Objective: Our objective was to assess the cost effectiveness of apixaban versus edoxaban in the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF) in Spain.
Methods: We customized a Markov model with ten health states to estimate the lifetime economic and clinical outcomes in 6-week cycles. The efficacy (clinical event rates per 100 patient-years) and safety data were derived from a pairwise indirect treatment comparison. The analysis was conducted from both the national health service (NHS) and societal perspectives, and included pharmaceutical costs (retail price plus value-added tax (VAT) and applicable national deductions) according to daily dosages (apixaban 10 mg (5 mg twice daily (bid)) and edoxaban 60 or 30 mg) and complications and disease-management costs, obtained from national databases. Utilities for quality-adjusted life-year (QALY) calculations reflected EuroQoL 5-Dimension scores in patients with AF. An annual discount rate of 3% was applied for costs (€, year 2019 values) and outcomes.
Results: In a 1000-patient cohort, apixaban 5 mg bid versus edoxaban 60 mg could avoid five strokes, six major bleedings and 29 clinically relevant non-major bleedings (CRNMBs). Compared with edoxaban 30 mg, apixaban could avoid 21 strokes and two SEs. An increase in bleedings was observed with apixaban (seven haemorrhagic strokes, 48 major bleedings and 17 CRNMBs). Apixaban yielded 0.04 additional QALYs compared with edoxaban 60 mg or 30 mg. Incremental costs/QALY were €9639.33 and €354.22 for apixaban versus edoxaban 60 mg and edoxaban 30 mg, respectively, from the NHS perspective and €7756.62 for apixaban versus edoxaban 60 mg from the societal perspective. Apixaban was dominant versus edoxaban 30 mg from the societal perspective. Sensitivity analyses confirmed the robustness of the model.
Conclusions: This study suggests that apixaban 5 mg bid is a cost-effective alternative to edoxaban for stroke prevention in the AF population in Spain.
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http://dx.doi.org/10.1007/s41669-019-00186-7 | DOI Listing |
Cochrane Database Syst Rev
January 2025
Department of Pharmacy Practice, University of Connecticut, Storrs, CT 06269, USA.
Background: Guideline-recommended strategies to interrupt chronic anticoagulation with warfarin or direct oral anticoagulants (DOAC) during the perioperative period of cardiac implantable electronic device (CIED) surgery differ worldwide. There is uncertainty concerning the benefits and harms of interrupted and uninterrupted anticoagulation in patients undergoing CIED surgery.
Objectives: To assess the benefits and harms of interrupted anticoagulation (IAC) with either warfarin or DOAC in the perioperative period of CIED surgery versus uninterrupted anticoagulation (UAC), with or without heparin bridging, during an equivalent time frame, for CIED surgery.
J Am Heart Assoc
January 2025
Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division Brigham and Women's Hospital and Harvard Medical School Boston MA USA.
Background: Epistaxis is common with antithrombotic therapy and is often troublesome to patients, yet its frequency, severity, and outcomes are poorly characterized.
Methods And Results: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) randomized 21 105 patients with atrial fibrillation and CHADS2 risk score ≥2 to higher-dose edoxaban regimen (60 mg daily, dose-reduced to 30 mg), lower-dose edoxaban regimen (30 mg, dose reduced to 15 mg, daily), or warfarin. Bleeds were adjudicated using International Society on Thrombosis and Haemostasis criteria.
Contemp Clin Trials
January 2025
TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, United States of America.
Background: Primary results from randomized clinical trials (RCT) only inform on the average treatment effect in the studied population, and it is critical to understand how treatment effect varies across subpopulations. In this paper we describe a clustering-based approach for the assessment of Heterogeneity of Treatment Effect (HTE) over patient phenotypes, which maintains the unsupervised nature of classical subgroup analysis while jointly accounting for relevant patient characteristics.
Methods: We applied phenotype-based stratification in the ENGAGE AF-TIMI 48 trial, a non-inferiority trial comparing the effects of higher-dose edoxaban regimen (direct anticoagulant) versus warfarin (vitamin K antagonist) on a composite endpoint of stroke and systemic embolism in 14,062 patients with atrial fibrillation.
Thromb Haemost
November 2024
Division of Hematology and Thromboembolism, Department of Medicine, Population Health Research Institute, Hamilton, Ontario, Canada.
Background: Although most patients with atrial fibrillation (AF) receiving a direct oral anticoagulant (DOAC) do not require drug concentration measurements, there are situations where such information could be useful. Existing guidance documents provide usual on-therapy ranges for drug concentrations, but these have important limitations.
Methods: This is a systematic review and meta-analysis of studies reporting trough and peak levels of DOAC regimens approved for stroke prevention in AF.
Clin Appl Thromb Hemost
November 2024
Department of Hepatopancreatobiliary Surgery, Ganzhou People's Hospital, Ganzhou, Jiangxi, China.
Background: This systematic review aimed to evaluate the comparative effectiveness and safety of direct oral anticoagulants (DOACs) compared to traditional anticoagulation (vitamin K antagonists or low-molecular-weight heparins) in cirrhotic patients with portal vein thrombosis (PVT).
Methods: We conducted a literature search in PubMed and Embase databases up to May 2024. Studies were selected according to the PICOS criteria, focusing on cirrhotic patients with PVT treated with DOACs (dabigatran, rivaroxaban, apixaban, or edoxaban) compared to traditional anticoagulation.
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