PP181 Direct Comparison Of The Effectiveness And Safety Of Apixaban, Dabigatran, Rivaroxaban, And Warfarin: Subgroup Analyses Of Medicare Beneficiaries

2020 ◽  
Vol 36 (S1) ◽  
pp. 19-19
Author(s):  
Lanting Yang ◽  
Maria M. Brooks ◽  
Nancy W. Glynn ◽  
Yuting Zhang ◽  
Samir Saba ◽  
...  

IntroductionNo studies have directly compared the effectiveness and safety of direct oral anticoagulants (DOACs) and warfarin in patients with atrial fibrillation (AF), with or without a history of ischemic stroke and transient ischemic attack (TIA). This is important for two reasons: first, previous research reports important differences between DOACs and warfarin across other patient subgroups, and second, patients with previous stroke or TIA have a high risk of recurrent stroke.MethodsUsing 2012–2014 Medicare claims data, we identified patients newly diagnosed with AF in 2013–014 who started taking apixaban, dabigatran, rivaroxaban, or warfarin. We categorized the patients according to whether they had a history of stroke or TIA. We constructed Cox proportional hazard models that included indicator variables for treatment groups, a history of stroke or TIA, and the interaction between them, and controlled for demographic and clinical characteristics.ResultsThe hazard ratio (HR) for stroke with dabigatran, compared with warfarin, was 0.64 (95% confidence interval [CI]: 0.48–0.85) for patients with a history of stroke or TIA and 0.94 (95% CI: 0.75–1.16) for patients without a history of stroke or TIA (p-value for interaction = 0.034). In patients with previous stroke or TIA, the risk of stroke was lower with dabigatran (HR 0.64, 95% CI: 0.48–0.85) and rivaroxaban (HR 0.70, 95%CI: 0.56–0.87), compared with apixaban, but there was no difference for patients in the other subgroup.ConclusionsDOACs were generally more effective than warfarin for preventing stroke. The superiority of dabigatran was more pronounced in patients with a history of stroke or TIA. The comparative effectiveness of DOACs differed substantially between patients with and without a history of stroke or TIA; specifically, apixaban was less effective in patients with a history of stroke or TIA. Our results reinforce the need to tailor anticoagulation to patient characteristics and to support the investigation of the underlying mechanisms associated with DOACs.

2019 ◽  
Vol 8 (12) ◽  
pp. 2228 ◽  
Author(s):  
Jiesuck Park ◽  
So-Ryoung Lee ◽  
Eue-Keun Choi ◽  
Soonil Kwon ◽  
Jin-Hyung Jung ◽  
...  

We investigated the effectiveness and safety of direct oral anticoagulants (DOACs) for secondary prevention in patients with atrial fibrillation (AF), particularly focusing on subgroups of patients with severe, disabling, and recent stroke. Using the Korean National Health Insurance Service claims database between January 2010 and April 2018, we selected OAC-naïve patients with non-valvular AF and a history of stroke. Cumulative risks for recurrent stroke, major bleeding, composite outcome (recurrent stroke + major bleeding), and mortality were compared between DOAC and warfarin groups. Among 61,568 patients, 28,839 and 32,729 received warfarin and DOACs, respectively. Compared with warfarin, DOACs were associated with lower risks of recurrent stroke (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.62–0.72), major bleeding (HR 0.73, 95% CI 0.66–0.80), composite outcome (HR 0.69, 95% CI 0.65–0.73), and mortality. DOAC use resulted in a consistent trend of improved outcomes in the subgroups of patients with severe, disabling, and recent stroke. In conclusion, DOACs were associated with lower risks of recurrent stroke, major bleeding, composite clinical outcomes, and mortality in patients with AF and a history of stroke. These results were consistent across all types of DOACs and subgroups of patients with severe, disabling, and recent stroke.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M I Bernal ◽  
C E Scatularo ◽  
I M Cigalini ◽  
J C C Jauregui ◽  
J I Ortego ◽  
...  

Abstract Background In the last decade, direct oral anticoagulants (DOACs) were incorporated as an alternative for anticoagulation in patients with venous thromboembolism. Although they have a better pharmacologic profile than vitamin K antagonists (VKAs), the use of these drugs is not massive. Purpose Assess the rate of use of DOACs in acute pulmonary embolism (PE) patients (P) in Argentina and analyze the determinants of their use. Methods Based on a registry of 684 P admitted for acute PE in 75 academic centers between October 2016 and November 2017, we performed an analysis of DOACs prescription at discharge. A conventional statistical analysis was performed, to assess the differences between the P that received DOACs or other anticoagulants using univariate and multivariate models. Results 579 of 601 P who survived were discharged with anticoagulant treatment: 348 (60%) received VKA; 108 (19%) received DOACs (49% Rivaroxaban, 34% Apixaban, 17% Dabigatran) and 123 (21%) received low molecular weight heparins. Patients who received DOACs had lower severity of PE and less risk of bleeding. The main baseline characteristics are described in table 1. Also, those patients who received DOACs at discharge had fewer in-hospital complications (heart failure, infections or bleeding; all p<0.05). In the multivariate analysis, health insurance (OR 7.45, 95% CI: 1.74–31.9, p<0.01) was an independent predictor of DOACs prescription at discharge. The history of previous heart failure (OR 0.19, 95% CI: 0.04–0.84, p=0.03) or oncologic disease (OR 0.49; 95% CI: 0.27–0.89; p=0.02) were inversely and independent predictors for DOACs prescription. Variable DOACs Other anticoagulants P OR CI (95%) Male sex 51 (47.2%) 196 (41.6%) 0.29 – – Age 64.3±17.6 63.3±16.6 0.61 – – Health insurance 106 (98.1%) 402 (85.4%) 0.01 9.1 (2.2–37.7) CKD without dialysis 2 (1.9%) 34 (7.3%) 0.06 0.24 (0.06–1.03) Heart failure 2 (1.9%) 55 (11.7%) 0.01 0.14 (0.03–0.59) Oncology disease 16 (14.8%) 127 (27%) 0.01 0.47 (0.27–0.83) Previous anticoagulation 3 (2.8%) 44 (9.3%) 0.03 0.28 (0.08–0.91) sPESI 1±1.12 1.28±1.11 0.02 0.78 (0.64–0.96) RIETE 1.71±1.17 2.05±1.33 0.02 0.81 (0.68–0.97) CKD: Chronic kidney disease; TIA: Transient ischemic attack. Conclusions The rate of use of DOACs in survivors of an acute PE in Argentina was 19%, and this P present lower clinical risk, fewer co-morbidities and greater access to health coverage.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.E Strange ◽  
C Sindet-Pedersen ◽  
G Gislason ◽  
C Torp-Pedersen ◽  
E.L Fosboel ◽  
...  

Abstract Introduction In recent years, there has been a surge in the utilization of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis. Randomized controlled trials have compared TAVI to surgical aortic valve replacement (SAVR) in patients at high-, intermediate-, and low perioperative risk. As TAVI continues to be utilized in patients with lower risk profiles, it is important to investigate the temporal trends in “real-world” patients undergoing TAVI. Purpose To investigate temporal trends in the utilization of TAVI and examine changes in patient characteristics of patients undergoing first-time TAVI. Methods Using complete Danish nationwide registries, we included all patients undergoing first-time TAVI between 2008 and 2017. To compare patient characteristics, the study population was stratified according to calendar year in the following groups: 2008–2009, 2010–2011, 2012–2013, 2014–2015, and 2016–2017. Results We identified 3,534 patients undergoing first-time TAVI. In 2008–2009, 180 patients underwent first-time TAVI compared with 1,417 patients in 2016–2017, resulting in a 687% increase in TAVI procedures performed. During the study period, the median age remained stable (2008–2009: Median age 82 year [25th–75th percentile: 78–85] vs. 2016–2017: Median age 81 years [25th–75th percentile: 76–85]; P-value: 0.06). The proportion of men undergoing first-time TAVI increased over the years (2008–2009: 49.4% vs 2016–2017: 54.9%; P-value for trend: &lt;0.05), also the proportion with diabetes increased (2008–2009: 12.2% vs. 2016–2017: 19.3%; P-value for trend: &lt;0.05). The proportion of patients with a history of stroke decreased over the years (2008–2009: 13.9% vs. 2016–2017: 12.1%; P-value for trend: &lt;0.05). The same trend was seen in patients with a history of myocardial infarction (2008–2009: 24.4% vs. 2016–2017: 11.9%; P-value for trend: &lt;0.05), ischaemic heart disease (2008–2009: 71.7% vs. 2016–2017: 29.4%; P-value for trend: &lt;0.05), and heart failure (2008–2009: 45.6% vs. 2016–2017: 29.4%; P-value for trend: &lt;0.05). Conclusions In this nationwide study, there was a marked increase in the utilization of TAVI in the years 2008–2017. Patients undergoing first-time TAVI had a decreasing comorbidity burden, while the age of the patients at first-time TAVI remained stable. Funding Acknowledgement Type of funding source: None


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 ◽  
...  

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.


2021 ◽  
pp. 174749302110265
Author(s):  
Moamina Ismail ◽  
Vincent CT Mok ◽  
Adrian Wong ◽  
Lisa Au ◽  
Brian Yiu ◽  
...  

Background Stroke not only substantially increases the risk of incident dementia early after stroke, the risk remains elevated years after. Aim We aimed to determine the risk factors of dementia onset more than 3-6 months after stroke or transient ischemic attack (TIA). Methods This is a single center prospective cohort study. We recruited consecutive subjects with stroke/TIA without early-onset dementia. We conducted an annual neuropsychological assessment for 5 years. We investigated the association between baseline demographic, clinical, genetic (APOEε4 allele), and radiological factors, as well as incident recurrent stroke, with delayed-onset dementia using Cox proportional hazards models. Results 1,007 patients were recruited, of which 88 with early-onset dementia and 162 who lost to follow-ups were excluded. 49 (6.5%) out of 757 patients have incident delayed-onset dementia. The presence of ≥ 3 lacunes, history of ischemic heart disease (IHD), history of ischemic stroke and a lower baseline Hong Kong version of the Montreal Cognitive Assessment (MoCA) score, were significantly associated with delayed-onset dementia. APOEε4 allele, medial temporal lobe atrophy, and recurrent stroke were not predictive. Conclusion The presence of ≥ 3 lacunes, history of IHD, history of ischemic stroke and a lower baseline MoCA score, are associated with delayed-onset dementia after stroke/TIA.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Zubkova ◽  
T Lubimceva ◽  
A Topchian ◽  
K Davtyan ◽  
E Artiykhina ◽  
...  

Abstract Background Standard treatment for patients with atrial fibrillation is pulmonary vein isolation (PVI). There are two widely adopted methods for PVI - cryoballon ablation (CBA) and radiofrequency (RF) ablation. There are several randomized studies evaluating different periprocedural anticoagulation strategies in patients undergoing PVI, and those mainly related to RF ablation procedures. However, there is a lack of data on safety of different anticoagulation strategies in CBA. Purpose To analyze the current anticoagulation approaches in patients undergoing cryoballoon ablation, the incidence and types of hemorrhagic and thromboembolic periprocedural events. The analysis was performed on data from the National cryoballoon AF ablation registry (NCT03040037). Methods Nineteen centers prospectively entered data into a web-based platform. The full data on AC therapy was available in 719 subjects. The specialists evaluated ischemic events clinically, and those included stroke, transient ischemic attack, pulmonary embolism or extracranial systemic embolism. Major bleedings were registered and classified according to the ISTH criteria. Results The mean CHA2DS2-VASc score was 2.0±1.4; mean BMI 29.5±4.8; mean GFR 92±28.9 ml/min. Periprocedurally, 574 (79.8%) subjects received direct oral anticoagulants (DOACs), 113 (15.7%) anti-vitamin K drugs (mainly warfarin); 16 (2%) patients received antiplathelet therapy. Uninterrupted DOAC therapy was used in 251 (34.9%) cases. Uninterrupted warfarin therapy was used in 36 (2%) patients. Bridging therapy was used in 325 (45.2%) patients. The total number of major adverse events was 25 (3.5%): 24 of them hemorrhagic and 1 transient ischemic attack (1 female patient on rivaroxaban with bridging). Five (0.7%) patients had hemopericardium: 3 - on uninterrupted rivaroxaban, 1 – rivaroxaban with bridging, 1 – interrupted apixaban. Seventeen (2.5%) patients had groin vascular complications and 1 -hemoptysis. Three patients died within 30 days following CBA from non-cardiovascular causes. There were no statistically significant differences in complications between patients receiving different periprocedural anticoagulation. Conclusions About 45% of patients referred for CBA receive bridging anticoagulation therapy in the periprocedural period. Although this is not in line with the current guidelines, we found no meaningful difference in complication rates between different anticoagulation approaches. CBA might be associated with different from RF ablation safety profile and requires randomized trials on periprocedural anticoagulation. Funding Acknowledgement Type of funding source: Other. Main funding source(s): RF President's council grant


2021 ◽  
pp. 1-8
Author(s):  
Masaki Naganuma ◽  
Yuichiro Inatomi ◽  
Toshiro Yonehara ◽  
Makoto Nakajima ◽  
Mitsuharu Ueda

<b><i>Background and Purpose:</i></b> Anticoagulant drugs, including vitamin K antagonist (VKA) and direct oral anticoagulants (DOACs), can reduce stroke severity and are associated with good functional outcomes. Some patients are prescribed lower-than-recommended doses of DOACs; whether these have similar effects has not been clarified. <b><i>Methods:</i></b> We retrospectively evaluated 1,139 consecutive ischemic stroke and transient ischemic attack patients with atrial fibrillation. Patients were divided into 5 groups according to their preceding anticoagulant drug therapies: no anticoagulant therapy (AC<sub>n</sub>), undercontrolling VKA doses (VKA<sub>uc</sub>), recommended, controlling VKA doses (VKA<sub>rec</sub>), prescribed underdoses of DOAC (DOAC<sub>ud</sub>), and recommended doses of DOAC (DOAC<sub>rec</sub>). We investigated the associations between these anticoagulant drug therapies and patients’ initial stroke severity and 3-month outcomes. <b><i>Results:</i></b> Median National Institutes of Health Stroke Scale scores at admission were as follows: AC<sub>n</sub>: 16, VKA<sub>uc</sub>: 15, VKA<sub>rec</sub>: 9, DOAC<sub>ud</sub>: 5, and DOAC<sub>rec</sub>: 7. When the AC<sub>n</sub> group was used as a reference, regression analysis showed that VKA<sub>rec</sub> (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.01–2.21), DOAC<sub>ud</sub> (OR 2.84, 95% CI: 1.47–5.66), and DOAC<sub>rec</sub> (OR 1.83, 95% CI: 1.23–2.74) were associated with milder stroke severity, while VKA<sub>uc</sub> was not. Median 3-month modified Rankin Scale scores were 2 in the DOAC<sub>ud</sub> and DOAC<sub>rec</sub> groups and 4 in all other groups. After adjusting for confounding factors, DOAC<sub>ud</sub> (OR 3.14, 95% CI: 1.50–6.57) and DOAC<sub>rec</sub> (OR 1.67, 95% CI: 1.05–2.64) were associated with good 3-month outcomes while VKA<sub>uc</sub> and VKA<sub>rec</sub> were not. <b><i>Conclusions:</i></b> In patients with atrial fibrillation, recommended doses and underdoses of DOACs reduced stroke severity on admission and were associated with good 3-month outcomes.


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