scholarly journals Gender Related Differences in Gastrointestinal Bleeding With Oral Anticoagulation in Atrial Fibrillation

2022 ◽  
Vol 27 ◽  
pp. 107424842110546
Author(s):  
Eliana Ferroni ◽  
Gentian Denas ◽  
Nicola Gennaro ◽  
Ugo Fedeli ◽  
Vittorio Pengo

Background: DOACs are characterized by a higher incidence of gastrointestinal bleeding and this may be different among males and females. Female patients were underrepresented in the DOAC pivotal trials. We aimed to assess real-world differences in gastrointestinal bleeding with oral anticoagulants (DOACs and VKAs) among males and females with atrial fibrillation. Methods: We performed a population-based retrospective analysis on linked administrative claims. Atrial fibrillation patients of 65 years and above were considered. Bleeding risk factors were assessed through HASBED and previous history of gastrointestinal disease. A time-to-event analysis compared gastrointestinal bleeding between males and females. Results: The overall cohort consisted of 15338 (55% female) DOAC and 44542 (50% female) VKA users. Most of the patients showed HASBED ≥2. Incidence rate of GI bleeding was higher in females as compared to males among DOAC users (0.90% vs 0.59%), and significant gender difference in GI bleeding was found, after adjustment, in the Cox regression analysis (HR 1.48, 95%CI 1.02-2.16). In the VKA group, no significant difference among genders was found in the time-to-event analysis. Conclusions: Our data suggest that female patients treated with DOACs have a higher risk of GI bleeding versus male patients; this difference is not observed in VKA patients.

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Jun Young Lee ◽  
Jae Won Yang ◽  
Jae Seok Kim ◽  
Seong Ok Choi ◽  
Byoung Geun Han

Abstract Background and Aims Atrial fibrillation (AF) is common arrhythmia in end stage renal disease patients. Although, the need of anticoagulation to prevent stroke and thromboembolism is increasing, the efficacy of anticoagulation is not proven in most of study. We retrospectively analyzed the risk and benefit of anticoagulation in dialysis patients with AF. Method By using medical record, we retrospectively analyzed all data of 99 patients who received dialysis therapy and diagnosed AF. Results Among 99 patients who diagnosed AF with dialysis 36 patients received anticoagulation (17 coumadin, 19 apixaban 2.5mg bid), 63 patients received no anticoagulation. There was no significant difference of baseline characteristics between anticoagulation, and no anticoagulation patients. Although no anticoagulation group experienced more all-cause (39.7% vs 32.4%, p=0.572) and cardiovascular mortality (17.6% vs 10.8%, p=0.197) than anticoagulation group it was not statistically significant. Compared to apixaban 2.5mg bid patients, coumadin anticoagulation patients experienced more frequent mfig ajor adverse cardiovascular events (35.3% vs 15.8%, p=0.109) but it was not statistically significant in multi variate Cox regression analysis (Hazard ratio 1.143, 95% Confidence Interval 0.503-2.597). Conclusion Apixaban 2.5mg bid was not inferior than coumadin considering risk and benefit of anticoagulation in dialysis patients.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4268-4268
Author(s):  
Alessia Pepe ◽  
Maria Marsella ◽  
Antonella Meloni ◽  
Valeria Caldarelli ◽  
Maria Chiara Dell'Amico ◽  
...  

Abstract Abstract 4268 Introduction. Heart disease remains the main cause of mortality in thalassemia major patients. Female patients with thalassemia major have a proved lower prevalence of cardiac complications than males and survive longer. It has been suggested that females have a better compliance than males, and therefore accumulate less iron in crucial organs like the heart (Borgna-Pignatti C et al, Haematologica 2004). The aim of our study was to verify if the decreased prevalence of cardiac disease in females could be attributed to lesser iron accumulation in their hearts as measured by multislice multiecho T2* Magnetic Resonance Imaging (MRI) technique. Methods. We performed a retrospective review of the MRI results and of clinical data about the thalassemia major patients enrolled in the Myocardial Iron Overload in Thalassemia (MIOT) project. The MIOT is a network where MRI is performed using standardized and validated procedures and the MRI and thalassemia centers are linked by a web-based network, configured to collect patients' clinical and diagnostic data (Meloni A et al, Int J Med Inform 2009). Myocardial iron concentrations were measured by T2* multislice multiecho technique (Pepe A et al, JMRI 2006).Biventricular function parameters were quantitatively evaluated by cine images. Results. Seven hundred and seventy six thalassemia patients (370 males) were present in the MIOT database having undergone at least one MRI exam. The prevalence of cardiac disease (heart dysfunction and/or arrhythmias requiring medications) was significantly higher in males than in females (males 28% vs females 17%; P<0.0001). The analysis of different chelation treatments did not demonstrate a significant difference between patients with and without cardiac disease (P=0.59), nor between sexes (P=0.46). In addition, there was no difference in the reported compliance to chelation therapy between males and females (P=0.52). Global heart T2* values were significantly lower in both males and females with heart dysfunction (males: 20 ± 15 ms; females: 18 ± 12 ms), compared to those without dysfunction (males: 29 ± 11 ms; females: 27 ± 13 ms) (P<0.0001), but no difference was observed according to sex (Figure 1A). Global heart T2* values were not significantly lower in patients with arrhythmias compared to those without arrhythmias, nor was there a significant difference between sexes (Figure 1B). Conclusions. The confirmed higher prevalence of cardiac disease in males with thalassemia major was not correlated to a worse compliance to chelation therapy or to an higher cardiac iron burden. Increased survival of female thalassemia major patients seems to not be attributed to lower cardiac iron overload. It can be hypothesized that females tolerate iron toxicity better, possibly as an effect of reduced sensitivity to chronic oxidative stress. Disclosures: No relevant conflicts of interest to declare.


2016 ◽  
Vol 116 (10) ◽  
pp. 754-763 ◽  
Author(s):  
Francisco Moscoso Costa ◽  
Jorge Ferreira ◽  
Miguel Mendes ◽  
João Carmo

SummaryIn the RE-LY clinical trial, dabigatran presented a better effectiveness/ safety profile when compared to warfarin. However, clinical trials are not very representative of the real-world setting. We aimed to assess the performance of dabigatran in real-world patients with atrial fibrillation (AF) by means of a systematic review and meta-analysis of observational comparison studies with vitamin K antagonists (VKA). We searched PubMed, Embase and Scopus databases until November 2015 and selected studies according to the following criteria: observational study performed with nonvalvular AF patients; reporting adjusted hazard ratios (HR) of clinical events in a follow-up period; for dabigatran 75 mg, 110 mg or 150 mg versus VKA. Twenty studies were selected which included 711,298 patients, 210,279 of which were treated with dabigatran and the remaining 501,019 with VKA. Ischaemic stroke incidence was of 1.65 /100 patient-years for dabigatran and 2.85/100 patient-years for VKA (HR 0.86, 95 % confidence interval of 0.74–0.99). Major bleeding rate was 3.93/100 patient-years for dabigatran and 5.61/100 patient-years for VKA (0.79, 0.69–0.89). Risk of mortality (0.73, 0.61–0.87) and intracranial bleeding (0.45, 0.38–0.52) were significantly lower in patients treated with dabigatran when compared to patients on VKA. Risk of gastrointestinal (GI) bleeding was significantly higher in patients treated with dabigatran (1.13, 1.00–1.28). No significant difference was observed in risk of myocardial infarction (0.99, 0.89–1.11). In this combined analysis of real-world observational comparison studies with VKA, dabigatran was associated with a lower risk of ischaemic stroke, major bleeding, intracranial bleeding and mortality, higher risk of GI bleeding and a similar risk of myocardial infarction.Supplementary Material to this article is available online at www.thrombosis-online.com.


Vascular ◽  
2018 ◽  
Vol 26 (6) ◽  
pp. 641-646 ◽  
Author(s):  
G Torsello ◽  
MV Usai ◽  
S Scali ◽  
P Kubilis ◽  
FJ Veith ◽  
...  

Objective Gender-related differences in outcomes in complex endovascular aortic repair have not been profoundly investigated. Use of low profile abdominal devices as in chimney endovascular repair may be beneficial for female patients with pararenal pathologies. With the chimney technique, there is no need for large introduction sheaths. This could be an advantage in case of smaller in diameter iliac access especially in combination with stenosis or elongation. Aim of the present study was to compare the perioperative and mid-term outcomes between males and females patients treated with the chimney/snorkel technique for pararenal aortic pathologies. Methods The PERICLES registry collected the world wide experience with the chimney technique. According to the gender, patients were classified in two cohorts. Primary endpoints were freedom from occlusion of the chimney grafts and reintervention. Secondary endpoints included access site complications and need for surgical or interventional revision, Endoleak Type I rate, 30-day overall complications and mortality. Univariate comparison P-values were generated using either the likelihood ratio χ2 test, the Fisher exact test, the Wilcoxon rank sum test, or the log rank test. Kaplan–Meier curves estimated the outcomes in the long run. Results A total of 412 patients underwent Ch-EVAR, 71 (17%) females and 341 (83%) males with a mean age for both groups being 74 years were included in the present study. After 36 months of mean follow-up, no statistically significant difference was observed between the two cohorts regarding re-interventions ( P= .44). Freedom from occlusion rates at 36 months did not differed between the two groups (females 84% vs. 80% for males ( P= .033). For patients receiving more than one chimney stent, the odds of having a complication did not differ between males and females (M:F OR = 2.0, 95% CI: 0.6–6.4, P = 0.228); 30-day mortality was 0% in the female group, instead five male patients died within one month. ( P = 0.59). The incidence of acute renal failure was low in both groups without statistical difference: 2 (3.1%) vs. 13 (4.6%) 58 ( P = 1.00). Neither patient received an endoconduit to insert the abdominal device. Conclusions No statistically significant difference regarding the freedom from reintervention and chimney graft patency was observed between the two genders. The results highlight the beneficial use of the chimney technique in female patients who can have potentially higher risk of access complications.


Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Temidayo Abe ◽  
Samuel Ogbuchi ◽  
Taiwo Ajose ◽  
Ajibola Babatunde ◽  
Chinonyelum Nwagbara ◽  
...  

Introduction: Recent studies have demonstrated poor outcomes in patients with takotsubo cardiomyopathy (TCM). It is important to determine the predictors of these outcomes for appropriate risk stratification and to decrease the overall disease burden. Physical stressors and preexisting heart failure have been associated with poorer outcomes, however, the impact of alcohol use (ETOH) has not been discussed. Aim: To determine if underlying alcohol use is associated with poorer outcomes in patients with TCM. Methods: We recruited 6750 patients from 2011, 2012 National Inpatient Sample, 6325 had TCM alone while 425 had TCM and ETOH use. Our outcomes of interest were overall mortality, mechanical hemodynamic support (MHS) acute respiratory failure(ARF), cardiac arrest (SCA), cardiogenic shock, and atrial fibrillation. All clinical characteristics were defined as per the International Classification of Diseases 9th revision (ICD-9) codes. Logistic regression was used to estimate the odds ratio of the outcomes in the study compared to the control group while stratified analysis was used to adjust for age and sex both accounting for underlying comorbidities. Results: There was no significant difference between the two groups in the rates of atrial fibrillation (11.1% vs 10.4%; P= 0.656), cardiogenic shock (6.2% vs 4.7%; P= 0.201), MHS (2.3% vs 1.4%; P= 0.221) and overall mortality (4.1% vs 3.8%; p=0.702). Rates of ARF (29.9%, vs 18.2%; P< 0.0001) and SCA (4.9% vs 3.0%; P=0.025) were higher in patients with TCM+ETOH compared to TCM alone. Table 1 displays the adjusted odds ratios for the outcomes. Compared to the participants with TCM alone, odd ratios of ARF was significantly higher in patients with TCM+ETOH. Table 2 displays the stratified analysis based sex. Compared with TCM alone, female patients with TCM+ETOH are more likely to develop ARF, cardiogenic shock and SCA. Conclusion: Preexisting alcohol use is associated with poorer outcomes in female patients with TCM.


Author(s):  
Peter Vibe Rasmussen ◽  
Frederik Dalgaard ◽  
Gunnar Hilmar Gislason ◽  
Axel Brandes ◽  
Søren Paaske Johnsen ◽  
...  

Abstract Aims Gastrointestinal bleeding (GI-bleeding) is frequent in patients with atrial fibrillation (AF) treated with oral anticoagulation (OAC) therapy. We sought to investigate to what extent lower GI-bleeding represents the unmasking of an occult colorectal cancer. Methods and results A total of 125 418 Danish AF patients initiating OAC therapy were identified using Danish administrative registers. Non-parametric estimation and semi-parametric absolute risk regression were used to estimate the absolute risks of colorectal cancer in patients with and without lower GI-bleeding. During a maximum of 3 years of follow-up, we identified 2576 patients with lower GI-bleeding of whom 140 patients were subsequently diagnosed with colorectal cancer within the first year of lower GI-bleeding. In all age groups, we observed high risks of colorectal cancer after lower GI-bleeding. The absolute 1-year risk ranged from 3.7% [95% confidence interval (CI) 2.2–6.2] to 8.1% (95% CI 6.1–10.6) in the age groups ≤65 and 76–80 years of age, respectively. When comparing patients with and without lower GI-bleeding, we found increased risk ratios of colorectal cancer across all age groups with a risk ratio of 24.2 (95% CI 14.5–40.4) and 12.3 (95% CI 7.9–19.0) for the youngest and oldest age group of ≤65 and &gt;85 years, respectively. Conclusion In anticoagulated AF patients, lower GI-bleeding conferred high absolute risks of incident colorectal cancer. Lower GI-bleeding should not be dismissed as a benign consequence of OAC therapy but always examined for a potential underlying malignant cause.


Author(s):  
Stephan Willems ◽  
Katrin Borof ◽  
Axel Brandes ◽  
Günter Breithardt ◽  
A John Camm ◽  
...  

Abstract Aims Clinical practice guidelines restrict rhythm control therapy to patients with symptomatic atrial fibrillation (AF). The EAST-AFNET 4 trial demonstrated that early, systematic rhythm control improves clinical outcomes compared to symptom-directed rhythm control. Methods and results This prespecified EAST-AFNET 4 analysis compared the effect of early rhythm control therapy in asymptomatic patients (EHRA score I) to symptomatic patients. Primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome, analyzed in a time-to-event analysis. At baseline, 801/2633 (30.4%) patients were asymptomatic [mean age 71.3 years, 37.5% women, mean CHA2DS2-VASc score 3.4, 169/801 (21.1%) heart failure]. Asymptomatic patients randomized to early rhythm control (395/801) received similar rhythm control therapies compared to symptomatic patients [e.g. AF ablation at 24 months: 75/395 (19.0%) in asymptomatic; 176/910 (19.3%) symptomatic patients, P = 0.672]. Anticoagulation and treatment of concomitant cardiovascular conditions was not different between symptomatic and asymptomatic patients. The primary outcome occurred in 79/395 asymptomatic patients randomized to early rhythm control and in 97/406 patients randomized to usual care (hazard ratio 0.76, 95% confidence interval [0.6; 1.03]), almost identical to symptomatic patients. At 24 months follow-up, change in symptom status was not different between randomized groups (P = 0.19). Conclusion The clinical benefit of early, systematic rhythm control was not different between asymptomatic and symptomatic patients in EAST-AFNET 4. These results call for a shared decision discussing the benefits of rhythm control therapy in all patients with recently diagnosed AF and concomitant cardiovascular conditions (EAST-AFNET 4; ISRCTN04708680; NCT01288352; EudraCT2010-021258-20).


2019 ◽  
Vol 70 (5) ◽  
pp. 1582-1585 ◽  
Author(s):  
Ionela Silivastru (Cozlea) ◽  
Gabriela Keresztesi ◽  
Arthur Atilla Keresztesi ◽  
Daniel Laurentiu Cozlea ◽  
Carmen Caldararu ◽  
...  

The risk of bleeding in atrial fibrillation patients on direct oral anticoagulant treatment increases with age; particularly dabigatran is associated with a higher risk of gastrointestinal bleeding in elderly patients, low body mass ([48 kg) and women due to the induced dyspepsia. We aimed to evaluate the safety of direct oral anticoagulants (DOAC) dabigatran, rivaroxaban and apixaban by comparing each agent with a widely used vitamin K antagonist (VKA)-acenocoumarol in terms of bleeding event rates. A retrospective study regarding bleeding events in atrial fibrillation patients treated with oral anticoagulation (OAC) was performed. Haematuria, epistaxis and haemoptysis were considered minor events and intracranial bleeding, gastrointestinal bleeding (superior or inferior), blood transfusion after haemorrhagic events linked to OAC treatment were considered to be major events. A number of 219 atrial fibrillation patients were included using electronic medical records: 118 patients treated with DOAC s (82 using dabigatran, 28 on rivaroxaban regimen and 8 cases treated with apixaban) and 101 cases had vitamin K antagonists treatment (acenocumarol). A total of 75 bleeding events were encountered (70 minor and 5 major). A higher number of events were encountered in patients treated with DOAC s, but with no statistically significant difference compared to acenocumarol. The associated risk factors did not play a decisive role in bleeding events in the two treatment groups. No statistical significant difference was noted between the occurrence of haemorrhagic events and the class of oral anticoagulant treatment used (DOAC vs. VKA).


2018 ◽  
Vol 32 (05) ◽  
pp. 448-453 ◽  
Author(s):  
Daniel Berman ◽  
Kelly Rogers ◽  
Justin Griffin ◽  
Kevin Bonner

AbstractSurgical repair of articular cartilage defects in the knee currently utilizes surgical algorithms based on absolute defect size. These algorithms, which have not been validated, are currently utilized not only by surgeons but also by insurance carriers for justification of reimbursement policy. However, current algorithms do not account for morphological differences between individual patients and defect size relative to condylar dimension. We hypothesized that a significant difference in relative defect size compared with condylar dimension may exist between individuals. A 3T magnetic resonance imaging from 220 skeletally mature patients, 110 males and 110 females, were analyzed. Exclusion criteria included degenerative arthritis, anatomical defects, poor image quality, and genetic abnormalities such as dwarfism. Utilizing a radiological curved measurement probe, the femoral condylar articular width was obtained for both the medial and lateral condyles. The mean condylar width from a reproducible anatomic location representing the maximal condylar dimension was measured. Statistical analysis was performed using a two-sample t-test. The lateral condyle articular cartilage width (mm) for males and females was 31.62 ± 3.54 and 26.53 ± 3.70, respectively (p < 0.0001). The medical condyle articular cartilage width was 27.26 ± 4.42 and 23.05 ± 4.11 (p < 0.00001). There was a width variation up to 22.66 mm between male patients and 22.10 mm between female patients. Differences up to 28.26 mm were found between males and females. A condylar defect measuring 10 mm represents as little as 24.29% of a condyle in some males versus as much as 77.46% in smaller females. Existing surgical algorithms for condylar chondral defects apply absolute size to patients regardless of individual condylar variations. Our study suggests the relative sizes of the defect vary significantly from male to female patients as well as within the same gender. Future studies may investigate clinical outcomes utilizing surgical algorithms that take into account these differences.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1844.3-1844
Author(s):  
T. Kawaguchi ◽  
M. Ogasawara ◽  
K. Yamaji ◽  
N. Tamura

Background:Japan is the world’s most aged country. The number of patients with polymyalgia rheumatic (PMR) is expected to increase more.Classification criteria including ultrasound findings were published in 2012(1), but the ability to differentiate PMR from other mimicking diseases was unknown.It is difficult to diagnose PMR accurately. We will clarify whether recently reported ultrasound findings (2, 3) which could be characteristic in PMR are helpful for distinguishing from other mimicking diseases and treatment outcome in suspected PMR patients. Neither diagnostic laboratory test nor specific antibody exist, and inflammatory markers such as C reactive protein and erythrocyte sedimentation rate are not specific.Objectives:Patients who were clinically suspected of PMR and underwent ultrasound examination from 2008 to 2018. And Patients who visited the hospital with PMR and were diagnosed with PMR from 2008 to 2018.Methods:Patients who visited the hospital and were diagnosed with PMR were extracted from the medical record database of the hospital. Patients who had been administrated GC at the first visit and whose records were not confirmed were excluded. Patients who were clinically diagnosed with PMR without ultrasound(Cli-PMR), patients who were diagnosed with PMR with ultrasound reports(US-Cli-PMR), patients who were diagnosed by the ultrasound expert only based on ultrasound images(US-PMR).Patient were followed up for one year. Clinical diagnoses were confirmed at the 6 months and 12 months since the first GC administration.Three groups were compared with each other in the rate of diagnosis change and the time intervals between the initiation of GC treatment and the occurrence of events: recurrence, methotrexate introduction and the normalization of C reactive protein.the Kaplan–Meier method was used to evaluate the outcomes. Statistical analyses were conducted with R software, version 3.5.2 (R Foundation for Statistical Computing) and EZR(4).Results:545 PMR patients were extracted. 403 of 545 was excluded because of preexisting GC therapy and record availability.At the 6 months follow-up, 92.8% of the non-US PMR group and 97% of US-PMR group remain PMR and at the 12 months follow-up 88.8% and 95% respectively. There was no significant difference in the three time-to-event outcomes.Conclusion:Ultrasound did not contribute the improvement of the PMR outcomes. However, this finding was affected by confounding factors for example assignment to ultrasound and atypical cases and rheumatologists’ uncertainness. Despite confounding factors, US-PMR group was not inferior. These findings showed that ultrasound may be useful for the complicated cases.References:[1]ARTHRITIS & RHEUMATISMVol. 64, No. 4, April 2012, pp 943–954[2]Clin Med Insights Arthritis Musculoskelet Disord 2017;10: 1179544117745851.[3]Biomed Res Int 2017;2017: 4272560.[4]Bone Marrow Transplantation 2013: 48, 452–458Disclosure of Interests:None declared


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