Xarelto (Rivaroxaban) Prophylaxis Reduces the Risk of Thromboembolic Events Following Knee Osteotomy Without Increased Bleeding Complications

Author(s):  
Seth L. Sherman ◽  
Troy Pashuck ◽  
Elliott Voss ◽  
Andrew Garrone ◽  
Emily Leary ◽  
...  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Johannes Herrmann ◽  
Quirin Notz ◽  
Tobias Schlesinger ◽  
Jan Stumpner ◽  
Markus Kredel ◽  
...  

Abstract Background Coronavirus disease 2019 (COVID-19) associated coagulopathy (CAC) leads to thromboembolic events in a high number of critically ill COVID-19 patients. However, specific diagnostic or therapeutic algorithms for CAC have not been established. In the current study, we analyzed coagulation abnormalities with point-of-care testing (POCT) and their relation to hemostatic complications in patients suffering from COVID-19 induced Acute Respiratory Distress Syndrome (ARDS). Our hypothesis was that specific diagnostic patterns can be identified in patients with COVID-19 induced ARDS at risk of thromboembolic complications utilizing POCT. Methods This is a single-center, retrospective observational study. Longitudinal data from 247 rotational thromboelastometries (Rotem®) and 165 impedance aggregometries (Multiplate®) were analysed in 18 patients consecutively admitted to the ICU with a COVID-19 induced ARDS between March 12th to June 30th, 2020. Results Median age was 61 years (IQR: 51–69). Median PaO2/FiO2 on admission was 122 mmHg (IQR: 87–189), indicating moderate to severe ARDS. Any form of hemostatic complication occurred in 78 % of the patients with deep vein/arm thrombosis in 39 %, pulmonary embolism in 22 %, and major bleeding in 17 %. In Rotem® elevated A10 and maximum clot firmness (MCF) indicated higher clot strength. The delta between EXTEM A10 minus FIBTEM A10 (ΔA10) > 30 mm, depicting the sole platelet-part of clot firmness, was associated with a higher risk of thromboembolic events (OD: 3.7; 95 %CI 1.3–10.3; p = 0.02). Multiplate® aggregometry showed hypoactive platelet function. There was no correlation between single Rotem® and Multiplate® parameters at intensive care unit (ICU) admission and thromboembolic or bleeding complications. Conclusions Rotem® and Multiplate® results indicate hypercoagulability and hypoactive platelet dysfunction in COVID-19 induced ARDS but were all in all poorly related to hemostatic complications..


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
M. Unverdorben ◽  
C. von Heymann ◽  
A. Santamaria ◽  
M. Saxena ◽  
T. Vanassche ◽  
...  

Abstract Background Annually > 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated. Methods Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality. Results Of the 1442 patients, 280 (19%) were < 65, 550 (38%) were 65–74, 514 (36%) 75–84, and 98 (7%) were 85 years old or older. With increasing age, comorbidities and risk scores were higher. Any bleeding complications were uncommon across all ages, ranging from 3.9% in patients < 65 to 4.1% in those 85 years or older; major bleeding rates in any age group were ≤ 0.6%. Interruption rates and duration increased with advancing age. Thromboembolic events were more common in the elderly, with all nine events occurring in those > 65, and seven in patients aged > 75 years. Conclusion Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed. Trial registration: NCT# 02950168, October 31, 2016


2008 ◽  
Vol 99 (06) ◽  
pp. 1049-1052 ◽  
Author(s):  
Urs Kistler ◽  
Inès Quervain ◽  
Urs Munzinger ◽  
Nils Kucher

SummaryThe rate of bleeding complications after major orthopedic surgery approximates 2%. It is unclear whether a systematic switch of routine thromboprophylaxis has an impact on the rate of postoperative bleeding complications. We analyzed prospectively recorded postoperative bleeding complications and symptomatic venous thromboembolic events in 8,176 consecutive orthopedic patients at the Schulthess Clinic Zurich during a systematic switch of thromboprophylaxis from nadroparin to enoxaparin in the year 2004. Overall, 3,893 patients received nadroparin in the first nine-month observation period before the switch and 4,283 patients received enoxaparin in the second nine-month observation period after the switch. Overall, 96 (2.5%) patients in the first period and 70 (1.6%) patients in the second period suffered a postoperative bleeding complication requiring surgical revision, puncture, or transfusion (p<0.01). Five objectively confirmed symptomatic venous thromboembolic events during hospitalization in the first period and three events in the second period were recorded. In conclusion, the switch of thromboprophylaxis in a large orthopedic clinic did not cause an increase of postoperative bleeding complications and therefore was accompanied by high patient safety.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4534-4534
Author(s):  
Khanh D. Vu ◽  
Deborah A. Thomas ◽  
Julie C. Hubbard ◽  
Stefan Faderl ◽  
Jorge Cortes ◽  
...  

Abstract Background: Pts with cancer are at increased risk of thromboembolic events with potentially life-threatening consequences. The incidence of VTE in cancer pts has been estimated at 1 in 250. Although most of these episodes are associated with solid tumors, VTE is also observed in pts with acute leukemias, even in the presence of thrombocytopenia. Anticoagulation in this pt population can be particularly problematic if pts are undergoing myelosuppressive chemotherapy. VTE prophylaxis is often not given because of the perceived high risk of bleeding with a presumed low risk of VTE. Method: As little is known about the incidence and significance of VTE in pts with acute leukemia, we conducted a retrospective chart review of 223 pts with ALL, BL, or LL who received a hyper-CVAD regimen (fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone alternating with methotrexate and cytarabine) with or without rituximab, maintenance chemotherapy (with L-asparaginase only months #7 & 18), allogeneic stem cell transplant (SCT), or salvage chemotherapy at our institution from November 1999 to May 2005. The median observation period was 112 weeks (range 1–328). Results: The median age was 51 yrs (range 19–75). 70% were ALL, (50% were Philadelphia positive ALL), 20% Burkitt’s or Burkitt’s-like, and 10% LL. Thirty nine of 223 pts (18%) had confirmed VTE by imaging studies: 12.5% prior to or at the time of diagnosis, 57.5% during consolidation chemotherapy, and 27.5% during maintenance chemotherapy, SCT, or supportive care. Location of VTE varied by site: 3/39 (8%) pulmonary embolus, 16/39 (41%) lower extremity, 2/39 (5%) central venous catheter (CVC), and 18/39 (46%) upper extremity. Two of the 18 with upper extremity VTEs did not have CVC, and an additional 2 had bilateral upper extremity thromboses. The platelet counts were reviewed near the time of VTE diagnosis: 22/39 (56%) had greater than 100 × 109/L, 17/39 (44%) were less than that value, with 76% below 50,000 × 109/L. Conclusion: Pts with ALL, BL, and LL undergoing therapy are at risk for developing VTE. Thrombocytopenia does not preclude development of VTE. A more detailed analysis will be forthcoming regarding the risk factors for VTE in this pt population, the current medical practices and bleeding complications with VTE prophylaxis and treatment, and the effect on therapy administration and overall survival. Practice guidelines for management of acute leukemia pts with thromboembolic events should be pursued.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 216-216
Author(s):  
Mario von Depka ◽  
Stefanie Döpke ◽  
Anja Henkel-Klene ◽  
Cornelia Wermes ◽  
Mahnaz Ekhlasi-Hundrieser ◽  
...  

Abstract Introduction During pregnancy women have a four- to five-fold increased risk of thromboembolism (TE) compared to women who are not pregnant. Among the most important risk factors for TE in pregnancy is the presence of thrombophilia. Multiple reports have described an association between antithrombin (AT) deficiency and an increased rate of thromboembolic events especially during pregnancy. As the placental development depends on well-balanced pro- and anticoagulant mechanisms, thrombophilia, e.g. AT deficiency may be associated with poor pregnancy outcome. Despite anticoagulation with low molecular weight heparin (LMH) during pregnancy and the postpartum period alone, women with AT deficiency are still at a high risk to develop TE, especially perinatal and during puerperium because of withheld anticoagulation to prevent bleeding complications. Therefore, several guidelines recommend the administration of antithrombin concentrates during high risk situations as pregnancy. Here, we present the results of our study on the usage of AT concentrates in pregnant women with AT deficiency who either suffered from fetal loss or thromboembolism prior inclusion. Methods In total, 22 pregnancies in 19 patients (age: 31.9±4.7; 22-41) with AT deficiency were included in this open-label, single-center study. Ten patients (53%) had a history of fetal loss, 9/19 (47%) patients hat a history of thromboembolism. During all pregnancies AT concentrate (AT-C) was administered, in 18/22 (81.8%) pregnancies LMH was given in addition. Prior pregnancy losses (21/30, 70%) occurred in all trimester (t1: n=11, t2: n=5, and in t3: n=5). Historical live birth rate (LBR) was 30%. Blood samples were collected in all trimesters and postpartum to analyze AT activity and antigen, endogenous thrombin potential (ETP), thrombin-antithrombin-complex (TAT), Fragment 1+2 (F1+2) and c-reactive protein test (CRP). A total of 114 uneventful pregnancies of 113 healthy women served as controls. Furthermore, the mean doses of AT concentrates/kg BW and the mean total number of infusions were calculated. Results In total, 21 pregnancies (95.5%) were successful. Mean total requirement of AT concentrate per pregnancy was 79.454 IU (range: 3.000-272.000 IU) during 27.8 treatment days per pregnancy (range: 1-88). Our data show an increase of F1+2 in the course of pregnancy. Mean levels of F1+2 at t1, t2 and t3 (t1= 255.9 ± 107.6, t2= 360.9 ± 117.4, t3= 545.3 ± 220.3 pmol/L) were significantly higher than in controls (t1= 82.2 ± 43, t2= 140 ± 100.2, t3= 183.5 ± 103.1, p<.001). Mean level of TAT was higher (3.1 ± 1.4 ng/mL) than in controls (1.7 ± 1.6 ng/mL, p=.001) in t1, whereas mean TAT in t2 and t3 was lower than in controls (3.8 ± 1.3 vs. 4.8 ± 1.9, p=.03; 5.0 ± 1.4 vs. 6.1 ± 3.0 ng/mL, n.s., resp.). No thromboembolic events occurred. In patients receiving AT-C, LBR increased from 30% to 95.5% (p<0.001) with a relative risk of 49.0 to develop pregnancy loss without anticoagulant treatment (5.7 – 421.8; 95% CI). Conclusion In patients with AT deficiency receiving AT concentrate and LMH we could demonstrate a significant increase of LBR from 30% to 95.5%. Furthermore, no thromboembolic events occurred, though almost half of the patients had a history of thromboembolism. There was no clear evidence of increased hypercoagulability. We conclude that combined AT concentrate and LMH are safe and efficacious for mother and child in preventing thromboembolism and pregnancy loss. Further studies to evaluate the exact mode of anticoagulation and benefit of combining AT concentrate and LMH are warranted. Disclosures: No relevant conflicts of interest to declare.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Garcia Bras ◽  
T Mano ◽  
T Rito ◽  
A Castelo ◽  
V Ferreira ◽  
...  

Abstract Introduction Adults with congenital heart disease (ACHD) are at an increased risk for thromboembolic events and atrial arrhythmias are common in this population. Non-vitamin K anatagonist oral anticoagulants (NOACs) prescription is increasing, however data on efficacy and safety in ACHD is unclear, particularly in patients (P) with complex CHD. The aim of the study was to review the use of NOACs in various types of ACHD and assess its safety and efficacy. Methods Evaluation of consecutive ACHD P started on NOAC therapy from 2014 to 2020. P were followed-up for bleeding or thromboembolic events and mortality. CHA2DS2-VASc and HASBLED scores were calculated and risk factors for bleeding were identified. Results 93 ACHD P were included, mean age 52±15 years, 58% female, 44% with complex CHD (3.2% with Fontan circulation), with diagnosis of: 22.2% atrial septal defect, 20% tetralogy of Fallot, 11.1% transposition of the great arteries, 10% Ebstein's anomaly, 8.9% ventricular septal defect, 7.8% pulmonary stenosis, 5.6% ductus arteriosus, 4.4% AV septal defect, 3.4% univentricular heart, 3.4% coarctation of aorta, 2.2% supra-aortic stenosis and 1% with Uhl disease. Most P were anticoagulated with rivaroxaban (43%), followed by edoxaban (24%), apixaban (20%), and dabigatran (13%). The indications for anticoagulation were: atrial arrhythmias (81%), pulmonary embolism (PE) (6.3%), atrial thrombi (4.3%), thromboprophylaxis in Fontan circulation (3.2%), deep vein thrombosis (3.2%) and stroke (2%). 66% of P had a CHA2DS2-VASc score ≥2 and 82% HASBLED score ≤2. In a mean follow-up of 41±21 months (400.4 patient-years), there were embolic events in 2P (1 splenic infarction and 1 PE) albeit both were in the context of oral anticoagulation interruption. The cardiovascular mortality was 2% and allcause mortality 5%, however with no relation to thrombosis or bleeding events. 6 P (6.5%) suffered a minor and 3 P (3.2%) suffered a major bleeding, a median time of 12 (IQR 15) months after starting NOAC therapy. The annual risk for bleeding was 2.2%/patient/year. P with bleeding events showed no significant difference regarding age (55±16 vs 52±15 years, p=0.587), gender (13% female vs 5.1% male, p=0.295) or CHD type (p=0.582). 8.6% of P required dose reduction, mostly for bleeding (3.2%) or renal impairment (2.2%). Renal disease was a strong risk factor for major bleeding (HR 14.6 [95% CI 1.23–73.6], p=0.033 and multivariate analysis showed that an increased HASBLED score was an independent predictor of minor (adjusted HR 3.44 [95% CI 1.13–10.52], p=0.030) and major (adjusted HR 5.29 [95% CI 1.14–24.45], p=0.033) bleeding complications. Conclusion Anticoagulation with NOACs is a safe and effective option for selected ACHD P, although bleeding complications were not negligible, particularly in P with renal disease. Larger scale research studies are required, especially regarding complex CHD such as P with Fontan circulation. FUNDunding Acknowledgement Type of funding sources: None.


1986 ◽  
Vol 56 (03) ◽  
pp. 243-246 ◽  
Author(s):  
Matthias Koller ◽  
Ursula Schoch ◽  
Peter Buchmann ◽  
Felix Largiadèr ◽  
Arthur von Felten ◽  
...  

SummaryIn two randomized double-blind studies perioperative bleeding complications and thromboembolic events were assessed in 189 patients (pts) undergoing elective visceral surgery after subcutaneous administration of a low molecular weight (LMW) heparin fragment (KABI fragment 2165) or unfractionated (UF) heparin. The first study comparing 1 x 7′500 anti-factor Xa IU LMW heparin daily with 2 x 5′000 IU UF heparin was interrupted because of excessive bleeding complications (LMW heparin: 11/23 pts, UF heparin: 2/20 pts, p <0.01). In the second study (146 pts) the dose of LMW heparin was reduced to 1 x 2′500 anti-factor Xa IU. Bleeding complications (LMW heparin: 14.9%, UF heparin: 15.3%) and thromboembolic events (LMW heparin: 2.86%, UF heparin: 2.94%) were equal among the two groups.2′500 anti-factor Xa IU/day of this LMW heparin fragment, corresponding to 15 mg/day, is the lowest dose of a LMW heparin used in a randomized clinical trial and was found to be a safe and efficient regimen in perioperative thrombosis prophylaxis. An advantage of LMW heparin over UF heparin is its once daily administration.


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
L Kuffer ◽  
M I Koerber ◽  
F Nettersheim ◽  
T Tichelbaecker ◽  
C Hohmann ◽  
...  

Abstract Introduction Non-bacterial thrombotic endocarditis (NBTE) is characterised by non-infectious vegetations on the cardiac valves and is typically seen in patients with malignancies or systemic lupus erythematosus. Risk of thromboembolic events is high and treatment of choice consists of anticoagulation, if feasible, as well as treatment of the underlying disease. Severe valvular dysfunction is rarely seen and in these cases, surgical valve replacement is usually performed. Case presentation A 28-year old female patient presented with left-sided hemiparesis persisting for several hours. Angio-CT scan of the brain revealed a branch occlusion of the middle cerebral artery with a correlating infarct core and without an area of penumbra. Blood tests showed decreased thrombocyte levels (45 x109/l). Given the thrombocytopenia and the time between the onset of symptoms and presentation, no thrombolysis was administered. A subsequently performed transoesophageal echocardiography for diagnostic work-up of cardioembolic sources of stroke revealed a right ventricular thrombus and vegetations on the aortic valve causing severe aortic regurgitation with a holodiastolic flow reversal in the descending aorta (Fig. 1 (a) and (b) showing a large central coaptation defect). There were no of signs of infection or inflammation and blood cultures remained negative, thus infectious endocarditis was unlikely. A bone marrow biopsy led to the diagnosis of acute promyeolocytic leukemia (PML). Despite the inherent high risk of bleeding due to PML, anticoagulation with unfractionated heparin was initiated and treatment with prednisolone, all-trans retinoic acid and arsenic trioxide was started. After three weeks of therapy aortic valve vegetation size decreased considerably leading to dramatic reduction of aortic regurgitation (Fig. 1 (c) and (d)). No further embolic event or bleeding occurred. Conclusion This case is remarkable in many aspects. First, PML typically causes bleeding complications whereas NBTE is characterised by a high risk of thromboembolic events. Thus, the decision to start or not to start anticoagulation is challenging. Second, NBTE, unlike infectious endocarditis, rarely causes severe valvular dysfunction and reported treatment in most cases consisted of surgical valve replacement or repair. However, in this case, conservative treatment alone led to almost complete resolution of valvular vegetations and of aortic regurgitation. We conclude that conservative treatment of severe valvular disease in the setting of NBTE should be strongly considered, especially given the small number of cases reported worldwide. Abstract P630 Figure. Fig.1


2016 ◽  
Vol 115 (02) ◽  
pp. 392-398 ◽  
Author(s):  
Francesco Orlandini ◽  
Francesca Marchini ◽  
Alessia Marinaro ◽  
Rosanna Bonacci ◽  
Paola Bonanni ◽  
...  

SummaryAcute medical patients have a high risk of venous thromboembolic events (VTE). Unfortunately, the fear of bleeding complications limits the use of antithrombotic prophylaxis in this setting. To stratify the VTE and haemorrhagic risk, two clinical scores (PADUA, IMPROVE) have recently been developed. However, it is not clear how many patients have a concomitant high VTE and haemorrhagic risk and what is the use of prophylaxis in this situation. To clarify these issues we performed a prospective cohort study enrolling consecutive patients admitted to internal medicine. Patients admitted to internal medicine (January to December 2013) were included. VTE and haemorrhagic risk were evaluated in all the included patients. Use and type of anti-thrombotic prophylaxis was recorded. A total of 1761 patients (mean age 77.6 years) were enrolled; 76.8 % (95 % CI 74.7–78.7) were at high VTE risk and 11.9 % (95 % CI 10.4–13.5) were at high haemorrhagic risk. Anti-thrombotic prophylaxis was used in 80.5 % of patients at high VTE risk and in 6.5 % at low VTE risk (p< 0.001), and in 16.6 % at high haemorrhagic risk and in 72.5 % at low haemorrhagic risk (p< 0.001). Prophylaxis was used in 20.4 % at both high VTE and haemorrhagic risk and in 88.9 % at high VTE risk but low haemor-rhagic risk. At multivariate-analysis, use of prophylaxis appeared highly influenced by the VTE risk (OR 68.2, 95 % CI 43.1 - 108.0). In conclusion, many patients admitted to internal medicine were at high risk of VTE. Since almost 90 % of them were at low haemorrhagic risk, pharmacological prophylaxis may be safely prescribed in most of these patients.Supplementary Material to this article is available online at www.thrombosis-online.com.


2021 ◽  
Vol 2 (4) ◽  
pp. 377-385
Author(s):  
Ana Sekulić ◽  
Olivera Marinković ◽  
Davor Mrda ◽  
Borislav Tošković ◽  
Marija Zdravković ◽  
...  

Introduction: The infection caused by the SARS-CoV-2 virus is known to cause a hypercoagulable condition resulting in acute thrombotic events. Thromboembolic events occur in as many as 21.0% of cases with a mortality rate of about 74.0% in persons infected with COVID-19. Anticoagulant therapy is used in severe COVID-19 infections in order to prevent thrombosis and has been shown to reduce mortality. The use of anticoagulants is not without risks. Bleeding complications can range from mild to severe or even life-threatening, such as retroperitoneal bleeding into the psoas muscle. Case report: We present a case of a patient who developed a complication of bleeding into the retroperitoneal space during the treatment of bilateral bronchopneumonia caused by the SARS-CoV-2 virus. After the diagnosis was established, on the basis of a clinical examination, laboratory and radiological examinations, and after initial conservative treatment at the UHMC Bežanijska kosa, the patient underwent embolization of the left lumbar arteries from the right inguinal fossa, during procedural analgosedation. After the radiological procedure, the recovery was satisfactory, but due to the impossibility of resorption of an encapsulated hematoma with a zone of central necrosis, a mini left lumbotomy and evacuation of the hematoma were performed. The patient was discharged from the hospital on the 23rd day of admission in stable general condition. Conclusion: The effect of anticoagulant therapy, especially in patients with existing risk factors, early diagnosis, and prompt therapy of spontaneous retroperitoneal hematomas is imperative to reduce mortality from this severe complication, in patients with the COVID-19 infection.


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