scholarly journals GW28-e0461 Durations of Anticoagulation and Major Bleeding Risk of Vitamin K Antagonists for Venous Thromboembolism: A Meta-Analysis

2017 ◽  
Vol 70 (16) ◽  
pp. C84
Author(s):  
Wei Wang ◽  
Chunyan Wu ◽  
Han Yu ◽  
Yang Yang ◽  
Jue Li
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Bleeding Risk

Perioperative Management Of Patients On Dabigatran – a Prospective Cohort Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3637-3637
Author(s):  
Sam Schulman ◽  
James Douketis ◽  
Rebecca Barty, MLT ◽  
Agnes Y.Y. Lee ◽  
Marc Carrier ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Research Funding ◽  
Perioperative Management ◽  
Vitamin K Antagonists ◽  
Bleeding Risk ◽  
Minor Bleeding ◽  
Off Label Use ◽  
Off Label

Abstract Background The risk of major bleeding in association with perioperative management of vitamin K antagonists is about 3% according to systematic reviews. We performed this study to evaluate the safety of perioperative management of dabigatran using a specified protocol. Methods Patients at least 18 years old, treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The last dose of dabigatran before the procedure was at 24 h (creatinine clearance [CrCl] > 50 mL/min and standard bleeding risk), 48 h (CrCl 31-50 mL/h or increased bleeding risk) or 96 h (CrCl 31-50 mL/h and increased bleeding risk). Resumption was in the evening of the procedure with the first dose of 75 mg (hemostasis secured and low bleeding risk), postop day 1, 2 or 3, depending on the complexity of the surgery and consequences of a bleeding complication; all prespecified. Patients were followed for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism and death and an independent committee adjudicated these events by. We calculated a sample size of 283 cases to exclude a doubling of major bleeding compared to historical warfarin with heparin bridging. The study was funded by Heart and Stroke Foundation Canada. Results We included 286 patients, mean age of 70.6 years (standard deviation, 11.7), 44 (15%) patients had CrCl 31-50 mL/min and 2 (0.7%) had 30 mL/min or less. The planned procedure was considered as “increased bleeding risk” in 102 (36%) patients. The last dose of dabigatran was at 24, 48 and 96 h before surgery in 160, 103 and 23 patients, respectively. Resumption with 75 mg the same day was in 139 patients. Major bleeding occurred in 3 patients (1.05%; 2 adjudicated so far); a 70-year-old male underwent ultrasound-guided drainage of abdomen and was readmitted after 17 days due to rectal bleeding and light headedness; the second patient, an 81-year-old male bled more than expected during the procedure of wide resection of myxosarcoma with free flap rotation and received blood transfusions during surgery, and a 69-year-old male bled 1200 mL during hip revision arthroplasty and received 3 units of red cells. Minor bleeding was observed in 9 adjudicated cases and reported in 10 additional, so far not adjudicated, cases. There were no strokes, systemic emboli, transient ischemic attacks, venous thromboembolic events or deaths. Three serious adverse events were reported (chest pain, congestive heart failure, wound infection) Conclusion With our protocol for perioperative management of dabigatran the risk of major bleeding compares favorably with historical data on vitamin K antagonists. Disclosures: Schulman: Bayer Healthcare: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria, Research Funding. Off Label Use: Dabigatran etexilate is an oral direct thrombin inhibitor approved for the prevention of stroke in patients with atrial fibrillation and (outside the US) for prevention of venous thromboembolism in patients undergoing total hip or knee replacement. This presentation includes discussion of the following off-label use of dabigatran: treatment of venous thromboembolism. Douketis:Boehringer Ingelheim: Consultancy, Honoraria. Lee:Boehringer Ingelheim: Honoraria. Heddle:CIHR: Research Funding; Canadian Blood Services: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Health Canada: Research Funding.

Meta-analysis comparing impact of age, sex and renal function on the efficacy and safety of new oral anticoagulants vs. vitamin K antagonists for the treatment of acute venous thromboembolisms

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J She ◽  
B.Z Zhuo
Keyword(s):  
Renal Function ◽  
Venous Thromboembolism ◽  
Creatinine Clearance ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Funding Source ◽  
Efficacy And Safety ◽  
Acute Venous Thromboembolism

Abstract Background New direct oral anticoagulants (NOACs), as a preferable treatment option for acute venous thromboembolism (VTE) have been recommended with practical advantages as compared to Vitamin K antagonists (VKAs) in clinical practice. Purpose In our study, we performed a meta-analysis to determine the efficacy and safety of NOACs vs. VKAs in patients with different age, sex and renal function for the treatment of VTE. Methods Electronic databases (accessed October 2019) were systematically searched to identify RCTs evaluating apixaban, dabigatran, edoxaban, and rivaroxaban versus VKAs for the treatment of acute venous thromboembolism. Results NOACs was associated with a borderline higher efficacy in female (OR 0.79, 95% CI 0.62–1.02), and a significantly higher efficacy in patients with age more than 75 (OR 0.51, 95% CI 0.32–0.80) and creatinine clearance less than 50 mL/min (OR 0.57, 95% CI 0.32–0.99). NOACs also show advantage in terms of major or clinically relevant non-major bleeding in male (OR 0.72, 95% CI 0.60–0.86), and patients with creatinine clearance more than 50 mL/min (OR 0.75, 95% CI 0.67–0.84). Conclusions NOACs have exhibited clinical preference among patients with acute VTE as compared to VKA with significantly decreased thrombosis events and lower bleeding complications, especially in patients with age more than 75 and creatinine clearance less than 50 mL/min. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): This study was supported by the National Natural Science Foundation of China (81800390) and the Natural Science Foundation of Shaanxi province (2018KW067).

Comparison of Bleeding Risk Scores in Elderly Patients Receiving Extended Anticoagulation with Vitamin K Antagonists for Venous Thromboembolism

2021 ◽  
Author(s):  
Andrea N. Frei ◽  
Odile Stalder ◽  
Andreas Limacher ◽  
Marie Méan ◽  
Christine Baumgartner ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Elderly Patients ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Predictive Performance ◽  
Roc Curves ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Likelihood Ratios ◽  
Risk Categories

Abstract Background In elderly patients with venous thromboembolism (VTE), the decision to extend anticoagulation beyond 3 months must be weighed against the bleeding risk. We compared the predictive performance of 10 clinical bleeding scores (VTE-BLEED, Seiler, Kuijer, Kearon, RIETE, ACCP, OBRI, HEMORR2HAGES, HAS-BLED, ATRIA) in elderly patients receiving extended anticoagulation for VTE. Methods In a multicenter Swiss cohort study, we analyzed 743 patients aged ≥65 years who received extended treatment with vitamin K antagonists after VTE. The outcomes were the time to a first major and clinically relevant bleeding. For each score, we classified patients into two bleeding risk categories (low/moderate vs. high). We calculated likelihood ratios and the area under the receiver operating characteristic (ROC) curve for each score. Results Over a median anticoagulation duration of 10.1 months, 45 patients (6.1%) had a first major and 127 (17.1%) a clinically relevant bleeding. The positive likelihood ratios for predicting major bleeding ranged from 0.69 (OBRI) to 2.56 (Seiler) and from 1.07 (ACCP) to 2.36 (Seiler) for clinically relevant bleeding. The areas under the ROC curves were poor to fair and varied between 0.47 (OBRI) and 0.70 (Seiler) for major and between 0.52 (OBRI) and 0.67 (HEMORR2HAGES) for clinically relevant bleeding. Conclusion The predictive performance of most clinical bleeding risk scores does not appear to be sufficiently high to identify elderly patients with VTE who are at high risk of bleeding and who may therefore not be suitable candidates for extended anticoagulation.

scholarly journals Different Finite Durations of Anticoagulation and Outcomes following Idiopathic Venous Thromboembolism: A Meta-Analysis

Thrombosis ◽  
2010 ◽  
Vol 2010 ◽  
pp. 1-9 ◽  
Author(s):  
Aaron B. Holley ◽  
Christopher S. King ◽  
Jeffrey L. Jackson ◽  
Lisa K. Moores
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Data Extraction ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Secondary Prophylaxis ◽  
First Episode ◽  
Short Course ◽  
Recurrent Venous Thromboembolism ◽  
Prospective Trials

Introduction. Controversy remains over the optimal length of anticoagulation following idiopathic venous thromboembolism. We sought to determine if a longer, finite course of anticoagulation offered additional benefit over a short course in the initial treatment of the first episode of idiopathic venous thromboembolism. Data Extraction. Rates of deep venous thrombosis, pulmonary embolism, combined venous thromboembolism, major bleeding, and mortality were extracted from prospective trials enrolling patients with first time, idiopathic venous thromboembolism. Data was pooled using random effects meta-regression. Results. Ten trials, with a total of 3225 patients, met inclusion criteria. For each additional month of initial anticoagulation, once therapy was stopped, recurrent venous thromboembolism (0.03 (95% CI: −0.28 to 0.35); ), mortality (−0.10 (95% CI: −0.24 to 0.04); ), and major bleeding (−0.01 (95% CI: −0.05 to 0.02); ) rates measured in percent per patient years, did not significantly change. Conclusions: Patients with an initial idiopathic venous thromboembolism should be treated with 3 to 6 months of secondary prophylaxis with vitamin K antagonists. At that time, a decision between continuing with indefinite therapy can be made, but there is no benefit to a longer (but finite) course of therapy.

Management and outcome of major bleeding in patients receiving vitamin K antagonists for venous thromboembolism

2018 ◽  
Vol 171 ◽  
pp. 74-80 ◽  
Author(s):  
Farès Moustafa ◽  
Alexander Stehouwer ◽  
Pieter Kamphuisen ◽  
Joan Carles Sahuquillo ◽  
Ángel Sampériz ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists

scholarly journals Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and cancer a meta-analysis

2020 ◽  
Author(s):  
Marco Valerio Mariani ◽  
Michele Magnocavallo ◽  
Martina Straito ◽  
Agostino Piro ◽  
Paolo Severino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Significant Risk ◽  
Bleeding Complications ◽  
Efficacy And Safety

Abstract Background Direct oral anticoagulants (DOACs) are recommended as first-line anticoagulants in patients with atrial fibrillation (AF). However, in patients with cancer and AF the efficacy and safety of DOACs are not well established. Objective We performed a meta-analysis comparing available data regarding the efficacy and safety of DOACs vs vitamin K antagonists (VKAs) in cancer patients with non-valvular AF. Methods An online search of Pubmed and EMBASE libraries (from inception to May, 1 2020) was performed, in addition to manual screening. Nine studies were considered eligible for the meta-analysis involving 46,424 DOACs users and 182,797 VKA users. Results The use of DOACs was associated with reduced risks of systemic embolism or any stroke (RR 0.65; 95% CI 0.52–0.81; p 0.001), ischemic stroke (RR 0.84; 95% CI 0.74–0.95; p 0.007) and hemorrhagic stroke (RR 0.61; 95% CI 0.52–0.71; p 0.00001) as compared to VKA group. DOAC use was associated with significantly reduced risks of major bleeding (RR 0.68; 95% CI 0.50–0.92; p 0.01) and intracranial or gastrointestinal bleeding (RR 0.64; 95% CI 0.47–0.88; p 0.006). Compared to VKA, DOACs provided a non-statistically significant risk reduction of the outcomes major bleeding or non-major clinically relevant bleeding (RR 0.94; 95% CI 0.78–1.13; p 0.50) and any bleeding (RR 0.91; 95% CI 0.78–1.06; p 0.24). Conclusions In comparison to VKA, DOACs were associated with a significant reduction of the rates of thromboembolic events and major bleeding complications in patients with AF and cancer. Further studies are needed to confirm our results.

P690Incidence of events between vitamin K antagonists and direct oral anticoagulants in patients with cancer

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Pardo Sanz ◽  
L M Rincon ◽  
G De Lara ◽  
A Tamayo ◽  
L C Belarte ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Patients With Cancer

Abstract Background Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We aimed to evaluate the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with breast cancer. We also compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. Methods It is an ambispective observational multicentric study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain in the period 2011–2018. A total of 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. The incidence of thromboembolic and major bleeding events according to the antithrombotic strategy with VKAs or DOACs was evaluated in the cohort of 637 patients with cancer. Analysis were conducted using SPSS software V.22.0 and R V.3.5.1, with a two-tailed significance value of 0.05. Results Mean follow-up was 3.1 years. Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. There was no evidence that the incidence of ischemic stroke/systemic embolism differed between patients with cancer treated with AVK and DOAC after CHA2DS2-VASc adjustment: HR 0.91 (95% CI, 0.42–1.99). In addition, no significant differences in the incidence of major bleeding events were found between DOACs and VKA after adjustment for HAS-BLED score: HR 1.53 (95% CI, 0.93–2.53) (Figure 3). Gastrointestinal bleeding was the main source of haemorrhages in both groups (45% of bleedings among patients treated with DOACs and, 37% in VKAs group). Metastatic disease or active chemotherapy were studied as potential covariates but none of them posed any relevant change in the result. Kaplan-Meier analysis Conclusions Cancer patients treated with DOACs did not differ versus those treated with VKAs with regards to stroke or systemic embolism in a model adjusted for CHA2DS2-VASc. Neither significant differences were found for bleeding events in a model adjusted for baseline HASBLED.

Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants

2015 ◽  
Vol 114 (11) ◽  
pp. 1076-1084 ◽  
Author(s):  
Franziska Michalski ◽  
Luise Tittl ◽  
Sebastian Werth ◽  
Ulrike Hänsel ◽  
Sven Pannach ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Case Fatality ◽  
Bleeding Risk ◽  
Vitamin K Antagonist ◽  
Bleeding Complications ◽  
Treatment Rate

SummaryAtrial fibrillation (AF) patients treated with well-controlled vitamin K antagonists (VKAs) may benefit less from non-vitamin K antagonist oral anticoagulants (NOACs) because they are supposed to be at low risk of thromboembolic and bleeding complications. However, little is known about the selection, management, and outcome of such “stable” VKA patients in current practice. We assessed characteristics, VKA persistence and 12 months' outcome of AF patients selected for VKA continuation. On March 1, 2013, the Dresden NOAC registry opened recruitment of patients continuing on VKA for sites that had been actively recruiting AF patients treated with NOACs in the prior 18 months. Patient characteristics were compared with those of NOAC patients from the same sites. Four hundred twenty-seven VKA patients had a significantly lower bleeding risk profile compared with 706 patients selected for NOAC treatment. For VKA, international normalised ratio time-in-therapeutic range before enrolment was 71% and increased to 75% during a mean follow-up of 15 months. Rates of stroke/transient ischaemic attack/systemic embolism were 1.3/100 patient-years (intention-to-treat) and 0.94/100 patient-years (as-treated). On-treatment rate of ISTH major bleeding was 4.15/100 patient-years (95% CI 2.60–6.29) with a case-fatality rate of 16.3% (all-cause mortality at day 90 after major bleeding). In conclusion, in daily care, AF patients selected for VKA therapy are healthier than those treated with NOAC, demonstrate a high quality of anticoagulant control and very low stroke rates. However, despite adequate patient selection and INR control, the risk of major VKA bleeding is unacceptably high and bleeding outcome is poor.

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