Abstract TP413: Baseline Characteristics and Clinical Outcomes of a Non-valvular Atrial Fibrillation Patient Population Treated with Dabigatran or Warfarin - A Retrospective Database Analysis

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Shannon L Reynolds ◽  
Srinivas Annavarapu ◽  
Chad Moretz ◽  
Stephen Stemkowski ◽  
Richard Sheer ◽  
...  

Objective: This study evaluated safety and effectiveness outcomes among non-valvular atrial fibrillation (NVAF) patients treated with dabigatran or warfarin using an administrative claims database. Methods: NVAF patients with no oral anticoagulant (OAC) use prior to their first prescription claim for FDA-approved dosages of either dabigatran or warfarin between 01-Oct-2010 and 30-Apr-2014 were identified. Patients aged 18-89 years with medical and pharmacy benefits were selected. Patients with valvular heart disease, transient causes of AF, or hyperthyroidism at baseline were excluded. Patients were followed until discontinuation of index medication, OAC switch, disenrollment, death, or end of observation period. Dabigatran and warfarin patients were propensity score matched (PSM, 1:2) using baseline demographics and clinical characteristics. Outcomes were measured either using diagnosis codes from all service lines in medical claims (Method A) or using an algorithm to derive principal diagnosis (Method B). Outcome measurements using Method B are comparable to prior database studies that used principal diagnosis. Safety and effectiveness outcomes of the matched cohorts were assessed using Cox-proportional hazards models. Results: A total of 7,245 dabigatran (1,016 receiving 75 mg and 6,229 receiving 150 mg) and 14,490 warfarin patients were analyzed (Table 1). The patients were 56% male, with a mean age of 74 years, mean CHADS 2 stroke risk score of 2.2, and mean HAS-BLED bleeding risk score of 3.4. Based on the hazard ratios, lower risks for primary (major bleeding) and secondary (hemorrhagic stroke, major intracranial bleeding, major extracranial bleeding [major urogenital and other bleeding], and death) outcomes were observed in the PSM dabigatran cohort compared to warfarin cohort (Method B). Conclusions: These results are largely consistent with findings from previous studies that support the benefits of dabigatran therapy in NVAF patients.

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Craig Coleman ◽  
Muralikrishna Tangirala ◽  
Thomas Evers

Introduction: Continuous use of oral anticoagulant (OAC) therapy is essential for reducing the risk of stroke in patients with non-valvular atrial fibrillation. To date, no single study has compared persistence and discontinuation rates between rivaroxaban, dabigatran and warfarin users. Hypothesis: To compare persistence and discontinuation rates between rivaroxaban, dabigatran and warfarin users with non-valvular atrial fibrillation. Methods: A retrospective cohort analysis of the United States MarketScan claims databases was performed. This included adult patients newly initiated on rivaroxaban, dabigatran or warfarin between 1 November 2011 and 31 December 2013 with a baseline CHA2DS2-VASc score ≥2, ≥2 atrial fibrillation diagnosis codes (427.31) and ≥6 months of continuous medical and pharmacy benefits prior to OAC initiation (index date). Propensity score matching was performed in a two-step process to match patients on rivaroxaban with dabigatran 1:1 and with warfarin 1:1. Patients were followed until the earliest of in-hospital death, end of continuous enrolment or end of study period. Persistence was defined as absence of refill gap of >60 days. Discontinuation was defined as no additional refill for >90 days and through end of follow-up. Cox proportional hazards models were estimated to examine hazard ratios (HRs) of OAC non-persistence and discontinuation. Results: A total of 32,634 patients were included (N=10,878/OAC group). At 3 months’ follow-up, treatment persistence was 79.2%, 69.6% and 70.9% for rivaroxaban, dabigatran and warfarin users, respectively, dropping to 70.2%, 57.8% and 58.8% after 6 months, 60.1%, 44.7% and 42.0% after 1 year and 50.4%, 30.6% and 26.5% after 2 years. On regression, rivaroxaban use was associated with a decreased hazard of non-persistence compared with dabigatran (HR=0.64; 95% confidence interval [CI] 0.62-0.67) and warfarin (HR=0.62; 95% CI 0.59-0.64), and a decreased rate of discontinuation versus dabigatran (HR=0.61; 95% CI 0.58-0.64) and warfarin (HR=0.65; 95% CI 0.62-0.68). Conclusions: This matched patient analysis indicated significantly higher persistence and lower discontinuation rates with rivaroxaban compared with dabigatran and warfarin.


2017 ◽  
Vol 117 (06) ◽  
pp. 1072-1082 ◽  
Author(s):  
Xiaoyan Li ◽  
Steve Deitelzweig ◽  
Allison Keshishian ◽  
Melissa Hamilton ◽  
Ruslan Horblyuk ◽  
...  

SummaryThe ARISTOTLE trial showed a risk reduction of stroke/systemic embolism (SE) and major bleeding in non-valvular atrial fibrillation (NVAF) patients treated with apixaban compared to warfarin. This retrospective study used four large US claims databases (MarketScan, PharMetrics, Optum, and Humana) of NVAF patients newly initiating apixaban or warfarin from January 1, 2013 to September 30, 2015. After 1:1 warfarin-apixaban propensity score matching (PSM) within each database, the resulting patient records were pooled. Kaplan-Meier curves and Cox proportional hazards models were used to estimate the cumulative incidence and hazard ratios (HRs) of stroke/SE and major bleeding (identified using the first listed diagnosis of inpatient claims) within one year of therapy initiation. The study included a total of 76,940 (38,470 warfarin and 38,470 apixaban) patients. Among the 38,470 matched pairs, 14,563 were from MarketScan, 7,683 were from PharMetrics, 7,894 were from Optum, and 8,330 were from Humana. Baseline characteristics were balanced between the two cohorts with a mean (standard deviation [SD]) age of 71 (12) years and a mean (SD) CHA2DS2-VASc score of 3.2 (1.7). Apixaban initiators had a significantly lower risk of stroke/SE (HR: 0.67, 95 % CI: 0.59–0.76) and major bleeding (HR: 0.60, 95 % CI: 0.54–0.65) than warfarin initiators. Different types of stroke/SE and major bleeding – including ischaemic stroke, haemorrhagic stroke, SE, intracranial haemorrhage, gastrointestinal bleeding, and other major bleeding – were all significantly lower for apixaban compared to warfarin treatment. Subgroup analyses (apixaban dosage, age strata, CHA2DS2-VASc or HAS-BLED score strata, or dataset source) all show consistently lower risks of stroke/SE and major bleeding associated with apixaban as compared to warfarin treatment. This is the largest “real-world” study on apixaban effectiveness and safety to date, showing that apixaban initiation was associated with significant risk reductions in stroke/SE and major bleeding compared to warfarin initiation after PSM. These benefits were consistent across various high-risk subgroups and both the standard-and low-dose apixaban dose regimens.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.


Circulation ◽  
2016 ◽  
Vol 133 (suppl_1) ◽  
Author(s):  
Faye L Norby ◽  
Lindsay G Bengtson ◽  
Lin Y Chen ◽  
Richard F MacLehose ◽  
Pamela L Lutsey ◽  
...  

Background: Rivaroxaban is a novel oral anticoagulant approved in the US in 2011 for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Information on risks and benefits among rivaroxaban users in real-world populations is limited. Methods: We used data from the US MarketScan Commercial and Medicare Supplemental databases between 2010 and 2013. We selected patients with a history of NVAF and initiating rivaroxaban or warfarin. Rivaroxaban users were matched with up to 5 warfarin users by age, sex, database enrollment date and drug initiation date. Ischemic stroke, intracranial bleeding (ICB), myocardial infarction (MI), and gastrointestinal (GI) bleeding outcomes were defined by ICD-9-CM codes in an inpatient claim after drug initiation date. Cox proportional hazards models were used to assess the association between rivaroxaban vs. warfarin use and outcomes adjusting for age, sex, and CHA2DS2-VASc score. Separate models were used to compare a) new rivaroxaban users with new warfarin users, and b) switchers from warfarin to rivaroxaban to continuous warfarin users. Results: Our analysis included 34,998 rivaroxaban users matched to 102,480 warfarin users with NVAF (39% female, mean age 71), in which 487 ischemic strokes, 179 ICB, 647 MI, and 1353 GI bleeds were identified during a mean follow-up of 9 months. Associations of rivaroxaban vs warfarin were similar in new users and switchers; therefore we pooled both analyses. Rivaroxaban users had lower rates of ICB (hazard ratio (HR) (95% confidence interval (CI)) = 0.72 (0.46, 1.12))) and ischemic stroke (HR (95% CI) = 0.88 (0.68, 1.13)), but higher rates of GI bleeding (HR (95% CI) = 1.15 (1.01, 1.33)) when compared to warfarin users (table). Conclusion: In this large population-based study of NVAF patients, rivaroxaban users had a non-significant lower risk of ICB and ischemic stroke than warfarin users, but a higher risk of GI bleeding. These real-world findings are comparable to results reported in published clinical trials.


Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Mengkun Chen ◽  
Ning Ding ◽  
Lena Mathews ◽  
Ron C Hoogeveen ◽  
Christie M Ballantyne ◽  
...  

Introduction: Growth differentiation factor 15 (GDF-15) is a marker of oxidative stress and inflammation and has been associated with several cardiovascular disease (CVD) phenotypes. However, conflicting results have been reported regarding the association of GDF-15 with incident atrial fibrillation (AF) in the general population. Hypotheses: Higher GDF-15 level is associated with increased risk of incident AF independent of potential confounders. Methods: In 10,101 White and Black ARIC participants (mean age 60 years and 20.9% Blacks) free of AF at baseline (1993-95), we quantified the association of GDF-15 and incident AF using three Cox proportional hazards models. GDF-15 was measured by SOMA scan assay. AF was defined by hospitalizations with AF diagnosis or death certificates (ICD-9 codes: 427.31-427.32; ICD-10 codes: I48.x) or AF diagnosis by ECG at subsequent ARIC visits. Results: There were 2165 cases of incident AF over a median follow-up of 20.7 years (incidence rate 12.1 cases/1,000 person-years). After adjusting for demographic characteristics and cardiovascular risk factors, log GDF-15 was significantly associated with incident AF (hazard ratio 1.42 (1.25-1.63) for top vs. bottom quartile) (Model 1 in Table ). The result was robust even further adjusting for history of other CVD phenotypes and cardiac markers (Models 2 and 3 in Table ). In Model 3, quartiles of high-sensitive cardiac troponin T (hs-cTnT) did not demonstrate significant associations with incident AF. Conclusions: In community-based population, elevated GDF-15 level was independently and robustly associated with incident AF (even more strongly than troponin). These results suggest the involvement of GDF-15 in the development of AF and the potential of GDF-15 as a risk marker to identify individuals at high risk of AF.


2019 ◽  
Vol 48 (2) ◽  
pp. 240-249 ◽  
Author(s):  
Alpesh Amin ◽  
Allison Keshishian ◽  
Oluwaseyi Dina ◽  
Amol Dhamane ◽  
Anagha Nadkarni ◽  
...  

AbstractAtrial fibrillation (AF) prevalence increases with age; > 80% of US adults with AF are aged ≥ 65 years. Compare the risk of stroke/systemic embolism (SE), major bleeding (MB), net clinical outcome (NCO), and major adverse cardiac events (MACE) among elderly non-valvular AF (NVAF) Medicare patients prescribed direct oral anticoagulants (DOACs) vs warfarin. NVAF patients aged ≥ 65 years who initiated DOACs (apixaban, dabigatran, and rivaroxaban) or warfarin were selected from 01JAN2013-31DEC2015 in CMS Medicare data. Propensity score matching was used to balance DOAC and warfarin cohorts. Cox proportional hazards models estimated the risk of stroke/SE, MB, NCO, and MACE. 37,525 apixaban–warfarin, 18,131 dabigatran–warfarin, and 55,359 rivaroxaban–warfarin pairs were included. Compared to warfarin, apixaban (HR: 0.69; 95% CI 0.59–0.81) and rivaroxaban (HR: 0.82; 95% CI 0.73–0.91) had lower risk of stroke/SE, and dabigatran (HR: 0.88; 95% CI 0.72–1.07) had similar risk of stroke/SE. Apixaban (MB: HR: 0.61; 95% CI 0.57–0.67; NCO: HR: 0.64; 95% CI 0.60–0.69) and dabigatran (MB: HR: 0.79; 95% CI 0.71–0.89; NCO: HR: 0.84; 95% CI 0.76–0.93) had lower risk of MB and NCO, and rivaroxaban had higher risk of MB (HR: 1.08; 95% CI 1.02–1.14) and similar risk of NCO (HR: 1.04; 95% CI 0.99–1.09). Compared to warfarin, apixaban had a lower risk for stroke/SE, MB, and NCO; dabigatran had a lower risk of MB and NCO; and rivaroxaban had a lower risk of stroke/SE but higher risk of MB. All DOACs had lower risk of MACE compared to warfarin.


2018 ◽  
Vol 25 (12) ◽  
pp. 1316-1323 ◽  
Author(s):  
Marijn Albrecht ◽  
Chantal M Koolhaas ◽  
Josje D Schoufour ◽  
Frank JA van Rooij ◽  
M Kavousi ◽  
...  

Background The association between physical activity and atrial fibrillation remains controversial. Physical activity has been associated with a higher and lower atrial fibrillation risk. These inconsistent results might be related to the type of physical activity. We aimed to investigate the association of total and types of physical activity, including walking, cycling, domestic work, gardening and sports, with atrial fibrillation. Design Prospective cohort study. Methods Our study was performed in the Rotterdam Study, a prospective population-based cohort. We included 7018 participants aged 55 years and older with information on physical activity between 1997–2001. Cox proportional hazards models were used to examine the association of physical activity with atrial fibrillation risk. Models were adjusted for biological and behavioural risk factors and the remaining physical activity types. Physical activity was categorised in tertiles and the low group was used as reference. Results During 16.8 years of follow-up (median: 12.3 years, interquartile range: 8.7–15.9 years), 800 atrial fibrillation events occurred (11.4% of the study population). We observed no association between total physical activity and atrial fibrillation risk in any model. After adjustment for confounders, the hazard ratio and 95% confidence interval for the high physical activity category compared to the low physical activity category was: 0.71 (0.80–1.14) for total physical activity. We did not observe a significant association between any of the physical activity types with atrial fibrillation risk. Conclusion Our results suggest that physical activity is not associated with higher or lower risk of atrial fibrillation in older adults. Neither total physical activity nor any of the included physical activity types was associated with atrial fibrillation risk.


2019 ◽  
Vol 119 (06) ◽  
pp. 971-980 ◽  
Author(s):  
Christopher Hohmann ◽  
Stefan H. Hohnloser ◽  
Josephine Jacob ◽  
Jochen Walker ◽  
Stephan Baldus ◽  
...  

AbstractGeriatric characteristics such as high age, multi-morbidity, polypharmacy and frailty are common in patients with atrial fibrillation (AF). In a retrospective study using a German claims database, effectiveness (ischaemic stroke/systemic embolism) and safety (intracerebral, gastrointestinal and major extracranial bleeding) were compared in patients with non-valvular AF starting non-vitamin K oral antagonists (NOACs) (apixaban, dabigatran and rivaroxaban) and phenprocoumon. Cox proportional hazards models were used to calculate adjusted hazard ratios, and interaction terms of the treatment group and geriatric status (defined by age ≥75 years, frailty, ≥ 4 co-morbidities and polypharmacy) were entered into the model. A total of 42,562 and 27,939 patients initiated NOAC and phenprocoumon treatment (mean age 74 years ± 11, 51% male) with a follow-up time of 147,785 person-years. Note that 52.9% of patients were elderly, 50.8% were frail, 37.0% were co-morbid and 46.5% had polypharmacy. NOAC use was not associated with effectiveness and gastrointestinal bleeding, neither in geriatric nor in non-geriatric patients. The hazard of major extracranial and intracranial bleeding was significantly decreased for NOAC use, with similar risk reduction in geriatric and non-geriatric patients: major extracranial bleeding 0.70 (95% confidence interval [CI], 0.56–0.87) to 0.73 (95% CI, 0.60–0.89) for the geriatric groups and 0.71 (95% CI, 0.56–0.93) to 0.76 (0.59–0.98) for the non-geriatric groups (p-values for interaction > 0.6); and intracranial bleeding 0.52 (95% CI, 0.39–0.69) to 0.59 (95% CI, 0.47–0.73) for the geriatric groups and 0.54 (95% CI, 0.37–0.79) to 0.65 (95% CI, 0.49–0.86) for the non-geriatric groups (p-values for interaction > 0.2). Hence, NOACs showed similar effectiveness and superior safety in geriatric and non-geriatric patients.


Author(s):  
Sanna Kärkkäinen ◽  
Karri Silventoinen ◽  
Pia Svedberg ◽  
Annina Ropponen

Abstract Purpose Musculoskeletal diagnoses (MSD) are one of the largest diagnostic groups for disability pensions (DP). This study investigated the associations between life events and DP due to MSD, considering sociodemographic, health, and familial factors. Methods The study sample included 18,530 Finnish twins, 24–64 years old at baseline, who responded to a questionnaire in 1981 including a 21-item life event inventory. Information on DP with diagnosis codes (ICD codes: M00–M99) were obtained from the official national pension registers. Life events were divided into family- and work-related events. “Positive change in life” was analyzed separately. Cox proportional hazards models were used to calculate hazard ratios (HR) with 95% confidence intervals (CI). Results During the follow-up of 23 years, 1273 (7%) individuals were granted DP due to MSD. In discordant pair analysis, family-related events (≥ 4 events) increased (HR 1.63, 95% CI 1.31, 2.03) and the absence of such events decreased (HR 0.68, 95% CI 0.48, 0.95) the risk of DP due to MSD. For work-related events (≥ 3 events), the risk estimates were non-significant when controlling for familial factors. Having had a positive change in life decreased the risk of DP due to MSD (HR 0.79, 95% CI 0.65, 0.96) while controlling for familial confounding, but were non-significant in the full model controlling for various covariates (HR 0.91, 95% CI 0.75, 1.12). Conclusions The associations between life events and the risk of DP due to MSD are complex and potentially affected by familial and other confounding factors including sociodemographics and health.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
P Krisai ◽  
O Streicher ◽  
P Meyre ◽  
P Haemmerle ◽  
F Steiner ◽  
...  

Abstract Background Atrial fibrillation (AF) is a common finding in patients undergoing cavotricuspid isthmus ablation for isthmus dependent right atrial flutter (RAF). Little is known about the time of its occurrence. Purpose We aimed to investigate the incidence of AF early after RAF ablation in a well-defined, prospective cohort. Methods A total of 255 participants with RAF ablation from 5 centers and at least one completed follow-up were included. Structured clinical follow-up was performed at 3, 6 and 12 months including a 24 hour Holter-ECG. The endpoint was incidence of AF detected clinically or by Holter-ECG. Risk factors associated with the occurrence of AF were assessed using separate, univariate Cox proportional-hazards models. Results Mean age was 67 years, 80% were male and previous episodes of AF were known in 40%. Over a mean follow-up of 7.4 (±4.4) months AF was detected in 35 (13.7%) participants after RAF ablation (Figure A). After 3, 6 and 12 months AF was detected in 18 (7.1%), 30 (11.7%) and 34 (13.3%) patients. No difference in the incidence of AF after RAF ablation was found comparing patients with and without a history of AF (log-rank p value = 0.44) (Figure B). Comparing patients with and without AF during follow-up, there was no difference in age (68 vs 66 years, p = 0.36), sex (69 vs 81% male, p = 0.08), prior heart failure (29 vs 19%, p = 0.20), hypertension (43 vs 38%, p = 0.56) or left atrial volume (46.6 vs 39.6 ml, p = 0.10), but patients with previous AF had a lower left ventricular ejection fraction (LVEF) (45.7 vs 52.3%, p = 0.02). In separate, univariate Cox proportional-hazards models only increasing LVEF (Hazard ratio 0.97, 95% confidence interval (0.95; 0.99, p = 0.02)) was associated with a lower risk of incident AF after RAF ablation, but no other risk factor. Conclusions AF occurred in 13.7% of patients early after cavotricuspid isthmus ablation for RAF. There was no difference in the occurrence of AF between patients with and without previously known episodes of AF. Only impaired LVEF was associated with AF occurrence. Abstract Figure


2016 ◽  
Vol 116 (11) ◽  
pp. 975-986 ◽  
Author(s):  
Allison Keshishian ◽  
Shital Kamble ◽  
Xianying Pan ◽  
Jack Mardekian ◽  
Ruslan Horblyuk ◽  
...  

SummaryIn addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in ‘real world’ clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013–31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012–31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39–0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50–0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83–1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36–2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.


Sign in / Sign up

Export Citation Format

Share Document