Rivaroxaban Versus Enoxaparin For Prevention Of Venous Thromboembolism In Elective Total Hip Replacement: A Retrospective Cohort Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1145-1145
Author(s):  
Stephanie W Young ◽  
Jason Kielly ◽  
Maria Mathews ◽  
Andrew Furey ◽  
Kuljit Grewal ◽  
...  

Abstract Introduction Rivaroxaban, an oral anti-Xa inhibitor, was approved in 2008 in Canada for prevention of venous thromboembolism (VTE) post elective total hip replacement (THR). Studies completed in elective THR patients showed superiority or noninferiority of rivaroxaban over injectable low molecular weight heparin (LMWH) for prevention of VTE, with no difference in trial defined major bleeding. Many centres use rivaroxaban for VTE prevention post THR as standard of care. Our centre introduced rivaroxaban for THR patients in May 2009. As there is limited data on real world experience with this agent, beyond bleeding and VTE events, we evaluated the change in VTE prophylaxis for this indication. Methods A retrospective cohort study was completed comparing the change in use of a LMWH, enoxaparin, to rivaroxaban for VTE prophylaxis for elective THR patients ≥ 19 years not requiring therapeutic anticoagulation. The setting was a regional health authority servicing a population of 290 000, and the timeframe was 18 months before and 18 months after the introduction of rivaroxaban, allowing a 3 month period in between for incorporation of rivaroxaban into routine care. Patients with THR completed pre introduction of rivaroxaban were in the enoxaparin (E) group and patients with THR completed post introduction were in either the enoxaparin and rivaroxaban (E+R, given sequentially) group, or the rivaroxaban (R) group. Data were abstracted from computerized and paper records using a standardized form. Data collected included demographics, medical and medication history, risk factors for bleeding and VTE, type of anesthesia, VTE prophylaxis details, post-discharge community health (CH) nursing visits and hospital visits (emergency room (ER) and inpatient admissions), and major bleeding or VTE events. Hospital visits and VTE were assessed up to 30 days, and major bleeding up to 2 days, after the last presumed dose of medication. Primary outcomes were differences between E, E+R, and R in hospital visits, as well as referrals to, and reasons for, post discharge CH nursing visits. Results There were 246 THR procedures in E, 43 in E+R, and 190 in R. Baseline characteristics were similar between the three groups. For E, E+R, R, 52%, 49% and 53% were female with a mean age of 64, 62, 64 years and a mean BMI of 31, 32, 31 kg/m2. There was no difference in surgery duration (mean 92, 97, 91 min for E, E+R, R), or number of patients transfused (19, 16, 14% for E, E+R, R). More patients (74%) in E+R received regional anesthesia exclusively, compared to E (57%) and R (52%), p=0.01. There was no difference in post-surgery time to VTE prophylaxis initiation (mean of 22, 22, 23 hours for E, E+R, R). There was a difference in the length of stay (mean 7.1, 8.4, 6.3 days for E, E+R, R, p=0.005), as well as total duration of prophylaxis (mean 10.4, 16.1, 14.5 days for E, E+R, R, p<0.0001). Patients in the E+R sequentially received a mean of 1.7 days of enoxaparin, then 14.2 days of rivaroxaban. Post discharge, there was no difference in the number of patients with at least one ER visit (7.3, 9.3, 6.3% for E, E+R, R, p=0.775) or hospital admission (3.3, 9.3, 2.6%, p=0.096). Most patients had a referral for CH nursing visits (94, 91, 95% for E, E+R, R, p=0.253). Most referrals requested dressing changes (81, 77, 82% for E, E+R, R, p=0.720) and removal of staples (91, 96, 91%, for E, E+R, R, p=0.671). The mean number of days post discharge for staple removal was 4.1, 4.3, 5.1 days for E, E+R, R, p<0.0001. The most common frequency of dressing changes requested was every 2 days (74, 63, 60% for E, E+R, R, p=0.009). Medication administration was requested for patients in E only (84, 0, 0% for E, E+R, R, p<0.0001), with a frequency of once daily (98%). Symptomatic VTE occurred in 1.6, 2.3, and 2.1% of patients for E, E+R, and R. There were 5 major bleeding events in E (2 extra-surgical site bleeds, 3 unexpected surgical site bleeds), and 0 events in both E+R and R. Conclusion This study provides useful data, beyond VTE and bleeding events, on the impact of a change in VTE prophylaxis post elective THR. No statistically significant difference was observed in post discharge hospital visits. Most patients had post discharge CH nursing visits requested; the overall requested visit frequency was reduced for all patients receiving rivaroxaban. Differences in type of anesthesia, length of stay, and duration of prophylaxis were noted for E+R. Differences between this group and R should be further explored. Disclosures: Grewal: Bayer: Honoraria.

2021 ◽  
Vol 8 (2) ◽  
pp. 4228-4232
Author(s):  
Vo Thanh Toan ◽  
To Dong Kha ◽  
Bui Van Anh

Introduction: Our research aims to evaluate the effectiveness of thromboprophylaxis using enoxaparin in patients undergoing hip replacement. Methods: A retrospective cohort study was conducted based on medical records of patients aged 40 years and older undergoing hip replacement. Exclusion criteria included patients who had used anticoagulants to prevent other diseases, patients with a history of chronic renal failure, liver failure, cancer or allergy to anticoagulants, and patients with indicated mechanical prophylaxis. In our study, 65 patients were randomized into 2 groups - the control group and the venous thromboembolism (VTE) prophylaxis group (receiving subcutaneous enoxaparin 40 mg daily for 7 - 14 days). Preventive effectiveness was evaluated based on the comparison of VTE incidence after surgery between the groups. Results: In our study, most of the patients were over 60 years old (79.2%). No case of pulmonary embolism was recorded. There were 11 patients in the control group (17.2%) who developed deep venous thrombosis (DVT) versus 2 patients in the prophylaxis group (3.1%). After adjusting for postoperative hospital stay, use of enoxaparin reduced the risk of DVT by 89.7% (OR 0.103, 95% confidence interval 0.019-0.569, p=0.009), especially in patients over 60 years old (OR 0.147, 95% confidence interval 0.026 - 0.822, p = 0.029). Conclusion: This study demonstrates that using enoxaparin significantly reduces the incidence of DVT in patients undergoing hip replacement, especially in patients over 60 years old.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1157-1157
Author(s):  
Minh Phan ◽  
Sonia John ◽  
Ana Isabel Casanegra ◽  
Alfonso Tafur

Abstract Abstract 1157 Background: Venous thromboembolism [VTE] is the second highest cause of mortality among patients with cancer. However, pharmacological thromboprophylaxis for patients with solid tumor is only recommended during hospitalization. Primary outpatient thromboprophylaxis is not a widely accepted practice. Objective: Determine safety and efficacy of outpatient primary VTE prophylaxis in patients with solid tumors. Data sources: A systematic review was conducted using MEDLINE and EMBASE up to June 2012. Key search words included venous thromboembolism, malignancy, anticoagulants, and chemotherapy. Studies were considered for our meta-analysis if they included outpatient primary pharmacological thromboprophylaxis in adult patients with active solid cancer. All the information was independently reviewed by 2 of the authors [MP, SJ] and a third reviewer resolved discrepancies. The measure of association was calculated with R (R: A Language and Environment for Statistical, R Development Core Team, www.R-project.org), R META package (Version 0.8–2, Author: Guido Schwarzer). The Q statistic was calculated and a formal test of homogeneity was conducted. Random-effects model was preferred in case of heterogeneity. Results: A total of 1371 abstracts were reviewed and 29 manuscripts were fully abstracted. Eight randomized controlled trials including 6706 patients were analyzed. There were less VTE events with outpatient prophylaxis: odds ratio [OR] of 0.53 (95% CI, 0.40–0.70). Six studies used low or ultra-low molecular weight heparin and two studies used warfarin. In the subgroup analysis of heparin based primary prophylaxis, there was a significant reduction in VTE events [OR 0.47, 95% CI, 0.34–0.64], no significant heterogeneity [FIG 1]. In addition, there was no difference in major bleeding events between groups [OR 1.48, 95% CI, 0.89–2.46]. Five studies reported mortality data; there was significant heterogeneity between studies. Conclusions: Heparin based outpatient VTE prophylaxis in patients with solid tumors reduced by half the risk of VTE with no significant differences in major bleeding events. The current publications do not allow a meaningful grouped analysis of survival data, improved patient selection is necessary in order to adequately target VTE prevention strategies. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3678-3678
Author(s):  
Anat Gafter-Gvili ◽  
Genady Drozdinsky ◽  
Oren Zusman ◽  
Shiri Kushnir ◽  
Leonard Leibovici

Background and Aims Venous thromboembolism (VTE) is considered as a preventable cause of death for hospitalized patients. Current guidelines recommend pharmacologic prophylaxis for medical patients considered high risk for VTE, despite failure of studies to show reduction in mortality. We aimed to assess the benefit and safety of VTE prophylaxis in acutely ill medical patients hospitalized in internal medicine wards. Methods Retrospective cohort study of all patients admitted to the internal medicine and acute geriatric departments, with an admission lasting more than 48 hours, during 2012-2018. Patients who received pharmacologic prophylaxis were compared to those who did not. The primary outcome was 30-day mortality. Secondary outcomes were the 90 day incidence of pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), and major bleeding. Propensity-weighted logistic multivariable analysis was performed. Results A total of 18890 patient-unique episodes were included in the analysis. Of them 3206 (17%) received prophylaxis. A total of 1309 (6.9%) died. 540/1309 (41.3%) of those who received VTE prophylaxis died and 769/1309 (58.7%) of those who did not receive prophylaxis died. VTE Prophylaxis was not associated with a reduction in mortality, multivariate-adjusted OR 0.99 (95% CI 0.84-1.14). One hundred and forty two patients (0.7%) developed VTE. The frequency of VTE among patients who received VTE prophylaxis was 31% (44/142) compared with 69% (98/142) in patients who did not receive prophylaxis. The frequency of VTE in patients who had a Padua score ≥4 and received VTE prophylaxis, was 1.9% (30/1573) compared with 1.6% (44/2797) in those with a Padua score ≥4 who did not receive prophylaxis. 74/142 (52.1%) of patients with VTE had a Padua score ≥4, 44/1309 (1.4%) of those who received VTE prophylaxis and 98/15864 (0.6%) of those who did not. VTE Prophylaxis was not associated with reduction in VTE in the whole cohort, multivariable-adjusted OR 1.09 (95% CI 0.52-2.29). VTE prophylaxis was associated with an increase in major bleeding (multivariable-adjusted OR 1.24, 95% CI 1.04-1.48) Conclusion The current practice of routinely administering VTE prophylaxis to medically ill patients considered at high risk for VTE, resulted in a high risk for bleeding a without clear clinical benefit, and should be reassessed. Disclosures No relevant conflicts of interest to declare.


2019 ◽  
Vol 12 ◽  
pp. 1179545X1986381 ◽  
Author(s):  
Daniel Dybdahl ◽  
Grant Walliser ◽  
Michelle Pershing ◽  
Christy Collins ◽  
David Robinson

Background: The appropriate dose of enoxaparin for venous thromboembolism (VTE) prophylaxis in low body weight patients is unknown. Objective: The aim of this study is to evaluate the impact of enoxaparin dosing on major and minor bleeding events in low body weight patients. Methods: This was a retrospective cohort study of patients weighing less than 45 kg receiving subcutaneous (SC) enoxaparin for VTE prevention. The primary objective was to determine whether enoxaparin dose was associated with major and minor bleeding. The secondary objective was to determine the incidence of VTE by enoxaparin dose. Results: There were 173 patients included in the study, of which 37 patients received 2 different courses of enoxaparin during hospitalization, resulting in 210 enoxaparin courses. Among all enoxaparin courses, 16.2% were associated with major bleeding and 5.2% with minor bleeding. There was no difference in the incidence of major bleeding by dose (enoxaparin 30 mg SC daily, 30 mg SC twice daily, or 40 mg SC daily; P = .409). Patients who experienced major bleeding were older (54.9 ± 16.1 years) than patients who did not (48.4 ± 18.4 years) ( P = .043). There was no difference in the incidence of minor bleeding by dosing schedule ( P = .14). No patients experienced a VTE. Conclusion and Relevance: The risk of bleeding was similar by enoxaparin dose but increased with age in low body weight patients. Given the low incidence of VTE in this study, it is reasonable to consider decreasing the prophylactic enoxaparin dose in low body weight patients, especially in the elderly population.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7074-7074
Author(s):  
Emma Ryan ◽  
Julia Salinaro ◽  
Laura J Havrilesky ◽  
Brittany Anne Davidson

7074 Background: Venous thromboembolism (VTE) is a major cause of morbidity and mortality among cancer patients. The Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients (AVERT) randomized controlled trial concluded that apixaban is a safe and effective option for VTE prophylaxis in high-risk ambulatory cancer patients initiating a new chemotherapy regimen. We performed a cost-effectiveness analysis from a health system perspective to determine if apixaban is a feasible prophylactic strategy for this population. Methods: A decision model was created from a third party payer perspective with a time horizon of 6 months, based on the treatment arms of the AVERT trial: (1) apixaban 2.5 mg twice daily for 6 months during active chemotherapy versus (2) placebo. Rates of VTE (4.2% apixaban vs 10.2% placebo), major bleeding (3.5% vs 1.8%) and clinically relevant nonmajor bleeding (CRNMB) (7.3% vs 5.5%) were modeled from the results of the AVERT trial. Cost estimates for treatments and events were obtained from wholesale drug costs, previously published studies and Medicare reimbursement data, and adjusted for inflation to 2018 dollars. Quality adjusted life years were calculated based on previously published utility values for the health states of advanced cancer, DVT, PE, and major bleeding events. An exploratory analysis was performed comparing prophylactic aspirin to no prophylaxis assuming a VTE rate of 7.2%, major bleeding rate of 3.5%, and CRNMB rate of 7.3%, based on the conservative assumptions that while aspirin may not be as effective at preventing VTE, the rate of clinically significant bleeding events would be similar or greater than that of apixaban. Results: In the base case model, apixaban is more costly and more effective than placebo (ICER = $5,013,190/QALY), and the cost per VTE prevented in the apixaban arm is $33,000. In one-way sensitivity analysis, if the cost of apixaban were reduced by 40% from $3,197 to $1,250 for a 6 month course, this could potentially be a cost-effective prophylaxis strategy with an ICER less than $100,000/QALY. In the alternative analysis, aspirin dominates placebo as it is both more effective and less expensive, and remains cost-effective even when the rate of clinically recognized bleeding with aspirin exceeds 15%. Conclusions: Further investigation into less costly prophylactic options such as generic direct oral anticoagulants (once available) and aspirin is warranted prior to broader implementation of a VTE prophylaxis strategy in this population.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 6-6 ◽  
Author(s):  
Angela Lee ◽  
Frank Oley ◽  
Mimi Lo ◽  
Richard Fong ◽  
Mary McGann ◽  
...  

Background: Management of venous thromboembolism (VTE) in patients with central nervous system (CNS) malignancies is challenging as there is an increased risk of recurrent VTE and intracranial hemorrhage (ICH). Low molecular weight heparins (LMWH) have historically been the standard of care for treatment of cancer-associated thrombosis (CAT). Current guidelines recommend direct oral anticoagulants (DOACs) for CAT treatment, but patients with CNS malignancies have limited representation in the supporting clinical trials. This multicenter, retrospective cohort study evaluated the safety and efficacy of DOACs compared to LMWH for CAT in patients with primary brain tumors or secondary brain metastases. Patients/Methods: In this multicenter, retrospective cohort study, adult patients with a diagnosis of primary brain tumor or secondary brain metastases who received either a DOAC or LMWH for CAT were evaluated. The primary outcome was the incidence of any bleeding event within a 6-month period following the initiation of anticoagulation. Secondary outcomes included incidence of recurrent VTE events, major bleeding, clinically relevant non-major bleeding (CRNMB), and minor bleeding, within a 6-month period following the initiation of anticoagulation. Patients were excluded if their indication for anticoagulation was stroke, non-cancer-associated VTE, or VTE prophylaxis, were on LMWH for one week or less while bridging to warfarin, or received a diagnosis of VTE at an outside hospital. All bleeding events were defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria. Primary and secondary outcomes were analyzed using Fisher's exact test for categorical variables and Wilcoxon rank-sum tests for non-parametric continuous variables. Results: Between January 1, 2012 to October 9, 2019, one-hundred eleven patients met inclusion criteria. Of the patients who met inclusion criteria, 26 (23.4%) patients had primary brain tumors and 85 (76.6%) patients had secondary brain metastases. Bleeding events occurred in 7 of 55 patients (12.7%) in the DOAC group compared to 13 of 56 (23.2%) patients in the LMWH group (RR 0.55, 95% CI 0.24-1.27). Recurrent VTE events occurred in 3 of 55 (5.5%) patients in the DOAC group compared to 3 of 56 (5.4%) patients in the LMWH group (RR 1.02, 95% CI 0.21-4.83). Major bleeding occurred in 3 of 55 (5.5%) patients in the DOAC group, compared to 4 of 56 (7.1%) patients in the LMWH group (RR 0.76, 95% CI 0.18-3.26). There were no differences in the rates of CRNMB and rates of minor bleeding between groups. Conclusion: In this multicenter retrospective cohort study, therapeutic anticoagulation with DOACs showed no significant difference in bleeding events or recurrent VTE events when compared to LMWH, in patients with primary brain tumors or secondary brain metastases. We conclude that DOACs may be potentially safe and efficacious for VTE treatment in patients with primary brain tumors or secondary brain metastases. As prescribing practices are expected to continue to shift towards DOACs, this study provides preliminary evidence of the safety of DOACs in this high-bleeding risk patient population. Disclosures No relevant conflicts of interest to declare.


2018 ◽  
Vol 69 (9) ◽  
pp. 2465-2466
Author(s):  
Iustin Olariu ◽  
Roxana Radu ◽  
Teodora Olariu ◽  
Andrada Christine Serafim ◽  
Ramona Amina Popovici ◽  
...  

Osseointegration of a dental implant may encounter a variety of problems caused by various factors, as prior health-related problems, patients� habits and the technique of the implant inserting. Retrospective cohort study of 70 patients who received implants between January 2011- April 2016 in one dental unit, with Kaplan-Meier method to calculate the probability of implants�s survival at 60 months. The analysis included demographic data, age, gender, medical history, behavior risk factors, type and location of the implant. For this cohort the implants�survival for the first 6 months was 92.86% compared to the number of patients and 97.56% compared to the number of total implants performed, with a cumulative failure rate of 2.43% after 60 months. Failures were focused exclusively on posterior mandible implants, on the percentage of 6.17%, odds ratio (OR) for these failures being 16.76 (P = 0.05) compared with other localisations of implants, exclusively in men with median age of 42 years.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Cordero ◽  
J.M Garcia-Acuna ◽  
M Rodriguez-Manero ◽  
B Cid ◽  
B Alvarez Alvarez ◽  
...  

Abstract Background In 2019 the Academic Research Consortium of high-bleeding risk (ARC-HBR) proposed a new and binary definition of high-bleeding risk (HBR) patients based on the presence of 1 major or 2 minor criteria. Methods Prospective study of all consecutive patients admitted for ACS in two different centers. We analyzed bleeding incidence in patients with 1 major criteria (1MC) vs. 2 minor criteria (2mC) using the 2019 ARC-HBR consensus. Bleeding events were collected according those fitting definitions 3 or 5 of the BARC consortium. Results We included 8,724 patients included and 40.9% we classified as HBR; 20.9% for 1MC and 20.0% for 2mC. In-hospital mayor bleeding rate was 8.6%; no-HBR patients had 0.3%, 2mC 15.1% and 1MC 29.7% (p&lt;0.001 for the comparison). In contrast, the statistically highest in-hospital mortality was observed in patients with 2mC (11.4%), followed by patients with 1MC (8.0%) and no-HBR patients (2.0%). During follow-up (median time 57.8 months) all-cause mortality rate was 21.0% and cardiovascular dead 14.2%. The incidence of post-discharge major bleeding was 10.5%. No-HBR patients had the lowest bleeding rate (7.4%) and no difference was observed in patients with 1MC (14.6%) or 2mC (15.8%) (figure). The multivariate analysis, adjusted by age, gender, medical treatment, atrial fibrillation and revascularization and considering all-cause mortality as competing risk, showed independent association of 1MC (sHR: 1.46, 95% 1.22–1.75) and 2mC (sHR: 1.31, 95% CI 1.05–1.63) with post-discharge major bleeding. Conclusions HBR patients according to the 2019 ARC-HBR containing 2mC or 1MC are at similar and higher risk of in-hospital or post-discharge bleeding events Funding Acknowledgement Type of funding source: None


2021 ◽  
pp. 001857872098714
Author(s):  
S. P. Veeranki ◽  
Z. Xiao ◽  
A. Levorsen ◽  
M. Sinha ◽  
B. Shah

Introduction: Little is known about outcomes associated with enoxaparin versus unfractionated heparin (UFH) for venous thromboembolism (VTE) prophylaxis in abdominal surgery patients in U.S. clinical practice. The purpose of this study was to compare VTE, all-cause mortality, PE-related in-hospital mortality, and hospital costs during abdominal surgery hospitalization and the 90 days post-discharge between patients who received enoxaparin versus UFH prophylaxis. Materials and Methods: Using the Premier Healthcare Database, abdominal surgery patients who received at least 1 day of VTE prophylaxis with enoxaparin or UFH were identified between January 1, 2010 and September 30, 2016. Clinical outcomes were assessed using multivariable logistic regression models and cost outcomes were assessed using generalized linear models. Results: Of 363,669 patients identified, 59% received enoxaparin and 41% UFH. In adjusted analyses, there were statistically significant lower odds of VTE (OR 0.80; 95% CI 0.65-0.97), all-cause mortality (OR 0.67; 95% CI 0.60-0.75), and major bleeding (OR 0.88; 95% CI 0.82-0.94) during the hospitalization for enoxaparin versus UFH, but no differences during the 90-days post-discharge or for PE-related mortality. There was a statistically significant lower total hospital cost with enoxaparin versus UFH during index hospitalization ($8,913 vs $9,017, P < .0001), but not post-discharge ($3,342 vs $3,368, P = .42). Unadjusted rates of heparin-induced thrombocytopenia (index:0.1% vs 0.3%; post-discharge: 0.02% vs 0.06%) were reported for enoxaparin and UFH, respectively. Conclusion: In contemporary U.S. hospital practice, statistically significant lower odds of VTE, all-cause mortality and major bleeding with enoxaparin versus UFH prophylaxis were found during abdominal surgery hospitalizations.


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