Effectiveness and Safety of Apixaban Versus Warfarin in Obese Patients with Nonvalvular Atrial Fibrillation Enrolled in Medicare and Veteran Affairs

Deitelzweig, Steve; Sah, Janvi; Kang, Amiee; Russ, Cristina; Preib, Madison T; Dhamane, Amol; Ratiu, Anna; Cato, Matthew; Alfred, Tamuno; Levi, Edi; Fusco, Manuela Di

doi:10.1016/j.amjcard.2021.09.047

Cited by 8 publications

(7 citation statements)

References 26 publications

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“…However, our findings were consistent with the subgroup analysis of EU randomised patients of ARISTOTLE showing an HR of 0.92 (95% CI: 0.56,1.52) for stroke/SE 71 . Our findings were consistent with the results of the recent study by Deitelzweig et al(2022) in the United States, which investigated the effects across BMI groups and showed similar conclusions to our study 72 . Another US-based study by Deitelzweig et al(2020) investigated the effects in the obese population only and had similar results to the obese group in our study 73 .…”

Section: Discussionsupporting

confidence: 93%

Emulating a target trial to assess effect modification: an application to obesity in the comparative effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation using electronic health records

Bin Hammad,

Powell,

Baptiste

et al. 2023

Preprint

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Anticoagulation therapy is recommended for patients with non-valvular atrial fibrillation (NVAF) and an increased risk of stroke. Although apixaban showed superiority over warfarin in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study, little is known about their effects in overweight and obese patients, with concerns that obesity might undermine apixaban's effects due to the fixed dosing across body mass index (BMI) groups. We emulated a target trial similar to the ARISTOTLE study using Clinical Practice Research Datalink (CPRD) linked data to estimate the 36-month risk ratios (RR) and risk differences of the effects of apixaban compared to warfarin in NVAF patients in a composite of stroke/systemic embolism (SE), major bleeding and all-cause mortality. In 55,826 patients, apixaban did not differ across groups of BMI in stroke/SE with RR (95% CI) of 1.15 (0.81, 1.62) in normal weight, 1.06 (0.70, 1.61) in overweight and 1.23 (0.69, 2.17) in obese patients. In major bleeding, apixaban was not superior to warfarin in the normal weight group (RR (95% CI) 1.10 (0.76, 1.60) but superior in overweight (RR (95% CI) 0.73 (0.57, 0.93) and obese (RR (95 % CI) 0.67 (0.52, 0.87) groups. In NVAF, the effectiveness and safety of apixaban compared to warfarin were consistent across BMI groups.

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Section: Discussionsupporting

confidence: 93%

Emulating a target trial to assess effect modification: an application to obesity in the comparative effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation using electronic health records

Bin Hammad,

Powell,

Baptiste

et al. 2023

Preprint

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“…It is noteworthy that most of the previous studies compared either multiple DOAC agents or apixaban to warfarin [ 12 – 14 ], while in our study, both groups were on apixaban but stratified based on BMI. As far as we know, this is one of the first studies that compared the use of apixaban among morbid obese patients to non-morbid obese using BMI ≥40 kg/m 2 .…”

Section: Discussionmentioning

confidence: 93%

“…Consistently, a single-center retrospective study of obese patients (weight > 120 kg vs. < 120 kg) with AF showed a lower incidence of stroke, VTE, and PE in patients using dabigatran, rivaroxaban, or apixaban (2.5% in patients weighing ≥120 kg versus 3.1% in patients weighing < 120 kg ( P = 0.632)) [ 23 ]. Moreover, a retrospective cohort study assessing apixaban effectiveness in morbidly obese (BMI > 40 kg/m 2 or weight > 120 kg) patients with AF showed no difference between the risk of stroke or Systemic Embolism (SE) between apixaban and warfarin (HR: 0.66 (95% CI 0.32–1.33) [ 14 ] These findings could be related to the obesity paradox phenomenon, which refers to the fact that obesity in somepatients with multiple disease comorbidities could be a protective factor leading to a reduction in mortality [ 24 , 25 ]. The phenomenon is not fully understood, and the evidence available to support this phenomenon’s existence has several limitations [ 24 , 25 ].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study

et al. 2022

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Background The benefit of apixaban to reduce stroke risk in morbidly obese patients with nonvalvular atrial fibrillation (AF) is still undetermined. The International Society of Thrombosis and Hemostasis recommends avoiding the use of direct oral anticoagulants (DOAC)s in morbidly obese patients (body mass index > 40 or weight > 120 kg) because of limited clinical data. This exploratory study aims to evaluate the effectiveness and safety of using apixaban in morbidly obese (body mass index (BMI) ≥ 40) patients with AF. Methods An exploratory retrospective cohort study was conducted at a single-center, including adult patients with non-valvular AF using apixaban between 01/01/2016 and 31/12/2019. Patients were excluded if they were known to have liver cirrhosis Child-Pugh C, mechanical valve, serum creatinine > 1.5 mg/dL, follow up < 3 months, or using apixaban with a dose of ≤5 or > 10 mg/day. Included patients were categorized into two groups based on their BMI (BMI<40 Vs. BMI ≥ 40). The primary outcome was all thrombotic events, while the secondary outcomes were major and minor bleeding after apixaban initiation. Propensity score (PS) matching was used (1:1 ratio) based on the patient’s age, gender, and HAS-BLED score. Results A total of 722 patients were eligible; 254 patients were included after propensity score matching based on the selected criteria. The prevalence of all thrombotic events was similar between the two groups in the first year of apixaban initiation (OR (95%CI): 0.58 (0.13, 2.5), p-value = 0.46). In addition, the odds of developing major and minor bleeding were not statistically significant between the two groups (OR (95%CI): 0.39 (0.07, 2.03), p-value = 0.26 and OR (95%CI): 1.27 (0.56, 2.84), p-value = 0.40), respectively). Conclusion This exploratory study showed similar effectiveness and safety of apixaban use in both morbid and non-morbid obese patients with non-valvular AF. However, a larger randomized controlled trial with a longer follow-up period needs to confirm our findings.

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“…examined electronic health record data of Veteran Affairs and Medicare NVAF obese patients, including 6112 who were severely obese (BMI ≥ 40 kg/m 2 ), and they demonstrated that stroke risk in apixaban-treated patients ( n = 13,604) was similar (HR 0.82; 95% CI 0.66-1.03) and that bleeding risk was lower (HR 0.62; 95% CI 0.54-0.70), compared with that for warfarin-treated patients ( n = 12,918). 35 A recent meta-analysis of subgroups of phase III RCTs, post hoc analyses of RCTs, and observational cohorts assessing the safety and effectiveness of DOACs vs warfarin in NVAF patients across BMI categories also found that obese DOAC (BMI ≥ 30 kg/m 2 ) users were at similar risk for stroke/SE (HR 0.87; 95% CI 0.73-1.04) and major bleeding (HR 0.90; 95% CI 0.81-1.01). 36 Another meta-analysis including only the 4 DOAC vs warfarin RCTs ( R andomized E valuation of L ong-term Anticoagulation Therap y [RE-LY], ROCKET-AF, ARISTOTLE, and ENGAGE AF-TIMI 48) stratified by BMI also found similar efficacy and safety with DOACs vs warfarin.…”

Section: Discussionmentioning

confidence: 99%

Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin Among Obese Patients With Atrial Fibrillation

Boivin‐Proulx

Potter

Dorais³

et al. 2022

CJC Open

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Effectiveness and Safety of Apixaban Versus Warfarin in Obese Patients with Nonvalvular Atrial Fibrillation Enrolled in Medicare and Veteran Affairs

Cited by 8 publications

References 26 publications

Emulating a target trial to assess effect modification: an application to obesity in the comparative effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation using electronic health records

Emulating a target trial to assess effect modification: an application to obesity in the comparative effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation using electronic health records

Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study

Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin Among Obese Patients With Atrial Fibrillation

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