Although direct‐acting oral anticoagulants (DOACs) have widespread first‐line use for treatment and prevention of venous thromboembolism (VTE), uncertainty remains regarding their efficacy and safety ...in patients with obesity. We reviewed available data for use of DOACs for VTE treatment and prevention in patients with obesity, including phase 3, phase 4, meta‐analyses, and pharmacokinetic and pharmacodynamics studies. In addition, we reviewed available data regarding DOACs in bariatric surgery. We provide updated guidance recommendations on using DOACs in patients with obesity for treatment and prevention of VTE, as well as following bariatric surgery.
Abstract
Background
International guidelines have endorsed the use of edoxaban or rivaroxaban as an alternative to low-molecular-weight heparin (LMWH) for the treatment of acute venous ...thromboembolism (VTE) in cancer patients. Recently, a large randomized controlled trial of apixaban versus dalteparin in patients with cancer was completed. We performed an updated meta-analysis to assess the efficacy and safety of direct oral anticoagulants (DOACs) versus LMWH in patients with cancer-associated VTE.
Methods
MEDLINE, EMBASE, and CENTRAL (Cochrane Controlled Trials Registry) were systematically searched up to March 30, 2020 for randomized controlled trials comparing DOACs versus LMWH for the treatment of VTE in patients with cancer. The two coprimary outcomes were recurrent VTE and major bleeding at 6 months. Data were pooled by the Mantel–Haenszel method and compared by relative risk ratios (RRs) and 95% confidence intervals (CIs).
Results
Four randomized controlled studies (2,894 patients) comparing apixaban, edoxaban, or rivaroxaban with dalteparin were included in the meta-analysis. Recurrent VTE occurred in 75 of 1,446 patients (5.2%) treated with oral factor Xa inhibitors and in 119 of 1,448 patients (8.2%) treated with LMWH (RR 0.62; 95% CI 0.43–0.91;
I
2
, 30%). Major bleeding occurred in 62 (4.3%) and 48 (3.3%) patients receiving oral factor Xa inhibitors or LMWH, respectively (RR 1.31; 95% CI 0.83–2.08;
I
2
, 23%).
Conclusion
In patients with cancer-associated VTE, oral factor Xa inhibitors reduced the risk of recurrent VTE without a significantly higher likelihood of major bleeding at 6 months compared with LMWH.
Abstract
This position paper provides a comprehensive guide for optimal follow-up of patients with acute pulmonary embolism (PE), covering multiple relevant aspects of patient counselling. It serves ...as a practical guide to treating patients with acute PE complementary to the formal 2019 European Society of Cardiology guidelines developed with the European Respiratory Society. We propose a holistic approach considering the whole spectrum of serious adverse events that patients with acute PE may encounter on the short and long run. We underline the relevance of assessment of modifiable risk factors for bleeding, of acquired thrombophilia and limited cancer screening (unprovoked PE) as well as a dedicated surveillance for the potential development of chronic thromboembolic pulmonary hypertension as part of routine practice; routine testing for genetic thrombophilia should be avoided. We advocate the use of outcome measures for functional outcome and quality of life to quantify the impact of the PE diagnosis and identify patients with the post-PE syndrome early. Counselling patients on maintaining a healthy lifestyle mitigates the risk of the post-PE syndrome and improves cardiovascular prognosis. Therefore, we consider it important to discuss when and how to resume sporting activities soon after diagnosing PE. Additional patient-relevant topics that require Focused counselling are travel and birth control.
Graphical Abstract
Graphical Abstract
Overview of main conclusions of the position paper. APS, antiphospholipid antibody syndrome; aPTT, activated partial thromboplastin time; CTEPH, chronic thromboembolic pulmonary hypertension; PE, pulmonary embolism.
The routine use of modern computed tomography scanners has led to an increased detection of incidental pulmonary embolism (PE), in particular in patients with cancer. The clinical relevance of these ...incidental findings is unknown.
In this retrospective cohort study, oncology patients in whom PE was objectively proven between 2004 and 2010 and anticoagulant treatment was started, were included. Fifty-one patients with incidental PE and 144 with symptomatic PE were observed for 1 year to compare the risks of recurrent venous thromboembolism (VTE), bleeding complications, and mortality. Kaplan-Meier and Cox survival analyses were performed.
Incidental and symptomatic patients did not differ with respect to mean age, sex, cancer type and stage, and risk factors for VTE. As a result from evolving treatment guidelines, approximately half of the patients in both groups received long-term treatment with vitamin K antagonists in stead of currently recommended low-molecular-weight heparin. The 12-month cumulative incidence of recurrent VTE was 13.3% in the incidental group versus 16.9% in the symptomatic group (P = .77). Notably, 20% VTE events recurred after premature termination of anticoagulant therapy. The risk of major bleeding complications was also comparable in the two groups (12.5% for incidental patients and 8.6% for symptomatic patients; P = .5). The respective 12-month mortality risks were 52.9% and 53.3% (P = .7).
Our findings suggest that oncology patients diagnosed with and treated for incidental PE, have similar high rates of recurrent VTE, bleeding complications, and mortality, as compared with oncology patients who develop symptomatic PE.
Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a ...significant increase in major bleeding.
Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding.
Prophylactic anticoagulant therapy is standard practice after total hip or knee arthroplasty, with a minimum recommended duration of 10 days.
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After total hip arthroplasty, extended prophylaxis for 5 weeks after surgery reduces the incidence of symptomatic and asymptomatic venous thromboembolism more effectively than does short-term prophylaxis.
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New deep-vein thromboses have been shown to form after the discontinuation of short-term prophylaxis.
3
Several meta-analyses suggest that extended thromboprophylaxis after total hip arthroplasty leads to a reduction in symptomatic venous thromboembolic events, without increasing the risk of major bleeding.
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These findings led to a grade 1A recommendation for extended thromboprophylaxis after total . . .
Idarucizumab was 100% effective in reversing the anticoagulant effect of dabigatran among 300 patients with uncontrolled bleeding (median time to bleeding cessation, 2.5 hours) and among 200 patients ...who required an urgent procedure (median time to procedure initiation, 1.6 hours).
Abstract Background Recent improvements in atrial fibrillation diagnosis and management have prompted the initiation of various registries, predominantly to assess adherence to new guidelines, but ...also to address the pending questions of safety and effectiveness of newly introduced management options in ‘real world’ clinical practice settings. In this review we appraise antithrombotic treatment patterns for stroke prevention in atrial fibrillation registries. Methods and Results We searched PubMed, Science Direct and the Cochrane databases for registries focusing on stroke thromboprophylaxis in atrial fibrillation. Registry data show that over the last decade, the proportion of patients receiving oral anticoagulation has increased (from about 67% to over 80%), while the proportion of those treated with aspirin only or untreated has diminished. Vitamin K antagonists (VKAs) are being gradually replaced by non-VKA oral anticoagulants (NOACs) as the more prevalent option. Regional and country differences in anticoagulation are evident, with its highest uptake in Europe (90.2%) and lowest in Asia (57.4%). Moreover, oral anticoagulation is given to approximately 50% of patients with no stroke risk factors, whereas over a third of high-risk subjects are not anticoagulated but often prescribed antiplatelet therapy alone or untreated. Guideline non-adherent thromboprophylaxis results in an increase in all-cause mortality and thromboembolism. Conclusions Registry data show that despite an increase in anticoagulation rates over the last decade, management gaps in stroke prevention are still evident with about third of patients not treated in line with the guidelines. Mortality rates of atrial fibrillation patients remain relatively high, mostly due to the comorbid disease.
Objective To prospectively validate the HERDOO2 rule (Hyperpigmentation, Edema, or Redness in either leg; D-dimer level ≥250 μg/L; Obesity with body mass index ≥30; or Older age, ≥65 years), which ...states that women with none or one of the criteria can safely discontinue anticoagulants after short term treatment.Design Prospective cohort management study.Setting 44 secondary or tertiary care centres in seven countries.Participants Of 3155 consecutive eligible participants with a first unprovoked venous thromboembolism (VTE, proximal leg deep vein thrombosis or pulmonary embolism) who completed 5-12 months of short term anticoagulant treatment, 370 declined to participate, leaving 2785 enrolled participants. 2.3% were lost to follow-up.Interventions Women with none or one of the HERDOO2 criteria were classified as at low risk of recurrent VTE and discontinued anticoagulants (intervention arm), whereas anticoagulant management for high risk women (≥2 HERDOO2 criteria) and men was left to the discretion of the clinicians and patients (observation arm).Main outcome measure Recurrent symptomatic VTE (independently and blindly adjudicated) over one year of follow-up.Results Of 1213 women, 631 (51.3%) were classified as low risk and 591 discontinued oral anticoagulant treatment. In the primary analysis, 17 low risk women who discontinued anticoagulants developed recurrent VTE during 564 patient years of follow-up (3.0% per patient year, 95% confidence interval 1.8% to 4.8%). In 323 high risk women and men who discontinued anticoagulants, 25 had VTE during 309 patient years of follow-up (8.1%, 5.2% to 11.9%), whereas in 1802 high risk women and men who continued anticoagulants 28 had recurrent VTE during 1758 patient years of follow-up (1.6%, 1.1% to 2.3%).Conclusions Women with a first unprovoked VTE event and none or one of the HERDOO2 criteria have a low risk of recurrent VTE and can safely discontinue anticoagulants after completing short term treatment.Trial registration clinicaltrials.gov NCT00967304.
Idarucizumab for Dabigatran Reversal Pollack, Charles V; Reilly, Paul A; Eikelboom, John ...
New England journal of medicine/The New England journal of medicine,
08/2015, Letnik:
373, Številka:
6
Journal Article
Recenzirano
Odprti dostop
Intravenous idarucizumab, an antibody fragment of a human antibody specific for dabigatran, produced rapid reversal of the anticoagulant effect in patients with bleeding or an urgent surgical ...indication with no apparent toxic effects or rebound hypercoagulable state.
A non–vitamin K antagonist oral anticoagulant, dabigatran etexilate (dabigatran) is an oral thrombin inhibitor that is licensed for the prevention of stroke in patients with nonvalvular atrial fibrillation and for the prevention and treatment of venous thromboembolism. Although dabigatran is associated with less serious bleeding than warfarin,
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–
3
life-threatening bleeding can occur; in addition, dabigatran-treated patients may require urgent surgery or intervention, and dabigatran can increase the risk of perioperative bleeding. To improve the treatment of such patients, a specific dabigatran-reversal agent would be beneficial.
Idarucizumab, a monoclonal antibody fragment, binds dabigatran with an affinity that is 350 times as . . .
Abstract
International and national guidelines recommend low-molecular-weight heparin for the treatment of venous thromboembolism (VTE) in patients with cancer. The aim of the Caravaggio study is to ...assess whether oral apixaban is non-inferior to subcutaneous dalteparin for the treatment of acute proximal deep vein thrombosis and/or pulmonary embolism in patients with cancer. The study is an investigator-initiated, multi-national, prospective, randomized, open-label with blind end-point evaluation (PROBE), non-inferiority clinical trial (NCT03045406). Consecutive patients are randomized to receive oral apixaban or subcutaneous dalteparin for 6 months. Apixaban is given at a dose of 10 mg twice daily for the first 7 days and then 5 mg twice daily; dalteparin is given at a dose of 200 IU/kg for the first month and then 150 IU/kg once daily. The primary outcome of the study is objectively confirmed recurrent VTE as assessed by a central independent adjudication committee unaware of study treatment allocation. The primary safety outcome is major bleeding defined according to the guidelines of the International Society of Thrombosis and Haemostasis. Assuming a 6-month incidence of the primary outcome of 7% with dalteparin and an upper limit of the two-sided 95% confidence interval of the hazard ratio below the pre-specified margin of 2.00, 1,168 patients will be randomized considering an up to 20% loss in total patient-years (
β
= 80%;
α
one-sided = 0.025). The Caravaggio study has the potential, along with other recently performed or on-going studies, to make less cumbersome the management of VTE in patients with cancer by replacing parenteral with oral anticoagulation.
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