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Vascular Health and Risk Management 2024While treatment interruption of non-vitamin K antagonist oral anticoagulants (NOACs) for elective surgery or procedures among patients with atrial fibrillation (AF) is...
Perioperative Management in Patients with Atrial Fibrillation Treated with Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Minor Bleeding Risk Procedure: Rationale and Protocol for the PERIXa Study.
BACKGROUND
While treatment interruption of non-vitamin K antagonist oral anticoagulants (NOACs) for elective surgery or procedures among patients with atrial fibrillation (AF) is becoming more prevalent, there remains insufficient evidence regarding the optimal perioperative management of NOACs, particularly procedures with minor bleeding risks.
OBJECTIVE
This study aims to evaluate the safety and effectiveness of a simplified, standardized protocol for perioperative management of direct factor Xa inhibitors in patients, with AF undergoing procedures associated with minor bleeding risk.
METHODS
This multicenter, prospective single-arm registry study plans to enroll patients undergoing procedures with minor bleeding risk who were prescribed direct factor Xa inhibitors for AF. The procedures with minor bleeding risk will include gastrointestinal endoscopy for diagnostic purposes, selected dental procedures, and ocular surgery for cataracts or glaucoma. For apixaban, patients will withhold the last evening dose and resume either from the evening dose of the procedure day or the following morning, depending on the bleeding risk of the patient. For edoxaban or rivaroxaban, patients will withhold only a single dose on the procedure day. The primary outcome is the occurrence of major bleeding events within 30 days. Secondary outcomes include systemic thromboembolism, all-cause mortality, and a composite of major and clinically relevant non-major bleeding events.
CONCLUSION
This study has the potential to generate evidence regarding the safety of perioperative management for patients, with AF undergoing procedures associated with minor bleeding risk.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT05801068.
Topics: Humans; Atrial Fibrillation; Administration, Oral; Factor Xa Inhibitors; Prospective Studies; Risk Factors; Treatment Outcome; Perioperative Care; Registries; Risk Assessment; Pyrazoles; Time Factors; Pyridones; Hemorrhage; Pyridines; Drug Administration Schedule; Rivaroxaban; Multicenter Studies as Topic; Research Design; Thiazoles
PubMed: 38774425
DOI: 10.2147/VHRM.S455530 -
Drug Design, Development and Therapy 2024Atrial fibrillation (AF) is the most common abnormal heart rhythm in elderly patients. Rivaroxaban has been widely used for stroke prevention. The anticoagulant response... (Comparative Study)
Comparative Study
OBJECTIVE
Atrial fibrillation (AF) is the most common abnormal heart rhythm in elderly patients. Rivaroxaban has been widely used for stroke prevention. The anticoagulant response to rivaroxaban increases with age, which may make elderly patients susceptible to adverse outcomes resulting from small differences in bioavailability between generic and brand products.
METHODS
We designed a cohort study of ≥65-year-old inpatients with AF. Sociodemographic and laboratory measures of qualified patients who received brand or generic rivaroxaban for at least 72 hours at the study hospital from January 2021 to June 2023 were collected retrospectively. The primary outcome was the incidence of bleeding.
RESULTS
A total of 1008 qualifying patients were included for analysis, with 626 (62.1%) receiving brand rivaroxaban and 382 (37.9%) receiving generic rivaroxaban. After propensity score matching and weighting to account for confounders, the odds ratios comparing brand vs generic rivaroxaban (95% confidence intervals) for the bleeding was 1.15 (0.72-1.82). Results from subgroup analyses of patients with age ≥85, HAS-BLED score ≥ 3, containment of antiplatelet drugs, and female patients were consistent with the primary analysis.
CONCLUSION
It provides evidence regarding the clinical safety outcome of generic rivaroxaban in the elderly AF population that may be particularly susceptible to adverse outcomes resulting from small allowable differences in pharmacokinetics.
Topics: Humans; Atrial Fibrillation; Rivaroxaban; Aged; Female; Hemorrhage; Male; Aged, 80 and over; Drugs, Generic; Retrospective Studies; Factor Xa Inhibitors; Inpatients; Cohort Studies; Stroke
PubMed: 38765878
DOI: 10.2147/DDDT.S459658 -
International Journal of Women's Health 2024Isolated splenic vein thrombosis (ISVT) is a very rare venous thromboembolism in the absence of pancreatic diseases, which can cause acute abdominal pain and chronic...
Isolated splenic vein thrombosis (ISVT) is a very rare venous thromboembolism in the absence of pancreatic diseases, which can cause acute abdominal pain and chronic left-side portal hypertension. Herein, we reported a 40-year-old female patient who developed ISVT after taking oral contraceptives. Anticoagulation with oral rivaroxaban was the first-line choice of therapy in this case. Since then, abdominal pain alleviated, but she did not achieve vessel recanalization. Thus, a 7-day systemic thrombolysis with urokinase was given. Abdominal pain disappeared, but ISVT was not significantly improved. During follow-up period, long-term anticoagulation with oral rivaroxaban was given. Collectively, this case indicates the possibility of oral contraceptives as a risk factor of ISVT as well as anticoagulation combined with systemic thrombolysis as a choice of treatment for ISVT. Certainly, long-term follow-up is necessary in this case.
PubMed: 38765206
DOI: 10.2147/IJWH.S462610 -
JPMA. the Journal of the Pakistan... Apr 2024Endomyocardial fibrosis secondary to hyper-eosinophilic syndrome also known as Loeffler's Endocarditis is a rare cause of restrictive cardiomyopathy. If left untreated,...
Endomyocardial fibrosis secondary to hyper-eosinophilic syndrome also known as Loeffler's Endocarditis is a rare cause of restrictive cardiomyopathy. If left untreated, it carries a very high morbidity and mortality rate. The case of a 20 years old girl, a known case of polyarticular juvenile idiopathic arthritis since the age of 13 years was reported at Federal Government Polyclinic Hospital, Islamabad on 14th May 2022. She presented with an acute history of shortness of breath and cough for two weeks. Her initial echocardiogram showed suspicion of Loeffler's Endocarditis, which is attributed to be an adverse effect of etanercept- a tumour necrosis factor (TNF) inhibitor, which she had been prescribed for her arthritis. The patient is currently being managed with high doses of steroids, therapeutic anticoagulation with rivaroxaban, carvedilol for tachycardia and mycophenolate mofetil as an immunosuppressant.
Topics: Humans; Female; Arthritis, Juvenile; Endomyocardial Fibrosis; Young Adult; Etanercept; Hypereosinophilic Syndrome; Echocardiography
PubMed: 38751280
DOI: 10.47391/JPMA.8648 -
Texas Heart Institute Journal May 2024Current venous thromboembolism guidelines recommend using direct oral anticoagulants (DOACs) over warfarin regardless of obesity status; however, evidence remains... (Comparative Study)
Comparative Study
BACKGROUND
Current venous thromboembolism guidelines recommend using direct oral anticoagulants (DOACs) over warfarin regardless of obesity status; however, evidence remains limited for the safety and efficacy of DOAC use in patients with obesity. This retrospective analysis sought to demonstrate the safety and efficacy of DOACs compared with warfarin in a diverse population of patients with obesity in light of current prescribing practices.
METHODS
A retrospective cohort study was conducted at a large academic health system between July 2014 and September 2019. Adults with an admission diagnosis of deep vein thrombosis (DVT) or pulmonary embolism, with weight greater than 120 kg or a body mass index greater than 40, and who were discharged on an oral anticoagulant were included. Outcomes included occurrence of a thromboembolic event (DVT, pulmonary embolism, or ischemic stroke), bleeding event requiring hospitalization, and all-cause mortality within 12 months following index admission.
RESULTS
Out of 787 patients included, 520 were in the DOAC group and 267 were in the warfarin group. Within 12 months of index hospitalization, thromboembolic events occurred in 4.23% of patients in the DOAC group vs 7.12% of patients in the warfarin group (hazard ratio, 0.6 [95% CI, 0.32-1.1]; P = .082). Bleeding events requiring hospitalization occurred in 8.85% of DOAC patients vs 10.1% of warfarin patients (hazard ratio, 0.93 [95% CI, 0.57-1.5]; P = .82). A DVT occurred in 1.7% and 4.9% of patients in the DOAC and warfarin groups, respectively (hazard ratio, 0.35 [95% CI, 0.15-0.84]; P = .046).
CONCLUSION
No significant differences could be determined between DOACs and warfarin for cumulative thromboembolic or bleeding events, pulmonary embolism, ischemic stroke, or all-cause mortality. The risk of DVT was lower with apixaban and rivaroxaban. Regardless of patient weight or body mass index, physicians prescribed DOACs more commonly than warfarin.
Topics: Humans; Retrospective Studies; Female; Male; Warfarin; Obesity; Anticoagulants; Middle Aged; Venous Thromboembolism; Administration, Oral; Aged; Treatment Outcome; Factor Xa Inhibitors; Hemorrhage; Follow-Up Studies
PubMed: 38748549
DOI: 10.14503/THIJ-23-8260 -
Seminars in Nephrology May 2024Atrial fibrillation (AF) is highly prevalent in patients with chronic kidney disease (CKD). It is associated with an increased risk of stroke, which increases as kidney... (Review)
Review
Atrial fibrillation (AF) is highly prevalent in patients with chronic kidney disease (CKD). It is associated with an increased risk of stroke, which increases as kidney function declines. In the general population and in those with a moderate degree of CKD (creatinine clearance 30-50 mL/min), the use of oral anticoagulation to decrease the risk of stroke has been the standard of care based on a favorable risk-benefit profile that had been established in seminal randomized controlled trials. However, evidence regarding the use of oral anticoagulants for stroke prevention is less clear in patients with severe CKD (creatinine clearance <30 mL/min) and those receiving maintenance dialysis, as these individuals were excluded from such large randomized controlled trials. Nevertheless, the direct oral anticoagulants have invariably usurped vitamin K antagonists as the preferred choice for oral anticoagulation among patients with AF across all strata of CKD based on their well-defined safety and efficacy and multiple pharmacokinetic benefits (e.g., less drug-drug interactions). This review summarizes the current literature on the role of oral anticoagulation in the management of AF among patients with CKD and highlights current deficiencies in the evidence base and how to overcome them.
PubMed: 38744617
DOI: 10.1016/j.semnephrol.2024.151517 -
Cureus Apr 2024A coronary artery aneurysm (CAA) is a localized dilatation of a coronary artery segment >1.5 times the diameter of the adjacent normal segment. CAA is more common in men...
A coronary artery aneurysm (CAA) is a localized dilatation of a coronary artery segment >1.5 times the diameter of the adjacent normal segment. CAA is more common in men than women and has multiple etiologies, including genetic causes, infections, and atherosclerotic diseases. Kawasaki disease is the most common cause of CAA in children, whereas atherosclerosis is the most common etiology in adults. We present the case of a male in his 30s who presented with sudden-onset chest pain and inferior ST segment elevation on an ECG. Echocardiography revealed preserved left ventricular function and mild hypokinesia. The patient underwent an emergency coronary angiogram that showed an ostial right CAA with thrombi. He was initially managed with a glycoprotein IIb/IIIa inhibitor tirofiban infusion, followed by triple therapy with aspirin, clopidogrel, and rivaroxaban. The patient underwent magnetic resonance imaging of his head, which was normal, and he did not attend outpatient computed tomography coronary angiography. The patient was discharged with lifelong rivaroxaban 20 mg once daily.
PubMed: 38741823
DOI: 10.7759/cureus.58063 -
BMC Gastroenterology May 2024Portal vein thrombosis (PVT) is a common complication of liver cirrhosis that can aggravate portal hypertension. However, there are features of both PVT and cirrhosis...
BACKGROUND AND AIMS
Portal vein thrombosis (PVT) is a common complication of liver cirrhosis that can aggravate portal hypertension. However, there are features of both PVT and cirrhosis that are not recapitulated in most current animal models. In this study, we aimed to establish a stable animal model of PVT and cirrhosis, intervene with anticoagulant, and explore the related mechanism.
METHODS
First, 49 male SD rats received partial portal vein ligation (PPVL), and 44 survival rats were divided into 6 groups: PPVL control group; 4-week, 6 -week, 8-week, and 10-week model group; and the rivaroxaban (RIVA)-treated group. The rats were intoxicated with or without carbon tetrachloride (CCl) for 4-10 weeks. Seven normal rats were used as the normal controls. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels and parameters for blood coagulation were all assayed with kits. Liver inflammation, collagen deposition and hydroxyproline (Hyp) levels were also measured. The extrahepatic macro-PVT was observed via portal vein HE staining, etc. The intrahepatic microthrombi was stained via fibrin immunohistochemistry. The portal blood flow velocity (PBFV) and diameter were detected via color Doppler ultrasound. Vascular endothelial injury was evaluated by von Willebrand Factor (vWF) immunofluorescence. Fibrinolytic activity was estimated by western blot analysis of fibrin and plasminogen activator inhibitor-1 (PAI-1).
RESULTS
After PPVL surgery and 10 weeks of CCl intoxication, a rat model that exhibited characteristics of both cirrhosis and extra and intrahepatic thrombi was established. In cirrhotic rats with PVT, the PBFV decreased, both factors of pro- and anti-coagulation decreased, but with relative hypercoagulable state, vascular endothelial injured, and fibrinolytic activity decreased. RIVA-treated rats had improved coagulation function, increased PBFV and attenuated thrombi. This effect was related to the improvements in endothelial injury and fibrinolytic activity.
CONCLUSIONS
A new rat model of PVT with cirrhosis was established through partial portal vein ligation plus CCl intoxication, with the characteristics of macrothrombi at portal veins and microthrombi in hepatic sinusoids, as well as liver cirrhosis. Rivaroxaban could attenuate PVT in cirrhosis in the model rats. The underlying mechanisms of PVT formation in the rat model and pharmacological action of rivaroxaban are related to the regulation of portal blood flow, coagulant factors, and vascular endothelial cell function.
Topics: Animals; Portal Vein; Rivaroxaban; Male; Ligation; Venous Thrombosis; Carbon Tetrachloride; Rats, Sprague-Dawley; Disease Models, Animal; Rats; Factor Xa Inhibitors; Liver Cirrhosis; Liver Cirrhosis, Experimental; Liver; Alanine Transaminase; Aspartate Aminotransferases
PubMed: 38741060
DOI: 10.1186/s12876-024-03253-4 -
International Journal of Emergency... May 2024Pulmonary embolism is a common and potentially fatal condition. Exogenous estrogens in contraceptives are associated with an increased risk of venous thrombo-embolism....
BACKGROUND
Pulmonary embolism is a common and potentially fatal condition. Exogenous estrogens in contraceptives are associated with an increased risk of venous thrombo-embolism. However, discontinuation of a combined oral contraceptive can lead to severe withdrawal bleeding in an anticoagulated patient.
CASE PRESENTATION
We report a case of a 47-year-old female who presented to the emergency room with a two-day history of worsening shortness of breath and chest pain. Her chronic medication included a combined oral contraceptive pill. Transthoracic echocardiogram showed pulmonary hypertension and right ventricular dilatation. Computerized tomography scan revealed bilateral pulmonary embolism. She received thrombolysis with alteplase and was started on rivaroxaban. Five days after discharge, however, she was readmitted with severe vaginal bleeding.
DISCUSSION AND CONCLUSION
We describe a case of submassive pulmonary embolism, treated with thrombolysis and anticoagulation, who developed severe vaginal bleeding after stopping the contraceptive pill. This case highlights the importance of detailed menstrual history taking when initiating anticoagulation in women. Discontinuation of oral contraceptives, while important in reducing the risk of recurrent thrombosis, could be postponed until the end of the recommended course of anticoagulation and until a safe alternative form of contraception has been established, if required.
PubMed: 38741056
DOI: 10.1186/s12245-024-00639-9 -
Clinical and Translational Science May 2024The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to... (Randomized Controlled Trial)
Randomized Controlled Trial
The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to inadequate anticoagulant effect, and therefore, it is recommended to use the higher doses at fed state. However, proper posology may represent a barrier for some patients. Therefore, the aim of this study was to evaluate innovative rivaroxaban-containing formulations designed to eliminate the food effect to ensure reliable absorption and thus to improve patient adherence with the treatment. Three prototypes (Cocrystal, HPMCP and Kollidon) with rivaroxaban were developed and their bioavailability and food effect in comparison to the reference product was tested in open label, randomized, single oral dose, crossover studies, where test products were administered under fasting and fed conditions and the reference product was administered under fed conditions. Comparable bioavailability for all tested prototypes both under fed and fasting conditions was demonstrated as the 90% confidence intervals of the geometric mean ratios for area under the concentration-time curve remained within the standard acceptance range of 80.00%-125.00%. An innovative immediate release form of rivaroxaban with no food effect on drug bioavailability has been developed, which may represent an important step toward increasing adherence, improving treatment outcome and reducing health care costs.
Topics: Humans; Rivaroxaban; Male; Cross-Over Studies; Biological Availability; Adult; Female; Food-Drug Interactions; Administration, Oral; Fasting; Middle Aged; Factor Xa Inhibitors; Young Adult; Drug Compounding; Meals
PubMed: 38738493
DOI: 10.1111/cts.13820