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Direct oral anticoagulants versus vitamin K antagonists in epistaxis patients: A systematic review and meta-analysis.
Stanković, P, Hoch, S, Rudhart, S, Obradović, D, Dagres, N, Wilhelm, T
Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery. 2022;(2):255-263
Abstract
OBJECTIVE Epistaxis is the most common otolaryngological emergency and up to one third of patients in treated on an inpatient basis take oral anticoagulants (OAC). Direct oral anticoagulants (DOAC), an OAC subgroup, have been on the market since 2010 and are being increasingly prescribed due to the cardiological and haematological guidelines that favour them over vitamin K antagonists (VKA), the older of the OAC subgroups. The present study aims to investigate which subgroup of epistaxis patients taking OACs has a more favourable outcome. DESIGN/SETTING A systematic review and meta-analysis were performed according to the PRISMA 2020 statement using the PubMed and Cochrane Library databases. Continuous data were analysed and standardised mean difference (SMD) was calculated according to Hedges' g. Dichotomous data were analysed, and the Mantel-Haenszel method was applied to establish the odds ratio (OR). Heterogeneity was assessed according to the I2 statistics. MAIN OUTCOME/RESULTS A total of eight reports covering 1390 patients were included in the final synthesis. The pooled analysis demonstrated significantly shorter hospital stays in the DOAC group (SMD = -0.22, 95% CI-0.42 to -0.02, p = .03) and a significantly higher rate of posterior bleeding in the VKA group (OR = .39, 95% CI 0.23 to 0.68, p = .001). No statistically significant differences with regard to recurrence rates, admission rates, the need for transfusion or surgical intervention (p = .57, .12, .57 and .38 respectively) were found. CONCLUSION According to this meta-analysis, epistaxis patients taking DOACs have a more favourable outcome than patients taking VKAs.
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Direct Oral Anticoagulants for the Treatment of Cancer-Associated Venous Thromboembolism: A Latin American Perspective.
Athanazio, RA, Ceresetto, JM, Marfil Rivera, LJ, Cesarman-Maus, G, Galvez, K, Marques, MA, Tabares, AH, Ortiz Santacruz, CA, Santini, FC, Corrales, L, et al
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2022;:10760296221082988
Abstract
Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in patients with cancer. On the basis of results from randomized controlled trials, direct oral anticoagulants (DOACs) are now recommended for the treatment of cancer-associated VTE. The decision to use a DOAC requires consideration of bleeding risk, particularly in patients with gastrointestinal (GI) malignancies, the cost-benefit and convenience of oral therapy, and patient preference. While efficacy with apixaban, edoxaban, and rivaroxaban versus dalteparin has been consistent in the treatment of cancer-associated VTE, heterogeneity is evident with respect to major GI bleeding, with an increased risk with edoxaban and rivaroxaban but not apixaban. Although cost and accessibility vary in different countries of Latin America, DOACs should be considered for the long-term treatment of cancer-associated VTE in all patients who are likely to benefit. Apixaban may be the preferred DOAC in patients with GI malignancies and LMWH may be preferred for patients with upper or unresected lower GI tumors. Vitamin K antagonists should only be used for anticoagulation when DOACs and low molecular weight heparin are inaccessible or unsuitable.
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Efficacy and safety of direct oral anticoagulants versus vitamin K antagonist for portal vein thrombosis in cirrhosis: A systematic review and meta-analysis.
Koh, JH, Liew, ZH, Ng, GK, Liu, HT, Tam, YC, De Gottardi, A, Wong, YJ
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2022;(1):56-62
Abstract
INTRODUCTION AND AIM Portal vein thrombosis (PVT) is associated with a higher risk of liver-related complications. Recent guidelines recommend direct-acting anticoagulants (DOAC) in patients with cirrhosis and non-tumoral PVT. However, data on the efficacy and safety of DOAC in these patients remain limited. We aim to investigate the efficacy and safety of DOAC compared to vitamin K antagonists (VKA) to treat non-tumoral PVT in patients with cirrhosis. METHODS We performed a systematic search of six electronic databases using MeSH term and free text. We selected all studies comparing the use of DOACs with vitamin K antagonist to treat PVT in cirrhosis. The primary outcome was PVT recanalization. Secondary outcomes were and PVT progression, major bleeding, variceal bleeding and death. RESULTS From 944 citations, we included 552 subjects from a total of 11 studies (10 observational and 1 randomized trial) that fulfilled the inclusion criteria. We found that DOAC were associated with a higher pooled rate of PVT recanalization (RR = 1.67, 95%CI: 1.02, 2.74, I2 = 79%) and lower pooled risk of PVT progression (RR = 0.14, 95%CI: 0.03-0.57, I2 = 0%). The pooled risk of major bleeding (RR = 0.29, 95%CI: 0.08-1.01, I2 = 0%), variceal bleeding (RR = 1.29, 95%CI: 0.64-2.59, I2 = 0%) and death (RR = 0.31, 95%CI: 0.01-9.578, I2 = 80%) was similar between DOAC and VKA. CONCLUSION For the treatment of PVT in patients with cirrhosis, the bleeding risk was comparable between DOAC and VKA. However, DOAC were associated with a higher pooled rate of PVT recanalization. Dedicated randomized studies are needed to confirm these findings.
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Non-Vitamin K Antagonists Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Valves: A Systematic Review and Meta-Analysis.
Cardoso, R, Ternes, CMP, Justino, GB, Fernandes, A, Rocha, AV, Knijnik, L, d'Avila, A, Lopes, RD
The American journal of medicine. 2022;(2):228-234.e1
Abstract
BACKGROUND Patients with atrial fibrillation and bioprosthetic valves are at high risk for thromboembolic events. The pooled efficacy and safety of non-vitamin K oral anticoagulants (NOACs), as a class, relative to warfarin in this population is not well-known. We aimed to compare the efficacy and safety of NOACs relative to warfarin in patients with bioprosthetic valves or valve repair. METHODS We systematically searched EMBASE, PubMed, and Cochrane databases for randomized controlled trials comparing NOACs to warfarin in patients with atrial fibrillation and bioprosthetic valves or valve repair. We pooled outcomes for stroke or systemic embolism, ischemic stroke, hemorrhagic stroke, and major bleeding. RESULTS We included 4 trials with 1379 patients, of whom 723 (52.4%) received a NOAC. Mean follow-up ranged from 90 days to 2.8 years. In the pooled analysis, stroke or systemic embolism was significantly lower in patients treated with NOACs (1.9%) compared with warfarin (3.7%) (odds ratio [OR] 0.43; 95% confidence interval [CI] 0.22-0.85; P = .02). Ischemic stroke (OR 0.72; 95% CI 0.18-2.93), hemorrhagic stroke (OR 0.18; 95% CI 0.03-1.05), cardiovascular death (OR 0.78; 95% CI 0.38-1.62), and all-cause mortality (OR 0.94; 95% CI 0.55-1.62) were not significantly different among groups. Major bleeding was significantly lower in patients treated with NOAC (2.8%) compared with warfarin (4.7%) (OR 0.49; 95% CI 0.28-0.88; P = .02). CONCLUSIONS In patients with atrial fibrillation and bioprosthetic valves or valve repair, NOACs are associated with a reduced incidence of thromboembolic events and major bleeding as compared with warfarin. Thus, NOACs may be considered a preferred option for this patient population.
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Anticoagulants for stroke prevention in heart failure with reduced ejection fraction.
Schäfer, A, Flierl, U, Bauersachs, J
Clinical research in cardiology : official journal of the German Cardiac Society. 2022;(1):1-13
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Abstract
Impaired left-ventricular ejection-fraction (LV-EF) is a known risk factor for ischemic stroke and systemic embolism in patients with heart failure (HF) even in the absence of atrial fibrillation. While stroke risk is inversely correlated with LV-EF in HF patients with sinus rhythm, strategies using anticoagulation with Vitamin-K antagonists (VKA) were futile as the increase in major bleedings outweighed the potential benefit in stroke reduction. Non-Vitamin K oral anticoagulants (NOACs) proved to be an effective and in general safer approach for stroke prevention in patients with atrial fibrillation and may also have a favourable risk-benefit profile in HF patients. In HF patients with sinus rhythm, the COMPASS trial suggested a potential benefit for rivaroxaban, whereas the more dedicated COMMANDER-HF trial remained neutral on overall ischemic benefit owed to a higher mortality which was not influenced by anticoagulation. More recent data from subgroups in the COMMANDER-HF trial, however, suggest that there might be a benefit of rivaroxaban regarding stroke prevention under certain circumstances. In this article, we review the existing evidence for NOACs in HF patients with atrial fibrillation, elaborate the rationale for stroke prevention in HF patients with sinus rhythm, summarise the available data from anticoagulation trials in HF with sinus rhythm, and describe the patient who might eventually profit from an individualised strategy aiming to reduce stroke risk.
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Prevention of nNon-Vitamin K Oral Anticoagulants-Related Gastrointestinal Bleeding With Acid Suppressants: A Systematic Review and Meta-Analysis.
Dong, Y, He, S, Li, X, Zhou, Z
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2022;:10760296211064897
Abstract
Whether the use of acid suppressants can reduce non-vitamin K oral anticoagulants (NOACs)-related gastrointestinal bleeding (GIB) remains unclear. To systemically evaluate the effect of acid suppressants on the risk of GIB in patients treated with NOACs. All related studies were searched in four databases (Cochrane, Embase, PubMed, and Web of Science) from their establishment to August 10, 2021. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used to identify studies and Stata 16.0 software was used for meta-analysis, including sensitivity and subgroup analysis. Six retrospective cohort studies were included in this study. The use of acid suppressants significantly reduced the GIB risk in patients taking NOACs, with an overall relative risk (RR) of 0.70 (95% confidence interval [CI]: 0.61-0.82; P < 0.001; I2 = 56.3%). This trend of reduced risk for GIB in NOACs was more significant in upper GIB (UGIB; RR: 0.45; 95%CI: 0.22-0.90; P = 0.025; I2 = 71.1%). The reduction was stronger for dabigatran than for rivaroxaban and apixaban. The least reduction in the risk of GIB with acid suppressant co-therapy was rivaroxaban (dabigatran: RR: 0.53; 95% CI: 0.45-0.62; P = <0.001; I2 = 39.8%; apixaban: RR: 0.67; 95% CI: 0.54-0.84; P = <0.001; I2 = 0; rivaroxaban: RR: 0.73; 95% CI: 0.66-0.81; P = <0.001; I2 = 37.6%). The included studies revealed the protective effect of acid suppressants against NOACs-related GIB, especially in the upper gastrointestinal tract. The protective effect was even stronger in patients using dabigatran than in those using Xa inhibitors (rivaroxaban and apixaban).
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Net clinical benefit of a reduced dose of DOACs in non-valvular atrial fibrillation: A meta-analysis of randomized trials.
Thomopoulos, C, Ntalakouras, J, Polyzos, D, Konstantinidis, D, Palaiodimou, L, Tsivgoulis, G, Tsioufis, C
Pharmacological research. 2022;:105902
Abstract
BACKGROUND In standard dosing, direct Oral Anticoagulants (DOACs) are used as an alternative to warfarin to prevent ischemic stroke and systemic embolism in non-valvular Atrial Fibrillation (AF). However, randomized comprehensive evidence considering the efficacy and safety of the low-dose DOACs in the same setting is still lacking. Toward this end, we conducted a meta-analysis of randomized trials to estimate the risk/benefit ratio, in terms of net clinical benefit, by comparing a reduced dose of DOACs and warfarin. METHODS We searched three electronic databases, covering the period until end-February 2021. All-cause death, non-fatal stroke/systemic embolism, and major bleeding events, with or without the inclusion of myocardial infarction, were used to define two different net clinical benefit outcomes. In addition, we evaluated different component outcomes of net clinical benefit as secondary outcomes. Finally, risk ratios and 95% Confidence Intervals (CI) of each outcome were calculated (random-effects model). RESULTS In the four randomized trials included (n = 29,779 patients), the net clinical benefit - with or without the inclusion of myocardial infarction - of low-dose DOACs, compared to warfarin, was a 12% (95% CI, 7%-16%) or a 10% (95% CI, 5%-13%) reduction of events, respectively. Compared to warfarin, the reduced dose of DOACs decreased death outcomes, major bleeding events, and hemorrhagic stroke, whereas all thrombotic outcomes were not different among the groups. CONCLUSIONS DOACs at low dosing present a more favorable net clinical benefit profile compared to warfarin.
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Recent Advances in Anticoagulant Treatment of Immune Thrombosis: A Focus on Direct Oral Anticoagulants in Heparin-Induced Thrombocytopenia and Anti-Phospholipid Syndrome.
Carré, J, Jourdi, G, Gendron, N, Helley, D, Gaussem, P, Darnige, L
International journal of molecular sciences. 2021;(1)
Abstract
For more than 10 years, direct oral anticoagulants (DOACs) have been increasingly prescribed for the prevention and treatment of thrombotic events. However, their use in immunothrombotic disorders, namely heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS), is still under investigation. The prothrombotic state resulting from the autoimmune mechanism, multicellular activation, and platelet count decrease, constitutes similarities between HIT and APS. Moreover, they both share the complexity of the biological diagnosis. Current treatment of HIT firstly relies on parenteral non-heparin therapies, but DOACs have been included in American and French guidelines for a few years, providing the advantage of limiting the need for treatment monitoring. In APS, vitamin K antagonists are conversely the main treatment (+/- anti-platelet agents), and the use of DOACs is either subject to precautionary recommendations or is not recommended in severe APS. While some randomized controlled trials have been conducted regarding the use of DOACs in APS, only retrospective studies have examined HIT. In addition, vaccine-induced immune thrombotic thrombocytopenia (VITT) is now a part of immunothrombotic disorders, and guidelines have been created concerning an anticoagulant strategy in this case. This literature review aims to summarize available data on HIT, APS, and VITT treatments and define the use of DOACs in therapeutic strategies.
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Anticoagulant Reversal in Gastrointestinal Bleeding: Review of Treatment Guidelines.
Milling, TJ, Refaai, MA, Sengupta, N
Digestive diseases and sciences. 2021;(11):3698-3714
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Abstract
BACKGROUND Patients receiving anticoagulant therapies, such as vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs), commonly experience gastrointestinal (GI) bleeding as a complication and may require anticoagulant reversal prior to endoscopic treatment. Anticoagulant reversal agents include prothrombin complex concentrates (PCCs; including 3 or 4 coagulation factors), plasma, vitamin K, and target-specific DOAC reversal agents (e.g., idarucizumab and andexanet alfa). AIM: To review current US, as well as international, guidelines for anticoagulant reversal agents in patients on VKAs or DOACs presenting with GI bleeding prior to endoscopy, guideline-based management of coagulation defects, timing of endoscopy, and recommendations for resumption of anticoagulant therapy following hemostasis. Supporting clinical data were also reviewed. METHODS This is a narrative review, based on PubMed and Internet searches reporting GI guidelines and supporting clinical data. RESULTS GI-specific guidelines state that use of reversal agents should be considered in patients with life-threatening GI bleeding. For VKA patients presenting with an international normalized ratio > 2.5, guidelines recommend PCCs (specifically 4F-PCC), as they may exhibit greater efficacy/safety compared with fresh frozen plasma in reversal of VKA-associated GI bleeding. For DOAC patients, most guidelines recommend targeted specific reversal agents in the setting of GI bleeding; however, PCCs (primarily 4F-PCC) are often listed as another option. Resumption of anticoagulant therapy following cessation of GI bleeding is also recommended to reduce risks of future thromboembolic complications. CONCLUSIONS The utility of anticoagulant reversal agents in GI bleeding is recognized in guidelines; however, such agents should be reserved for use in truly life-threatening scenarios.
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Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis.
Goette, A, Eckardt, L, Valgimigli, M, Lewalter, T, Laeis, P, Reimitz, PE, Smolnik, R, Zierhut, W, Tijssen, JG, Vranckx, P
Clinical research in cardiology : official journal of the German Cardiac Society. 2021;(6):831-840
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Abstract
AIMS: This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. METHODS Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1-12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. RESULTS Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654-1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711-1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). CONCLUSION After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.