Risk Of Bleeding
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Hong Liang ◽  
Launia White ◽  
Ryan M Chadha ◽  
J Ross Renew

In the era of “fast-track’ liver transplantation (LT), neuromuscular blockade (NMB) antagonists such as neostigmine or sugammadex are used to achieve the restoration of neuromuscular function. While sugammadex reverses NMB faster than neostigmine, it has been shown to prolong prothrombin time (PT) and activated thromboplastin time (aPTT). However, this agent’s impact on coagulation during LT is not understood. We compare bleeding risk associated with sugammadex versus neostigmine during liver transplantation. This is a single-center, retrospective review of LT patients who received NMB antagonists intraoperatively between 01/01/2015 to 05/31/2018 at Mayo Clinic in Florida. The primary outcomes were postoperative day (POD) 0-1 bleeding events and POD 0 values of aPTT and INR. Total 241 patients were included, with 135 patients in the neostigmine group (NG) and 106 in the sugammadex group (SG). POD 0-1 postoperative bleeding requiring transfusion occurred in 20% of NG versus 10.4% in SG. POD 0-1 re-operation for bleeding occurred in 1.5% in NG vs. 0% in SG. POD 0 mean INR was 2.0±0.4 in both groups. POD 0 mean aPTT was 45.5±7.9 in NG vs. 49.3±9.0 in SG. Our retrospective study suggests that sugammadex is not associated with an increased risk of bleeding compared to neostigmine use.

2021 ◽  
Vol 12 ◽  
René Zeiss ◽  
Bernhard J. Connemann ◽  
Carlos Schönfeldt-Lecuona ◽  
Maximilian Gahr

Introduction: Until now, methods of pharmacovigilance as disproportionality analysis were not capable of proving the otherwise well-established increased bleeding risk related to antidepressants (ADs). As bleeding events with ADs often occur in combination with antithrombotics, they might not be considered causative of, but merely “linked” with, the bleeding event. Therefore, we hypothesized that the causality assessment of bleeding events in association with ADs and the competitive impact of antithrombotics are factors contributing to the non-findings of previous pharmacovigilance studies.Methods: We performed a case/non-case study based on data from VigiBaseTM and calculated reporting odds ratios (RORs) for 25 ADs. We used individual case safety reports (ICSRs) that were differently categorized in the database regarding their type of association between drug and event. Furthermore, we investigated the competitive impact of antithrombotics by comparing RORs with and without ICSRs related to antithrombotics.Results: Analysis of ICSRs that were categorized as causally associated resulted in the detection of only two signals (citalopram and escitalopram; upper gastrointestinal bleeding). Analysis of ICSRs irrespective of the type of association resulted in the detection of signals in 8 out of 25 ADs (regarding bleeding, in general, gastrointestinal bleeding and upper gastrointestinal bleeding). Consideration of ICSRs associated with antithrombotics as competitive substances did not have a major impact on signal detection in our analysis.Conclusion: Categorization of the type of association between drug and event affects the results of quantitative signal detection. Causality assessment seems to play a major role in signal detection, probably particularly concerning rare, unknown, or clinically insignificant adverse drug reactions. ADs appear to significantly increase the bleeding risk, even independent of antithrombotic comedication.

2021 ◽  
Mengyi Sun ◽  
Weichen Cui ◽  
Linping Li

Abstract Background: Ticagrelor is currently recommended for patients with acute coronary syndrome (ACS). However, recent studies have yielded controversial results. Objective: To compare the clinical outcomes of ticagrelor and clopidogrel in ACS patients.Methods: Three electronic databases were queried until April 1, 2021. Major adverse cardiovascular event (MACE) was the primary efficacy endpoint. The secondary efficacy endpoints included stroke, stent thrombosis (ST), cardiovascular (CV) death, all-cause death, and myocardial infarction (MI). The safety endpoints were (major and minor) bleeding. Odds ratios (ORs) and 95% confidence intervals (CIs) and were calculated to represent the estimated effect sizes.Results: Nine clinical trials and 18 observational studies with 269,935 ACS patients were included. No significant difference was detected in MACE (OR 0.76, 95% CI 0.54-1.06, p = 0.11, I² = 66.74%), but ticagrelor introduced a higher risk of bleeding (1.49, 1.14-1.94, 0.00, 63.97%) and minor bleeding (1.57, 1.08-2.30, 0.02, 59.09%) in clinical trials. The secondary efficacy endpoints differed between clinical trials and observational studies. Subgroup analysis demonstrated that ticagrelor showed better therapeutic effects in patients underwent PCI (0.38, 0.23-0.63, 0.00, 0) than those intended for PCI (1.02, 0.70-1.49, 0.93, 68.99%). Meanwhile ticagrelor showed different therapeutic effects on ACS patients of different ethnicities and from different countries.Conclusion:This meta-analysis demonstrated that ticagrelor is not superior to clopidogrel in MACE but is associated with a higher risk of bleeding in ACS patients. Different PCI strategies, ethnicities, and countries may be the factors that contribute to different therapeutic efficacy of ticagrelor.

Jallouli A ◽  
Michouar M ◽  
Laghfiri N ◽  
Errami A Ait ◽  
Oubaha S ◽  

Hepatobiliary complications of sickle cell disease are rare, cirrhosis remains very exceptional, especially in heterozygous forms of the disease. We report the case of a 19-year-old patient whose etiologic investigation of hemolytic anemia revealed heterozygous sickle cell disease complicated by hepatic cirrhosis. The diagnosis of cirrhosis was made due to the presence of signs of hepato-cellular insufficiency, portal hypertension syndrome and hepatic dysmorphia on imaging. The etiological assessment was negative. The liver biopsy was not performed due to the risk of bleeding. The interest of this observation is to evoke hepato-biliary complications (in particular cirrhosis) in patients with sickle cell anemia, in order to avoid a pejorative evolution burdened with serious complications.

Circulation ◽  
2021 ◽  
Vol 144 (16) ◽  
pp. 1323-1343
Paolo Calabrò ◽  
Felice Gragnano ◽  
Giampaolo Niccoli ◽  
Rossella Marcucci ◽  
Marco Zimarino ◽  

Contemporary evidence supports device-based transcatheter interventions for the management of patients with structural heart disease. These procedures, which include aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure, profoundly differ with respect to clinical indications and procedural aspects. Yet, patients undergoing transcatheter cardiac interventions require antithrombotic therapy before, during, or after the procedure to prevent thromboembolic events. However, these therapies are associated with an increased risk of bleeding complications. To date, challenges and controversies exist regarding balancing the risk of thrombotic and bleeding complications in these patients such that the optimal antithrombotic regimens to adopt in each specific procedure is still unclear. In this review, we summarize current evidence on antithrombotic therapies for device-based transcatheter interventions targeting structural heart disease and emphasize the importance of a tailored approach in these patients.

2021 ◽  
Vol 1 (29) ◽  
pp. 47-51
A. P. Pereverzev ◽  
O. D. Ostroumova

Every drug may cause central nervous system, gastrointestinal tract or cardiovascular system adverse drugs reactions (ADRs). At the same time, doctors often do not have sufficient information about possible food-drug interactions, in particular, garlic. But this spice is shown to increase the risks of developing ADRs. From the beginning of the 20th century to the present, garlic has been the subject of many chemical studies, which have revealed some differences in the chemical composition of the studied preparation (fresh or stored garlic). The most important chemical ingredients found in garlic are divided into two groups: sulfur-containing (allicin [diallyl thiosulfinate], allyl methanesulfinate, alliin [S-allyl-L-cysteine sulfoxide, diallyl disulfide, DADS], S-allylmethyl cysteine, diallyl trisulfide [diallyl trisulfide, DATS], allyl methyl trisulfide, allyl methyl disulfide, diallyl tetrasulfide, allyl methyl tetrasulfide, dimethyl trisulfide, diallyl sulfide, 2-vinyl-4-H1,3-dithiine, 3-vinyl-4.-H1,2-dithiin) and sulfur-free compounds. Most of the pharmacological effects of garlic are due to sulfur compounds, in particular allicin. In animal, in vitro and clinical studies, it has been shown that garlic can interact with various drug througt pharmacokinetic or pharmacodynamic way. For example, garlic extract has shown to inhibit the metabolic activity of CYP2C9*1, 2C19, 3A4, 3A5, 3A7, but not CYP2D6. It has also been shown that garlic can affect the function thrombocyte and blood clotting, which leads to an increased risk of bleeding, which is especially important in the case of its simultaneous use with antiplatelet agents and/or anticoagulants. This article provides an overview of the open literature on the risks and benefits of the simultaneous use of drugs and products containing garlic.

2021 ◽  
pp. 68-76
S. R. Gilyarevskiy ◽  
N. G. Bendeliani ◽  
M. V. Golshmid ◽  
I. M. Kuzmina

The article presents updated information on the frequency of use of non-recommended low dosing of direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban). It gives substantiation of the urgency of the issue of providing the maximum efficiency of the use of anticoagulants in clinical practice, taking into account the high prevalence of atrial fibrillation and the pharmacological characteristics of the most commonly used drugs. The effects of such an unreasonable reduction in anticoagulant doses in elderly and senile patients are discussed. The results of recent observational studies that assessed the relationship between the use of direct oral anticoagulants and the risk of adverse clinical outcomes are presented. The data on the relationship between the use of unreasonably low dosing of anticoagulants in patients with atrial fibrillation, which were recently obtained during the implementation of the GARFIELD-AF registry, are discussed. The data on a rather high variability of concentrations of direct oral anticoagulants are presented. The frequency of using apixaban in an unreasonably reduced dose, as well as the effects of using non-recommended doses of apixaban hold a specific place in the article. The unreasonableness of attempts to further reduce the risk of bleeding due to unreasonable reduction of apixaban dosing is emphasized, taking into account the stable data on the high safety of recommended dosing of apixaban, as well as the possible decrease in the effect if the dose reduction is not recommended. The data on the criteria for dose reduction, which are adopted in different countries, are presented. The proposed terms to designate different doses of direct oral anticoagulants, depending on their study in the course of large, randomized trials are discussed.

2021 ◽  
Vol 12 ◽  
Xiangkai Zhao ◽  
Jian Zhang ◽  
Jialin Guo ◽  
Jinxin Wang ◽  
Yuhui Pan ◽  

Background: Dual antiplatelet therapy combining aspirin with a P2Y12 adenosine diphosphate receptor inhibitor is a therapeutic mainstay for acute coronary syndrome (ACS). However, the optimal choice of P2Y12 adenosine diphosphate receptor inhibitor in elderly (aged ≥65 years) patients remains controversial. We conducted a meta-analysis to compare the efficacy and safety of ticagrelor and clopidogrel in elderly patients with ACS. Methods: We comprehensively searched in Web of Science, EMBASE, PubMed, and Cochrane databases through 29th March, 2021 for eligible randomized controlled trials (RCTs) comparing the efficacy and safety of ticagrelor or clopidogrel plus aspirin in elderly patients with ACS. Four studies were included in the final analysis. A fixed effects model or random effects model was applied to analyze risk ratios (RRs) and hazard ratios (HRs) across studies, and I2 to assess heterogeneity.Results: A total number of 4429 elderly patients with ACS were included in this analysis, of whom 2170 (49.0%) patients received aspirin plus ticagrelor and 2259 (51.0%) received aspirin plus clopidogrel. The ticagrelor group showed a significant advantage over the clopidogrel group concerning all-cause mortality (HR 0.78, 95% CI 0.63–0.96, I2 = 0%; RR 0.79, 95% CI 0.66–0.95, I2 = 0%) and cardiovascular death (HR 0.71, 95% CI 0.56–0.91, I2 = 0%; RR 0.76, 95% CI 0.62–0.94, I2 = 5%) but owned a higher risk of PLATO major or minor bleeding (HR 1.46, 95% CI 1.13–1.89, I2 = 0%; RR 1.40, 95% CI 1.11–1.76, I2 = 0%). Both the groups showed no significant difference regarding major adverse cardiovascular events (MACEs) (HR 1.06, 95% CI 0.68–1.65, I2 = 77%; RR 1.04, 95% CI 0.69–1.58, I2 = 77%).Conclusion: For elderly ACS patients, aspirin plus ticagrelor reduces cardiovascular death and all-cause mortality but increases the risk of bleeding. Herein, aspirin plus ticagrelor may extend lifetime for elderly ACS patients compared with aspirin plus clopidogrel. The optimal DAPT for elderly ACS patients may be a valuable direction for future research studies.

Po-Yin Chang ◽  
weiting wang ◽  
Wei-Lun Wu ◽  
Hui-Chin Chang ◽  
Chen-Huan Chen ◽  

Background and Purpose: Oral anticoagulants (OACs) prevent stroke recurrence and vascular embolism in patients with acute ischaemic stroke (AIS) and atrial fibrillation (AF). Current guidance recommends a “1-3-6-12 day”’ rule to resume OACs after AIS, based mainly on empirical consensus. This study investigated the suitability of guideline-recommended timing for OAC initiation. Methods: To overcome immortal time bias, we emulated a sequence of randomized placebo-controlled trials and constructed 90 propensity score-matched cohorts of 12,307 patients with AF and AIS from 2012 to 2016. We compared the risk of composite effectiveness and safety outcome in the early vs no OAC use group and in the delayed vs no OAC use. Indirect comparison between early and delayed use was conducted using a network meta-analysis. Results: Across the groups of AIS severity, the risks of composite outcome or effectiveness outcome were lower in the OAC use group than the no use group and the risks were similar between the early and delayed use groups. In patients with severe AIS, those receiving early OACs use had an increased risk of safety outcome, with HR of 2.10 (CI: 1.13-3.92) compared with those without OAC use, and HR of 1·44 (CI: 0·99-2·09) compared with those receiving delayed use. Conclusions: In AF patients with severe AIS, early OAC use before the guideline-recommended days appeared to increase the risk of bleeding events, although the OAC initiation time seemed not to affect the risk of serious vascular events. The optimal severity-specific timing for OAC initiation after AIS requires further evaluation

2021 ◽  
Vol 10 (20) ◽  
pp. 4702
Benedikt Treml ◽  
Sasa Rajsic ◽  
Tobias Hell ◽  
Dietmar Fries ◽  
Mirjam Bachler

Tigecycline is a novel glycylcycline broad-spectrum antibiotic offering good coverage for critically ill patients experiencing complicated infections. A known side effect is a coagulation disorder with distinct hypofibrinogenemia. To date, the information on possible risk factors and outcomes is sparse. Therefore, the aim of this study is to examine the time course of fibrinogen level changes during tigecycline therapy in critically ill patients. Moreover, we sought to identify risk factors for coagulopathy and to report on clinically important outcomes. We retrospectively reviewed all intensive care patients admitted to our General and Surgical Intensive Care Unit receiving tigecycline between 2010 and 2018. A total of 130 patients were stratified into two groups based on the extent of fibrinogen decrease. Patients with a greater fibrinogen decrease received a higher dose, a longer treatment and more dose changes of tigecycline, respectively. In regard to the underlying pathology, these patients showed higher inflammation markers as well as a slightly reduced liver synthesis capacity. We, therefore, conclude that such a fibrinogen decrease may be based upon further impairment of liver synthesis during severe inflammatory states. To decrease the risk of bleeding, cautious monitoring of coagulation in critically ill patients treated with high-dose tigecycline is warranted.

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