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Clinical Interventions in Aging 2024Rivaroxaban, a non-vitamin K antagonist oral anticoagulant, has become widely used for the management of venous thromboembolism (VTE) in adult patients. However, few...
BACKGROUND
Rivaroxaban, a non-vitamin K antagonist oral anticoagulant, has become widely used for the management of venous thromboembolism (VTE) in adult patients. However, few trials have explored the efficacy and safety of rivaroxaban in VTE patients over 80 years of age. This necessitates further real-world studies of rivaroxaban across elderly populations.
METHODS
We performed a retrospective single center study involving extremely aged VTE sufferers treated with rivaroxaban. The sample comprised 121 patients newly initiated on rivaroxaban diagnosed between January 2018 and January 2020. Patients were followed up for no less than 2 years. The effectiveness outcome was the disappearance of thromboembolism. The safety outcome was the incidence of major bleeding events. Comorbidities and complications were recorded throughout the entire study.
RESULTS
The efficacy outcome occurred in 114 of 121 patients (94.21%) and the safety outcome occurred in 12 of 121 patients (9.91%). Increased hemorrhages were observed in patients with infection (15.15% vs 7.80%), but no significant difference was observed due to limited sample size (P=0.3053). Patients with an age-adjusted Charlson comorbidity index score higher than 6 points exhibited higher bleeding rates (14.08% vs 4.00%; P=0.0676) and lower thrombus cure rates (88.73% vs 100%; P=0.0203).
KEY CONCLUSIONS
Patients with infection should be more careful of bleeding events during rivaroxaban therapy. An age-adjusted Charlson comorbidity index score higher than 6, which predicted poor survival, indicated inferior safety and efficacy of rivaroxaban.
AIM
To investigate the efficacy and safety of Rivaroxaban in an aged venous thromboembolism patient population under real-world conditions.
Topics: Humans; Rivaroxaban; Retrospective Studies; Male; Female; Venous Thromboembolism; Aged, 80 and over; Factor Xa Inhibitors; Hemorrhage; Cross-Sectional Studies; Treatment Outcome; Comorbidity
PubMed: 38915432
DOI: 10.2147/CIA.S405075 -
Cureus May 2024Intra-abdominal hemorrhage resulting from a ruptured, large hepatic cyst in a polycystic liver disease (PCLD) patient is rare and potentially fatal if not addressed...
Successful Coil Embolization of Active Bleeding From a Replaced Left Hepatic Artery to the Left Gastric Artery Associated With a Traumatic Rupture of a Simple Hepatic Cyst Causing Hemodynamic Instability.
Intra-abdominal hemorrhage resulting from a ruptured, large hepatic cyst in a polycystic liver disease (PCLD) patient is rare and potentially fatal if not addressed promptly. Only a few isolated cases have previously been reported. The usual patient profile consists of elderly patients on anticoagulation, as is demonstrated in our case. Intra-hepatic cysts are broadly classified into congenital, traumatic, infectious, parasitic, and neoplastic. Congenital intra-hepatic cysts can consist of both simple and PCLD, as is outlined in our case. Simple cysts are usually asymptomatic, but occasionally they may achieve larger dimensions and lead to complications such as rupture, obstruction, infection, hemorrhage, and even portal hypertension. We present an uncommon case of a 78-year-old patient with PCLD on rivaroxaban who presented initially with diffuse abdominal pain, distension, and progression into hemodynamic instability. A computerized tomography (CT) scan revealed a ruptured left hepatic lobe cyst, causing hemoperitoneum and resulting in an acute abdomen. This case was complicated by the patient's anticoagulation status and anomalous hepatic vasculature pattern. Interventional radiology (IR) successfully identified the aberrant bleeding vessel and stopped the active extravasation with super-selective coil embolization.
PubMed: 38910654
DOI: 10.7759/cureus.60907 -
Scientific Reports Jun 2024The number of patients with atrial fibrillation is increasing, and frailty prevalence increases with age, posing challenges for physicians in prescribing anticoagulants... (Observational Study)
Observational Study
The number of patients with atrial fibrillation is increasing, and frailty prevalence increases with age, posing challenges for physicians in prescribing anticoagulants to such patients because of possible harm. The effects of frailty on anticoagulant therapy in older Japanese patients with nonvalvular atrial fibrillation (NVAF) are unclear. Herein, we prescribed rivaroxaban to Japanese patients with NVAF and monitored for a mean of 2.0 years. The primary endpoint was stroke or systemic embolism. The secondary endpoints were all-cause or cardiovascular death, composite endpoint, and major or non-major bleeding. Frailty was assessed using the Japanese long-term care insurance system. A multiple imputation technique was used for missing data. The propensity score (PS) was obtained to estimate the treatment effect of frailty and was used to create two PS-matched groups. Overall, 5717 older patients had NVAF (mean age: 73.9 years), 485 (8.5%) were classified as frail. After PS matching, background characteristics were well-balanced between the groups. Rivaroxaban dosages were 10 and 15 mg/day for approximately 80% and the remaining patients, respectively. Frailty was not associated with the primary endpoint or secondary endpoints. In conclusion, frailty does not affect the effectiveness or safety of rivaroxaban anticoagulant therapy in older Japanese patients with NVAF.Trial registration: UMIN000019135, NCT02633982.
Topics: Humans; Atrial Fibrillation; Aged; Male; Female; Frailty; Rivaroxaban; Aged, 80 and over; Anticoagulants; Japan; Stroke; Frail Elderly; Hemorrhage; Factor Xa Inhibitors; East Asian People
PubMed: 38909144
DOI: 10.1038/s41598-024-65237-4 -
The Journal of International Medical... Jun 2024The gold standard therapy for end-stage heart failure is cardiac transplantation. However, in the face of a donor shortage, a mechanical assist device such as the left...
The gold standard therapy for end-stage heart failure is cardiac transplantation. However, in the face of a donor shortage, a mechanical assist device such as the left ventricular assist device HeartMate 3 (Abbott Laboratories, Abbott Park, IL, USA) serves as bridging therapy to transplantation and/or destination therapy. Current guidelines recommend anticoagulation with a vitamin K antagonist in combination with low-dose aspirin. We herein report a challenging anticoagulation regimen in a patient with a HeartMate 3 in whom systemic anticoagulation with warfarin was not feasible for 4 years because of low compatibility and a rare X-factor deficiency. This is a rare hematological disorder, estimated to affect approximately 1 in every 500,000 to 1,000,000 people in the general population. The patient finally received a modified anticoagulation regimen involving the combination of rivaroxaban and clopidogrel without warfarin. Under this regimen, the patient remained free of thromboembolic complications for 4 years with placement of the left ventricular assist device. This case illustrates that under specific circumstances, long-term absence of warfarin therapy is feasible in patients with a HeartMate 3.
Topics: Humans; Heart-Assist Devices; Warfarin; Thromboembolism; Anticoagulants; Male; Heart Failure; Middle Aged; Clopidogrel; Rivaroxaban; Withholding Treatment
PubMed: 38901839
DOI: 10.1177/03000605241258474 -
Molecules (Basel, Switzerland) Jun 2024Oral anticoagulant therapy (OAT) for managing atrial fibrillation (AF) encompasses vitamin K antagonists (VKAs, such as warfarin), which was the mainstay of...
Oral anticoagulant therapy (OAT) for managing atrial fibrillation (AF) encompasses vitamin K antagonists (VKAs, such as warfarin), which was the mainstay of anticoagulation therapy before 2010, and direct-acting oral anticoagulants (DOACs, namely dabigatran etexilate, rivaroxaban, apixaban, edoxaban), approved for the prevention of AF stroke over the last thirteen years. Due to the lower risk of major bleeding associated with DOACs, anticoagulant switching is a common practice in AF patients. Nevertheless, there are issues related to OAT switching that still need to be fully understood, especially for patients in whom AF and heart failure (HF) coexist. Herein, the effective impact of the therapeutic switching from warfarin to DOACs in HF patients with AF, in terms of cardiac remodeling, clinical status, endothelial function and inflammatory biomarkers, was assessed by a machine learning (ML) analysis of a clinical database, which ultimately shed light on the real positive and pleiotropic effects mediated by DOACs in addition to their anticoagulant activity.
Topics: Humans; Atrial Fibrillation; Heart Failure; Machine Learning; Anticoagulants; Administration, Oral; Male; Female; Aged; Chronic Disease; Warfarin
PubMed: 38893525
DOI: 10.3390/molecules29112651 -
Research and Practice in Thrombosis and... May 2024The bleeding risk associated with direct oral anticoagulants (DOACs) remains a major concern, and rapid reversal of anticoagulant activity may be required. Although...
BACKGROUND
The bleeding risk associated with direct oral anticoagulants (DOACs) remains a major concern, and rapid reversal of anticoagulant activity may be required. Although specific and nonspecific hemostatic biotherapies are available, there is a need for small-molecule DOAC reversal agents that are simple and cost-effective to produce, store, and administer.
OBJECTIVES
To identify and characterize a small molecule with procoagulant activity as a DOAC reversal agent.
METHODS
We sought to identify a small procoagulant molecule by screening a chemical library with a plasma clotting assay. The selected molecule was assessed for its procoagulant properties and its ability to reverse the effects of the DOACs in a thrombin generation assay. Its activity as a DOAC reversal agent was also evaluated in a tail-clip bleeding assay in mice.
RESULTS
The hemostatic molecule (HeMo) dose-dependently promoted thrombin generation in plasma, with dose values effective in producing half-maximum response ranging between 3 and 5 μM, depending on the thrombin generation assay parameter considered. HeMo also restored impaired thrombin generation in DOAC-spiked plasma and reversed DOAC activity in the mouse bleeding model. HeMo significantly reduced apixaban-induced bleeding from 709 to 65 μL (vs 43 μL in controls; < .01) and dabigatran-induced bleeding from 989 to 155 μL (vs 126 μL in controls; < .01).
CONCLUSION
HeMo is a small-molecule procoagulant that can counterbalance hemostatic disruption by a thrombin inhibitor (dabigatran) or factor Xa inhibitors (apixaban and rivaroxaban). The compound's effective clot formation and versatility make it a possible option for managing the inherent hemorrhagic risk during DOAC therapy.
PubMed: 38882463
DOI: 10.1016/j.rpth.2024.102426 -
Breast Disease 2024An 85-year-old Chinese lady presented with a 5-day history of a painless left breast lump. There was no fever, nipple discharge, or history of trauma. She had a past...
An 85-year-old Chinese lady presented with a 5-day history of a painless left breast lump. There was no fever, nipple discharge, or history of trauma. She had a past medical history of atrial fibrillation that was managed with an oral anticoagulant. Mammography demonstrated a dense mass in the upper outer quadrant of the left breast. Ultrasound showed an irregular, heterogeneous 4.7 cm lesion containing debris and cystic spaces with raised peripheral vascularity at the 2 o'clock position, 3 cm from nipple. No internal vascularity was detected. This was managed as a haematoma and rivaroxaban was withheld. Follow-up imaging 3-weeks later showed persistence of the lesion. Bedside needle aspiration yielded haemoserous fluid with immediate reduction in size of the lesion. However, 2 weeks after aspiration, there was recurrence of the 'haematoma'. Multidisciplinary review of the clinical history, examination and imaging was sought, and biopsy of the irregularly thickened areas with vascularity along the periphery of the lesion was recommended. Vacuum-assisted biopsy was performed, and histology returned as metaplastic carcinoma. A recurring 'haematoma' should always prompt a search for a secondary cause, with features such as irregular thickened walls and papillary/nodular components requiring further evaluation with biopsy for histopathological correlation.
Topics: Humans; Female; Hematoma; Breast Neoplasms; Aged, 80 and over; Diagnosis, Differential; Mammography; Metaplasia; Recurrence
PubMed: 38875024
DOI: 10.3233/BD-240006 -
Annals of Medicine Dec 2024Little is known how individual time-in-therapeutic-range (TTR) impacts the effectiveness and safety of warfarin therapy compared to direct oral anticoagulants (DOACs) in...
BACKGROUND
Little is known how individual time-in-therapeutic-range (TTR) impacts the effectiveness and safety of warfarin therapy compared to direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF).
OBJECTIVE
To compare the effectiveness and safety of standard dose DOACs to warfarin in patients with AF, while categorizing warfarin treated patients into quartiles based on their individual TTR.
MATERIALS AND METHODS
We conducted a nationwide study including all patients with new-onset AF between 2011 and 2018 in Finland. Hazard ratios (HR) were calculated using Cox regression analysis with the inverse probability of treatment weighted method to assess the risks of ischaemic stroke (IS), intracranial haemorrhage (ICH) and mortality for users of apixaban ( = 12,426), dabigatran ( = 4545), rivaroxaban ( = 12,950) and warfarin ( = 43,548).
RESULTS
The median TTR for warfarin users was 72%. Compared to the second best TTR quartile (reference), the risk of IS was higher in the two poorest TTR quartiles, and lower in the best TTR quartile and on rivaroxaban [2.35 (95% confidence interval, 1.85-2.85), 1.44 (1.18-1.75), 0.60 (0.47-0.77) and 0.72 (0.56-0.92)]. These differences were non-significant for apixaban and dabigatran. HR of ICH was 6.38 (4.88-8.35) and 1.87 (1.41-2.49) in the two poorest TTR groups, 1.44 (1.02-1.93) on rivaroxaban, and 0.58 (0.40-0.85) in the best TTR group compared to the reference group. Mortality was higher in the two poorest TTR groups and lowest in the best TTR group.
CONCLUSIONS
The outcome was unsatisfactory in the two lowest TTR quartiles - in half of the patients treated with warfarin. The differences between the high TTR groups and standard dose DOACs were absent or modest.
Topics: Humans; Warfarin; Atrial Fibrillation; Male; Female; Aged; Anticoagulants; Finland; Rivaroxaban; Pyridones; Middle Aged; Pyrazoles; Dabigatran; Administration, Oral; Aged, 80 and over; Cohort Studies; Intracranial Hemorrhages; Stroke; Ischemic Stroke; International Normalized Ratio; Treatment Outcome
PubMed: 38873855
DOI: 10.1080/07853890.2024.2364825 -
Clinical and Applied... 2024To examine the effectiveness of rivaroxaban compared to enoxaparin in patients diagnosed with cancer and venous thromboembolism. (Meta-Analysis)
Meta-Analysis Comparative Study Review
OBJECTIVE
To examine the effectiveness of rivaroxaban compared to enoxaparin in patients diagnosed with cancer and venous thromboembolism.
METHODS
A search of Pub Med, Scopus, and Google Scholar, from inception through April 2023 was conducted. Articles comparing rivaroxaban with enoxaparin in patients with cancer and VTE/PE/DVT were included. Review Manager Version 5.2 was utilised for the analysis of the following outcomes; VTE, PE, DVT, major bleeding, and mortality.
RESULTS
A total of 8 articles and 2276 patients were included in the final analysis. Pooled analysis showed that rivaroxaban had a statistically insignificant reduced association with VTE occurrence (RR:0.83, 95% CI:0.58-1.18, P:0.3) as well as a statically insignificant reduction in major bleeding (RR:0.79, 95% CI:0.53-1.18, P:0.25). Analysis showcased that there was an insignificant reduction of mortality rivaroxaban as compared to enoxaparin (RR:0.74, 95% CI: 0.46-1.20, P:0.23).
CONCLUSION
Rivaroxaban can serve as a viable alternative to enoxaparin, with no appreciable drawbacks, for preventing and managing VTE in patients with malignancy.
Topics: Humans; Anticoagulants; Enoxaparin; Hemorrhage; Neoplasms; Recurrence; Rivaroxaban; Venous Thromboembolism
PubMed: 38870350
DOI: 10.1177/10760296241261364 -
Thrombosis and Haemostasis Jun 2024Prethrombin-1 is a Gla-domain lacking enzymatically inactive split product that results from the cleavage of fragment 1 from prothrombin by thrombin in a feedback...
INTRODUCTION
Prethrombin-1 is a Gla-domain lacking enzymatically inactive split product that results from the cleavage of fragment 1 from prothrombin by thrombin in a feedback reaction.
METHODS
A prethrombin-1 preparation derived from human plasma was tested for its hemostatic and thrombogenic properties. Animal models of nail clipping (for rabbits) and tail clipping (for mice) were developed to measure blood loss in FVIII-inhibitor or rivaroxaban anticoagulated rabbits and mice, respectively. A modified Wessler test was used in rabbits to assess the thrombogenic potential by Wessler score and clot weight. Studies were performed in groups of three to six for prethrombin-1 dose escalation and comparison with prothrombin, Beriplex®, FEIBA®, and saline as a control. Data were analyzed using t-statistics or the Mann Whitney U test as applicable.
RESULTS
Prethrombin-1 has excellent hemostatic properties in anticoagulated mouse and rabbit bleeding models. Wessler tests suggest that in contrast to activated and nonactivated prothrombin complexes, prethrombin-1 has negligible thrombogenic potential.
CONCLUSION
The thrombin zymogen prethrombin-1 promotes hemostasis with reduced risk of thrombosis. Prethrombin-1 may have potential to become a life-saving treatment for patients who bleed or are at risk of bleeding.
PubMed: 38866044
DOI: 10.1055/s-0044-1787720