-
Thrombosis Research Jan 2020Extrapolation of clinical trial results comparing warfarin and direct-acting oral anticoagulant (DOAC) users experiencing major hemorrhage to clinical care is... (Clinical Trial)
Clinical Trial
BACKGROUND
Extrapolation of clinical trial results comparing warfarin and direct-acting oral anticoagulant (DOAC) users experiencing major hemorrhage to clinical care is challenging due to differences seen among non-randomized oral anticoagulant users, bleed location, and etiology. We hypothesized that inpatient all-cause-mortality among patients presenting with major hemorrhage differed based on the home-administered anticoagulant medication class, DOAC versus warfarin.
METHODS
More than 1.5 million hospitalizations were screened and 3731 patients with major hemorrhage were identified in the REDS-III Recipient Database. Propensity score matching and stratification were used to account for potentially confounding factors.
RESULTS
Inpatient all-cause-mortality was lower for DOAC (HR = 0.60, 95%CI 0.45-0.80, p = 0.0005) before accounting for confounding and competing events. Inpatient all-cause-mortality for 1266 propensity-score-matched patients compared using proportional hazards regression did not differ (HR = 0.84, 95%CI 0.58-1.22, p = 0.36). Inpatient all-cause-mortality in stratified analyses (warfarin as reference) produced: HR = 0.69 (95%CI 0.31-1.55) for traumatic head injuries; HR = 1.10 (95%CI 0.62-1.95) for non-traumatic head injuries; HR = 0.62 (95%CI 0.20-1.94) for traumatic, non-head injuries; and HR = 0.69 (95%CI 0.29-1.63) for non-traumatic, non-head injuries. Mean time to discharge was shorter for DOAC (HR = 1.17, 95%CI 1.05-1.30, p = 0.0034) in the propensity score matched analysis. Plasma transfusion occurred in 42% of warfarin hospitalizations and 11% of DOAC hospitalizations. Vitamin K was administered in 63% of warfarin hospitalizations.
CONCLUSIONS
After accounting for differences in patient characteristics, location of bleed, and traumatic injury, inpatient survival was no different in patients presenting with major hemorrhage while on DOAC or warfarin.
Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Blood Component Transfusion; Factor Xa Inhibitors; Hemorrhage; Humans; Inpatients; Plasma; Retrospective Studies; Stroke; Warfarin
PubMed: 31794885
DOI: 10.1016/j.thromres.2019.11.024 -
Journal of Interventional Cardiac... Jun 2022To investigate whether co-administration of antiarrhythmic dronedarone and anticoagulant rivaroxaban would increase the risks of hemorrhage after atrial fibrillation... (Observational Study)
Observational Study
PURPOSE
To investigate whether co-administration of antiarrhythmic dronedarone and anticoagulant rivaroxaban would increase the risks of hemorrhage after atrial fibrillation (AF) ablation.
METHODS
A total of 100 patients with AF who underwent radiofrequency catheter ablation (CA) in the Department of Cardiology, the Affiliated Hospital of Qingdao University from 2019-12 to 2020-11 were included. Patients were divided into an oral dronedarone and rivaroxaban group (D-R group, N = 50) and an oral amiodarone and rivaroxaban group (A-R group, N = 50) according to the postoperative antiarrhythmic and anticoagulation strategies. Patients in 2 groups were given propensity score matching (PSM) to obtain a sample with balanced inter-group covariates. A retrospective observational study was conducted. After 3 months of follow-up, the incidence of clinically relevant non-major bleeding (CRNMB), major hemorrhages, and early AF recurrence was observed.
RESULTS
After PSM, 41 patients were included in each group. With similarly distributed baseline characteristics and ablation characteristics after PSM, the CRNMB rate after AF ablation was significantly higher in the D-R group than in the A-R group (26.8% versus 7.3%, P = 0.02), and no major hemorrhages were detected in both groups. No significant difference was observed in the sinus rhythm maintenance rate between the D-R group and the A-R group (26.8% vs. 22.0%, P = 0.43).
CONCLUSIONS
Compared to co-administration of amiodarone and rivaroxaban, co-administration of dronedarone and rivaroxaban increases the risk of CRNMB but it does not increase the risk of major hemorrhages in blanking period after AF ablation.
Topics: Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Catheter Ablation; Dronedarone; Hemorrhage; Humans; Rivaroxaban
PubMed: 35050451
DOI: 10.1007/s10840-022-01128-w -
Journal of Neurology Dec 2022Intracerebral hemorrhage (ICH) associated with direct oral anticoagulant (DOAC) usage confers significant mortality/disability. We aimed to understand the clinical and...
BACKGROUND AND AIMS
Intracerebral hemorrhage (ICH) associated with direct oral anticoagulant (DOAC) usage confers significant mortality/disability. We aimed to understand the clinical and neuroimaging features associated with developing ICH among DOAC users.
METHODS
Clinical and radiological data were collected from consecutive DOAC users with ICH (DOAC-ICH) and age-matched controls without ICH from a single referral center. The frequency/distribution of MRI markers of hemorrhage risk were assessed. Baseline demographics and neuroimaging markers were compared in univariate tests. Significant associations (p < 0.1) were entered into a multivariable regression model to determine predictors of ICH.
RESULTS
86 DOAC-ICH and 94 ICH-free patients were included. Diabetes, coronary artery disease, prior ischemic stroke, smoking history, and antiplatelet usage were more common in ICH patients than ICH-free DOAC users. In the neuroimaging analyses, severe white matter hyperintensities (WMHs), lacunes, cortical superficial siderosis (cSS), and cerebral microbleeds (CMBs) were more common in the ICH cohort than the ICH-free cohort. In the multivariable regression, diabetes [OR 3.53 95% CI (1.05-11.87)], prior ischemic stroke [OR 14.80 95% CI (3.33-65.77)], smoking history [OR 3.08 95% CI (1.05-9.01)], CMBs [OR 4.07 95% CI (1.45-11.39)], and cSS [OR 39.73 95% CI (3.43-460.24)] were independently associated with ICH.
CONCLUSIONS
Risk factors including diabetes, prior stroke, and smoking history as well as MRI biomarkers including CMBs and cSS are associated with ICH in DOAC users. Although screening MRIs are not typically performed prior to initiating DOAC therapy, these data suggest that patients of high-hemorrhagic risk may be identified.
Topics: Humans; Anticoagulants; Cerebral Hemorrhage; Ischemic Stroke; Magnetic Resonance Imaging; Neuroimaging; Risk Factors; Siderosis; Administration, Oral
PubMed: 35997817
DOI: 10.1007/s00415-022-11333-2 -
Scientific Reports Feb 2023Anti-tuberculosis treatment can cause significant drug-drug interaction and interfere with effective anticoagulation. However, there is a lack of evidence and...
Anti-tuberculosis treatment can cause significant drug-drug interaction and interfere with effective anticoagulation. However, there is a lack of evidence and conflicting data on the optimal oral anticoagulation in patients treated for tuberculosis. We investigated the safety and effectiveness of anticoagulation with non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in patients on anti-tuberculosis treatment. Patients on concomitant oral anticoagulation and anti-tuberculosis treatment including rifampin were identified from the Korean nationwide healthcare database. Subjects were censored at discontinuation of either anticoagulation or rifampin. The outcomes of interest were major bleeding, death, and ischemic stroke. A total 2090 patients (1153 on warfarin, 937 on NOAC) were included. NOAC users, compared to warfarin users, were older, had a lower prevalence of hypertension, heart failure, ischemic stroke, and aspirin use and a higher prevalence of cancer, with no significant differences in CHADS-VASc or HAS-BLED scores. There were 18 major bleeding events, 106 deaths, and 50 stroke events during a mean follow-up of 2.9 months. After multivariable adjustment, the use of NOAC was associated with a lower risk of incident ischemic stroke (HR 0.51, 95% CI 0.27-0.94), while there was no significant difference in risk for major bleeding or death compared with warfarin. These results suggest that NOACs have better effectiveness for stroke prevention and similar safety compared with warfarin in patients on concomitant anti-tuberculosis treatment. This is the first study assessing the safety and effectiveness of NOACs compared to warfarin in this clinical scenario.
Topics: Humans; Warfarin; Anticoagulants; Administration, Oral; Rifampin; Atrial Fibrillation; Stroke; Hemorrhage; Ischemic Stroke; Antitubercular Agents; Treatment Outcome
PubMed: 36739307
DOI: 10.1038/s41598-023-29185-9 -
Clinical Pharmacology and Therapeutics Jun 2021Chronic kidney disease is a common comorbidity among patients taking direct-acting oral anticoagulants (DOACs). Herein, we evaluate the influence of kidney function on... (Randomized Controlled Trial)
Randomized Controlled Trial
Chronic kidney disease is a common comorbidity among patients taking direct-acting oral anticoagulants (DOACs). Herein, we evaluate the influence of kidney function on stroke or systemic embolism (SEE), hemorrhage, and composite end points (stroke/SEE/hemorrhage/death and stroke/SEE/death) among patients on DOACs and warfarin. Baseline kidney function was categorized as glomerular filtration rate (GFR) ≥ 60 (reference), 45-59, and < 45mL/min/1.73 m for participants in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) (n = 18,049), Apixaban for Reduction in Stroke and Other Thromboembolic Events (ARISTOTLE) (n = 18,187), and The Effective Anticoagulation with Factor Xa Next Generation in AF (ENGAGE AF) (n = 20,798) trials. Incidence of events was compared across GFR categories. Hazard ratios for events were estimated using Cox regression using intention-to-treat analysis adjusting for known predictors. A large proportion of participants had GFR < 60 (25-29% had 45 ≤ GFR < 60 and 9.5-12.6% with GFR < 45). Compared with patients with GFR ≥ 60, warfarin users across the trials with GFR ≥ 45-59 and GFR < 45 had a higher incidence of hemorrhage (P values < 0.0001) and warfarin users in the ARISTOTLE and ENGAGE trials had higher incidence of stroke/SEE (P values ≤ 0.05). Compared with patients with GFR ≥ 60, dabigatran users with GFR ≥ 45-59 and GFR < 45 had a higher incidence of stroke/SEE (P ≤ 0.02), hemorrhage (P < 0.001), and both composite end points (P < 0.0001). Compared with patients with GFR ≥ 60, apixaban and edoxaban users with GFR ≥ 45-59 and GFR < 45 had a higher incidence of hemorrhage (P values ≤ 0.05) and composite end points (P values ≤ 0.05). After adjustment, compared with patients with GFR ≥ 60, warfarin users with GFR < 60 in the ARISTOTLE and RE-LY trials had a higher risk of hemorrhage (P < 0.05), as did dabigatran (P < 0.001) and edoxaban (P ≤ 0.005) users, while apixaban users did not exhibit an increased risk (P = 0.08 GFR ≥ 45-59; P = 0.71 GFR < 45). Kidney function significantly influences the safety and efficacy of oral anticoagulants.
Topics: Aged; Endpoint Determination; Factor Xa Inhibitors; Female; Glomerular Filtration Rate; Hemorrhage; Humans; Incidence; Kidney Function Tests; Male; Middle Aged; Renal Insufficiency, Chronic; Risk Assessment; Stroke; Thromboembolism; Warfarin
PubMed: 33278832
DOI: 10.1002/cpt.2131 -
Frontiers in Neurology 2022[This corrects the article DOI: 10.3389/fneur.2022.832903.].
[This corrects the article DOI: 10.3389/fneur.2022.832903.].
PubMed: 36341125
DOI: 10.3389/fneur.2022.1055360 -
BMC Oral Health Jun 2021Gingivitis is the most prevalent form of periodontal disease in children and adolescents, being strongly associated to some socioeconomic factors and oral health...
BACKGROUND
Gingivitis is the most prevalent form of periodontal disease in children and adolescents, being strongly associated to some socioeconomic factors and oral health behaviours. This study aimed to assess the prevalence of gingivitis and its association with socio-demographic factors and oral health-related behaviours in children aged 12-15 years in Guangdong, Southern China.
METHODS
A total of 7680 children were sampled using an equal-sized, stratified, multistage, random sampling method and clinically examined between December 2015 and April 2016. A questionnaire on socio-demographic factors and oral health-related behaviours related to gingivitis was completed by each of the selected children. Gingival bleeding was recorded using the Community Periodontal Index probe, and children with a gingival bleeding positive score ≥ 10% were defined as having gingivitis. A multivariate logistic regression analysis was performed to assess the association between socio-demographic factors and gingivitis. All statistical tests were performed at a two-sided significance level of 0.05.
RESULTS
The weighted prevalence of gingivitis among 12-15-year-old children was 29.6%, with 22.6% having localised gingivitis and 7.0% having generalised gingivitis. Age differences were observed in the prevalence of gingivitis, whereas urban-rural differences were not. According to the multivariate logistic regression analysis results, factors such as increasing age, being the only child, lack of regular annual dental check-up, and heavy dental calculus were significantly associated with higher prevalence of gingivitis. In addition, the association of gingivitis with these factors was inconsistent among the urban and rural areas.
CONCLUSIONS
Dental calculus and oral health behaviour were found to be important factors for maintaining the gingival health of children aged 12-15 years in Guangdong. Maintaining gingival health in children requires promoting positive oral health behaviours and regular dental prophylaxis.
Topics: Adolescent; Child; China; Cross-Sectional Studies; Dental Calculus; Gingival Hemorrhage; Gingivitis; Humans; Oral Health; Prevalence
PubMed: 34134691
DOI: 10.1186/s12903-021-01666-1 -
Clinical and Applied... 2021Peripheral artery disease (PAD) is a common disease affecting over 200 million people worldwide. PAD is associated with significant limb and cardiovascular morbidity and... (Meta-Analysis)
Meta-Analysis
Peripheral artery disease (PAD) is a common disease affecting over 200 million people worldwide. PAD is associated with significant limb and cardiovascular morbidity and mortality which is reduced by antiplatelet and antithrombotic therapy. However, the optimal type, dose, and time of antithrombotic therapy is still uncertain.We searched 4 electronic databases from January 1, 1990, to June 1, 2020, for randomized controlled trials of patients who received oral anticoagulant and antiplatelet therapy for PAD. The primary outcome was a composite of acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, death from cardiovascular events, or death from any cause. Secondary outcomes included major bleeding, fatal bleeding, and intracranial hemorrhage events.We identified 3 studies that satisfied inclusion and exclusion criteria. Compared with antiplatelet alone, oral anticoagulant plus antiplatelet therapy improved acute limb ischemia (p < 0.00001), stroke (p = 0.005), and major amputation events (p = 0.11). However, oral anticoagulant plus antiplatelet therapy was not effective for prevention of myocardial infarction (p = 0.23), death from cardiovascular events (p = 0.65), or death from any cause (p = 0.66). Additionally, a significant increase in major bleeding events was demonstrated (p < 0.00001). There was no significant difference in fatal bleeding (p = 0.16) or intracranial hemorrhage events (p = 0.43). This meta-analysis showed that oral anticoagulant plus antiplatelet therapy for PAD may improve acute limb ischemia and major amputation or stroke risk compared with antiplatelet therapy alone, but could increase the risk of major bleeding events. On the other hand, measuring myocardial infarction, death, fatal bleeding, or intracranial hemorrhage risk remains controversial.
Topics: Administration, Oral; Aged; Anticoagulants; Female; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic
PubMed: 33783251
DOI: 10.1177/1076029621996810 -
World Journal of Gastroenterology May 2023Delayed bleeding is a major and serious adverse event of endoscopic submucosal dissection (ESD) for early-stage gastrointestinal tumors. The rate of post-ESD bleeding... (Review)
Review
Delayed bleeding is a major and serious adverse event of endoscopic submucosal dissection (ESD) for early-stage gastrointestinal tumors. The rate of post-ESD bleeding for gastric cancer is higher (around 5%-8%) than that for esophagus, duodenum and colon cancer (around 2%-4%). Although investigations into the risk factors for post-ESD bleeding have identified several procedure-, lesion-, physician- and patient-related factors, use of antithrombotic drugs, especially anticoagulants [direct oral anticoagulants (DOACs) and warfarin], is thought to be the biggest risk factor for post-ESD bleeding. In fact, the post-ESD bleeding rate in patients receiving DOACs is 8.7%-20.8%, which is higher than that in patients not receiving anticoagulants. However, because clinical guidelines for management of ESD in patients receiving DOACs differ among countries, it is necessary for endoscopists to identify ways to prevent post-ESD delayed bleeding in clinical practice. Given that the pharmacokinetics (, plasma DOAC level at both trough and T) and pharmacodynamics (, anti-factor Xa activity) of DOACs are related to risk of major bleeding, plasma DOAC level and anti-FXa activity may be useful parameters for monitoring the anti-coagulate effect and identifying DOAC patients at higher risk of post-ESD bleeding.
Topics: Humans; Endoscopic Mucosal Resection; Postoperative Hemorrhage; Retrospective Studies; Anticoagulants; Stomach Neoplasms; Risk Factors; Gastric Mucosa
PubMed: 37274799
DOI: 10.3748/wjg.v29.i19.2916 -
Journal of Clinical Medicine Sep 2020Anticoagulation carries a tremendous therapeutic advantage in reducing morbidity and mortality with venous thromboembolism and atrial fibrillation. For over six decades,... (Review)
Review
Anticoagulation carries a tremendous therapeutic advantage in reducing morbidity and mortality with venous thromboembolism and atrial fibrillation. For over six decades, traditional anticoagulants like low molecular weight heparin and vitamin K antagonists like warfarin have been used to achieve therapeutic anticoagulation. In the past decade, multiple new direct oral anticoagulants have emerged and been approved for clinical use. Since their introduction, direct oral anticoagulants have changed the landscape of anticoagulants. With increasing indications and use in various patients, they have become the mainstay of treatment in venous thromboembolic diseases. The safety profile of direct oral anticoagulants is better or at least similar to warfarin, but several recent reports are focusing on spontaneous hemorrhages with direct oral anticoagulants. This narrative review aims to summarize the incidence of spontaneous hemorrhage in patients treated with direct oral anticoagulants and also offers practical management strategies for clinicians when patients receiving direct oral anticoagulants present with bleeding complications.
PubMed: 32942757
DOI: 10.3390/jcm9092984