Retrospective Comparison of Doac with Enoxaparin in Gastrointestinal and Urothelial Cancers

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 21-21
Author(s):  
Shafia Rahman ◽  
Juan Trias ◽  
Mohammad Barouqa ◽  
Margarita Kushnir ◽  
Henny H. Billett

Introduction: Venous thromboembolic disease (VTE) is a common cause of morbidity and mortality in patients with cancer. Cancer associated thrombosis (CAT) is associated with poor prognosis, worse survival and increased care costs. Previous trials demonstrated the non-inferiority of DOACs to LMWH for the treatment of CAT, but there is concern for a possible increased incidence of bleeding, particularly in patients with gastrointestinal (GI) and urothelial (GU) cancers. Current guidelines suggest a preference for enoxaparin with these diagnoses. The aim of our study is to elucidate the safety of DOACs in the treatment of GI and GU cancer associated thrombosis at our institution. Methods: Retrospective chart review of patients with GI or GU cancer associated thrombosis who received either enoxaparin or DOACs (apixaban or rivaroxaban) was performed. The baseline characteristics, duration of anticoagulation (AC) and bleeding events (BEs) were compared between the two groups. The bleeding events were classified according to ISTH categories. Statistical analysis was done using R studio (V1.3.1056). Results: All patients from 01/2001 - 01/2020 with active GI or GU cancer and associated thrombosis who had received enoxaparin or a DOAC were included in the study. Of 262 patients reviewed, 206 (78.6 %) received a DOAC and 56 (21.4%) received enoxaparin. The baseline characteristics between the two groups are depicted in Table 1. Patients in the DOAC group had lower ECOG scores than those on enoxaparin: 79.7% of DOAC and 26.8% of enoxaparin patients had ECOG scores of 1-2. Patients on DOACs were less likely to have metastatic disease (58.7% vs. 78.6%) but were more likely to have additional risk factors for bleeding (p=0.004): 24 patients (11.7%) on DOACs were also on an antiplatelet agent (19 on aspirin, 5 on clopidogrel), compared to 4 patients (7.1%) in enoxaparin group (3 on aspirin, 1 on clopidogrel). Clot distribution was similar between the two groups. The majority of patients, 70.4% in the DOAC group and 73.2% in the enoxaparin group, had no BEs. There was no statistically significant difference in the cumulative incidence (CI) of bleeding between the DOAC and enoxaparin groups (p-value 0.65) Figure 1. In the DOAC group, 109 patients (52.9%) received apixaban and 97 patients (47.1%) received rivaroxaban. There were 26 (23.9%) and 35 (36.8%) BE in the apixaban and rivaroxaban subgroups respectively, Table 2. Of those on apixaban, 13/26 had GI bleeding (12 had underlying GI and 1 patient had GU cancer) and 10/26 had GU bleeding(all with underlying GU cancer). Of those on rivaroxaban 18/35 had GI bleeding (all with underlying GI cancer) and 11/35 had GU bleeding (6 patients had GU and 5 had GI cancer). Conclusion: Our study suggests that physician preferences play a major role in the choice of AC. Most physicians preferred DOACs even for patients with GI/GU cancers when patients had better ECOG scores and non-metastatic disease. However, these were also the same patients that were then more likely to have been exposed to additional risk factors for bleeding. BEs between DOACs and enoxaparin were similar and, between the DOACs, somewhat more favorable with apixaban than rivaroxaban. Randomized clinical trials, controlling for physician choice and bleeding risk factor, are necessary valid comparisons for the best choice of anticoagulation. Disclosures No relevant conflicts of interest to declare.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19501-e19501 ◽  
Author(s):  
Amar Harry Kelkar ◽  
Asha R. Dhanarajan ◽  
Mona Arti Kelkar ◽  
John R. Wingard

e19501 Background: Management of acute leukemia is often complicated by acute venous thromboembolism (VTE) and bleeding. However, it is unknown which risk factors contribute to these VTE and bleeding events, how they impact survival, or whether they warrant VTE prophylaxis. Methods: A retrospective study was conducted at the University of Florida Health Shands Hospital System. The study included patients aged 18 or older with acute leukemia who received induction chemotherapy between January 2000 and December 2011. Bleeding was defined as clinically significant non-major bleeding and major bleeding per the International Society on Thrombosis and Haemostasis guidelines. VTE was defined as pulmonary embolism, deep vein thrombosis of the upper or lower extremities, or visceral vein thrombosis. Results: Of the 250 patients with acute leukemia, 65 had VTE, 60 had bleeding, and 152 had no significant VTE or bleeding. There were 27 patients with both VTE and bleeding. There were no significant differences in demographics or disease types between these three groups. There was a total of 77 VTE events and 72 bleeding events. We performed a logistic regression analysis in a mixed model to identify risk factors for VTE and bleeding, considering leukemia type, presence of infection, chemotherapy, number of comorbidities, VTE prophylaxis, and transplant as covariates. Presence of infection and number of comorbidities were significantly associated with VTE (p = 0.0094 and 0.0009, respectively). We did not find any significant risk factor associated with bleeding. Kaplan-Meier survival analysis showed a non-significant difference in survival between the non-VTE, non-bleed group and the VTE group (Logrank test, p = 0.52). In contrast, survival in the non-VTE, non-bleed group was significantly higher than the bleed group (Logrank test, p = 0.0006). The table demonstrates higher two-year survival in the non-VTE, non-bleed group (68.7%) compared to the VTE and bleed groups (54.4% and 30.3%, respectively). Conclusions: Acute leukemia patients without VTE or bleeding had significantly higher duration of survival than patients with bleeding. Patients with acute leukemia and presence of infection or multiple comorbidities may warrant greater consideration of VTE prophylaxis. [Table: see text]


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Nirupama Vellanki ◽  
kevin kennedy ◽  
Edward W Grandin ◽  
Jose Nunez ◽  
Shweta R Motiwala ◽  
...  

Intro: Women have been shown to have higher risk of bleeding after adverse cardiovascular events. Bleeding events are a major cause of morbidity and mortality in patients with continuous flow left ventricular assist devices (cf-LVADs). There are few studies that have demonstrated that women with cf-LVADs may be at higher risk of bleeding, however the sex differences in specific bleeding events has not been studied in a large multi-center patient population of patients with cf-LVADs. We sought to investigate the relationship between sex and specific types of bleeding events in patients with cf-LVADs. Methods: We included 16,534 patients from the INTERMACS registry, a national multicenter database of patients implanted with cf-LVAD between 2012-2017. Using a cox proportional hazards model, we assessed the relationship between sex and bleeding events after adjusting for relevant covariates*. Bleeding events were further stratified for the type of bleeding including GI bleeding, intracranial hemorrhage, and non-GI/CNS bleeding. Results: Women were more likely to have a bleeding event than men post-LVAD implantation (HR 1.19 p<0.0001). While the majority of bleeding events were GI bleeds, there was no significant difference in risk between men and women (p 0.7). After adjusting for covariates, women were more likely to have an intracranial hemorrhage (HR 1.38, p 0.002) and to have non-GI/non-CNS bleeding (HR 1.25, p<0.0001). Conclusion: Females are more likely than men to develop bleeding events post cf-LVAD implantation. While there was no significant sex difference in GI bleeding, women were more likely to have intracranial bleeding and non-GI/non-CNS bleeding.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1070-1070
Author(s):  
Shafia Rahman ◽  
Juan Trias ◽  
Margarita Kushnir ◽  
Henny H. Billett

Abstract Introduction: DOACs are absorbed in the gastrointestinal (GI) tract and DOAC elimination is primarily through the GI and genitourinary (GU) systems. The safety of DOACs in cancer associated thrombosis in subjects with malignant lesions in GI and GU malignancies has been of concern. Studies have been sparse and data conflicting. Methods: We identified patients with active GI and GU malignancies from July 2001 to July 2020 with confirmed VTE at our institution. Patients who received either enoxaparin or a DOAC (apixaban or rivaroxaban) were included in the study. Demographic, disease characteristics, VTE data and events were extracted from electronic medical records (EMR). Date of anticoagulation (AC) initiation was based on the first order and/or prescription of the anticoagulant. Patients were followed either to the earliest bleeding event (BE) or one year from initiation, whichever occurred first. BEs were categorized based on ISTH guidelines. Variables were compared between LMWH and DOAC cohorts, as well as between the apixaban and rivaroxaban cohorts, using t-tests for continuous variables and chi-squared tests or Fisher's exact test for categorical variables. Results: We identified a total of 206 patients, 159 in the DOAC and 47 in the LWMH groups. Table 1 describes the baseline characteristics of the study populations. Median age of patients, gender and BMI were comparable for all groups. When evaluated for type of cancer, 66.6% of patients had active GI malignancy while 33.3% had active GU tumors. The majority of the patients given DOACs had a better ECOG status than those in the LMWH group (p=0.0023), but no difference was noted for ECOG status between DOACs (p=0.69). Most patients had metastatic disease. The majority of the VTE events were in the form of DVTs. Concomitant aspirin intake was 9.4% in DOAC and 4.2% in LMWH groups. Cancer subtypes and AC choice data are given in detail in Table 2. LMWH use was higher in blacks and somewhat lower in the Hispanic population (Table 1). When anticoagulation choice was examined by primary tumor site (Table 2), disproportionately more patients with GU tumors were placed on LMWH while more GI cancers were given a DOAC (p=0.014). Extent and stage of the cancer did not appear to bias anticoagulant choice (p=0.62). Within the DOACs, rivaroxaban use was higher in the GI cancers but considerably less used in the GU malignancies (p=0.00049). There was one recurrent thrombosis in each of the apixaban (1/86) and the rivaroxaban (1/73) cohorts. There were no recurrent events in the LMWH (0/47) cohort. The majority of patients in the DOAC and LMWH groups, 88.1% and 86.4%, had no CRNMB or major bleeding events in the 1-year period after the initiation of the therapeutic AC (Table 3). Combined BE (clinically relevant non-major bleeding [CRNMB] and major bleeding rates) with apixaban, rivaroxaban and LMWH were 17.4% (15/86), 20.5% (15/73), and 19.1% (9/47) respectively. There were no fatal bleeding episodes in any of the groups. Most of the bleeding events on DOACs and LMWHs occurred in the same organ system as the primary cancer (Table 3) but there was no statistically significant difference in bleeding events between patients on DOACs or LMWH for GI, GU or all cancer types (p=0.63, 0.75 and 0.97 respectively). Within DOACs, we also noted no statistically significant difference in the bleeding events with apixaban as compared to rivaroxaban in patients with GI primary, GU primary or all cancer types together, (p=0.47, 0.94 and 0.62 respectively). Conclusion: No significant differences in major/CRNM bleeding events were found for patients with GI or GU cancer associated thrombosis given DOACs (apixaban/rivaroxaban) vs enoxaparin. The tumor site is often the site of bleeding, but no differences in tumor-specific site bleeding could be shown by anticoagulant choice. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 584-584 ◽  
Author(s):  
Shaan Dudani ◽  
Jeffrey Graham ◽  
Connor Wells ◽  
Sumanta K. Pal ◽  
Nazli Dizman ◽  
...  

584 Background: In mRCC, ipilimumab and nivolumab (ipi-nivo) is a 1L treatment option. Recent data have also shown efficacy of 1L PD(L)1-VEGF (PV) inhibitor combinations. The efficacy of these two strategies has not been compared. Methods: Using the IMDC dataset, patients (pts) treated with any 1L PV combination were compared to those treated with ipi-nivo. Multivariable Cox regression analysis was performed to control for imbalances in IMDC risk factors. Results: 164 pts received 1L IO combination therapy: 104 treated with PV combinations and 60 with ipi-nivo. Baseline characteristics and IMDC risk factors were comparable between groups (Table). When comparing PV combinations vs ipi-nivo, 1L response rates (RR) were 30% vs 39% (p = 0.29), time to treatment failure (TTF) was 13.2 (95% CI 8.3-16.1) vs 8.5 months (95% CI 5.7-14.0, p = 0.31), and median overall survival (OS) was not reached (NR) (95% CI 19.7-NR) vs NR (95% CI 27.6-NR, p = 0.39). When adjusted for IMDC risk factors, the hazard ratio (HR) for TTF was 0.77 (95% CI 0.44-1.35, p = 0.36) and the HR for death was 0.94 (95% CI 0.33-2.71, p = 0.91). Similar results were seen when restricting the cohort to IMDC intermediate/poor risk pts only. In pts receiving subsequent VEGF TKI monotherapy, second-line (2L) RR (13% vs 45%, p = 0.07) and TTF (5.5 vs 5.4 months, p = 0.80) for PV combinations (n = 15) vs ipi-nivo (n = 20) were not significantly different. Conclusions: There does not appear to be a superior 1L IO combination strategy in mRCC, as PV combinations and ipi-nivo have comparable RR, TTF and OS. Although there is a trend towards differences in RR, there does not appear to be a significant difference in TTF for patients receiving 2L VEGF TKI therapy. [Table: see text]


2010 ◽  
Vol 80 (3) ◽  
pp. 159-167 ◽  
Author(s):  
Gabriela Villaça Chaves ◽  
Gisele Gonçalves de Souza ◽  
Andréa Cardoso de Matos ◽  
Dra. Wilza Abrantes Peres ◽  
Silvia Elaine Pereira ◽  
...  

Objective: To evaluate retinol and β-carotene serum levels and their relationship with risk factors for cardiovascular disease in individuals with morbid obesity, resident in Rio de Janeiro. Methodology: Blood serum concentrations of retinol and β-carotene of 189 morbidly obese individuals were assessed. The metabolic syndrome was identified according to the criteria of the National Cholesterol Education Program (NCEP) and World Health Organization (WHO). Lipid profile, insulin resistance, basal insulin, glycemia, blood pressure, and anthropometry and their correlation with retinol and β-carotene serum levels were evaluated. Results: Metabolic syndrome diagnosis was observed in 49.0% of the sample. Within this percentage the levels of β-carotene were significantly lower when body mass index increased. Serum retinol didn't show this behavior. Serum retinol inadequacy in patients with metabolic syndrome (61.3%), according to WHO criterion, was higher (15.8%) than when the whole sample was considered (12.7%). When metabolic syndrome was diagnosed by NCEP criterion, β-carotene inadequacy was higher (42.8%) when compared to the total sample (37.5%). There was a significant difference between average β-carotene values of patients with and without metabolic syndrome (p=0.048) according to the classification of the NCEP. Lower values were found in patients with metabolic syndrome. Conclusion: Considering the vitamin A contribution in antioxidant protection, especially when risk factors for cardiovascular disease are present, it is suggested that great attention be given to morbidly obese. This could aid in prevention and treatment of cardiovascular disease, which affects a significant part of the population.


Author(s):  
Habib Yarizadeh ◽  
Alireza Bahiraee ◽  
Sara Asadi ◽  
Niloofar Sadat Maddahi ◽  
Leila Setayesh ◽  
...  

Abstract. Objective: The genetic variants near the melanocortin-4 receptor gene (MC4R), a key protein regulating energy balance and adiposity, have been related to obesity and cardiovascular risk factors. However, qualitative and quantitative aspects of diet may modulate the association of this polymorphism with obesity and cardiovascular diseases (CVDs). The aim of this study was to evaluate interactions among MC4R rs17782313, the Dietary Approaches to Stop Hypertension (DASH) diet and risk factors for CVDs. Method: This cross-sectional study was conducted on 266 Iranian women categorized by body mass index (BMI) range of 25–40 kg/m2 as overweight or obese. CVD risk factors included waist circumference (WC), lipid profile, blood pressure, insulin circulation and fasting blood sugar (FBS). Insulin and FBS were used to calculate homeostatic model assessment insulin resistance (HOMA-IR) Body composition was assessed by a multi-frequency bioelectrical impedance analyzer, InBody 770 scanner. Results: The findings of this study show that high adherence to the DASH diet in the CC groups were associated with decreased SBP and DBP compared to the TT group. In addition, a significant difference between women with high adherence to the DASH diet compared to low adherence was observed for body weight (p < 0.001), fat free mass (FFM) (p = 0.01) and BMI (p = 0.02). Women with the CC genotype had higher insulin (mg/dl) (mean and SD, for TT: 14.6 ± 4.6, TC: 17.3 ± 9.2, CC: 15.3 ± 4.8, p = 0.04) and HOMA-IR (mean for and SD, TT: 3.1 ± 1.07, TC: 3.9 ± 2.4, CC: 3.2 ± 1.1, p = 0.01) than TT group. Inclusion of potential confounding variables (age, physical activity, BMI and daily caloric intake) did not attenuate the difference. Conclusion: Among overweight/obese Iranian women with the CC genotype, incorporating the DASH diet may serve as a dietary prescription to decrease CVD risk. A dietary intervention trial is warranted.


2018 ◽  
Vol 1 (3) ◽  
pp. 26-38
Author(s):  
Abdulghani Mohamed Alsamarai ◽  
Shler Ali Khorshed

Background: Urinary tract infection is common with health impact in women and characterised by failure to treatment and recurrent episodes. Aim: This study was conducted to determine the risk factors for the development of urinary tract infection in diabetic and pregnant women in comparison to student female. Materials and methods: A prospective cross-sectional study conducted during the period from 1st of June 2015 to the end of January 2016. The population included in the study are 563 women, of them 425 were outpatients, and 138 were inpatients. Their age range between 18 and 80 years, with a mean age of 33.59±15.29 years. Urine samples collected and cultured on blood agar and MacConkey agar by spread plate technique. Bacterial colonies with different morphology were selected, purified and identified according to their biochemical characteristics using conventional standard methods. Results: In diabetic women, there were no significant difference in mean age and BMI values between culture positive and culture negative groups. However, pus cell mean scale was significantly higher [P=0.000] in women with urinary tract infection [1.76±1.25] than in those with negative culture [0.69±1.00]. In pregnant women, BMI mean value was significantly [P=0.013] lower in pregnant women with UTI [26.14] as compared to those without infection [26.99]. Pus cell scale mean value was significantly [P=0.000] higher in pregnant women with UTI [1.55] than women with negative UTI [0.85]. While there was no significant difference in mean age between UTI positive and negative pregnant women. In female student, there was a significant difference between UTI infected and non-infected in mean age [P=0.041] and pus cell scale [P=0.000]. However, BMI was not significantly different between infected and non-infected female student. Other risk factors association are variables in the 3 groups when analysed using X2, while AUC and OR show different trends of association between risk factors and UTI. Conclusion: BMI, pus cell scale, child number, delivery method, operation history and hospital setting were significantly associated with culture positivity in the 3 studied groups as determined by AUC. While OR confirmed association with pus sale scale in the 3 groups.


2015 ◽  
Vol 18 (4) ◽  
pp. 140 ◽  
Author(s):  
Mehmet Taşar ◽  
Mehmet Kalender ◽  
Okay Güven Karaca ◽  
Ata Niyazi Ecevit ◽  
Salih Salihi ◽  
...  

Background: Carotid artery disease is not rare in cardiac patients. Patients with cardiac risk factors and carotid stenosis are prone to neurological and cardiovascular complications. With cardiac risk factors, carotid endarterectomy operation becomes challenging. Regional anesthesia is an alternative option, so we aimed to investigate the operative results of carotid endarterectomy operations under regional anesthesia in patients with cardiac risk factors. <br />Methods: We aimed to analyze and compare outcomes of carotid endarterectomy under regional anesthesia with cardiovascular risk groups retrospectively. Between 2006 and 2014, we applied 129 carotid endarterectomy ± patch plasty to 126 patients under combined cervical plexus block anesthesia. Patients were divided into three groups (high, moderate, low) according to their cardiovascular risks. Neurological and cardiovascular events after carotid endarterectomy were compared.<br />Results: Cerebrovascular accident was seen in 7 patients (5.55%) but there was no significant difference between groups (P &gt; .05). Mortality rate was 4.76% (n = 6); it was higher in the high risk group and was not statistically significant (P = .180). Four patients required revision for bleeding (3.17%). We did not observe any postoperative surgical infection.<br />Conclusion: Carotid endarterectomy can be safely performed with regional cervical anesthesia in all cardiovascular risk groups. Comprehensive studies comparing general anesthesia and regional anesthesia are needed. <br /><br />


2020 ◽  
Vol 66 (1) ◽  
pp. 19-22
Author(s):  
Melania Macarie ◽  
Simona Maria Bataga ◽  
Monica Pantea ◽  
Razvan Opaschi ◽  
Simona Mocan ◽  
...  

AbstractObjective: This study aims to determine the correlation between risk factors and erosive esophagitis development.Methods: We conducted a retrospective observational study on a consecutive series of 19.672 patients who underwent upper gastrointestinal endoscopy between 01.01.2011-31.12.2017. A total of 3005 patients, diagnosed with erosive esophagitis, were included in the present study and stratified according to Los Angeles classification.Results: During the studied period we found 3005 patients with erosive esophagitis, sex ratio male to female was 1.3/1, the most common forms of esophagitis being grade A and B: 74.54% patients with esophagitis grade A, 14.80% patients with grade B; 5.29% patients were with grade C and 5.35% patients with esophagitis grade D. In severe esophagitis the male predominance was more prevalent (249 males, 71 female), with a sex ratio 3.50/1. The correlation of male gender with severe esophagitis was highly statistically significant (p < 0.0001, OR 2.97; 95% CI 2.25-3.91). Hiatal hernia was diagnosed in 1171 patients, the presence of large hiatal hernias, being an important predictor, with statistical significance (p < 0.0001, OR 3.41; 95% CI 2.22-5.21), for severe esophagitis development. Incidence of Helicobacter pylori infection was 11.51%, in the entire study group, with no statistical significant difference between patients with mild or severe esophagitis (12.02% vs 7.18%).Conclusion: Erosive esophagitis is a frequent disease, the most common forms being grade A and B. Male gender and the presence of hiatal hernia are the most important risk factors for erosive esophagitis development, in our study group.


2019 ◽  
Author(s):  
Daryl Brian O'Connor

Suicide is a global health issue accounting for at least 800,000 deaths per annum. Numerous models have been proposed that differ in their emphasis on the role of psychological, social, psychiatric and neurobiological factors in explaining suicide risk. Central to many models is a stress-diathesis component which states that suicidal behavior is the result of an interaction between acutely stressful events and a susceptibility to suicidal behavior (a diathesis). This article presents an overview of studies that demonstrate that stress and dysregulated hypothalamic-pituitary-adrenal (HPA) axis activity, as measured by cortisol levels, are important additional risk factors for suicide. Evidence for other putative stress-related suicide risk factors including childhood trauma, impaired executive function, impulsivity and disrupted sleep are considered together with the impact of family history of suicide, perinatal and epigenetic influences on suicide risk.


Sign in / Sign up

Export Citation Format

Share Document