Rate Of Venous Thromboembolic Events Research Articles

Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial

IntroductionFast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates...

Intravenous Tranexamic Acid Safely and Effectively Reduces Transfusion Rates in Revision Total Knee Arthroplasties.

The efficacy and safety of tranexamic acid (TXA) in primary total knee arthroplasty (TKA) have been well established. However, there have been limited data for revision TKAs. The primary aim was to assess the impact of intravenous TXA on transfusion rates and symptomatic venous thromboembolic events (VTEs) in a large revision TKA cohort with or without intravenous TXA utilization. A retrospective review of revision TKAs performed from 2005 to 2014 was performed, identifying 2,951 procedures (2,219 patients), in which TXA was utilized in 1,144 procedures (39%). The mean age was 65 years with 52% female patients in the TXA revision group and 67 years with 52% female patients in the non-TXA revision group. Transfusion rates and symptomatic VTEs were the primary outcomes assessed. Comparisons were performed between cohorts, utilizing a unique propensity model to mitigate bias, on the basis of TXA use and subsequently for aseptic or septic revision etiology. Significant reductions in transfusion rates with use of TXA were identified in revision TKAs overall (13% compared with 39%; p < 0.001 [adjusted relative risk, 1.7]), including revisions for both aseptic etiology (6% with TXA compared with 28% without TXA; p < 0.001) and septic etiology (31% with TXA compared with 54% without TXA; p < 0.001). The risk of a postoperative symptomatic VTE was not significantly different (adjusted p = 0.63) with use of TXA at 11 events (1.0%) compared with 24 events (1.3%) in the non-TXA group). Intravenous TXA significantly reduced transfusion rates in revision TKAs by approximately twofold, including cohorts revised for aseptic and septic etiologies. There was a very low rate of VTEs (1.2%) with no significant difference in the number of VTEs between groups after adjusting risk utilizing propensity modeling. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Khorana score and thromboembolic risk in stage II-III colorectal cancer patients: a post hoc analysis from the adjuvant TOSCA trial.

Background:The risk of venous thromboembolic events (VTE) during adjuvant chemotherapy for colorectal cancer (CRC) is unknown. We aim to evaluate if the Khorana score (KS) can predict this risk, and if it represents a prognostic factor for overall survival (OS) through a post hoc analysis of the phase III TOSCA trial of different durations (3- versus 6-months) of adjuvant chemotherapy.Methods:A logistic regression model was used to test the associations between the risk of VTE and the KS. The results are expressed as odds ratios (OR) with 95% confidence intervals (95% CI). To assess the effect of the KS on OS, multivariable analyses using Cox regression models were performed. The results are expressed as hazard ratios (HR) with 95% CI.Results:Among 1380 CRC patients with available data, the VTE risk (n = 72 events: 5.2%) was similar in the two duration arms (5.5% versus 4.9%), with 0.2% of patients belonging to the high-risk KS group. Rates of VTE were similar in the low- and intermediate-risk groups (4.8% versus 6.4%). KS did not represent an independent predictive factor for VTE occurrence. Chemotherapy duration was not associated with VTE risk. In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63–1.36; p = 0.6835).Conclusions:The use of the KS did not predict VTEs in a low–moderate thromboembolic risk population as CRC. These data did not support the use of KS to predict VTE during adjuvant chemotherapy, and suggest that other risk assessment models should be researched.

Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis.

An individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51–0.91, p = 0.008) and in the lower-risk group (RR: 0.69, 95% CI: 0.40 -1.20, p = 0.187). The modified IMPROVE VTE score with an elevated D-dimer identified a nearly threefold higher VTE risk subpopulation of patients where a significant benefit exists for ET using rivaroxaban.

Risk of Venous Thromboembolic Events in Patients with Osteonecrosis of the Femoral Head Undergoing Primary Hip Arthroplasty.

Previous data have shown patients with osteonecrosis of the femoral head (ONFH) have increased lifelong risk of unprovoked venous thromboembolic events (VTE) as compared with the general population, according to sharing common pathological mechanism of endothelial dysfunction. However, whether the risk of VTE increases in those ONFH patients undergoing major hip replacement surgery remains unclear. This is a retrospective nationwide Asian population-based study. From 1997 to 2013, a total of 12,232 ONFH patients receiving partial or total hip replacement for the first time and revision surgeries were retrospectively selected from Taiwan Health Insurance surgical files. By 1:1 matching on age, sex, surgical types, and socioeconomic status, 12,232 subjects without ONFH undergoing similar hip surgery were selected as non-ONFH group. The incidence and risk of post-surgery VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE), were compared between the ONFH and non-ONFH groups. Results showed that 53.8% of ONFH patients were male and the median age was 61.9 years old. During the mean follow-up period of 6.4 years, the incidences of VTE (1.4% vs. 1.2%), DVT (1.1% vs. 0.9%), and PE (0.4% vs. 0.4%) were slightly but insignificantly higher in the ONFH than in the non-ONFH group undergoing the same types of major hip replacement surgery (all p-values > 0.250). Concordantly, we found no evidence that the risk of VTE was increased in the ONFH patients as compared with the non-ONFH counterparts (adjusted HR 1.14; 95% CI 0.91–1.42; p = 0.262). There were also no increased risks for DVT and PE in the ONFH subgroups stratified by comorbidities, drug exposure to pain-killer or steroid, and follow-up duration after surgery, either. In conclusion, hip arthroplasty in Asian patients with ONFH is associated with similar rates of VTE as compared to patients with non-ONFH diagnoses.

Baseline Characteristics and Clinical Outcomes from the Cancer Associated Thrombosis - Patient Reported Outcomes with Rivaroxaban (COSIMO) Trial

Background: Patients living with cancer who develop venous thromboembolism (VTE) have a high risk of VTE recurrence, and traditional anticoagulants (low molecular weight heparin [LMWH] or vitamin K antagonists [VKAs]) are associated with significant treatment burdens. Rivaroxaban is a direct oral anticoagulant (DOAC) that may provide a more convenient treatment option for these patients. Methods: The COSIMO study was a multinational, prospective, non-interventional, single-arm cohort study designed to collect real-world data on patient treatment satisfaction and outcomes associated with rivaroxaban treatment following ≥4 weeks of LMWH/VKA therapy for the treatment of acute VTE in patients with active cancer. Here, we report on the secondary objectives, which were to provide descriptive analyses of clinical characteristics and patterns of use of anticoagulant treatment, and to assess the safety and effectiveness of rivaroxaban in this patient population. Results: Overall, 505 patients were enrolled, and the qualifying venous thromboembolic event was deep vein thrombosis (DVT) only in 45.3% of patients, pulmonary embolism (PE) only in 37.2% of patients, DVT with PE in 9.7% of patients, and catheter-associated DVT in 7.5% of patients (Table). The majority of patients had solid tumors (n=449, 88.9%); 56 patients had hematological malignancies. The most common reasons to switch to rivaroxaban were patient preference/quality of life (n=310, 61.4%) and physician decision (n=174, 34.5%). A total of 150 (29.7%) patients were treated with concomitant chemotherapy and 79 (15.6%) received concomitant radiotherapy. Overall, 117 (23.2%) patients discontinued the study: 59 (11.7%) died, 21 (4.2%) withdrew consent, and 17 (3.4%) were lost to follow-up. 80.2% of patients were treated with rivaroxaban for at least 3 months, and most patients (78.6%) received rivaroxaban 20 mg once daily on study entry. Treatment-emergent adverse events (AEs) were reported: 312 (61.8%) patients had an AE (148 [29.3%] serious AEs), and 95 (18.8%) patients had a bleeding event reported, of which 18 (3.6%) patients had an adjudicated major bleeding event. Adjudicated symptomatic and incidental VTE recurrence occurred in 15 (3.0%) and 3 (0.6%) patients, respectively. Adjudicated other site thromboembolic events such as splanchnic or cerebral vein thromboses were symptomatic in 1 (0.2%) patient and incidental in 1 (0.2%) patient. Conclusions: Observed incidence rates of VTE and bleeding events in COSIMO were similar to previous studies of DOACs for VTE treatment in patients with active cancer (Young AM et al. J Clin Oncol 2018;36:2017; Raskob GE et al. N Engl J Med 2018;378:615). Study governance Bayer AG Funding The COSIMO study is funded by Bayer AG and Janssen Pharmaceuticals. Trial protocol number NCT02742623. Registered 19 April 2016. Documented approval from appropriate independent ethics committees/institutional review boards will be obtained for all participating centers prior to study start. Patients were asked to provide signed informed consent forms before joining the study. Few patients have yet completed the study, and so no data are available to share. Acknowledgements Editorial assistance was provided by Kate Weatherall of Chameleon Communications Int. Ltd. with funding from Bayer AG and Janssen Scientific Affairs, LLC. Disclosures Maraveyas: Bristol-Myers Squibb: Honoraria; Bayer AG: Honoraria, Research Funding; Pfizer: Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Bayer HealthCare: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding. Lee:Pfizer: Consultancy, Honoraria; LEO Pharma: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding. Mantovani:Daiichi Sankyo: Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Bayer AG: Honoraria; Fondazione Charta: Consultancy; Pfizer: Honoraria. De Sanctis:Bayer US LLC: Employment, Equity Ownership. Abdelgawwad:Bayer AG: Employment. Fatoba:Bayer AG: Employment. Bach:Bayer AG: Employment. Cohen:Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ACI Clinical: Consultancy; CSL Behring: Consultancy; Aspen: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Boehringer-Ingelheim: Consultancy, Speakers Bureau; TRN: Consultancy; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; Temasek Capital: Consultancy; Boston Scientific: Consultancy; Guidepoint Global: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Leo Pharma: Consultancy; GLG: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Thromboprophylaxis in lower limb immobilisation after injury (TiLLI)

Venous thromboembolic disease is a major global cause of morbidity and mortality. An estimated 10 million episodes are diagnosed yearly; over half of these episodes are provoked by hospital admission/procedures...

Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial.

To assess the safety and efficacy of tranexamic acid (TXA) use in fractures of the pelvic ring, acetabulum, and proximal femur. Prospective, randomized controlled trial. Single Level 1 trauma center. Forty-seven patients were randomized to the study group, and 46 patients comprised the control group. The study group received 15 mg/kg IV TXA before incision and a second identical dose 3 hours after the initial dose. Transfusion rates and total blood loss (TBL) [via hemoglobin-dilution method and rates of venous thromboembolic events (VTEs)]. TBL was significantly higher in the control group (TXA = 952 mL, no TXA = 1325 mL, P = 0.028). The total transfusion rates between the TXA and control groups were not significantly different (TXA 1.51, no TXA = 1.17, P = 0.41). There were no significant differences between the TXA and control groups in inpatient VTE events (P = 0.57). The use of TXA in high-energy fractures of the pelvis, acetabulum, and femur significantly decreased calculated TBL but did not decrease overall transfusion rates. TXA did not increase the rate of VTE. Further study is warranted before making broad recommendations for the use of TXA in these fractures. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (ARM‐DVT): Methods of a prospective single‐arm management study

BackgroundUpper extremity deep vein thrombosis (UEDVT) constitutes approximately 10% of all deep vein thromboses (DVTs). The incidence of UEDVT is increasing in association with use of peripherally inserted central venous catheters. Treatment for UEDVT is derived largely from evidence for treatment of lower extremity DVT. Limited evidence exists for the use of a direct oral anticoagulant for the treatment of UEDVT. PopulationSequential patients identified within the Intermountain Healthcare System and University of Utah Healthcare system with symptomatic UEDVT defined as the formation of thrombus within the internal jugular, subclavian, axillary, brachial, ulnar, or radial veins of the arm. InterventionApixaban 10 mg PO twice daily for 7 days followed by apixaban 5 mg twice daily for 11 weeks. ComparisonThe historical literature review rate of venous thrombosis reported for recurrent clinically overt objective venous thromboembolism (VTE) and VTE‐related death. If the confidence interval for the observed rate excludes the threshold event rate of 4%, we will conclude that treatment with apixaban is noninferior and therefore a clinically valid approach to treat UEDVT. Sample SizeWe elected a sample size of 375 patients so that an exact 95% confidence interval would exclude an event rate of VTE in the observation cohort of 4%. OutcomeNinety‐day rate of new or recurrent objectively confirmed symptomatic venous thrombosis and VTE‐related death. The primary safety outcome is the composite of major and clinically relevant nonmajor bleeding.

Obesity is associated with postinjury hypercoagulability.

Obesity is linked to hypercoagulability with an increased risk of venous thromboembolic events (VTE) in the uninjured population. Therefore, we hypothesize that obesity (body mass index [BMI] ≥30 kg/m [BMI30]) is associated with a hypercoagulable state postinjury characterized by increased clot strength and resistance to fibrinolysis. Our prospective Trauma Activation Protocol database includes all trauma activations patients for whom a rapid thrombelastography is obtained within 60 minutes postinjury prior to any transfusions. The data set was then stratified by BMI and subjects with BMI30 were compared with those with BMI less than 30 kg/m). The following thrombelastography measurements were obtained: activated clotting time, clot formation rate (angle), maximum clot strength (MA), and % clot lysis 30 minutes after MA (LY30, %). Fibrinolysis shutdown (SD) was defined as LY30 < 0.6% and hyperfibrinolysis (HF) as LY30 greater than 7.6%. Continuous variables are expressed as median (interquartile range). Overall, 687 patients were included of whom 161 (23%) had BMI30. The BMI30 group was older, had a lower proportion of males and of blunt trauma, and was less severely injured. After adjustment for confounders, BMI30 was independently associated with lower odds of MA less than 55 mm (odds ratio [OR], 0.28; 95% confidence interval [CI], 0.13-0.60) and of HF (OR, 0.31; 95% CI, 0.10-0.97) and higher odds of SD (OR, 1.82; 95% CI, 1.09-3.05). No independent association was observed with angle less than 65° (OR 0.57 95% CI 0.30-1.05). While VTEs were more frequent among BMI30 patients (5.0 vs. 3.3%), this did not reach significance after confounding adjustment (p = 0.11). Obesity was protective against diminished clot strength and hyperfibrinolysis, and obesity was associated with an increased risk of fibrinolytic SD in severely injured patients. These findings suggest a relative hypercoagulability. Although no difference in VTEs was noted in this study, these findings may explain the higher rate of VTEs reported in other studies. Prognostic and Epidemiological, level III.

Comparison of Venous Thromboembolism Prophylactic Measures Post Coronary Artery Bypass Graft Surgery.

There is considerable debate surrounding venous thromboembolism (VTE) prophylaxis in patients post coronary artery bypass grafting (CABG) procedures. The American College of Chest Physicians guidelines report weak recommendations for starting VTE prophylaxis, but provide no specific guidance regarding timing or preferred prophylactic agent. This retrospective cohort study was designed to compare outcomes of post-cardiac surgery patients admitted to the cardiovascular intensive care unit (ICU) who received subcutaneous unfractionated heparin (UFH), with those who received subcutaneous enoxaparin for VTE prophylaxis. Between January 2013 and September 2017, 1085 patients were identified, and, after propensity score matching, 850 patients were selected for analysis. The primary outcomes were postoperative VTE and the occurrence of bleeding events up to 30 days postoperatively. Secondary outcomes included chest tube output, days mechanically ventilated, ICU length of stay, total hospital length of stay, and 30-day readmission rates. During the study period, rates of 2.03% for VTE events and 1.38% for bleeding events were reported in the entire cohort. After matching, the rates of VTE events (2.12% vs. 1.41%, p=0.43) and bleeding events (1.18% vs. 0.94%, p=1.00) were more frequent in the heparin group versus the enoxaparin group; these differences were not statistically significant. However, we did find a statistically significant increase in several secondary endpoints, including chest tube output, days mechanically ventilated, ICU length of stay, and total hospital length of stay, within the heparin cohort. Bleeding rates were similar to those previously published, despite the early initiation of VTE prophylaxis. We report no statistical difference in the rates of VTE or bleeding between chemical agents, but our results suggest enoxaparin may be a preferred agent over UFH.

Intravenous tranexamic acid safely and effectively reduces transfusion rates in revision total hip arthroplasty.

Tranexamic acid (TXA) has been shown to significantly reduce transfusion rates in primary total hip arthroplasties (THAs), but high-quality evidence is limited in the revision setting. The purpose of the current study was to compare the rate of blood transfusions and symptomatic venous thromboembolic events (VTEs) in a large cohort of revision THAs treated with or without intravenous (IV) TXA. We performed a retrospective review of 3264 revision THAs (2645 patients) between 2005 and 2014, of which 1142 procedures received IV TXA (1 g at incision and 1 g at closure). The mean age in the revision group with TXA was 65 years (28 to 95), with 579 female patients (51%). The mean age in the revision group treated without TXA was 67 years (21 to 98), with 1160 female patients (55%). Outcomes analyzed included rates of transfusion and symptomatic VTEs between procedures undertaken with and without TXA. These comparisons were performed for the overall cohort, as well as within cases subcategorized for aseptic or septic aetiologies. A propensity score was developed to minimize bias between groups and utilized age at revision THA, sex, body mass index, American Society of Anesthesiologists (ASA) score, preoperative anticoagulation, and year of surgery. Tranexamic acid significantly and substantially reduced the rate of blood transfusions after revision THA overall from 54% to 26% (p < 0.001; adjusted relative risk (RR) 1.6; 95% confidence interval (CI) 1.3 to 1.9), with a significant reduction in both aseptic (49% to 18%; p < 0.001) and septic (73% to 53%; p = 0.04) revisions. The rate of VTE was minimal overall, with three events (0.3%) in the TXA group and four events (0.2%) in the non-TXA group. There were no significant differences in VTE rates based on TXA use or aetiology of revision. Intravenous TXA significantly reduced transfusion rates during all-cause revision THAs, including a subgroup analysis of both aseptic and septic cohorts. Adjusted risk using propensity modelling showed no statistical difference in rates of VTEs between either group. Cite this article: Bone Joint J 2019;100-B(6 Supple B):104-109.

JAK Inhibitors in Rheumatology

In Germany, baricitinib and tofacitinib have been approved for the treatment of at least moderately active rheumatoid arthritis after the failure of conventional disease modifying anti-rheumatic drugs in 2017, and tofacitinib also for psoriatic arthritis and ulcerative colitis. Both baricitinib and tofacitinib can be taken orally and reversibly inhibit Janus kinases (JAK) and therefore the signaling of a large number of cytokines via the JAK/STAT pathway. JAK inhibitors have been shown to be at least as efficacious in rheumatoid arthritis as adalimumab and tofacitinib was also efficacious in psoriatic arthritis. Since they inhibit many cytokines, it is likely that in the future they will be applied for the treatment of further chronic inflammatory disorder such as connective tissue diseases and vasculitis. The adverse events of JAK inhibitors are comparable to those observed with biologicals, only herpes zoster is slightly more common. In the placebo-controlled trials, venous thromboembolic events (VTE) were more common in the baricitinib treated patients. The VTE rate does not appear to be elevated in baricitinib treated patients compared to RA cohorts however.In conclusion, JAK inhibitors are a powerful new treatment of RA and likely many other rheumatic diseases and fulfill an unmet need since they may be taken orally.

Clinical benefit of bevacizumab in Mexican ovarian cancer patients according to the intention of treatment by the oncologist.

e17097 Background: Ovarian cancer (OC) is the first cause of gynecological cancer, and the fifth cause of women cancer-death in US. In Mexico, more than 4,500 new cases of ovarian cancer are diagnosed yearly and it represents the second cause of gynecological cancer mortality. Bevacizumab (BVZ) is an antiangiogenic antibody that has been approved for first-line and recurrence therapy in OC patients. The aim of the study was to evaluate the clinical benefit of BVZ in different lines of treatment in Mexican OC patients. Methods: A total of 94 OC patients treated with BVZ were recruited at the Ovarian Cancer Program of the Instituto Nacional de Cancerología, from February 2012 to September 2018. Clinicopathological characteristics and toxicity was correlated with line of treatment. PFS curves were estimated by the Kaplan–Meier method, while comparisons among groups were analyzed with log-rank or Breslow tests. Results: Most of the patients were stage IIIC (69.1%) with HGSP histology (73.4%). 24 patients (25.5%) received BVZ as first-line treatment before debulking surgery (50% for suboptimal and 45.8% for optimal cytoreduction). 48 patients (51.1%) received BVZ for second-line (72.9% after a platinum-resistant and 27.1% after a platinum-sensitive recurrence) and 22 patients (23.4%) for three or more lines of treatment. Venous thromboembolic events (VTE) were more frequent in multi-treated patients ( P= 0.030). The median PFS was 23.7, 11.7 and 5.8 months for first, second and third or more lines, respectively. Patients with optimal debulking surgery had a better PFS compared with suboptimal and BVZ in first-line patients (24.8 vs 20.9; P= 0.050). Patients with BVZ in second-line who are a platinum-sensitive recurrence had better PFS compared to those with a platinum-resistant disease (15.1 vs 7.6; P= 0.040). Conclusions: OC patients had clinical benefit from treatment with BVZ when used as first-line and first recurrence treatments. The use of BVZ for third or later line treatment has a questionable benefit and is associated with a higher rate of VTE. Also, we highlight that 77% of the patients had the greatest-benefit while 33% had limited-benefit.

Venous Thromboembolism and Bleeding Adverse Events in Lower Leg, Ankle, and Foot Orthopaedic Surgery with and without Anticoagulants.

Currently, there is insufficient knowledge about the benefits of anticoagulant use for primary prevention of venous thromboembolism (VTE) and its inherent risk of bleeding adverse events in patients undergoing surgery distal to the knee. The study included patients who had undergone an orthopaedic procedure distal to the tibial articular surface when they were 18 years of age or older. Using retrospective information from a tertiary care referral center, we compared patient demographics, clinical findings, diagnostic reports, procedures performed, and the rate of symptomatic VTE and bleeding adverse events between patients who had and those who had not received anticoagulant prophylaxis. Propensity score matching was used to minimize selection bias due to prophylactic treatment allocation. A total of 5,286 patients who had received anticoagulant prophylaxis for below-the-knee surgery were successfully matched with 5,286 patients who had not received anticoagulant prophylaxis for such surgery. After propensity score matching, the standardized difference between the groups was <0.1 for all baseline characteristics, indicating a negligible difference between the groups. Patients who received anticoagulant prophylaxis had a significantly lower risk of developing a VTE compared with patients who did not (39 patients [0.7%] versus 99 patients [1.9%]), with an odds ratio (OR) of 0.38 (95% confidence interval [CI], 0.25 to 0.56; p < 0.001). In contradistinction, patients who received anticoagulant prophylaxis had a significantly higher risk of developing a bleeding adverse event than those who did not (115 [2.2%] versus 55 [1.0%]; OR, 2.18 [95% CI, 1.55 to 3.09]; p < 0.001). Anticoagulant prophylaxis reduced the risk of VTE after surgery distal to the tibial articular surface by 3-fold but resulted in a concomitant 2-fold increase in the risk of a bleeding adverse event. Large-scale, prospective studies are necessary to better understand the true incidence of such events, associated patient-specific risk factors, efficacy of various thromboprophylactic regimens, and patient-reported implications of such events. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Venous thromboembolism events among RA patients.

Background:Rheumatoid arthritis (RA) is associated with an increased risk for venous thromboembolism. However, so far, relatively few and small size-based studies have been conducted. We aimed to investigate the link between RA and venous thromboembolism utilizing a large sample of subjects originating from a large data base.Materials and methods:The study was performed utilizing the medical database of Clalit Health Services, the largest healthcare provider in Israel. We enrolled all patients with RA and age- and gender-matched controls. Chi-square and t-tests were used for univariate analysis and a logistic regression model was used for a multivariate analysis. RA patients were compared to controls regarding the proportion of venous thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or both). Multivariate logistic regression was employed to assess factors associated with thromboembolic events.Results:The study included 11,782 patients with RA and 57,973 age- and gender-matched controls. RA patients had a higher rate of venous thromboembolism events compared with controls (6.92% vs. 3.18%, respectively, p<0.001). RA and mean C-reactive protein levels were found to be independently associated with the proportion of thromboembolic events (OR 2.27 for RA and 1.07 for each 1 mg/dL increment of mean C-reactive protein, respectively).Conclusion:RA and C-reactive protein levels are independently associated with venous thromboembolic events. Physicians should be aware of such findings and have a lower threshold for suspecting detecting such events in patients with RA, mainly those with mean high levels of C-reactive protein.

AB143. 9. Comparison of functional outcomes of the ATTUNE total knee arthroplasty system versus its five closest competitors

Background: Total knee arthroplasty (TKA) system success is guided by validated patient reported outcome measures (PROMs). It is essential to continually innovate TKA to ensure an excellence of care for the vast numbers of prospective patients. Techniques and implant designs have evolved as a result of the strong evidence behind them. The primary outcome of this study is to analyse differences in PROMs after TKA comparing the ATTUNE knee system to its 5 closest competitors. Secondary outcome measures were to analyse rates of venous thromboembolic events (VTE), periprosthetic infection (PJI) and noninfective reoperation rates.

Hypercoagulability and Risk of Venous Thromboembolic Events in Endogenous Cushing's Syndrome: A Systematic Meta-Analysis.

Background: Hypercortisolism has been implicated in the development of venous thromboembolic events (VTE). We aimed to characterize VTE risk in endogenous Cushing's syndrome (CS) patients, compare that risk to other pathologies, and determine if there are any associated coagulation factor changes.Methods: Medline and Scopus search for “hypercortisolism” and “thromboembolic disease” from January 1980 to April 2017 to include studies that reported VTE rates and/or coagulation profile of CS patients. A systematic review and meta-analysis were performed.Results: Forty-eight studies met inclusion criteria. There were 7,142 CS patients, average age was 42 years and 77.7% female. Odds ratio of spontaneous VTE in CS is 17.82 (95%CI 15.24–20.85, p < 0.00001) when comparing to a healthy population. For CS patients undergoing surgery, the odds ratio (both with / without anticoagulation) of spontaneous VTE is 0.26 (95%CI 0.07–0.11, p < 0.00001)/0.34 (0.19–0.36, p < 0.00001) when compared to patients undergoing hip fracture surgery who were not treated with anticoagulants. Coagulation profiles in patients with CS showed statistically significant differences compared to controls, as reflected by increases in von Willebrand factor (180.11 vs. 112.53 IU/dL, p < 0.01), as well as decreases in activated partial thromboplastin time (aPTT; 26.91 vs. 30.65, p < 0.001) and increases in factor VIII (169 vs. 137 IU/dL, p < 0.05).Conclusion: CS is associated with significantly increased VTE odds vs. general population, but lower than in patients undergoing major orthopedic surgery. Although exact timing, type, and dose of anticoagulation medication remains to be established, clinicians might consider monitoring vWF, PTT, and factor VIII when evaluating CS patients and balance advantages of thromboprophylaxis with risk of bleeding.

Influence of the duration of hospital length of stay on frequency of prophylaxis and risk for venous thromboembolism among patients hospitalized for acute medical illnesses in the USA.

BackgroundWe evaluated whether the duration of hospital stay influences venous thromboembolism (VTE) prophylaxis patterns and VTE risk during hospitalization and post-discharge among patients hospitalized for acute illnesses in the USA.MethodsPatients hospitalized for acute illnesses were identified from the US MarketScan Commercial and Medicare databases (January 1, 2012–June 30, 2015). Patients were stratified by index hospital length of stay (LOS), with study groups with 1–3 day, 4–6 day, and ≥7 day LOSs. Use of VTE prophylaxis and VTE event rates during and after hospitalization (6-month follow-up) were evaluated.ResultsOf the overall population, 8647 had a 1–3 day LOS, 5551 had a 4–6 day LOS, and 3697 had a ≥7 day LOS. A greater proportion of patients with a 1–3 day LOS (66.2%) did not receive any VTE prophylaxis in comparison to patients with a 4–6 day LOS (55.0%) and ≥7 day LOS (48.8%; p<0.001). Proportions of patients with VTE events during the index hospitalization increased with longer hospital LOS (1–3 day LOS: 0.5%; 4–6 day LOS: 1.3%; ≥7 day LOS: 5.4%), as did proportions of patients with VTE events during the 6-month follow-up (1–3 day LOS: 2.4%; 4–6 day LOS: 2.7%; ≥7 day LOS: 4.2%).ConclusionAmong this study population of hospitalized acutely ill patients in the USA, VTE pharmacologic prophylaxis was underutilized, regardless of the duration of hospital stay. However, the risk for VTE events was substantial, with nearly 10% of those with a ≥7 day LOS having suffered a VTE event within 6 months.

Factors associated with venous thromboembolic events following ICU admission in patients undergoing spinal surgery: an analysis of 1269 consecutive patients.

In BriefIn a retrospective study the authors examined 1269 patients who underwent spinal surgery and were admitted to the intensive care unit (ICU) and identified factors that are associated with venous thromboembolic events (VTEs) in this "high risk" group. Amongst these high-risk factors were: surgeries longer than 4 hours, comorbid disease, patients needing an osteotomy, and patients undergoing spinal stabilization for fractures. Identification of factors that can be optimized prior to surgery will decrease the rates of VTE.