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

Khalid Al Sulaiman; Hisham A Badreldin; Ghazwa B Korayem; Abeer A Alenazi; Faisal Alsuwayyid; Abdulrahman Alrashidi; Mohammed Alhijris; Faisal Almutairi; Fahad Alharthi; Ramesh Vishwakarma; Omar Al Shaya; Abdulrahman Al Amri; Saqiba Tayyab; Abdulkareem M Al Bekairy; Ohoud Aljuhani

doi:10.1186/s12959-022-00379-x

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

Thromb J. 2022 May 2;20(1):25. doi: 10.1186/s12959-022-00379-x.

Authors

Khalid Al Sulaiman^{1

2

3

4}, Hisham A Badreldin^{1

3

4}, Ghazwa B Korayem⁵, Abeer A Alenazi⁶, Faisal Alsuwayyid³, Abdulrahman Alrashidi³, Mohammed Alhijris³, Faisal Almutairi³, Fahad Alharthi³, Ramesh Vishwakarma⁷, Omar Al Shaya^{1

3

4}, Abdulrahman Al Amri^{1

3

4}, Saqiba Tayyab⁸, Abdulkareem M Al Bekairy^{1

3

4}, Ohoud Aljuhani⁹

Affiliations

¹ Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
² Saudi Critical Care Pharmacy Research (SCAPE) Platform, Riyadh, Saudi Arabia.
³ College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
⁴ King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
⁵ Department of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman University, P.O.Box 84428, Riyadh 11671, Saudi Arabia. gbkorayem@pnu.edu.sa.
⁶ Pharmaceutical Care Department, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
⁷ Statistics Department, European Organization for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
⁸ Pharmaceutical Care Department, Care national hospital, Riyadh, Saudi Arabia.
⁹ Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.

Abstract

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.

Keywords: Apixaban; Atrial fibrillation; BMI ≥ 40; Bleeding; Morbidly obese; Thrombosis.