new oral anticoagulants
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2022 ◽  
Vol 12 (1) ◽  
pp. 107
Author(s):  
Mohammed Farhan A Alfarhan

Prophylactic anticoagulant therapy is recommended for reducing the risk of venous thromboembolism (VTE) after a total hip replacement (THR). However, it is not clear which anticoagulant is preferable. Hence, a systematic review and meta-analysis of randomized double-blind controlled trials (RDBCTs) were conducted to investigate the clinical efficacy and safety of enoxaparin in comparison with newer oral anticoagulants for the prevention of VTE after THR. The Cochrane Library, Scopus, Web of Science, Embase, and PubMed/Medline databases were used for PICO search strategy. Relative risks (RR) of symptomatic VTE, clinically relevant bleeding, mortality, and a net clinical endpoint were estimated employing a random effect meta-analysis. ITC and RevMan software were used for indirect and direct comparisons, respectively. Nine RDBCTs comprising 24,584 patients were included. As compared to enoxaparin, a reduced risk for symptomatic VTE was observed with rivaroxaban (confidence interval [CI]: 0.32–0.77; RR: 0.46%) and comparable with apixaban (0.12–1.26; 0.42%) and dabigatran (0.22–2.20; 0.70%). Contrarily to enoxaparin, a greater risk for clinically relevant bleeding was observed with rivaroxaban (1.03–1.48; 1.23%), comparable with dabigatran (0.96–1.33; 1.10%) and reduced with apixaban (0.19–5.66; 0.96%). In indirect or direct comparisons, the interventions did not differ on the net clinical endpoint. In conclusion, the findings of this meta-analysis revealed no significant difference in the efficacy and safety of new oral anticoagulants as compared to enoxaparin for the prevention of VTE after total hip replacement surgery.


Author(s):  
Paula Rocco Gomes Lima ◽  
Gisele Mara Silva Gonçalves ◽  
Roberta Cunha Matheus Rodrigues ◽  
Ana Railka de Souza Oliveira-Kumakura

ABSTRACT Objective: To characterize the self-reported adherence of patients with cardiovascular diseases to the use of new oral anticoagulants and to identify factors related to adherence to these drugs. Method: This is a descriptive, correlational, and cross-sectional study, carried out with outpatients. The collection of sociodemographic, clinical, and adherence data, through the Measurement of Adherence to Treatments, was made through telephone calls. Descriptive, correlation, and multiple linear regression analyses were used. Results: A total of 120 patients using new anticoagulants for 32.3 months, on average, participated in the study. More than half of the sample consisted of women, who were professionally inactive, with a mean age of 70.1 years and a mean family income of 6.7 minimum wages. The mean adherence score was 5.7, in a possible range between 1 and 6, indicating medication adherence. Inactive employment status, female sex, higher family income, and follow-up at a public outpatient clinic were related to greater adherence to these medications. Conclusion: The patients showed high adherence to new anticoagulants. Employment status, sex, family income, and type of outpatient follow-up were related to medication adherence, and should be considered in the design of interventions for this public.


2021 ◽  
Vol 8 ◽  
Author(s):  
Xiangyun Kong ◽  
Yong Zhu ◽  
Lianmei Pu ◽  
Shuai Meng ◽  
Lihan Zhao ◽  
...  

Introduction: The real-world treatment of atrial fibrillation (AF) often involves the prescription of new oral anticoagulants (NOACs) using dosing both lower and higher than recommended guidelines. Our study aimed to evaluate the efficacy and safety of non-recommended dosage of NOACs in AF patients.Methods: A systematic search was performed for relevant studies across multiple electronic databases (PubMed, Embase, Cochrane Library, Clinical Trials Registry) from inception to May 1, 2021. Multicenter randomized trials and observational studies were selected with key reporting measures for inclusion involved efficacy outcomes including stroke or systemic thromboembolism along with safety endpoints assessing major or clinically relevant bleeding events.Results: A total of 11 eligible studies were included involving 48,648 patients receiving recommended dose of NOACs and 50,116 patients receiving non-recommended dosage. Compared to AF patients treated with recommended dose regimens, administration of low dose of NOACs was associated with higher risk of stroke/systemic embolism (RR = 1.24, 95% CI 1.14–1.35, P < 0.00001), but without reducing bleeding risk (RR = 1.18, 95% CI 0.91–1.53, P = 0.21) and a higher risk of all-cause mortality (RR = 1.58, 95% CI 1.25–1.99, P = 0.0001). Moreover, high dose of NOACs was associated with higher risk of stroke and systemic embolism efficacy (RR = 1.71, 95% CI 1.06–2.76, P = 0.03) and a non-significant trend to a greater risk of major or clinically relevant bleeding (RR = 1.57, 95% CI 0.96–2.58, P = 0.07).Conclusions: AF patients treated with low dose of NOACs showed equivalent safety but with worse efficacy compared with recommended dose. High dose of NOACs was not superior to recommended dose regimens in preventing stroke/systemic embolism outcomes in AF patients.


2021 ◽  
Vol 15 (1) ◽  
pp. 56-61
Author(s):  
Sergey Martsevich ◽  
Yulia Lukina ◽  
Natalia Kutishenko

Aim: To assess the main characteristics of patients with non-valvular Atrial Fibrillation (AF) who are initially non-adherent to New Oral Anticoagulants (NOAC), and to identify factors associated with this version of non-adherence. Materials and Methods: The ANTEY study included 201 patients with non-valvular AF, who had indications and without contraindications for NOAC treatment. The patients had previously been advised to take oral anticoagulants but they did not comply with all medical recommendations. The observation period was 1 year, during which 2 in-person visits were performed: an inclusion visit (V0) and a visit (V1), as well as 1 telephone contact/follow up (FU); the interval between contacts was 6 months. All patients were recommended to take the NOAC by decision of the physician. During the V0, V1 and FU visits, the “National Society for Evidence-Based Pharmacotherapy (NSEPh) Adherence Scale” questionnaire was used to assess overall adherence and associated factors. 15 (7.5%) patients had not started NOAC therapy by the end of the study (primary non-adherent patients). Their characteristics are analysed in this work. Results: The main reasons for primary non-adherence to NOAC were high cost (33.3%), fears of adverse effects (AE) (33.3%), doubts about the need for treatment (13.3%) and the complex therapy regimen (13.3%). In the group of primary non-adherent patients in comparison with the rest of the patients there were significantly more patients with 1 point according to CHADS2VASc (20% and 2.2%, respectively, p = 0.029) and patients with 3 points according to HAS-BLED (33.3% and 9.1%, respectively, p = 0.006); they took antiplatelet drugs more often 73.3% versus 21.5%, respectively (p = 0.001). Full employment at work (OR = 5.2; CI95% [1.5; 18.1], p = 0.009), history of quitting smoking (OR = 5.1; CI95% [1.5; 17.0], p = 0,008), the presence of any pharmacotherapy AE (OR = 4.0; CI95% [1.01; 16.0], p = 0.048) increased the chance of primary non-adherence to NOAC by 4-5 times. Conclusion: The most vulnerable in relation to initiation of NOAC therapy for the prevention of thromboembolic complications in AF are those patients who continue to work or have any pharmacotherapy AE. The leading factors preventing the initiation of NOAC administration are their high cost, fear of the development of AE from the therapy, and patients’ doubts about the need for treatment with these drugs. The clinical trial registration number is NCT 03790917.


Heart ◽  
2021 ◽  
pp. heartjnl-2021-319702
Author(s):  
Ofra Barnett-Griness ◽  
Nili Stein ◽  
Antonio Kotler ◽  
Walid Saliba ◽  
Naomi Gronich

ObjectiveClinical models such as the HAS-BLED (standing for Hypertension, Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage) were developed to predict risk of major bleeding on vitamin K antagonists/antiplatelet therapy. We aimed to develop a model that will improve the ability to predict major bleeding events in patients with non-valvular atrial fibrillation (AF) treated with new oral anticoagulants (NOACs).MethodsClalit Health Services is the largest of four integrated healthcare organisations in Israel, which insures 4.7 million patients (53% of the population). We identified in Clalit Health Services all patients with AF, new users of an NOAC (2013–2017), and followed them until first occurrence of a major bleeding event, death, switch to another oral anticoagulant, 30 days after discontinuation of NOAC or end of follow-up (31 December 2019). Importance of the candidate model variables was estimated by inclusion frequencies across forward selection algorithm applied to 50 bootstrap samples. Then, backward selection algorithm using the modified Bayesian Information Criterion for competing risks was applied to select predictors for the final model.Results47 623 patients with AF prescribed NOAC were studied. 28 055 patients with AF, initiators of apixaban (mean age 78.7, SD 9.0), were included in the first phase and had 662 major bleeding events. Nine variables were selected for inclusion in a final points-based risk-scoring system: male sex, anaemia, thrombocytopaenia (<99×103/µL), concurrent antiplatelet therapy, hypertension, prior major bleeding, risk factors for a fall, low cholesterol level and low estimated glomerular filtration rate, with apparent area-under-curve (AUC) of 0.6546. Applicability of the model was then shown for 14 118 and 5450 patients with AF, initiators of dabigatran and rivaroxaban, where the score achieved c indices of 0.62 and 0.61, respectively.ConclusionsWe present a novel and simple risk score for prediction of major bleeding in patients with non-valvular AF treated with NOACs. Validation in additional cohorts is warranted.


Author(s):  
Ozgur Karcioglu ◽  
Sehmus Zengin ◽  
Bilgen Ozkaya ◽  
Eylem Ersan ◽  
Sarper Yilmaz ◽  
...  

Background and Objective: Direct (new) Oral Anticoagulants (DOACs) have emerged as a contemporary and promising option in the treatment of thromboses and VTE, while protecting the coagulation cascade against untoward bleeding events. They are used in the management and prophylaxis of Venous Thromboembolism (VTE) and other thrombotic diseases. The most prominent complication of these agents is bleeding. These agents have similar or lower rates of major intracranial hemorrhages, while they had a higher risk of major gastrointestinal bleeding when compared to warfarin. This manuscript is aimed to revise and update the literature findings to outline the side effects of DOACs in various clinical scenarios. Methods: A narrative review of currently published studies was performed. Online database searches were performed for clinical trials published before July 2021, on the efficacy and adverse effects attributed to the anticoagulant treatment, especially DOACs. A literature search via electronic databases was carried out, beginning with the usage of the agents in the Western Languages papers. The search terms initially included direct (new) oral anticoagulants, dabigatran, rivaroxaban, apixaban, edoxaban, idarucizumab, andexanet, prothrombin complex concentrates, and fresh frozen plasma. Papers were examined for methodological soundness before being included. Results: Severe bleeding episodes require aggressive interventions for successful management. Therefore, bleeding should be evaluated in special regard to the location and rate of hemorrhage, and total volume of blood loss. Patient's age, weight and organ dysfunctions (e.g., kidney/liver failure or chronic respiratory diseases) directly affect the clinical course of overdose. Conclusion: Management recommendations for hemorrhage associated with DOAC use vary, depending on the class of the culprit agent (direct thrombin inhibitor vs. FXa inhibitor), the clinical status of the patient (mild/ moderate vs. severe/life-threatening), and capabilities of the institution. Specific reversal agents (i.e., idarucizumab and andexanet alfa) can be used if available, while prothrombin complex concentrates, fresh frozen plasma and/ or tranexamic acid can also be employed as nonspecific replacement agents in the management of DOAC-related bleeding diathesis.


2021 ◽  
Author(s):  
Kaidireyahan Wumaier ◽  
Wenqian Li ◽  
Naifei Chen ◽  
Jiuwei Cui

Abstract Background: Recently, new oral anticoagulants (NOACs) have been included in guidelines for the treatment of cancer-associated thrombosis (CAT) to be extended to suitable cancer patients. The purpose of this study was to compare the cost-effectiveness of using NOACs and low molecular weight heparins(LMWHs) for treating CAT from the perspective of the Chinese healthcare system. Methods: A Markov model was constructed to estimate the cost-effectiveness of the two strategies with a 6-month and 5-year time horizon. Input parameters were either sourced from the clinical trial, published literature. The primary outcome of the model was reported as incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to test model uncertainty. Results: The 6-month cost of NOACs was $ 654.65 with 0.40 QALYs while the 6-month cost of LMWHs was $ 1719.31 with 0.37 QALYs. Similarly, treatment with NOACs had a lower cost ($ 657.85 vs. $ 1716.56) and more health benefits (0.40 QALY vs. 0.37 QALY) than treatment with LMWHs in a subgroup of patients with gastrointestinal malignancy. We found treatment with NOACs would result in a large reduction in cost($ 1447.22 vs. $ 3374.70) but a small reduction in QALYs (3.07 QALY vs. 3.09 QALY) compared with LMWHs over a 5-year time frame, resulting in an ICER of $ 112895.50/QALY. Sensitivity analysis confirmed the robustness of the results. Conclusion: As compared to LMWHs, NOACs can be a cost-saving anticoagulant choice for the treatment of CAT in the general oncology population and gastrointestinal malignancy population.Classification codes: I.


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