EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

Author(s):  
Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Michael P Lerario ◽  
Gino Gialdini ◽  
Daniel Lapidus ◽  
Mesha Shaw ◽  
Babak Navi ◽  
...  

Introduction: Patients with atrial fibrillation (AF) who experience intracranial hemorrhage (ICH) often cannot tolerate anticoagulant therapy and presumably face a higher risk of thromboembolism. However, there are little population-based data on long-term rates of stroke after ICH in patients with AF. Methods: Using validated diagnosis codes and administrative claims data from all nonfederal acute care hospitals and emergency departments in California, Florida, and New York from 2005 to 2012, we identified patients at their first encounter with a recorded diagnosis of AF. We excluded patients with diagnoses of stroke or ICH prior to their index visit or a diagnosis of stroke at the index visit. A time-varying covariate was used to account for ICH (intracerebral or subarachnoid hemorrhage) at the index visit or during follow-up. Kaplan-Meier survival statistics were used to calculate cumulative rates of stroke, and Cox proportional hazard analysis was used to evaluate the relationship between incident ICH and stroke while adjusting for the CHA 2 DS 2 VASc score. Results: During a mean 3.2 years of follow-up among 2,376,207 patients with AF, 25,243 (1.06%) developed ICH and 93,183 (3.92%) developed stroke. The cumulative 1-year rate of stroke was 6.50% (95% CI, 6.06-6.96%) after ICH versus 2.22% (95% CI, 2.20-2.24) in those without ICH. ICH remained associated with higher stroke risk after adjusting for the CHA 2 DS 2 VASc score (HR, 2.29; 95% CI, 2.18-2.40). Among patients with ICH, stroke risk rose in step with the CHA 2 DS 2 VASc score. Conclusions: In a large population-based cohort, patients with AF faced a substantially higher risk of stroke after ICH. This risk rose proportionally with increasing CHA 2 DS 2 VASc score. These findings point to patients with AF and ICH as a vulnerable population who may especially benefit from therapeutic alternatives to anticoagulant therapy for preventing thromboembolism in AF.


2019 ◽  
Vol 9 (1) ◽  
pp. 3.2-4
Author(s):  
Heidi Lehtola ◽  
Antti Palomäki ◽  
Pirjo Mustonen ◽  
Päivi Hartikainen ◽  
Juhani Airaksinen ◽  
...  

Medicine ◽  
2020 ◽  
Vol 99 (48) ◽  
pp. e23316
Author(s):  
Amal Alkhotani ◽  
Nouf Alrishi ◽  
Meshari Alharthi ◽  
Waleed Alzahrani

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Karol Quelal ◽  
Andrea Torres ◽  
Christian Torres ◽  
Alfonso Tafur

Introduction: Intracranial hemorrhage (ICH), is a potential complication of anticoagulation use in atrial fibrillation (AF). During the last decade, guidelines have evolved from recommending vitamin K antagonists to a preference for DOACs in the case of non-valvular AF after FDA approval in 2010. Data have reported that DOACs have a lower rate of ICH and an overall better clinical profile when compared to VKA. Aim: We sought to describe the rate of ICH and its associated mortality h with the increment in the use of DOACs over the period of 2006 to 2014 in the US population with AF. Methods: We queried the NIS database 2006-2014. AF patients, patients using long term anticoagulation, and intracranial hemorrhage admissions were selected using the appropriate ICD-9 codes. Time trend was analyzed using Chi-square. In-hospital mortality was evaluated by binomial logistic regression. Results: We found a 30740346 weighted population with AF between 2006 and 2014. 16.8 % were long term users of anticoagulants. Of them, 1.1% (n: 56400) were admitted due to ICH. Long term anticoagulation use in AF went from 13.3% in 2006 to 17.3% in 2010 (p<0.001). Among AF patients, 30.7% of patients had in-hospital death when admitted for ICH using long term anticoagulation. Long term anticoagulation was associated with increased in-hospital death in ICH patients aOR 1.31 (95% CI 1.24 - 1.39) when compared to those not using long term anticoagulation. Patients with AF and long term use of anticoagulants showed an increased frequency of in-hospital mortality from 32.7% in 2006 to 34.2% in 2007 and a decrease to 30.9% up to 2010. The decrease in mortality rate was more notorious from 2010 to 2014 going to 25.8% (p< 0.001). Conclusions: The rate of ICH diagnosis among anticoagulated atrial fibrillation patients has remained stable after the introduction of DOACs. Rates of inpatient death have decreased from 2006 to 2014 having the most notorious inflection point in 2010 after the progressive introduction of DOACs .


2020 ◽  
Vol 9 (24) ◽  
Author(s):  
Rachel M. Kaplan ◽  
Yoshihiro Tanaka ◽  
Rod S. Passman ◽  
Michelle Fine ◽  
Laura J. Rasmussen‐Torvik ◽  
...  

Background Direct‐acting oral anticoagulants are now the preferred method of anticoagulation in patients with atrial fibrillation. Limited data on efficacy and safety of these fixed‐dose regimens are available in severe obesity where drug pharmacokinetics and pharmacodynamics may be altered. The objectives of this study were to evaluate efficacy and safety in patients with atrial fibrillation taking direct‐acting oral anticoagulants across body mass index (BMI) categories in a contemporary, real‐world population. Methods and Results We performed a retrospective study of patients with atrial fibrillation at an integrated multisite healthcare system. Patients receiving a direct‐acting oral anticoagulant prescription and ≥12 months of follow‐up between 2010 and 2017 were included. The primary efficacy and safety outcomes were ischemic stroke or systemic embolism and intracranial hemorrhage. We performed Cox proportional hazards modeling to compute hazard ratios (HRs) adjusted for CHA 2 DS 2 ‐VASc score to examine differences by excess BMI categories relative to normal BMI. Of 7642 patients, mean±SD age was 69±12 years with a median (interquartile range) follow‐up of 3.8 (2.2–6.0) years. Approximately 22% had class 1 obesity and 19% had class 2 or 3 obesity. Stroke risks were similar in patients with and without obesity (HR, 1.2; 95% CI, 0.5–2.9; and HR, 0.68; 95% CI, 0.23–2.0 for class 1 and class 2 or 3 obesity compared with normal BMI, respectively). Risk of intracranial hemorrhage was also similar in class 1 and class 2 or 3 obesity compared with normal BMI (HR, 0.64; 95% CI, 0.35–1.2; and HR, 0.66; 95% CI, 0.35–1.2, respectively). Conclusions Direct‐acting oral anticoagulants demonstrated similar efficacy and safety across all BMI categories, even at high weight values.


Author(s):  
Joris J Komen ◽  
Tomas Forslund ◽  
Aukje K Mantel-Teeuwisse ◽  
Olaf H Klungel ◽  
Mia von Euler ◽  
...  

Abstract Aims To analyze 90-day mortality in AF patients after a stroke or a severe bleed and assess associations with the type of antithrombotic treatment at the event. Methods and Results From the Stockholm Healthcare database, we selected 6 017 patients with a known history of AF who were diagnosed with ischemic stroke, 3 006 with intracranial hemorrhage, and 4 291 with a severe gastrointestinal bleed (GIB). The 90-day mortality rates were 25.1% after ischemic stroke, 31.6% after intracranial hemorrhage, and 16.2% after severe GIB. We used Cox regression and propensity score matched analyses to test the association between antithrombotic treatment at the event and 90-day mortality. After intracranial hemorrhage, there was a significantly higher mortality rate in warfarin compared to NOAC treated patients (adjusted hazard ratio (aHR): 1.36 CI: 1.04 – 1.78). After an ischemic stroke and a severe GIB, patients receiving antiplatelets or no antithrombotic treatment had significantly higher mortality rates compared to patients on NOACs, but there was no difference comparing warfarin to NOACs (aHR 0.84 CI: 0.63 – 1.12 after ischemic stroke, aHR 0.91 CI: 0.66 – 1.25 after severe GIB). Propensity score matched analysis yielded similar results. Conclusion Mortality rates were high in AF patients suffering from an ischemic stroke, an intracranial hemorrhage, or a severe GIB. NOAC treatment was associated with a lower 90 day mortality after intracranial hemorrhage than warfarin.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I Cavallari ◽  
G Verolino ◽  
G Patti

Abstract Background Anticoagulation in patients with cancer and atrial fibrillation (AF) is particularly challenging given the higher risk of both thrombotic and bleeding complications in this setting. Data regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) in AF patients with malignancy remain unclear. Purpose In the present meta-analysis we further investigate the efficacy and safety of NOACs compared to warfarin in patients with AF and cancer assuming that available studies may be individually underpowered for endpoints at low incidence, i.e. stroke, major and intracranial bleeding. Methods We performed a systematic review and meta-analysis of studies comparing the use of NOACs vs. warfarin in AF patients with cancer. Efficacy outcome measures included stroke or systemic embolism, venous thromboembolism and mortality. Safety outcome measures were major bleeding and intracranial hemorrhage. Results We pooled data from 6 identified studies enrolling a total of 31,756 AF patients with cancer. Mean follow-up was 1.7 years. Patients with cancer had significantly increased annualized rates of venous thromboembolism (1.38% vs. 0.74%), major bleeding (9.01% vs. 5.13%), in particular major gastrointestinal bleeding (2.38% vs. 1.60%), and all-cause mortality (17.73% vs. 8.50%) vs. those without (all P values <0.001), whereas the incidence of stroke or systemic embolism and intracranial hemorrhage did not differ. Compared with warfarin, treatment with NOACs nominally decreased the risk of stroke or systemic embolism (5.41% vs. 2.70%; odds ratio, OR; 95% confidence intervals, CI 0.51, 0.26–1.01; P=0.05; Figure), mainly of ischemic stroke (OR 0.56; 95% CI 0.35–0.89; P=0.01), and the risk of venous thromboembolism (OR 0.51; 95% CI 0.42–0.61; P<0.001). In cancer patients receiving NOACs there was a significant reduction of major bleeding (3.95% vs. 4.66%; OR 0.66, 95% CI 0.46–0.94; P=0.02; Figure) and intracranial hemorrhage (0.26% vs. 0.66%; OR 0.25, 95% CI 0.08–0.82; P=0.02) vs. warfarin, with no difference in gastrointestinal major bleeding rates. Conclusion AF patients on oral anticoagulation and concomitant cancer are at higher risk of venous thromboembolism, major bleeding and all-cause mortality. NOACs may represent a safer and more effective alternative to warfarin also in this setting of patients.


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