Risks and outcomes of gastrointestinal malignancies in anticoagulated atrial fibrillation patients experiencing gastrointestinal bleeding

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T.F Chao ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
The Elderly ◽  
Prior History ◽  
Research Database ◽  
Gi Bleeding ◽  
Gi Tract ◽  
Gastrointestinal Malignancies ◽  
Risk Of Mortality ◽  
Gi Cancers

Abstract Background Oral anticoagulants (OACs) may serve as a type of “screening test” for the diagnosis of occult gastrointestinal (GI) tract malignancies through a clinical presentation with bleeding. Objective We aimed to investigate the 1-year incidence and predictors of GI cancers after GI bleeeding events among patients with atrial fibrillation (AF) treated with warfarin or NOACs. Second, we aimed to compare the risk of mortality after GI cancers between patients treated with warfarin or NOACs. Methods A total of 10,845 anticoagulated AF patients who experienced hospitalizations due to GI bleeding without prior history of GI cancers were identified from the Taiwan National Health Insurance Research Database. Patients were followed up for incident GI cancers for up to 1 year. Results Within 1 year after GI bleeding, 290 (2.67%) patients were diagnosed to have GI tract cancers. More patients treated with NOACs were diagnosed to have GI cancers than those receiving warfarin (68/1,759; 3.87% [NOACs] versus 222/9,086; 2.44% [warfarin], p<0.001) with an odds ratio (OR) 1.606 (95% CI: 1.208–2.117, p<0.001). Age (OR 1.025 [95% CI: 1.012–1.037] per 1 year increment) and male sex (1.356 [95% CI: 1.050–1.700]) were independently associated with the diagnosis of GI cancers within 1 year after GI bleeding. Among 290 patients diagnosed to have GI cancers, 131 (45.2%) experienced mortality within 1 year. The risk of mortality was lower for patients treated with NOACs compared to those receiving warfarin (23.5% versus 51.8%) with an adjusted hazard ratio (aHR) 0.441 (95% CI: 0.262–0.744, p<0.001) (Figure). Conclusions Incident GI cancers were diagnosed in 1 in 37 AF patients at 1 year after OAC-related GI bleeding, which were more common among patients treated with NOACs (1 in 26) compared to warfarin (1 in 41). Detailed surveys for occult GI cancers were necessary for these patients, especially for the elderly males. Survival curves Funding Acknowledgement Type of funding source: None

P4787Use of direct oral anticoagulants in patients with atrial fibrillation having a history of intracranial hemorrhage

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
S A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Research Database ◽  
Bleeding Events ◽  
Risk Of Mortality ◽  
Taiwan National Health Insurance ◽  
History Of

Abstract Background Patients with atrial fibrillation (AF) having a history of intracranial hemorrhage (ICH) were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. We aimed to compare the effectiveness and safety of DOACs and warfarin among AF patients having a history of ICH. Method A total of 4,540 AF patients having a CHA2DS2-VASc score ≥1 for males and ≥2 for females who had a history of ICH and received oral anticoagulants (DOACs in 3,493 and warfarin in 1,047) were identified from the Taiwan National Health Insurance Research Database. A propensity matching analysis was performed to balance the baseline differences, and 973 patients were finally identified in each groups. Results The risk of ischemic stroke did not differ significantly between warfarin and DOACs (4.41%/yr vs 4.87%/yr; HR 0.985, p=0.927). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.752 (0.573–0.986, p=0.040) for major bleeding and 0.614 (0.379–0.995, p 0.048) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR = 0.539; 95% CI = 0.453–0.642, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. Conclusion Compared to warfarin, DOACs were associated with a similar risk of ischemic stroke and better safety profiles among AF patient with a history of ICH.

P4789Comparisons of direct oral anticoagulants and warfarin in patients with atrial fibrillation and liver cirrhosis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
G Y H Lip ◽  
S A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Liver Cirrhosis ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Research Database ◽  
Bleeding Events ◽  
Risk Of Mortality ◽  
Taiwan National Health Insurance

Abstract Background Patients with atrial fibrillation (AF) and severe liver cirrhosis were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. In the present study, we compared the effectiveness and safety of DOACs and warfarin among AF patients with liver cirrhosis. Method A total of 3,691 AF patients with liver cirrhosis having a CHA2DS2-VASc score ≥1 for males and ≥2 for females and received oral anticoagulants (DOACs in 2,548 and warfarin in 1,143) were identified from the Taiwan National Health Insurance Research Database. The effectiveness and safety were compared between DOACs and warfarin groups. Results There was a trend suggesting a lower risk of ischemic stroke with DOACs compared to warfarin (2.91%/yr vs 3.41%/yr; HR 0.743, p=0.060). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.718 (0.573–0.899, p=0.004) for major bleeding and 0.509 (0.292–0.889, p=0.018) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR=0.483; 95% CI: 0.424–0.551, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. The results were essentially similar after the propensity matching analysis of 2 groups. Conclusion Compared to warfarin, DOACs were associated with a lower risk of ICH, major bleeding and mortality among AF patient with liver cirrhosis.

P4793Comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in the elderly Asian patients with atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
J N Liao ◽  
G Y H Lip ◽  
S A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Elderly Patients ◽  
Vitamin K ◽  
Stroke Prevention ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
The Elderly ◽  
Vitamin K Antagonist ◽  
Research Database

Abstract Background Stroke prevention in elderly patients with atrial fibrillation (AF) can be challenging. Comparisons of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in the elderly, at different age strata (age 65–74, 75–89, ≥90) in the daily practice have not been well described, particularly in Asians. We aimed to assess the clinical outcomes of NOACs compared warfarin for stroke prevention in elderly patients with AF. Methods A total of 64,169 AF patients aged ≥65 years receiving NOACs or warfarin prescription were identified from the Taiwan National Health Insurance Research Database. The risks of adverse events were compared between NOACs and warfarin in all patients age ≥65 and specifically, with different age strata; that is 65–74 years, 75–89 years and >90 years. Results Overall NOACs were associated with a significantly lower risk of ischemic stroke (adjusted hazard ratio [aHR] 0.869, 95% confidence interval [CI] 0.812–0.931), ICH (aHR 0.524, 95% CI 0.456–0.601), major bleeding (aHR 0,824, 95% CI 0.776–0.875), mortality (aHR 0.511, 95% CI 0.491–0.532) and composite adverse events (aHR 0.646, 95% CI 0.625–0.667) compared to warfarin. There was heterogeneity in treatment effect for NOACs versus warfarin in different age strata, but the results still favored NOACs even among the very elderly (>90 years). The absolute risk difference and reductions in ICH and composite adverse events with NOAC use were even greater among the elderly compared to warfarin (Figure). Conclusions Compared to warfarin, NOACs were associated with a significantly lower risk of adverse events, with heterogeneity in treatment effects among different age strata. Overall, the clear safety signal in favor of NOACs over warfarin was evident irrespective of age strata, being most marked in the most elderly.

scholarly journals The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e417-e426
Author(s):  
Carline J. van den Dries ◽  
Sander van Doorn ◽  
Patrick Souverein ◽  
Romin Pajouheshnia ◽  
Karel G.M. Moons ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Routine Care ◽  
P Value ◽  
Risk Of Mortality ◽  
Mortality Effect

Abstract Background The benefit of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) on major bleeding was less prominent among atrial fibrillation (AF) patients with polypharmacy in post-hoc randomized controlled trials analyses. Whether this phenomenon also exists in routine care is unknown. The aim of the study is to investigate whether the number of concomitant drugs prescribed modifies safety and effectiveness of DOACs compared with VKAs in AF patients treated in general practice. Study Design Adult, nonvalvular AF patients with a first DOAC or VKA prescription between January 2010 and July 2018 were included, using data from the United Kingdom Clinical Practice Research Datalink. Primary outcome was major bleeding, secondary outcomes included types of major bleeding, nonmajor bleeding, ischemic stroke, and all-cause mortality. Effect modification was assessed using Cox proportional hazard regression, stratified for the number of concomitant drugs into three strata (0–5, 6–8, ≥9 drugs), and by including the continuous variable in an interaction term with the exposure (DOAC vs. VKA). Results A total of 63,600 patients with 146,059 person-years of follow-up were analyzed (39,840 person-years of DOAC follow-up). The median age was 76 years in both groups, the median number of concomitant drugs prescribed was 7. Overall, the hazard of major bleeding was similar between VKA-users and DOAC-users (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.87–1.11), though for apixaban a reduction in major bleeding was observed (HR 0.81; 95% CI 0.68–0.98). Risk of stroke was comparable, while risk of nonmajor bleeding was lower in DOAC users compared with VKA users (HR 0.92; 95% CI 0.88–0.97). We did not observe any evidence for an impact of polypharmacy on the relative risk of major bleeding between VKA and DOAC across our predefined three strata of concomitant drug use (p-value for interaction = 0.65). For mortality, however, risk of mortality was highest among DOAC users, increasing with polypharmacy and independent of the type of DOAC prescribed (p-value for interaction <0.01). Conclusion In this large observational, population-wide study of AF patients, risk of bleeding, and ischemic stroke were comparable between DOACs and VKAs, irrespective of the number of concomitant drugs prescribed. In AF patients with increasing polypharmacy, our data appeared to suggest an unexplained yet increased risk of mortality in DOAC-treated patients, compared with VKA recipients.

Abstract 140: Comparison of Major Complication of Oral Anticoagulants in Non-Valvular Atrial Fibrillation: Systematic Review and Meta-Analyses

2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Hong Seok Lee
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Gi Bleeding ◽  
Ischemic Stroke Risk ◽  
Meta Analyses

Background: Oral anticoagulants known as a novel oral anticoagulant have been used for the management of non -valvular atrial fibrillation. There was no enough study regarding the efficacy and safety of three major new oral anticoagulants. We assessed major three oral anticoagulants in terms of major bleeding complication and stroke prevention by meta-analyses studies comparing those drugs. Method: Relevant studies were identified through electronic literature searches of MEDLINE, EMBASE, Cochrane library, and clinicaltrials.gov (from inception to February 24, 2016). RevMan and ITC software were used for direct comparisons, respectively. Results: Apixaban (N=6020), versus dabigatran(N=12038), apixaban versus rivaroxaban(N=8503) and rivaroxaban versus dabigatran were analyzed directly. There was significantly higher major bleeding risks in apixaban compared to dabigatran (both 110mg and 150mg) after adjusting baseline bleeding risk (Relative risk 3.41, 95% confidence interval(2.61 to 4.47) in 110mg, (5.62, 4.83 to 6.54) in 150mg. Intracranial bleeding risk in apixaban was significantly higher than in dabigatran (10.5, 6.10 to18.01). However, apixaban had less GI bleeding risk compared to dabigatran (0.80 , 0.65 to 0.98) and also had less ischemic stroke risk (0.31,0.22 to 0.42). Rivaroxaban showed higher major bleeding risk than dabigatran 110mg (2.34 , 1.81 to 3.03), however, Rivaroxaban had less bleeding risk compared to dabigatran 150mg (0.41, 0.35 to 0.46). Dabigatran 110mg and 150mg had less GI bleeding risk compared to rivaroxaban (0.31 , 0.24 to 0.39) and (0.23,0.17 to 0.29) respectively. Ischemic stroke risk was also decreased in dabigatran110mg (0.46, 0.38 to 0.57). and 150mg (0.66 ,0.52 to 0.83). Conclusion: Observed oral anticoagulants were associated with various complications. Overall, apixaban had higher intracranial bleeding risk than dabigatran. The highest GI bleeding risk in rivaroxaban compared to apixaban and dabigatran. Ischemic stroke risk was the highest in dabigatran. In conclusion, we may use those oral anticoagulant based on risks rates, however, a larger study with longer follow-up is needed to corroborate findings.

scholarly journals Switching to Another Oral Anticoagulant and Drug Discontinuation Among Elderly Patients With Nonvalvular Atrial Fibrillation Treated With Different Direct Oral Anticoagulants

2019 ◽  
Vol 25 ◽  
pp. 107602961987024 ◽  
Author(s):  
Christine L. Baker ◽  
Amol D. Dhamane ◽  
Jigar Rajpura ◽  
Jack Mardekian ◽  
Oluwaseyi Dina ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Oral Anticoagulant ◽  
Cox Regression ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Drug Discontinuation ◽  
Research Database ◽  
Nonvalvular Atrial Fibrillation ◽  
Study Population

We compared the risks of switching to another oral anticoagulant (OAC) and discontinuation of direct oral anticoagulants (DOACs) among elderly patients with nonvalvular atrial fibrillation (NVAF) who were prescribed rivaroxaban or dabigatran versus apixaban. Patients (≥65 years of age) with NVAF prescribed DOACs (January 1, 2013 to September 30, 2017) were identified from the Humana research database and grouped into DOAC cohorts. Cox regression analyses were used to evaluate whether the risk for switching to another OAC or discontinuing index DOACs differed among cohorts. Of the study population (N = 38 250), 55.9% were prescribed apixaban (mean age: 78.6 years; 49.8% female), 37.3% rivaroxaban (mean age: 77.4 years; 46.7% female), and 6.8% dabigatran (mean age: 77.0 years; 44.0% female). Compared to patients prescribed apixaban, patients prescribed rivaroxaban (hazard ratio [HR]: 2.08; 95% confidence interval [CI], 1.92-2.25; P < .001) or dabigatran (HR: 3.74; 95% CI, 3.35-4.18, P < .001) had a significantly higher risk of switching to another OAC during the follow-up; compared to patients prescribed apixaban, the risks of discontinuation were also higher for patients treated with rivaroxaban (HR: 1.10; 95% CI, 1.07-1.13, P < .001) or dabigatran (HR: 1.29; 95% CI, 1.23-1.35, P < .001).

P4780Effectiveness and safety of non-vitamin k antagonist oral anticoagulants in patients with atrial fibrillation and valvular heart disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I K Moon ◽  
S R Lee ◽  
E K Choi ◽  
E J Lee ◽  
J H Jung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Composite Outcome ◽  
Gi Bleeding ◽  
Warfarin Group

Abstract Background Patients with atrial fibrillation (AF) often have concomitant valvular heart disease (VHD), especially in Asia. There are limited data on non-vitamin K antagonist oral anticoagulants (NOAC) impact on outcomes for stroke prevention and bleeding for these patients in real world clinical practice. Purpose To investigate the effectiveness and safety of NOACs compared with warfarin in patients with AF and associated Evaluated Heartvalves, Rheumatic or Artificial (EHRA) type 2 VHD. Methods We identified oral anticoagulants naive patients with AF and EHRA type 2 VHD from the Korean National Health Insurance Service database between 2014 and 2016 (n=2,671 taking warfarin; n=3,058 taking NOAC). Six clinical outcomes including ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal bleeding (GI), major bleeding, all-cause death, and their composite outcome and fatal clinical events (any events that led to death within 30-day of its occurrence) were evaluated. Inverse probability of treatment weighting (IPTW) method was used to balance covariates between the two groups. Results After weighted using 5% trimmed IPTW method (n=2371 taking warfarin; n=2792 taking NOAC), the mean age was 71.2 years, male was 57% and CHA2DS2-VASc score was 3.9. During a mean 1.4-year follow-up, weighted incidence rate of ischemic stroke, ICH, GI bleeding, and all-cause death were lower in the NOAC group than in the warfarin group. Compared to warfarin, NOACs were associated with lower risks of ischemic stroke (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.53–0.96), GI bleeding (HR 0.50, 95% CI 0.35–0.72) and major bleeding (HR 0.61, 95% CI 0.45–0.80). Although NOAC and warfarin groups showed similar incidence rate of ICH, NOAC group was associated with a significantly lower risk of fatal ICH compared to warfarin group (HR 0.28, 95% CI 0.07–0.83). Overall, NOACs were associated with a lower risk of the composite outcome (HR 0.68, 95% CI 0.58–0.80). For an exploratory analysis, patients with EHRA type 1 VHD (n=366 taking warfarin; n=345 taking NOAC) was evaluated. In multivariable Cox regression analysis, NOAC group showed a comparable risk of ischemic stroke, ICH, all-cause death and composite outcome. Clinical outcome in AF patients with VHD Conclusion In this nationwide Asian AF population with EHRA type 2 VHD, NOAC use was associated with lower risks of ischemic stroke, major bleeding, all-cause death, and the composite outcome compared to warfarin.

scholarly journals Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation and Valvular Heart Disease

2019 ◽  
Vol 8 (10) ◽  
pp. 1624 ◽  
Author(s):  
Moon ◽  
Lee ◽  
Choi ◽  
Lee ◽  
Jung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Composite Outcome ◽  
Gi Bleeding ◽  
Valvular Heart Diseases

Background: There are limited data for non-vitamin K antagonist oral anticoagulants (NOACs) impact on outcomes for patients with atrial fibrillation (AF) and valvular heart diseases (VHDs). Methods: We identified patients with AF and associated Evaluated Heartvalves, Rheumatic or Artificial (EHRA) type 2 VHDs, and who had been naïve from the oral anticoagulants in the Korean National Health Insurance Service database between 2014 and 2016 (warfarin: n = 2671; NOAC: n = 3058). For analyzing the effect of NOAC on primary prevention, we excluded those with a previous history of ischemic stroke, intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding events. To balance covariates, we used the propensity score weighting method. Ischemic stroke, ICH, GI bleeding, major bleeding, all-cause death, and their composite outcome and fatal clinical events were evaluated. Results: During a follow-up with a mean duration of 1.4 years, NOACs were associated with lower risks of ischemic stroke (hazard ratio (HR): 0.71, 95% confidence interval (CI): 0.53–0.96), GI bleeding (HR: 0.50, 95% CI: 0.35–0.72), fatal ICH (HR: 0.28, 95% CI: 0.07–0.83), and major bleeding (HR: 0.61, 95% CI: 0.45–0.80) compared with warfarin. Overall, NOACs were associated with a lower risk of the composite outcome (HR: 0.68, 95% CI: 0.58–0.80). Conclusions: In this nationwide Asian AF population with EHRA type 2 VHDs, NOAC use was associated with lower risks of ischemic stroke, major bleeding, all-cause death, and the composite outcome compared to warfarin use.

scholarly journals Prescription of oral anticoagulants and antiplatelets for stroke prophylaxis in atrial fibrillation: nationwide time series ecological analysis

EP Europace ◽  
2020 ◽  
Vol 22 (9) ◽  
pp. 1311-1319 ◽  
Author(s):  
Jianhua Wu ◽  
Eman S Alsaeed ◽  
James Barrett ◽  
Marlous Hall ◽  
Campbell Cowan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Temporal Trends ◽  
Antiplatelet Agents ◽  
The Elderly ◽  
Early Years ◽  
Prescription Data ◽  
Ecological Analysis ◽  
General Practices

Abstract Aims To investigate trends in the prescription of oral anticoagulants (OACs) and antiplatelet agents for atrial fibrillation (AF). Methods and results Prescription data for 450 518 patients with AF from 3352 General Practices in England, was obtained from the GRASP-AF registry, 2009–2018. Annualized temporal trends for OAC and antiplatelet prescription were reported according to eligibility based on stroke risk (CHADS2 or CHA2DS2-VASc scores ≥1 or &gt;2, respectively). From 2009 to 2018, the prevalence of AF increased from 1.6% [95% confidence interval (CI) 1.5–1.7%] to 2.4% (2.3–2.5%), and for those with AF the proportion prescribed OAC increased from 47.6% to 75.0% (P-trend &lt; 0.001; relative risk 1.57, 95% CI 1.55–1.60) and for antiplatelet decreased from 37.4% to 9.2% (P-trend &lt; 0.001). In early-years (2009–2013), eligible patients aged ≥80 years were less likely to be prescribed OAC than patients aged &lt;80 years [odds ratio (OR) 0.55, 95% CI 0.51–0.59 for CHADS2≥1 in 2009] (all P-trends &lt; 0.001). This ‘OAC prescription gap’ reduced over the study period (OR 0.93, 0.90–0.96 in 2018). Whilst the prescription of direct oral anticoagulant (DOAC) as a proportion of all OAC increased from 0.1% (95% CI 0.0–0.2%) in 2011 to 58.8% (58.4–59.2%) in 2018, it was inversely associated with patient age (P-trend &lt; 0.001) and their risk of stroke. Conclusion Between 2009 and 2018, in England, the use of OAC for stroke prophylaxis in AF increased, with DOAC accounting for over half of OAC uptake in 2018. Despite a reduction in the OAC-prescription gap, a new paradox exists relating to DOAC prescription for the elderly and those at higher risk of stroke.

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