Enoxaparin Group Research Articles

Appropriateness of direct oral anticoagulant dosing for venous thromboembolism treatment.

Adherence to FDA-approved dosing for the direct oral anticoagulants (DOACs) based on renal function, hepatic function, and concomitant medications in a real-world setting has not been evaluated. The purpose of this retrospective cohort analysis was to determine the prescribing accuracy of DOAC dosing for venous thromboembolism (VTE) treatment compared with enoxaparin. The secondary outcomes were to describe the incidence of in-hospital VTE recurrence and bleeding on DOAC therapy. The study included 168 patients with 261 admissions for the DOAC group and 639 patients with 841 admissions for the enoxaparin group. Dosing was appropriate in 235/261 (90.0%) of patient admissions in the DOAC group. Among the DOAC doses administered, 233/2246 (10.4%) were contraindicated based on renal function, hepatic function, or drug interactions compared with 322/7293 (4.4%) of administered enoxaparin doses evaluated based on renal function, p < 0.001. Three recurrent VTEs, 3 major bleeding events, 1 probable major bleeding event, and 3 clinically relevant non-major bleeding events were observed during the study period. Although a majority of DOAC doses administered were appropriate, further education and close monitoring of these agents are warranted to increase appropriateness of therapy and improve patient safety.

Comparison of Enoxaparin and Rivaroxaban in Balance of Anti-Fibrinolysis and Anticoagulation Following Primary Total Knee Replacement: A Pilot Study.

BackgroundThis study aimed to assess whether the efficacy of tranexamic acid (TXA) would be altered when rivaroxaban or enoxaparin was used for thromboprophylaxis in primary total knee replacement (TKR). It was hypothesized that the hemostatic effect of TXA would be better with the use of enoxaparin.Material/MethodsA randomized clinical trial was conducted on 194 patients undergoing primary TKR for osteoarthritis. An intravenous dose of 15 mg/kg (TXA) and 1 g topical TXA were used. Patients randomly received enoxaparin or rivaroxaban prophylaxis when the drainage was less than 30 ml/h 6–8 h postoperatively. The primary endpoint was hidden blood loss (HBL). Indexes of total blood loss drainage, hemoglobin drop, transfusion, range of motion (ROM), HSS score, VAS pain score, knee swelling, length of hospital stay (LOHS), incidence of venous thromboembolism, major/minor bleeding, and wound complications were also compared between the groups.ResultsMore than 80% of patients initiated anticoagulation within 6 h postoperatively. No statistically significance difference was detected in terms of HBL (679.0±205.6 vs. 770.5±206.1, p=.062) or other bleeding index, ROM, or LOHS. The motion VAS pain score and knee swelling (16.7% vs. 6.1%, p=.021) were significantly lower, and HSS score at discharge was higher in the enoxaparin group. The rivaroxaban group had less asymptomatic deep venous (4.1% vs. 0%, p=.121) and muscular venous thrombosis (2.1% vs. 9.2%, p=.033); more ecchymosis (13.5% vs. 10.2%, p=.472), and wound complications (13.5% vs. 6.1%, p=.082). No episodes of transfusion, pulmonary embolism, or major bleeding occurred in either group.ConclusionsMore attention should be paid to the increased risk of wound complications and knee swelling associated with rivaroxaban, although the hidden blood loss was similar in both groups.

Optimal prophylactic method of venous thromboembolism for gastrectomy in Korean patients: Prospective randomized controlled trial.

7 Background: This study was conducted to evaluate the incidence of VTE after surgery gastric cancer patients and determined the optimal method of thromboembolic prophylaxis in Korean patients. Methods: In this trial, 682 patients were assigned to 2 groups; an intermittent pneumatic compression (IPC) with or without 40 mg of enoxaparin. The primary outcome was VTE incidence within 30 days of surgery; defined as deep vein thrombosis (DVT) or documented pulmonary thromboembolism (PTE). The duration of follow-up was 6 months. Results: The primary outcome was assessed in 666 patients. The overall incidence of VTE was 2.10%; that of IPC group was significantly higher than the IPC plus enoxaparin group. Among 14 patients with VTE; 13(92.8%) patients were diagnosed with asymptomatic DVT, 1 patient was diagnosed with PTE. The incidence of bleeding complication was significantly higher in IPC plus enoxaparin group. By month 6, no patient died. Conclusions: Although the incidence of VTE was significantly lower in IPC plus enoxaparin group, symptomatic event was extremely rare and no mortality was observed. In Korean patient with gastric cancer does not need conventional prophylaxis using heparin because of the extremely lower incidence of symptomatic VTE and relatively higher incidence of bleeding complication. Clinical trial information: NCT01448746. [Table: see text]

Comparison of Enoxaparin Sodium and Standard Heparin for Hemodialysis Anticoagulation

Background: Low-molecular-weight heparin (LMWH) has been suggested as an effective and safe anticoagulant for hemodialysis. The aim of our study was to investigate the effects of LMWH including minor bleeding, clotting formation in the extracorporeal dialysis circuit and their effect on the lipid profile in comparison with heparin. Methods: This randomized, crossover study with parallel design was conducted in 45 patients who required maintenance hemodialysis due to end-stage renal failure. Four patients with known bleeding disorders, receiving anticoagulant drugs and receiving drugs which could affect heparin activity were excluded. All patients were randomly assigned to receive either enoxaparin sodium (0.7 mg/kg) or standard heparin for a duration of 12 weeks, after which patients were crossed over to another therapy for a further 12 weeks. Enoxaparin sodium was administered 5 minutes before dialysis, injected into the arterial line pre- dialyser and heparin was administered 50 U/kg intravenously into the pre- dialyser arterial line followed by a maintenance dose of 1000 U per hour. Results: The mean age of the study population was of 65.18 (SD = 12.15) years. From these patients 22 (53%) were male and 19 (47%) were female. At the end of the first study phase, minor bleeding in patients receiving enoxaparin with dose of 0.25 mg/kg was significantly decreased in comparison to the patients receiving heparin (P: 0.03), although vascular compression time did not significantly differ between the heparin and enoxaparin groups. At the end of the second study phase, the enoxaparin group showed a significant increase in minor bleeding in comparison with the heparin group (P: 0. 04). In the enoxaparin arm, recurrent blood oozing from puncture sites led to the idea to reduce the dose of enoxaparin. After enoxaparin dose reduction, the frequency of minor bleeding decreased to 10% (from 19% to 10%) (P: 0.01). Vascular compression time was not statistically different in heparin and enoxaparin at the end of study (P: 0.1). There were no significant changes in serum lipids with either anticoagulant neither at the end of the 12th week nor at the end of the 24th week. Conclusions: This study suggests that a single-dose of enoxaparin is an effective and convenient alternative to standard heparin. The recommended dose of this study in Iranian patients is 0.25 mg/kg.

Bemiparin versus Enoxaparin in the Prevention of Venous Thromboembolism among Intensive Care Unit Patients.

Background:Critically ill patients are considered a high-risk group for developing venous thromboembolism (VTE). Due to their impaired cardiopulmonary reserve, these VTEs may result in significant morbidity and mortality. In this study, we compared two types of low molecular weight heparin, enoxaparin, and bemiparin, as regards to their efficacy and safety in VTE prevention among Intensive Care Unit (ICU) patients.Methods:This study was a prospective, randomized trial of 100 critically ill patients who are at high risk for developing VTE were included in this study and assigned to receive subcutaneous injections of either 3500 international units (IU) anti-factor Xa of bemiparin sodium or 40 mg of enoxaparin given once a day and patient were followed for 60 days after initiation of anticoagulant therapy for the development of documented deep venous thrombosis (DVT) using bilateral lower limb venous duplex, documented pulmonary embolism using computed tomography pulmonary angiography, and complications related to injectant anticoagulant.Results:Confirmed DVT was observed in two patients (4%) in the bemiparin group compared with 10 patients (20%) in the enoxaparin group with P < 0.05. Confirmed pulmonary embolism (PE) was observed in seven patients (14%) in the enoxaparin group with no recorded cases of confirmed PE in the bemiparin group (P < 0.05). No deaths were recorded in either group. Adverse events such as ecchymosis or hematoma at the injection site were observed in one patient (2%) in the bemiparin group and eight patients (16%) in the enoxaparin group (P < 0.05). There was no significant statistical difference between both groups as regards other adverse effects and complications related to the injectant anticoagulant.Conclusion:Bemiparin was superior to enoxaparin as a prophylactic anticoagulant for VTE in critically ill patients with less adverse local complications at the injection site. The study was registered on www.clinicaltrials.gov. Registration ID: NCT02795065. Registered June 8, 2016.

Combined Treatment with an Anticoagulant and a Vasodilator Prevents Steroid-Associated Osteonecrosis of Rabbit Femoral Heads by Improving Hypercoagulability.

Steroid-associated osteonecrosis of the femoral head remains a challenging problem in orthopedics worldwide. One pathomechanism is ischemia of the femoral head, as a result of thrombus formation and vasoconstriction. The present study investigates the effects of combination prevention with enoxaparin and EGb 761 on steroid-associated ONFH in rabbits. Rabbits were randomly divided into 5 groups (control group, model group, enoxaparin group, ginkgo group, and combination group). With the exception of the control group, the groups of rabbits were modeled with lipopolysaccharide and methylprednisolone acetate. Starting with modeling, the enoxaparin group and ginkgo group were injected with 1 μg/kg/day enoxaparin subcutaneously and orally given 40 mg/kg/day EGb 761 for 4 weeks, respectively; the combination group received both treatments. After modeling for 6 weeks, the hematology data indicated prolonged PT and APTT in the three prevention groups. The micro-CT examination revealed higher bone density and better structure; histomorphometry revealed significant pathological changes. Immunohistochemistry revealed higher expression of BMP-2 and VEGF, thus revealing better osteogenesis and angiogenesis activities. Among the three prevention groups, the combination group had the most efficient results. In conclusion, the combined prevention with an anticoagulant and a vasodilator has the potential to decrease the incidence of steroid-associated ONFH in rabbits.

Risk Factors for Bleeding Events with Enoxaparin, Dabigatran and Fondaparinux in Hospitalized Patients with Varying Levels of Renal Impairment

Background: Anticoagulants with renal elimination may accumulate in patients with renal impairment and potentially increase the risk of bleeding. Limited data are available to elucidate the potential bleeding risk present in patients with moderate renal impairment defined as creatinine clearance of 30-50 mL/min. Objective: To evaluate potential risk factors for bleeding over various renal function ranges in patients on enoxaparin, fondaparinux, or dabigatran. Methods: Retrospective chart review from 2010 until 2011 identified patients who incurred a bleeding episode on therapeutic dosed enoxaparin, dabigatran, or fondaparinux stratified according to renal function and presence of pre-defined potential risk factors for bleeding. Bleeding episodes identified using UHC Safety Intelligence, a selfreporting database used to identify safety improvement opportunities. Results: A total of 27 (2.16%) bleeding episodes were identified, 20 occurring during enoxaparin pharmacotherapy and 7 during treatment with dabigatran. There were no fondaparinux bleeds identified. Patients with normal renal function, moderate renal impairment and severe renal impairment incurred 9, 12 and 6 bleeds, respectively. Conclusion: A similar number of patients incurred bleeding episodes on enoxaparin in the normal renal function group and moderate renal impairment group. Patients experiencing bleeding episodes in the enoxaparin group with moderate renal impairment were of advanced age and female. Enoxaparin bleeding episodes were noted in patients with hypertension in all renal function ranges. Patients who bled on dabigatran had some degree of renal impairment and were of advanced age. Concomitant p-glycoprotein inhibitor use was observed in patients with bleeding episodes on dabigatran in patients with renal impairment.

Safety and Effectiveness of Enoxaparin as Venous Thromboembolism Prophylaxis after Gastric Cancer Surgery in Japanese Patients

Routine prophylaxis for venous thromboembolism (VTE) has been recommended after surgery not only in the West but also in Asia recently. The primary objective of this study was to investigate the safety and effectiveness of enoxaparin as a prophylaxis in patients undergoing distal, proximal, or total gastrectomy (TG) for gastric cancers. A total of 565 patients who underwent gastrectomy for gastric cancer were reviewed retrospectively. About 256 patients received postoperative prophylaxis with enoxaparin (2000 international unit twice daily for at least six days) and compression stockings; these patients were assigned to the enoxaparin group. About 257 patients comprised a historical control group, who used only compression stockings as a thromboprophylaxis. All patients underwent the same rehabilitation programs during the perioperative period. None of the patients developed symptomatic venous thromboembolism in either the enoxaparin group or the control group. The complication rate of bleeding was not significantly different between the two groups. Only one patient who used three antiplatelet agents concomitantly with enoxaparin required reoperation for anastomotic site bleeding. The usage of enoxaparin for venous thromboembolism prophylaxis is safe for Japanese patients after gastrectomy. But, cautious application is still needed especially when used concomitantly with other antiplatelet agents.

The Efficacy and Safety of Edoxaban for VTE Prophylaxis Post-Orthopedic Surgery: A Systematic Review.

Venous thromboembolism (VTE) is a common complication that manifests during and/or after hospitalization, as well as postsurgeries including orthopedic surgeries. Edoxaban is a new oral direct factor Xa inhibitor that has been recently approved for treating VTE in patients who have already been treated with a parenteral anticoagulant and for the prevention of stroke and non-central nervous system systemic embolism in patients with nonvalvular atrial fibrillation. The purpose of this systematic review was to evaluate the safety and efficacy of edoxaban for VTE prophylaxis after lower limb orthopedic surgery. A comprehensive search was conducted in Google Scholar, PubMed, MEDLINE, and ScienceDirect to identify potential records, then titles, abstracts, and full texts were screened using the inclusion criteria to filter out irrelevant studies. Moreover, the data extraction and quality assessment were undertaken using standardized tools, and the results were narratively synthesized and presented in tables. Six studies were included in this systematic review after screening 2989 records. The majority of studies demonstrated a statistically significant reduction in VTE events in the edoxaban group(s) compared to the dalteparin, placebo, or enoxaparin groups (P < .05). The differences in VTE cases in some studies reached to approximately 50% favoring edoxaban 30 mg over the comparator (P < .05). However, other studies uncovered a statistically insignificant difference between edoxaban and the comparator "enoxaparin" when used for VTE prophylaxis (P > .05). On the other hand, although edoxaban found to cause more bleeding, the differences between edoxaban and the comparator are statistically insignificant (P > .05). This study helped to amalgamate evidence with regard to the use of edoxaban for VTE prophylaxis post-lower limb orthopedic surgery. In line with the results of the reviewed studies, edoxaban seems to be highly effective in reducing VTE post-lower limb orthopedic surgery.

The effects of enoxaparin on the liver in experimental pneumoperitoneum model

To investigate the potential protective effects of enoxaparin against the adverse events of carbon dioxide (CO2) pneumoperitoneum. Thirty four rats were divided into three groups: Group 1 (sham) underwent insertion of Veress needle into the abdomen and 90 min of anesthesia with no gas insufflation. The animals in control and enoxaparin groups were subjected to 90 min of 14 mmHg CO2 pneumoperitoneum. Enoxaparin (100 u/kg) was administered subcutaneously to the rats in enoxaparin group one hour before the operation. After 90 min of pneumoperitoneum, the rats were allowed for reperfusion through 60 min. Blood and liver samples were obtained for biochemical and histopathological examination. Treatment with enoxaparin decreased the histopathological abnormalities when compared with the control group. The highest levels of oxidative stress parameters were found in control group. The use of enoxaparin decreased the levels of all oxidative stress parameters, but the difference between the control and enoxaparin groups was not statistically significant. Enoxaparin ameliorated the harmful effects of high pressure CO2 pneumoperitoneum on the liver.

Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

BackgroundPatients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown.MethodsPatients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding.ResultsA total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55).ConclusionsAmong acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218.)

Does Anticoagulant Medication Alter Fracture-Healing? A Morphological and Biomechanical Evaluation of the Possible Effects of Rivaroxaban and Enoxaparin Using a Rat Closed Fracture Model.

Low molecular weight heparin (LMWH) is routinely used to prevent thromboembolism in orthopaedic surgery, especially in the treatment of fractures or after joint-replacement. Impairment of fracture-healing due to increased bone-desorption, delayed remodelling and lower calcification caused by direct osteoclast stimulation is a well-known side effect of unfractioned heparin. However, the effect of LMWH is unclear and controversial. Recent studies strongly suggest impairment of bone-healing in-vitro and in animal models, characterized by a significant decrease in volume and quality of new-formed callus. Since October 2008, Rivaroxaban (Xarelto) is available for prophylactic use in elective knee- and hip-arthroplasty. Recently, some evidence has been found indicating an in vitro dose independent reduction of osteoblast function after Rivaroxaban treatment. In this study, the possible influence of Rivaroxaban and Enoxaparin on bone-healing in vivo was studied using a standardized, closed rodent fracture-model. 70 male Wistar-rats were randomized to Rivaroxaban, Enoxaparin or control groups. After pinning the right femur, a closed, transverse fracture was produced. 21 days later, the animals were sacrificed and both femora harvested. Analysis was done by biomechanical testing (three-point bending) and micro CT. Both investigated substances showed histomorphometric alterations of the newly formed callus assessed by micro CT analysis. In detail the bone (callus) volume was enhanced (sign. for Rivaroxaban) and the density reduced. The bone mineral content was enhanced accordingly (sign. for Rivaroxaban). Trabecular thickness was reduced (sign. for Rivaroxaban). Furthermore, both drugs showed significant enlarged bone (callus) surface and degree of anisotropy. In contrast, the biomechanical properties of the treated bones were equal to controls. To summarize, the morphological alterations of the fracture-callus did not result in functionally relevant deficits.

Fish oil attenuates neurologic severity of antiphospholipid syndrome in a mice experimental model

Introduction: Murine experimental models of antiphospholipid syndrome (eAPLS) showed neurologic dysfunction and therapeutic effect of the anticoagulant enoxaparin is well established. Omega-3 fatty acids and curcumin, tested in neuroinflammation and auto-immunity diseases, might be interesting therapeutic candidates. The aim of this study was to evaluate the effects of these candidates on neurologic severity in eAPLS. Methods: One month after immunization of BALB/c mice with beta-2-glycoprotein I, daily treatments were initiated with enoxaparin (1 mg/kg), omega-3 fatty acids (0.5 g/kg), and curcumin (200 mg/kg) for 3 months. Results: Mortality was significantly decreased by enoxaparin and omega-3 treatments. Fish oil and curcumin group exhibited the highest mean of swimming behavior in forced swim test in surviving mice. Mice under omega-3 fatty acids or curcumin presented low anxiety-like behavior in the elevated plus-maze test. Cerebral histopathology revealed heavy inflammatory infiltrates in cortical and subcortical regions with vacuolization, swelling, and degeneration of astrocytes in the control group, with aggravation under curcumin; no infiltrate was retrieved in enoxaparin and omega-3 groups. Conclusion: Our study is the first to demonstrate a potential therapeutic effect of omega-3 fatty acids in eAPLS. Enoxaparin and omega-3 fatty acids combination would be interesting for further investigation.

Fondaparinux vs. enoxaparin for the prevention of venous thromboembolism after total hip replacement: A meta-analysis.

The aim of the study was to compare the efficacy and safety profiles of fondaparinux and enoxaparin in preventing the venous thromboembolism (VTE) after total hip replacement. A systematic literature search in the PubMed, EMBASE and Cochrane library databases was performed to identify relevant articles published in English since inception up to November 16, 2014. The efficacy outcomes were all VTE, total deep vein thrombosis (DVT) and symptomatic VTE, while the safety outcome was major bleeding. Four eligible studies were included in the meta-analysis. The incidences of total VTEs and DVTs were significantly decreased with the use of fondaparinux when compared to enoxaparin [total VTE: risk ratio (RR)=0.59, 95% confidence interval (CI): 0.46–0.74, P<0.01; total DVT: RR=0.58, 95% CI: 0.46–0.74, P<0.01]. Significantly fewer symptomatic VTEs and major bleeding cases were observed for the enoxaparin group (symptomatic VTE: RR=2.62, 95% CI: 1.07–6.45, P=0.04; major bleeding: RR=1.75, 95% CI: 1.20–2.53, P<0.01). In conclusion, the pooled analysis revealed that, compared to enoxaparin, fondaparinux was significantly more effective in preventing VTE after total hip replacements in terms of total VTEs and DVTs, although this was accompanied with an increased risk of major bleeding. However, the pooled analysis of two small sample trials from Japan failed to demonstrate any significant advantage for fondaparinux compared to enoxaparin.

Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients: A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study

In the Re-NOVATE II study, oral dabigatran provided thromboprophylaxis after total hip arthroplasty and improved compliance postdischarge in a global population. This article aims to identify trends (if any) in the Indian population. In this prospective, double-blind, double-dummy study, patients scheduled for primary, unilateral, elective total hip arthroplasty were randomized to 220mg oral dabigatran once daily, starting with a 110mg half-dose, 1-4hours after surgery, or subcutaneous enoxaparin 40mg once daily, starting the evening before surgery. Each group received a placebo of the other study drug. The primary efficacy outcome was the composite of total venous thromboembolism (VTE) and all-cause mortality. Secondary outcome measures were composite of major VTE and VTE-related mortality during the treatment period. The major safety outcome was incidence of bleeding events. Of the 179 Indian patients randomized, 91 received oral dabigatran and 88 received subcutaneous enoxaparin for 28-35days. Total VTE and all-cause mortality occurred in 18.7% of patients in the dabigatran group and 13.7% in the enoxaparin group [odds ratio=1.4 (95% confidence interval 0.6, 3.5)]. Major VTE and VTE-related mortality was numerically lower in the dabigatran group (7.9%) compared with the enoxaparin group (9.9%). Safety outcomes were comparable between both groups. Dabigatran is an effective oral alternative to enoxaparin for thromboprophylaxis as demonstrated by the RE-NOVATE II study global results. Data analyzed in Indian patients indicate comparable effects of dabigatran etexilate for major efficacy and safety outcomes.

Efficacy and safety of fondaparinux versus enoxaparin in patients undergoing percutaneous coronary intervention treated with the glycoprotein IIb/IIIa inhibitor tirofiban.

BackgroundIn worldwide, the mortality rate of acute myocardial infarction (AMI) raises year by year. Although the applications of percutaneous coronary intervention (PCI) and anticoagulants effectively reduce the mortality of patients with acute coronary syndrome (ACS), but also increase the incidence of bleeding. Therefore, drugs with stable anticoagulant effects are urgently required.MethodsWe enrolled 894 patients with acute coronary syndrome who underwent percutaneous coronary intervention in Shenyang Northern Hospital from February 2010 to May 2012; 430 patients were included in the fondaparinux group (2.5 mg/d), and 464 were included in the enoxaparin group (1 mg/kg twice daily). Fondaparinux and enoxaparin were applied for 3–7 days. All patients were treated with tirofiban (10 μg/kg for 3 min initially and 0.15 μg/(kg · min) for 1 to 3 days thereafter). The primary efficacy endpoint was the incidence of a major adverse cerebrovascular or cardiovascular event. The primary safety endpoint was bleeding within 30 days and 1 year after percutaneous coronary intervention.ResultsOne-year data were available for 422 patients in the fondaparinux group and for 453 in the enoxaparin group. The incidence of a major adverse cerebrovascular or cardiovascular event (10.9 % vs 12.6 %, P = 0.433) and cardiac mortality (0.5 % vs 1.5 %, P = 0.116) were generally lower in the fondaparinux group than in the enoxaparin group, although the differences were not significant. Compared with the enoxaparin group, the fondaparinux group had a significantly decreased rate of bleeding at 30 days (0.9 % vs 2.8 %) and 1 year (2.4 % vs 5.4 %). In addition, the rate of major bleeding events was lower in the fondaparinux group, but this difference was not significant (0.2 % vs 0.9 %, 0.2 % vs 1.1 %).ConclusionsIn tirofiban-treated patients with acute coronary syndrome undergoing percutaneous coronary intervention, fondaparinux presented similar efficacy for ischemia events as enoxaparin. However, fondaparinux significantly decreased the incidence of bleeding, thus providing safer anticoagulation therapy.

N-acetylcysteine leads to greater ovarian protection than enoxaparin sodium in a rat ovarian torsion model

This study evaluated the effects of N-acetylcysteine (NAC) and enoxaparin on ovarian tissue preservation, ovarian reserve and oxidative damage following ovarian torsion/detorsion injury. Rats were divided into four groups (n = 6/group): control; ischaemia/reperfusion (I/R); I/R + NAC; I/R + enoxaparin. Twenty-four hours after detorsion, ovarian tissues were collected for histopathological analysis and measurement of tissue 8-OHdG, GSH, MDA, MPO and SOD concentrations, as well as pre- and post-operative circulating AMH concentrations. Administration of NAC resulted in more pre-antral follicles compared with enoxaparin treatment and haemorrhage and follicle cell degeneration were more pronounced in I/R + enoxaparin group than I/R + NAC group. Both NAC and enoxaparin led to a significant reduction in ovarian tissue 8-OHdG (P = 0.004 and P = 0.01, respectively) and MPO (P = 0.013 and P = 0.023, respectively) concentrations compared with I/R group, indicating a protective effect against I/R oxidative damage. Only NAC-treated animals showed a significant increase in GSH and SOD concentrations and decrease in MDA concentrations compared with I/R group (P = 0.007, P = 0.024 and P = 0.026, respectively). These results indicate that NAC is more effective than enoxaparin in minimizing ovarian damage and preserving ovarian reserve following ovarian torsion.

Effect of Preoperative Aspirin Replacement With Enoxaparin in Patients Undergoing Primary Isolated On-Pump Coronary Artery Bypass Grafting

Management of preoperative antiplatelet therapy in coronary artery bypass grafting (CABG) is variable among surgeons: guidelines collide with prejudices because replacement of aspirin with low-molecular-weight heparin is still performed because of a presumed minor bleeding risk. This study aims to analyze postoperative bleedings and complications in patients scheduled for elective primary isolated on-pump CABG, depending on preoperative aspirin treatment or its replacement with enoxaparin. In this cohort study, we propensity score matched 200 patients in whom aspirin was stopped at least 5 days before CABG and replaced with enoxaparin and 200 patients who continued aspirin therapy until the day before surgery. Postoperative bleedings and complications were monitored during hospitalization. Among patients who continued aspirin treatment, mean overall bleeding was 701.0 ± 334.6 ml, whereas in the matched enoxaparin group, it was significantly greater (882.6 ± 64.6 ml, p value <0.001); this was associated with reduced postoperative complications, lower values of postoperative C-reactive protein in aspirin takers, and a presumed protective effect for statins. After propensity score adjustment, aspirin treatment carried a protective effect against major postoperative bleeding (odds ratio 0.312, p = 0.001). In conclusion, postoperative bleeding is reduced in patients who continued aspirin, likely due to a reduction in postoperative inflammation. The practice of empirically discontinuing aspirin and replacing it with enoxaparin before CABG should be abandoned. Patients with coronary artery disease referred to CABG should continue antiplatelet medications until the surgical procedure. Those results might be extended to patients under oral anticoagulant therapy requiring CABG.

Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.

BackgroundIn the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan.MethodsThis was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n = 307) or enoxaparin 2000 IU (equivalent to 20 mg) twice daily (n = 303) for 11 to 14 days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding.ResultsThe incidence of VTE, based on venography and clinical surveillance, was 2.4 % in the edoxaban group and 6.9 % in the enoxaparin group (P <0.001). The absolute difference in the incidence of VTE was −4.5 % (95 % confidence interval [CI]: −8.6, −0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (P = 0.475).ConclusionsOral edoxaban 30 mg once daily was superior to subcutaneous enoxaparin 2000 IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding.

Fondaparinux vs. enoxaparin in patients with non-ST elevation acute coronary syndromes (NSTE-ACS) treated with percutaneous coronary intervention and tirofiban: an exploratory study in China.

Fondaparinux and enoxaparin are used in patients with acute coronary syndrome (ACS), but their effect in particular populations of patients is not well known. The objective was to explore the difference between fondaparinux and enoxaparin in patients with non-ST elevation ACS (NSTE-ACS) treated with percutaneous coronary intervention (PCI) and tirofiban. We prospectively enrolled 461 patients with NSTE-ACS treated with PCI, tirofiban, and either fondaparinux (n=229) or enoxaparin (n=232). Death, myocardial infarction, recurrent ischaemia and its composite outcome were assessed. The incidences of major or minor bleeding not related to coronary artery bypass grafting were also evaluated. The rates of death, MI or refractory angina did not differ between the fondaparinux and enoxaparin groups at day 7 (4·40% vs. 4·70%), 30 (7·90% vs. 8·60%) or 180 (9·60% vs. 10·80%). Similarly, there were not statistically significant differences in the rates of major bleeding at day 7 (0·87% vs. 2·16%), 30 (1·31% vs. 2·59%) or 180 (2·18% vs. 3·88%), or in the rates of minor bleeding at day 7 (3·49% vs. 6·47%), 30 (5·68% vs. 9·48%) or 180 (8·30% vs. 13·36%). In this relatively small study of Chinese patients with NSTE-ACS treated with tirofiban, there was no statistically significant difference in ischaemic or bleeding outcomes with the use of either fondaparinux or enoxaparin.