scholarly journals Safety of Rivaroxaban for Postoperative Venous Thromboembolism Prophylaxis Following Abdominal Body Contouring Surgery: 600 Patients

Author(s):  
Vasileios Vasilakis ◽  
Bill G Kortesis ◽  
Gaurav Bharti ◽  
Matthew H Isakson ◽  
Joseph P Hunstad

Abstract Background Reducing the incidence of venous thromboembolism (VTE) following abdominal body contouring surgery remains a top priority for patient safety. There is a lack of consensus regarding the optimal chemoprophylactic agent for postoperative VTE prophylaxis, and the role of oral anticoagulants warrants further investigation. Objectives The aim of this multisurgeon, single-institution study was to determine the safety and efficacy of a 7-day postoperative rivaroxaban regimen for VTE prophylaxis in abdominal body contouring surgery. Methods A retrospective chart review was performed of all patients who underwent abdominoplasty, circumferential body lift, fleur-de-lis panniculectomy, or circumferential fleur-de-lis panniculectomy at our surgical center from August 2014 to November 2019. A 7-day postoperative course of once-daily 10 mg rivaroxaban, starting on postoperative day 1, was administered to every patient unless there was a contraindication. The 2 primary endpoints were the incidence of VTE and bleeding events. Results A total of 600 patients were included in the study. There were no deaths. There were 4 (0.7%) incidents of VTE events: 2 (0.3%) patients suffered pulmonary embolus and 2 (0.3%) patients suffered a lower-extremity deep venous thrombosis. A total of 13 (2.2%) patients suffered complications related to bleeding. Of these, operative intervention for control and evacuation was required in 7 (1.2%) patients. Conclusions A 7-day postoperative course of once-daily rivaroxaban for VTE risk reduction in abdominal body contouring surgery is associated with a low incidence of VTE events and a low risk of bleeding complications. Level of Evidence: 4

2019 ◽  
Vol 39 (11) ◽  
pp. 1214-1221 ◽  
Author(s):  
Deniz Sarhaddi ◽  
Kyle Xu ◽  
Alex Wisbeck ◽  
Olivier Deigni ◽  
Sumesh Kaswan ◽  
...  

Abstract Background It is well established that abdominoplasty confers a uniquely high risk of venous thromboembolism (VTE) complications. However, chemoprophylaxis is not routinely utilized due to the risk of bleeding complications. Fondaparinux, a factor Xa inhibitor FDA approved in 2001 for postoperative VTE prophylaxis, has emerged as a safe option for preventing VTE complications after high-risk surgeries. Objectives The goal of this study was to examine the effectiveness and safety of fondaparinux for VTE chemoprophylaxis in patients undergoing abdominoplasty. Methods This is a single-center retrospective chart review from January 2008 to December 2014 of 492 patients who underwent abdominoplasty with or without an additional body procedure. Prior to 2011, no VTE chemoprophylaxis was utilized (n = 233). In 2011, the routine employment of postoperative chemoprophylaxis with fondaparinux was implemented (n = 259). Patient demographics and 2005 Caprini scores were evaluated. Primary outcomes included postoperative VTE and bleeding complications. Results There were no statistical differences in patient demographics or median Caprini score. The treatment group demonstrated a statistically significant reduction in the rate of VTE compared with the nontreatment group (0% vs 2.1%, respectively, P = 0.02). There was no statistically significant difference in the rate of hematoma requiring reoperation between the nontreatment and treatment groups (1.7% vs 2.3%, P = 0.76) or blood loss requiring transfusion (0% vs 0.8%, P = 0.5). Conclusions Fondaparinux for VTE chemoprophylaxis after abdominoplasty is efficacious in decreasing the risk of VTE in this susceptible patient population without increasing the risk of postoperative bleeding complications. Level of Evidence: 3


2019 ◽  
Vol 40 (9) ◽  
pp. 989-995 ◽  
Author(s):  
Vasileios Vasilakis ◽  
Gabriel M Klein ◽  
Michael Trostler ◽  
Muntazim Mukit ◽  
Jocellie E Marquez ◽  
...  

Abstract Background Venous thromboembolism (VTE) chemoprophylaxis warrants an individualized, risk-stratified approach, and constitutes a relatively controversial topic in plastic surgery. Objectives The aim of this study was to determine the safety of a 7-day postoperative enoxaparin regimen for VTE prophylaxis compared with a single preoperative dose of heparin in abdominal body contouring surgery. Methods This single-institution pre-post study investigated the safety of a 7-day enoxaparin postoperative regimen in abdominal body contouring procedures performed by a single surgeon from 2007 to 2018. Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction. Group I patients received a single dose of 5000 U subcutaneous heparin in the preoperative period, and no postoperative chemical prophylaxis was administered. Group II patients received 40 mg subcutaneous enoxaparin in the immediate preoperative period, then once daily for 7 days postoperatively. Results A total of 195 patients were included in the study, 66 in Group I and 129 in Group II. The groups demonstrated statistically similar VTE risk profiles, based on the 2005 Caprini risk-assessment model. There were no statistically significant differences in the 2 primary outcomes: postoperative bleeding and VTE events. Group I patients had higher reoperation rates (22.7% vs 10.1%, P = 0.029), which was secondary to higher rates of revision procedures. Conclusions A 7-day postoperative course of once-daily enoxaparin for VTE risk reduction in abdominal body contouring surgery does not significantly increase the risk of bleeding. Implementation of this regimen for postdischarge chemoprophylaxis, when indicated following individualized risk stratification, is appropriate. Level of Evidence: 4


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4964-4964 ◽  
Author(s):  
Zachary Crowther ◽  
Jamie Doyle ◽  
Stanford Taylor ◽  
Nadia Ali

Introduction: Venous thromboembolism (VTE) is a common complication in multiple myeloma (MM) patients for several reasons; hematologic malignancy itself is a VTE risk factor and standard of care immunomodulatory drugs (IMiDs) in combination with dexamethasone (Dex) increase the risk further. This combination therapy has a mean VTE incidence of 21.5% in studies that did not use thromboprophylaxis and is recommended for all patients on IMiDs, although the optimal thromboprophylactic regimen remains uncertain. In clinical practice, aspirin (ASA) is commonly prescribed for VTE prophylaxis due to the ease of use. Despite this, the incidence of VTE remains between 7-14%. There is a growing body of literature supporting the efficacy and safety of direct oral anticoagulants (DOACs) for the treatment of VTE in cancer populations. We wanted to assess the incidence of VTE despite ASA prophylaxis at our institution and to further characterize the role of DOACs in the MM population. To do this, we performed a chart review of all MM patients who had been treated with lenalidomide and a DOAC, assessing for VTE development and patient outcomes. Methods: We conducted a retrospective chart review of patients with the diagnosis of MM treated with lenalidomide therapy at Fox Chase Cancer Center at Temple University Hospital or Cottman Avenue after Jan 1st, 2015 to July 2019. Eligible patients were identified through electronic medical record data mining for patients that had been diagnosed with MM, had been prescribed lenalidomide, had been taking ASA while on lenalidomide, and switched to rivaroxaban, edoxaban or apixaban. For comparison, the number of patients treated with lenalidomide and ASA who did not switch to a DOAC were also identified. Patient charts were reviewed for VTE development and bleeding complications after DOAC administration. Results: 132 patients were identified who had a diagnosis of MM and had been prescribed lenalidomide between Jan 1, 2015 and July 31, 2019. These patients were also prescribed aspirin except for three who were already on a DOAC prior to starting lenalidomide. Of the total 132 patients, only 17 were prescribed a DOAC. Six of the patients were on DOACs for reasons other than VTE (atrial fibrillation N=4, atrial flutter N=1, marantic endocarditis N=1). Eleven patients were started on DOACs for VTE; incidence of 8.3% in our myeloma population. However three of these VTEs occurred within one month of high dose melphalan chemotherapy and autologous stem cell rescue. These three patients had been off lenalidomide for over one month prior to VTE. Eight of the 17 patients with VTE developed clots in the setting of active MM and concurrent therapy with IMiD/Dex, independent of hospitalizations or other provoking factors. This is an incidence of 6.0% for VTE directly attributed to therapy. Six patients were on lenalidomide and Dex, while two patients developed VTE while on pomalidomide and Dex. No patients on lenalidomide experienced recurrent VTEs after being switched to therapeutic dose DOAC. One patient on pomalidomide/Dex did experience recurrent VTE. We examined all 17 patients who were on DOACs, 16 of which had been on IMiD and DOACs concurrently. Three had minor bleeding events which all resolved spontaneously. One patient had a major bleeding event, which was a fatal ruptured cerebral aneurysm while on a DOAC and ASA concurrently. Conclusion: The incidence of VTE in our patient population receiving IMiD/Dex while on ASA prophylaxis therapy was similar to what has been previously reported in the literature. We examined the clinical outcomes of 16 patients treated with IMiDs and DOACs concurrently and found few bleeding events. The one major bleed was likely precipitated by malignant hypertension and not a direct result of being on a DOAC. Taken together these results further support the growing body of evidence that DOACs are effective and safe treatments for VTE in cancer patients, including MM. Moving forward, our clinical experience with treatment dose DOACs supports the use of prophylactic dose DOACs to potentially further reduce the incidence of VTE in this high-risk population. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
Author(s):  
ANTONINA OBAYO ◽  
Mzee Ngunga ◽  
Jasmit Shah ◽  
Ahmed Sokwala ◽  
Anders Barasa

Abstract Background: The purpose of this study is to determine the rates of bleeding associated with NOAC use. Methods: Patients diagnosed with venous thromboembolism (VTE) and treated with NOACs at a tertiary referral hospital in Kenya from January 2014 to December 2019 were recruited. They were followed up from commencement of oral anticoagulation to completion of therapy, the first major bleed, clinically relevant non-major bleed (CRNM), or minor bleeding. Data on bleeding was obtained from the hospital database and through telephone interviews. Unadjusted rates of the first major bleeding event or clinically relevant non-major bleeding (CRNM) were calculated as the number of bleeding events per 100 patient-years Results: Two hundred forty-three patients with VTE were recruited. 222(91.4%) were initiated on rivaroxaban, 12(4.9%) on dabigatran, 9(3.7%) on apixaban with a median follow-up of 213(119,477) days. The median age of the patients was 57(45, 71) years. A total of 64 bleeding events were identified in 41(16.9%) patients, 18.8 % were major, 17.2 % were clinically relevant non-major (CRNM), and 64.1 % were minor. The incidence rate for bleeding events was 22.1 per 100 patient-years. Gastrointestinal (GIT) bleeding was the most common major bleeding site. There were more females with bleeding events (70.7%) compared to males. Conclusions: In our cohort, most bleeding events were minor, with the GIT being the most common site of major bleeding and menorrhagia being the commonest cause of bleeding. Females had more major and CRNM than men.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Oshima ◽  
K Fujiu ◽  
Y Yoshida ◽  
H Matsunaga ◽  
J Matsuda ◽  
...  

Abstract Background In patients undergoing AF catheter ablation (CA), uninterpreted DOACs reduced bleeding events without increasing ischemic events compared with vitamin K antagonist, and the continuation of anticoagulants is recommended for AF ablation. However, in the past studies, patients received once-daily DOACs in the evening, not in the morning of the procedure day. Moreover, there has been no study comparing uninterrupted 4 DOACs; therefore, the safety and effect of uninterpreted DOACs taken just in the morning of AF ablation is unknown. Objective The purpose of this study was to compare bleeding complications and thromboembolism events between 4 DOACs in patients undergoing AF ablation. Method This study was the retrospective single-center cohort study of consecutive patients who underwent AF ablation between April 2014 to July 2019. All patients continued DOAC uninterruptedly including just in the morning of the procedure. The primary endpoint included major bleeding events within the first 30 days after CA. The secondary endpoints included the composite events of ischemic stroke, systemic embolism, myocardial infarction, and vascular death. Result A total of 713 patients (mean age 64±12 years, 72% male) were included in this analysis; enrolled patients were 88, 238, 218, and 169 respectively in dabigatran, rivaroxaban, apixaban and edoxaban group. At the baseline, the ratio of age ≥75 years and CHADS2 score was higher in apixaban group, though all other baseline variables were similar between them. The primary endpoint was observed 0%, 2.1%, 0.45%, and 4.7% respectively in dabigatran, rivaroxaban, apixaban, and edoxaban group (P=0.013) without significant difference about secondary endpoint between them (P=0.3). Comparing twice-daily vs once-daily DOACs, the primary endpoint was observed significantly lower in the twice-daily group than in once-daily group (0.32% and 3.2% respectively, P=0.0054), without any significant difference about secondary endpoint (0% and 0.73% respectively, P=0.26). Conclusion Taking DOACs also in the morning of AF ablation, uninterrupted twice-daily DOACs are safer than once-daily DOACs without increasing ischemic event, although twice-daily DOACs, especially apixaban, were used in higher aged patients. Figure 1 Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 27 ◽  
pp. 107602962097957
Author(s):  
Soo-Mee Bang ◽  
Jin-Hyoung Kang ◽  
Min Hee Hong ◽  
Jin-Seok Ahn ◽  
So Yeon Oh ◽  
...  

This study assessed epidemiologic data and clinical outcomes, including venous thromboembolism (VTE) recurrence and bleeding events, in patients with cancer-associated VTE, and assessed factors associated with clinical outcomes. Data were extracted from retrospective medical-chart review of adult patients diagnosed with cancer-associated deep vein thrombosis or pulmonary embolism who received anticoagulation treatment for ≥3 months. Patients were classified by: low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs), and other anticoagulants. First VTE recurrence and bleeding events, and factors associated with their occurrence, were assessed during the initial 6 months of treatment. Overall, 623 patients (age: 63.7 ± 11.3 years, 49.3% male) were included (119, 132, and 372 patients in LMWH, DOACs and other anticoagulants groups, respectively). The cumulative 6-month incidence of VTE recurrence was 16.6% (total), 8.3% (LMWH), 16.7% (DOACs), and 20.7% (other); respective bleeding events were 22.5%, 11.0%, 12.3%, and 30.7%). VTE recurrence and bleeding rates differed only between LMWH and other anticoagulants (HR 2.4, 95% CI: 1.2-5.0 and 3.6, 1.9-6.8, respectively). These results highlight the importance of initial VTE treatment choice for preventing VTE recurrence and bleeding events. LMWH or DOACs for ≥3 months can be considered for effective VTE management in cancer patients.


2019 ◽  
Vol 9 (5) ◽  
pp. 348-366
Author(s):  
G. G. Taradin ◽  
G. A. Ignatenko ◽  
N. T. Vatutin ◽  
I. V. Kanisheva

The presented review concerns contemporary views on specific aspects of anticoagulant and thrombolytic treatment of venous thromboembolism and mostly of acute pulmonary embolism. Modern classifications of patients with acute pulmonary embolism, based on early mortality risk and severity of thromboembolic event, are reproduced. The importance of multidisciplinary approach to the management of patients with pulmonary embolism with the assistance of cardiologist, intensive care specialist, pulmonologist, thoracic and cardiovascular surgeon, aimed at the management of pulmonary embolism at all stages: from clinical suspicion to the selection and performing of any medical intervention, is emphasized. Anticoagulant treatment with the demonstration of results of major trials, devoted to efficacy and safety evaluation of anticoagulants, is highlighted in details. Moreover, characteristics, basic dosage and dosage scheme of direct (new) oral anticoagulants, including apixaban, rivaroxaban, dabigatran, edoxaban and betrixaban are described in the article. In particular, the management of patients with bleeding complications of anticoagulant treatment and its application in cancer patients, who often have venous thromboembolism, is described. Additionally, modern approaches to systemic thrombolysis with intravenous streptokinase, urokinase and tissue plasminogen activators are presented in this review. The indications, contraindications, results of clinical trials devoted to various regimens of thrombolytic therapy, including treatment of pulmonary embolism by lower doses of fibrinolytic agents, are described.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sanghamitra Mohanty ◽  
CHINTAN G TRIVEDI ◽  
Joseph Gallinghouse ◽  
Domenico G Della Rocca ◽  
Carola Gianni ◽  
...  

Background: A considerable proportion of elderly patients are known to have coexistent atrial fibrillation (AF) and amyloidosis. Both conditions increase stroke risk. Objective: We evaluated the best anticoagulation strategy in a series of AF patients with amyloidosis. Methods: Consecutive AF patients with coexistent amyloidosis undergoing catheter ablation at our center were included in the analysis. Based on the stroke-prophylaxis approach they were divided into 2 groups; group 1: left atrial appendage occlusion (LAAO) with Watchman and group 2: oral anticoagulation. Following LAAO, all patients remained on full dose non-vitamin K oral anticoagulants (NOAC) for 45 days. Transesophageal echocardiogram (TEE) was performed at 45 days to assess completeness of closure. If the occlusion was complete, patients were kept on aspirin, 81 mg/day for long-term. In case of leak or dense ‘smoke’ in the left atrium (LA) or enlarged LA, they were prescribed half-dose NOAC. NOACs included dabigatran, apixaban, endoxaban and rivaroxaban. Group 2 patients remained on full-dose NOAC during the whole study period (1 year). All patients were prospectively followed up for 1 year. Results: A total of 87 patients were included in the analysis; group 1: 56 and group 2: 31 . CHA 2 DS 2 -VASc score was comparable between the groups (gr. 1: 3.7±1.6 and gr. 2: 3.2±1.7, p=0.18). The most commonly used NOACs were apixaban (45, 51.7%) and rivaroxaban (34, 39%). After the 45-day TEE, 34 patients from group 1 remained on baby-aspirin and 22 on half-dose NOAC. Of the 22, 12 patients had leaks <5 mm, 6 had large LA (mean diameter 5.2±1.4 cm) and 4 patients had dense LA smoke. At 1-year follow-up, 3 stroke and 1 transient ischemic attack were reported in group 1 on baby-aspirin (4/34, 11.8%). No stroke or bleeding complications occurred in the 22 patients on half-dose NOAC. In group 2 patients on full-dose OAC, a total of 5 (5/31, 16.1%) bleeding events (1 subdural hematoma and 4 GI bleedings) were recorded. Additionally, a stroke was reported that happened during brief discontinuation of OAC for another medical procedure. Conclusion: In our series of patients with coexistent AF and amyloidosis, half-dose NOAC following LAA occlusion procedure was observed to be the safest stroke-prophylaxis strategy.


2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi132-vi132
Author(s):  
Alissa Thomas ◽  
Heather Wright ◽  
Hannah Walker ◽  
Prachi Prasad ◽  
Kelly Chan ◽  
...  

Abstract Venous thromboembolism (VTE) impacts an estimated one in every three patients with malignant glioma (MG), resulting in increased morbidity and mortality. Despite the high prevalence and serious consequences of VTE, there is no outpatient standard of care prevention strategy. There have been three prospective clinical trials of VTE prophylaxis in patients with newly diagnosed MG, all of which used an injectable low molecular weight heparin (LMWH) product. We performed an open-label safety study of apixaban, a direct oral anticoagulant (DOAC), for VTE prevention in patients with newly diagnosed MG. All patients had surgery or biopsy two to twenty-one days prior to enrollment in the study. Patients were treated with apixaban 2.5 mg twice daily for up to 6 months. Peak and trough apixaban concentrations were measured at the beginning and end of treatment. Thirteen patients consented to the study and ten enrolled (2 screen-fail, 1 withdrawal). The patients have completed a mean of 4.5 cycles of apixaban (range 2 to 6, with 2 patients still undergoing treatment). There were no bleeding events while receiving apixaban. There were no hematologic or non-hematologic treatment-related adverse events. There were no VTE events observed in patients receiving apixaban. Two patients who came off treatment early due to disease progression developed VTEs after stopping prophylactic apixaban. Quality of life analysis is ongoing. In this pilot study we found that prophylactic dosing of 2.5 mg twice daily of apixaban was safe in the post-operative period for patients with newly diagnosed MG. Our preliminary results suggest that this may be a safe and effective prevention strategy for VTE prophylaxis in this high risk group of patients.


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