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Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

ABSTRACT: Antithrombotic drugs are consistently involved in medication-related adverse events (MRAEs) in hospitalized patients. We aimed to estimate the antithrombotic-related adverse event (ARAE) incidence between 2008 and 2016 and analyse their clinical context in hospitalized patients in The Netherlands. A post-hoc analysis of three national studies, aimed at adverse event (AE) identification, was performed. Previously identified AEs were screened for antithrombotic involvement. Crude and multi-level, case-mix adjusted ARAE and MRAE incidences were calculated. Various contextual ARAE characteristics were analysed. ARAE incidence between 2008 and 2016 decreased significantly in in-hospital deceased patients from 1.20% (95% confidence interval (CI): 0.63-2.27%) in 2008 to 0.54% (95% CI: 0.27-1.11%) in 2015/2016 (p = 0.02). In discharged patients ARAE incidence remained stable. By comparison, overall MRAE incidence remained stable for both deceased and discharged patients. Most ARAEs involved Vitamin-K antagonists (VKAs). Preventable ARAEs occurred more during weekends and with increasing multidisciplinary involvement. Antiplatelet and combined antithrombotic use seemed to be increasingly involved in ARAEs over time. ARAE incidence declined by 55% in deceased patients between 2008 and 2016. Opportunities for improving antithrombotic safety should target INR monitoring and care delivery aspects such as multidisciplinary involvement and weekend care. Future ARAE monitoring for the involvement of antiplatelet, combined antithrombotic and direct oral anticoagulant (DOAC) use is recommended.

SUBMITTER: Moesker MJ

PROVIDER: S-EPMC6617527 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

Moesker Marco J MJ Schutijser Bernadette C F M BCFM de Groot Janke F JF Langelaan Maaike M Spreeuwenberg Peter P Huisman Menno V MV de Bruijne Martine C MC Wagner Cordula C

Journal of clinical medicine 20190612 6

Antithrombotic drugs are consistently involved in medication-related adverse events (MRAEs) in hospitalized patients. We aimed to estimate the antithrombotic-related adverse event (ARAE) incidence between 2008 and 2016 and analyse their clinical context in hospitalized patients in The Netherlands. A post-hoc analysis of three national studies, aimed at adverse event (AE) identification, was performed. Previously identified AEs were screened for antithrombotic involvement. Crude and multi-level, ...[more]

PMID: 31212825

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Project description:BackgroundPatients with multiple clinical risk factors are a complex group in whom both bleeding and recurrent ischaemic events often occur during treatment with dual/triple antithrombotic therapy after percutaneous coronary intervention. Decisions on optimal antithrombotic treatment in these patients are challenging and not supported by clear guideline recommendations. A prospective observational cohort study was set up to evaluate patient-related factors, platelet reactivity, genetics, and a broad spectrum of biomarkers in predicting adverse events in these high-risk patients. Aim of the current paper is to present the study design, with a detailed description of the cohort as a whole, and evaluation of bleeding and ischaemic outcomes during follow-up, thereby facilitating future research questions focusing on specific data provided by the cohort.MethodsWe included patients with ≥ 3 predefined risk factors who were treated with dual/triple antithrombotic therapy following PCI. We performed a wide range of haemostatic tests and collected all ischaemic and bleeding events during 6-12 months follow-up.ResultsWe included 524 high-risk patients who underwent PCI within the previous 1-2 months. All patients used a P2Y12 inhibitor (clopidogrel n = 388, prasugrel n = 61, ticagrelor n = 75) in combination with aspirin (n = 397) and/or anticoagulants (n = 160). Bleeding events were reported by 254 patients (48.5%), necessitating intervention or hospital admission in 92 patients (17.5%). Major adverse cardiovascular events (myocardial infarction, stroke, death) occurred in 69 patients (13.2%).ConclusionThe high risk for both bleeding and ischaemic events in this cohort of patients with multiple clinical risk factors illustrates the challenges that the cardiologist faces to make a balanced decision on the optimal treatment strategy. This cohort will serve to answer several future research questions about the optimal management of these patients on dual/triple antithrombotic therapy, and the possible value of a wide range of laboratory tests to guide these decisions.

Project description:ContextImmune checkpoint blockade is associated with endocrine-related adverse events. Thyroid dysfunction during pembrolizumab therapy, an anti-programmed cell death 1 (PD-1) receptor monoclonal antibody, remains to be fully characterized.ObjectiveTo assess the incidence and characteristics of pembrolizumab-associated thyroid dysfunction.Design and settingThyroid function was monitored prospectively in melanoma patients who initiated pembrolizumab within an expanded access program at a referral oncology center. 18Fluorodeoxyglucose uptake on positron emission tomography/computed tomography (18FDG-PET/CT) was reviewed in cases compatible with inflammatory thyroiditis.PatientsNinety-nine patients with advanced melanoma (age, 26.3-93.6 years; 63.6% females) who received at least one administration of pembrolizumab.Main outcome measuresPatient characteristics, thyroid function (TSH, free T4), thyroid autoantibodies, and 18FDG-PET/CT.ResultsEighteen adverse events of thyroid dysfunction were observed in 17 patients. Thyrotoxicosis occurred in 12 patients, of which nine evolved to hypothyroidism. Isolated hypothyroidism was present in six patients. Levothyroxine therapy was required in 10 of 15 hypothyroid patients. Thyroid autoantibodies were elevated during thyroid dysfunction in four of 10 cases. Diffuse increased 18FDG uptake by the thyroid gland was observed in all seven thyrotoxic patients who progressed to hypothyroidism.ConclusionsThyroid dysfunction is common in melanoma patients treated with pembrolizumab. Hypothyroidism and thyrotoxicosis related to inflammatory thyroiditis are the most frequent presentations. Serial measurements of thyroid function tests are indicated during anti-PD-1 monoclonal antibody therapy. Thyrotoxicosis compatible with inflammatory thyroiditis was associated with diffuse increased 18FDG uptake by the thyroid gland. The prospective role of thyroid autoantibodies should be further investigated, together with the histopathological correlates.

Project description:BackgroundNotwithstanding its beneficial immunoprophylactic outcomes regarding leprosy and childhood TB, BCG vaccination may cause adverse events, particularly of the skin. However, this local hyper-immune reactivity cannot be predicted before vaccination, nor is its association with protection against leprosy known. In this study we investigated the occurrence of adverse events after BCG (re)vaccination in contacts of leprosy patients and analyzed whether the concomitant systemic anti-mycobacterial immunity was associated with these skin manifestations.MethodsWithin a randomized controlled BCG vaccination trial in Bangladesh, 14,828 contacts of newly diagnosed leprosy patients received BCG vaccination between 2012 and 2017 and were examined for adverse events 8 to 12?weeks post-vaccination. From a selection of vaccinated contacts, venous blood was obtained at follow-up examination and stimulated with Mycobacterium leprae (M. leprae) antigens in overnight whole-blood assays (WBA). M. leprae phenolic glycolipid-I-specific antibodies and 32 cytokines were determined in WBAs of 13 individuals with and 13 individuals without adverse events after vaccination.ResultsOut of the 14,828 contacts who received BCG vaccination, 50 (0.34%) presented with adverse events, mainly (80%) consisting of skin ulcers. Based on the presence of BCG scars, 30 of these contacts (60%) had received BCG in this study as a booster vaccination. Similar to the pathological T-cell immunity observed for tuberculoid leprosy patients, contacts with adverse events at the site of BCG vaccination showed elevated IFN-? levels in response to M. leprae-specific proteins in WBA. However, decreased levels of sCD40L in serum and GRO (CXCL1) in response to M. leprae simultaneously indicated less T-cell regulation in these individuals, potentially causing uncontrolled T-cell immunity damaging the skin.ConclusionSkin complications after BCG vaccination present surrogate markers for protective immunity against leprosy, but also indicate a higher risk of developing tuberculoid leprosy.Clinical trial registrationNetherlands Trial Register: NTR3087.

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Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

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Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

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