
America
Interventions & Outcomes  Independent variables: Rivaroxaban given at 2.5, 5, 10,
20, or 30mg BID or enoxaparin 30-40mg daily; hip or
knee replacement
 Dependent variable: development of VTE
Data Collection & Analysis  Data collection methods: bilateral venography 5-9 days
after surgery
 Data analysis methods: Logistic regression used to
analyze dose response relationship of rivaroxaban; 95%
CI used to derive patient population of mean age so
equal that there were equal numbers of patients in each
study and equivalent numbers of male and female
patients; Regression model used to rest differences in
dose response relationships with rivaroxaban between
hip and knee replacement groups; common odds ratio
used for enoxaparin versus rivaroxaban
Findings & Conclusions  VTE occurred in 16.1-24.4% of patients receiving
rivaroxaban 5-60mg, and 27.8% receiving enoxaparin.
 VTE with rivaroxaban occurred in 6.9-18.2% of
patients in the hip study, compared to 23.3-40.4% in
the knee study.
 There was a flat dose response relationship with
rivaroxaban for total VTE, p=0.39 (pp. 934-935)
Strengths & Limitations  Strengths: Studies performed under Declaration of
Helsinki and Good Clinical Practice guidelines;
received consent from local ethic review committees;
informed consent obtained from patients before
participation; independent Data and Safety Monitoring
Board monitored safety and efficacy throughout study
 Limitations: Studies were not powered to detect
differences between separate rivaroxaban and
enoxaparin doses; specific setting of drug
administration not acknowledged
Research
Rivaroxaban was found to be more effective at daily doses of
5-20mg than enoxaparin, for the prevention of VTE after a hip
or knee replacement.
Overholt, 2011)
Citation of Evidence Huisman, M.V., Quinlan, D.J., Dahl, O.E., & Schulman, S.
(2010).
Study Question or Hypothesis Are PO dabigatran and rivaroxaban as effective as enoxaparin
at preventing VTE after hip or knee arthroplasty?
Study Design Pooled-analysis of 6 RCTs; double-blinded

Sample Setting  Sample size: 18,405 total (10,220 in enoxaparin vs.
rivaroxaban group from a total of 3 studies)
 Location(s): Not given
Interventions & Outcomes  Independent variables: Enoxaparin SC 40mg once daily
or 30mg BID; rivaroxaban 10mg PO daily (10-15 days
in knee study and 28-35 days in hip study); hip or knee
arthroplasty
 Dependent variables: VTE development
Data Collection & Analysis  Data collection methods: lower limb venography
 Data analysis methods: Odds ratios for individual
outcomes were done for each study and pooled using
Mantel-Haenszel method; 95% CI; statistical
calculations done with Review Manager
Findings & Conclusions  When compared to rivaroxaban, enoxaparin showed a
2-fold higher risk of VTE development (1.2% versus
0.6%; OR, 2.04; 95% CI, 1.32 to 3.17; P<0.001;
number needed to treat, 167)
 When compared to dabigatran (220mg daily),
enoxaparin had similar risks of VTE development
(0.9% versus 1.1%; OR, 0.76; 95% confidence
interval [CI], 0.44 to 1.31) (pp. 654-655)
Strengths & Limitations  Strengths: All studies were approved by local research
ethics boards; all provided informed consent; follow-up
>99% in all 3 trials for enoxaparin vs. rivaroxaban
group
 Limitations: Study-level data used instead of patient-
level data; patients were excluded if they had impaired
renal function or were very old, which could decrease
generalizability
Research
Enoxaparin and dabigatran had similar efficacy rates.
However, when compared to rivaroxaban, enoxaparin had a
significant increase in risk of VTE development. Implications
were made to balance risks of bleeding with risks of VTE
events when choosing prophylactic therapy after orthopedic
surgery.
Overholt, 2011)
Citation of Evidence Kakkar, A.K., Brenner, B., Dahl, O.E., Eriksson, B.I., Mouret,
P., Muntz, J.,… Soglian, A.G. (2008).
Study Question or Hypothesis Is 5 weeks of PO Ribaroxaban more effective than 2 weeks of
SC Enoxaparin for preventing the development of VTE after
hip arthroplasty?
Study Design RCT; double-blinded; from February 2006 to April 2007
 Location(s): 123 centers across 21 countries

Interventions & Outcomes  Independent variables: Ribaroxaban PO daily for 31-39
days (with placebo injection for 10-14) or enoxaparin
SC for 10-14 days (with placebo pill for 31-39 days)
 Dependent variables: development of VTE
Data Collection & Analysis  Data collection methods: Bilateral venography done to
detect VTE day after last dose of medication
 Data analysis methods: Used SAS version 8.2; Mantel-
Haenszel weighting with corresponding asymptotic
two-sided 95% CI and two-sided p value; Fisher’s
exact test
Findings & Conclusions  VTE occurred in 17/864 (2.0%) patients receiving
rivaroxaban and in 81/869 (9.3%) in the enoxaparin
group (absolute risk reduction 7.3%, 95% CI 5.2-9.4;
p<0.0001) (p. 34)
board; informed consent obtained from patients
 Limitations: Adequate sample size was estimated to be
2500 patients. Of the 2,509 sampled, 776 were
excluded for various reasons as shown in the article on
Table 1 (no intake of study medication, indeterminate
venography, no planned surgery, incorrect time interval
between end of surgery and first dose of medication,
etc.). In addition, 348 patients in the rivaroxaban group
and 338 in the enoxaparin group did not have a
venography done. However, sensitivity analyses were
done.
Research
Extended use of rivaroxaban was significantly more effective
than short-term use of enoxaparin in the prevention of VTE
after hip arthroplasty.
Overholt, 2011)
Citation of Evidence Lassen, M.R., Ageno, W., Borris, L.C., Lieberman, J.R.,
Rosencher, N., Bandel, T.J., Misselwitz, F. (2008).
Study Question or Hypothesis Is oral rivaroxaban as efficient as subcutaneous enoxaparin for
preventing VTE after total knee arthroplasty?
Study Design RCT; double-blinded; from February 2006 to November 2006
 Setting: 147 centers
 Location: 19 countries
Interventions & Outcomes  Independent variables: PO rivaroxaban 10mg daily
after knee arthroplasty or SC enoxaparin 40mg daily
after knee arthroplasty both for 10-14 days
 Dependent variable: development of DVT

Data Collection & Analysis  Data collection methods: bilateral venography between
day 11-15
 Data analysis methods: Mantel-Haenszel weighting
used to estimate difference between incidences in
rivaroxaban group and enoxaparin group; 95% CI;
statistical power of 90% used with a two-sided type I
error rate of 5%
Findings & Conclusions  VTE occurred in 79/824 patients (9.6%) receiving
rivaroxaban and in 166/878 patients (18.9%) receiving
enoxaparin (absolute risk reduction, 9.2%; 95%
confidence interval [CI], 5.9 to 12.4; P<0.001)
 Major VTE events occurred in 9/908 patients (1.0%) in
rivaroxaban group and 24/925 (2.6%) in enoxaparin
group (weighted absolute risk reduction, 1.6%; 95%
CI, 0.4 to 2.8; P = 0.01; relative risk reduction, 62%;
95% CI, 18 to 82; P=0.02) (p. 2779)
board; informed consent obtained from patients; power
analysis
 Limitations: There were a low number of valid
venograms obtained. Therefore, recruitment was
increased from 2300 to 2500+ patients to meet
statistical power of the trial. Comparison groups were
well-balanced increasing generalizability, other than
females>males in rivaroxaban group (P=0.03).
Research
Rivroxaban given in a fixed daily dose is superior to
enoxaparin in preventing VTE in postop knee arthroplasty
patients.
Overholt, 2011)
Citation of Evidence Levitan, B., Yuan, Z., Turpie, A.G., Friedman, R.J., Homering,
M., Berlin, J.A.,… Berkowitz, S.D. (2014).
Study Question or Hypothesis What is the benefit-risk profile for rivaroxaban versus
enoxaparin in patients who had total hip or knee arthroplasty?
Study Design Pooled-analysis of RCTs; from February 7,2006 to January 31,
2008
 Location(s): Not given
Interventions & Outcomes  Independent variables: Rivaroxaban 10mg PO or 40mg
SC enoxaparin
Data Collection & Analysis  Data collection methods: chart review
 Data analysis methods: Post-hoc analysis; Kaplan-
Meier rates

Findings & Conclusions  Out of 10,000 patients, compared to enoxaparin,
rivaroxaban was expected to be associated with 38
fewer symptomatic VTE events (95% CI: -6 to 82)
 In 10,000 patients, compared with enoxaparin,
rivaroxaban was associated with 98 (95% CI: 27 to
169) fewer symptomatic VTE.
 The median time to onset for symptomatic VTE was 18
days for hip arthroplasty and 5 days for knee
arthroplasty.
 After both hip or knee arthroplasty, rivaroxaban
prevented more harmful events than enoxaparin. (pp.
161-162)
Strengths & Limitations  Strengths: Randomization in studies; groups under
study were well-balanced with similar surgical and
demographic characteristics
 Limitations: Different durations of anticoagulant use
were used in the four studies which could obscure
results; 95% CI overlaps in the study for the hip and
knee rate differences
Research
Rivaroxaban administration resulted in greater benefits than
harm when compared with enoxaparin after total hip or knee
arthroplasty.
Overholt, 2011)
Citation of Evidence Turpie, A.G., Lassen, M.R., Davidson, B.L., Bauer, K.A.,
Gent, M., Kwong, L.M.,… Cushner, F.D. (2009).
Study Question or Hypothesis Is rivaroxaban as effective as enoxaparin for
thromboprophylaxis after total knee arthroplasty?
Study Design RCT; double-blinded; from June 2006 to October 2007
 Setting: 131 centers; patient’s home after discharge
 Location(s): 12 countries
Interventions & Outcomes  Independent variables: Rivaroxaban 10mg once daily
with SC placebo or SC enoxaparin 30mg BID with PO
placebo
 Dependent variables: Development of VTE
Data Collection & Analysis  Data collection methods: bilateral venography between
days 11 and 15
 Data analysis methods: Mantel-Haenszel weighting
used to analyze the difference in the primary efficacy
outcome between rivaroxaban and enoxaparin with
corresponding asymptotic two-sided 95% CI; age,
weight, and BMI were analyzed with two-way
ANOVA, with georgraphical region and treatment
group as fixed effects; statistical tests were done with a
two-sided type I error rate of 5%

 Findings & Conclusions  In the modified intention-to-treat population, VTE
occurred in 67/965 (6.9%) of patients who received
rivaroxaban and in 97/959 (10.1%) of patients who
received enoxaparin (absolute risk reduction 3·19%,
95% CI 0·71–5·67; p=0·0118)
 In per-protocol population, VTE occurred in 58/864
(6.7%) patients receiving rivaroxaban and 82/878
(9.3%) patients receiving enoxaparin (weighted
absolute risk reduction 2·71%, 95% CI 0·17–5·25),
indicating superiority of rivaroxaban over enoxaparin
(p=0.0362) (p. 1676)
Strengths & Limitations  Strengths: Study done in accordance with Declaration
of Helsinki & local regulations; independent ethics
committees or institutional review boards approved the
protocol for each center; informed consent obtained
from patients before randomization; randomized;
adequate power analysis
 Limitations: Inadequate venograms to assess for VTEs
was higher than expected in study
Research
Rivaroxaban PO 10mg was significantly superior to SC
enoxaparin 30mg BID for preventing VTE after total knee
arthroplasty.
Overholt, 2011)
Citation of Evidence Turpie, A.G., Lassen, M.R., Eriksson, B.I., Gent, M.,
Berkowitz, S.D., Misselwitz, F.,…Kakkar, A.K. (2011).
Study Question or Hypothesis Is enoxaparin more effective than rivaroxaban for
thromboprophylaxis after hip or knee replacement surgery?
Study Design Pooled-analysis of four phase III RCT studies; between
February 7, 2006 and Jaunary 31, 2008
 Location: 41 countries
Interventions & Outcomes  Independent variables: enoxaparin 40mg SC daily or
enoxaparin 30mg SC BID daily or rivaroxaban 10mg
PO daily
 Data analysis methods: 95% CI; Odds Ratio; Cox
regression model
Findings & Conclusions  0.5% of patients (26/6183) developed of VTE as compared
to 1.0% (60/6200) of patients who received enoxaparin
(odds ratio 0.48 [95% CI 0.30–0.76]; p=0.001) (p. 447)

Strengths & Limitations  Strengths: Randomization; Studies done under
International Conference on Harmonization and Good
Clinical Practice, Declaration of Helsinki, and local
regulations; institutional review boards and ethics
committees approved studies; written informed consent
obtained before randomization
 Limitations: Different intensities of prophylaxis used
Research
Rivaroxaban is more effective than LMWH for VTE
prevention in patients who have undergone hip or knee
replacement.
Overholt, 2011)
Citation of Evidence Turpie, A.G., Haas, S., Kreutz, R., Mantovani, L.G.,
Pattanayak, C.W., Holberg, G.,… Jamal, W. (2013).
Study Question or Hypothesis Is rivaroxaban as effective as standard-of-care for
thromboprophylaxis after hip or knee replacement surgery?
Study Design Non-experimental, cohort study; from February 2009 to June
2011
 Location(s): 37 countries
Interventions & Outcomes  Independent variables: Rivaroxaban or LMWH or
unfractionated heparin, dabigatran, or vitamin K
antagonists; hip or knee replacement surgery
 Dependent variables: VTE development
 Data analysis methods: Logistic regression model used
to estimate propensity score for each patient; Estimated
odds ratios and CIs were calculated with a Bayesian
method
Findings & Conclusions  Symptomatic VTE 3 months after surgery occurred in
0.89% in the rivaroxaban group (n=8,778) and 1.35%
in the standard-of-care group (n=8,635; odds ratio [OR]
0.65; 95% confidence interval [CI] 0.49–0.87), and
0.91% and 1.31% (weighted) in the propensity score-
adjusted analysis (OR 0.69; 95% CI 0.56–0.85).
 In comparison to the standard-of-care group, patients
who receiving rivaroxaban had a significantly lower
rate of VTE, 0.65% versus 1.02% (OR 0.63; 95% CI
0.45-0.89) in the safety population and 0.65% and
1.03% in the adjusted safety population (PR 0.63; 95%
CI 0.49-0.81). (pp. 98-99)

Strengths & Limitations  Strengths: Written informed consent obtained in
countries where necessary; study approved by
European Medicines Agency and independent ethics
committee or an independent review board where
required; sample size
 Limitations: No randomization; Bayer Pharmaceuticals
sponsored the study and they manufacture rivaroxaban.
Many of the researchers in the study have connections
with Bayer (employees, stock holders, receive grants,
consultants, etc.) which creates a conflict of interest;
confounding variables not measured with propensity
score design; reporting bias
Research
In unselected patients who are undergoing knee or hip surgery,
oral rivaroxaban should be considered by physicians to help
improve prevention of VTE.
Level of Evidence Level IV, Rating System for the Hierarchy of Evidence for
Overholt, 2011)
Citation of Evidence Westendorf, J.B., Lutzner, J., Donath, L., Tittl, L., Knoth, H.,
Radke, O.C.,… Kuhlisch, E. (2013).
Study Question or Hypothesis Is LMWH or rivaroxaban more efficient for
thromboprophylaxis in hip and knee replacement surgery?
Study Design Non-experimental retrospective cohort study; from January
2006 to June 2011
 Setting: University Clinic “Carl Gustav Carus”
 Location: Dresden, Germany
Interventions & Outcomes  Independent variables: LMWH (fondaparinux 2.5mg)
SC daily or rivaroxaban 10mg PO daily for 35 days
postop
 Data analysis methods: Fisher’s exact test or Student’s
t-test and ANCOVA were used to compare differences
in baseline variables; Binary data analyzed using
logistic regression models; 95% CI; Length of hospital
stay analyzed using Kaplan-Meier estimation; Risk for
VTE modeled with Cox proportional hazard models
Findings & Conclusions  Symptomatic VTE results occurred in 4.1% of patients
taking LMWH and 2.1% taking rivaroxaban (p<0.001).
 Patients receiving LMWH had a higher rate of distal
DVT than those receiving rivaroxaban (2.5 vs. 1.1%;
p=0.011). However, a reduction of VTE with
rivaroxaban only found to be significant in hip surgery
patients, while reduction of VTE in knee surgery
patients failed to reach significance. (pp. 157-158)

Strengths & Limitations  Strengths: Sampling size comparable to large RCT
studies
 Limitations: No randomization; Study completed at one
center, decreasing generalizability; patients who were
taking rivaroxaban had more risk factors for DVT
(older, higher BMI, some with history of VTE) when
compared to LMWH group; different LMWH were
administered during observational period due to
changing protocols; no information was available on
development of VTE once patients were discharged;
reporting bias
Research
Rivaroxaban is more effective than LMWH for VTE
prevention in patients who have undergone hip or knee
replacement. Switching from LMWH to rivaroxaban could be
beneficial.
Level of Evidence Level IV, Rating System for the Hierarchy of Evidence for
Overholt, 2011)
Appendix B
Summary of Secondary Sources of Evidence
Citation of Evidence Nieto, J.A., Espada, N.G., Merino, R.G., & Gonzalez, T.C.
(2012).
Objective, Aim or Purpose “To compare the main efficacy and safety endpoints of the
pivotal randomised clinical trials (RCTs) on venous
thromboembolism (VTE) prevention after total hip (THR) or
knee (TKR) replacement with the new oral anticoagulants
(NAs) versus enoxaparin.” (p. 183)
Search Strategy No specific search terms given. Only states that RCTs were
obtained from medical literature.

Inclusion & Exclusion Criteria  Inclusion: English; patients aged 18 years-old or older;
enoxaparin SC 40mg daily or 30mg BID, rivaroxaban PO
10mg daily, apixaban PO 2.5mg BID, or dabigatran PO
220mg daily; hip or knee replacement surgery
 Exclusion: active bleeding, high bleeding risk,
contraindications for enoxaparin, kidney failure, abnormal
liver enzymes, specific medications, pregnancy or
breastfeeding, planned intermittent pneumatic
compression, need for continued anticoagulation, disorders
preventing bilateral venography
Data Extraction & Analysis  Data collection methods: review of previous studies,
chart review
 Data analysis methods: Chi-square test and I2 statistic
was used for heterogeneity of data; random-effects
model used to obtain risk-ratios and their correspondent
95% CI; funnel plot used to assess publication bias
Results, Recommendations &
Implications
 When comparing VTE rates to enoxaparin 40mg,
rivaroxaban showed superiority (RR 0.50; 95% CI
0.34-0.73), followed by apixaban (RR 0.63; 95% CI
0.36-1.01) and dabigatran, which showed equivalence
to enoxaparin (RR 1.02; 95% CI 0.86-1.20).
 VTE occurred in 927/10,245 (9.1%) of patients treated
with new anticoagulants (rivaroxaban, apixaban,
dabigatran) and 1,223/10,276 (11.9%) treated with
enoxaparin, favoring new anticoagulants (RR 0.71;
95% CI 0.56-0.90).
 In patients receiving anticoagulation after hip
arthroplasty, the benefit of new anticoagulants (28-39
days) was significant (RR 0.55; 95% CI 0.32-0.95). In
patients who underwent knee arthroplasty (new
anticoagulants for 6-14 days), the risk ratio was only
slightly reduced (RR 0.80; 95% CI 0.61-1.06).
 Significant heterogeneity was analyzed among trials
and subgroups (Chi square test, p<0.001). (pp. 186-
189)
 Recommendations for Practice: Rivaroxaban,
apixaban, and dabigatran showed more efficacies when
compared to enoxaparin after total hip and knee
replacement.
Strengths & Limitations  Strengths: 10 phase III RCTs included in meta-analysis
 Limitations: Mandatory bilateral venographies 24 hours
after last anticoagulant dose were required, however
relevant proportion of patients had venographs that
were no evaluable or either did not undergo
venography (26% to 35% in rivaroxaban group); 2 of
the researchers in the study received fees from Bayer,
the manufacturer of rivaroxaban. 1 research was an
investigator in trials sponsored by Bayer creating
conflicts of interest.
Level of Evidence Level I, Rating System for the Hierarchy of Evidence for
Overholt, 2011)
Legend

ABBREVIATION DEFINITION
BID Two times daily
BMI Body Mass Index
CI Confidence Interval
DVT Deep Vein Thrombosis
LMWH Low Molecular Weight Heparin
OR Odds Ratio
PO Oral
RCT Randomized Controlled Trial
RR Relative Risk
SAS Statistical Analysis System
SC Subcutaneously
VTE Venous thromboembolism
Appendix C
Figure 2. Levels of Evidence
Rating systemfor the Hierarchy of
Evidence for Intervention/Treatment
Questions
Level I Evidence from a systematic review or meta
analysis of all relevant RCTs.
Level II Evidence obtained from well-designed
RCTs.
Level III Evidence obtained from well-designed
controlled trials without randomization.
Level IV Evidence from well-designed case control
and cohort studies.
Level V Evidence from systematic reviews of
descriptive and qualitative studies
Level VI Evidence from single descriptive or
qualitative studies.

Level VII Evidence from the opinion of authorities
and/or reports of expert committees.
From Melnyk, B.M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing and
healthcare: A guide to best practice (6 ed.). Philadelphia: Lippincott Williams &
Wilkins.
Appendix D
Figure 1.
Search
Strategy
Inclusion:
within 10
years, human,
"Arthroplasty, Replacement,
Knee+" OR "Arthoplasty,
Replacement, Hip+"
Cinahl: 2324 Publications
PubMed: 12892 Publications
3 Duplicates; 27
Publications Remain
11 studies included
16 articlesexcluded:
8 did not include both
enoxaparin and rivaroxaban
5 not related to VTE
prevention
1 looked at
thromboprophylaxis on
wound healing
1 did not include
pharmacological
prophylaxis
1 on costeffectiveness
...AND "Rivaroxaban" AND
"Enoxaparin"
Cinahl: 4 Publications
PubMed: 26 Publications

English, ages 19-65

Running head: PREVENTION OF VENOUS THROMBOEMBOLISMS 29

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