Efficacy and safety of direct oral anticoagulant in morbidly obese patients with atrial fibrillation: systematic review and meta-analysis

Abstract

Aims We conducted a systematic review and meta-analysis on 3 outcomes. We assessed the efficacy and safety of direct oral anticoagulants (DOAC) compared to vitamin K antagonists (VKA) in morbidly obese patients with atrial fibrillation (AF). We compared the efficacy and safety of DOAC in obese patients and non-obese patients with AF. Finally, we updated the current knowledge of outcomes of AF patients with obesity compared to normal-weight patients regardless of anticoagulation type. Methods and results Using PubMed and Embase, we searched for literature published from inception to August 2020 for studies conducted in morbidly obese patients with AF who used DOACs and/or VKA for stroke or systemic embolism (stroke/SE) prevention that report efficacy and/or safety data. GRADE assessment was performed to determine the quality of the meta-analysis results. DOAC was not statistically different from VKA in reducing stroke/SE with RR of 0.85 (95%CI: 0.56 to 1.29; very low certainty evidence). Major bleeding risk was lower in the DOAC groups with RR of 0.62 (95%CI: 0.48 to 0.80; low certainty evidence). Obese patients with AF who used DOACs had lower risk of stroke/SE and similar major bleeding risk compared to nonobese patients with RR of 0.77 (95%CI: 0.70 to 0.84; low certainty evidence) and 1.02 (95%CI: 0.94 to 1.09; low certainty evidence), respectively. Obese patients with AF who used any type of anticoagulant had lower risk of stroke/SE compared to normal-weight patients with RR of 0.62 (95%CI: 0.57 to 0.69; low certainty evidence) Conclusions The use of DOACs in morbidly obese patients maybe reasonable if needed, but more dedicated studies are needed to make a more robust recommendation.

Direct Oral Anticoagulants in Patients with Obesity and Atrial Fibrillation: Position Paper of Italian National Association of Hospital Cardiologists (ANMCO)

“…Evaluating RCT data, Proietti et al [ 58 ] found an inverse association between BMI classes and outcomes, with a lower risk of stroke/systemic embolism and major bleeding in both overweight and obese patients compared to normal-weight patients. Similar findings were obtained with subsequent metanalyses [ 59 , 60 ] that included both RCTs and observational data.…”

“…However, PK data from populations with obesity, when available, are reassuring about drug exposure [ 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ]. Moreover, the outcome is always at least equal, if not better, in large retrospective and observational studies [ 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 ]. BMI is not a relevant covariate when tested [ 43 , 44 , 47 , 48 , 70 ].…”

“…Metanalyses have investigated the effects of different weight classes compared to normal-weight patients on thromboembolic and bleeding events [ 58 , 59 , 60 ]. Evaluating RCT data, Proietti et al [ 58 ] found an inverse association between BMI classes and outcomes, with a lower risk of stroke/systemic embolism and major bleeding in both overweight and obese patients compared to normal-weight patients.…”

“…Additional metanalyses evaluated data from both RCTs and real-life studies [ 60 , 67 , 68 ]. Grymonprez et al [ 68 ] analyzed stroke/systemic embolism, major bleeding, all-cause mortality, intracranial bleeding and gastrointestinal bleeding in DOACs vs. VKAs in class 1–2 (BMI ≥ 30 kg/m 2 ) and class 3 (BMI ≥ 40 kg/m 2 ) obese patients.…”

Expert Recommendations on the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) from India: Current Perspective and Future Direction

“…Also, major bleeding risk was lower in the NOAC groups with RR of 0.62. Thus, using NOACs in morbidly obese patients may be considered on a case-by-case basis, but more studies are needed to make a robust recommendation [64]. Evidence suggests that NOACs are as effective, if not superior, to warfarin for preventing stroke in obese patients with AF.…”