Maine Medical Center, Medical Education, Maine Medical Center Research Institute, Pharmacy
Humans, Electric Countershock, Retrospective Studies, Anticoagulants, Obesity
Purpose: Abnormal atrial rhythms, including atrial fibrillation (AF) and atrial flutter, are the most common cardiac arrhythmias. Patients often undergo direct current cardioversion (DCCV) to restore normal sinus rhythm (NSR). Previous studies demonstrate that anticoagulation during DCCV decreases the risk of stroke from 6.8% to 1%. Additionally, obese patients are at a heightened risk of developing atrial arrhythmias, and previous pharmacokinetic studies suggest that recommended doses of DOACs may not provide therapeutic anticoagulation in these patients. Landmark trials investigating the use of DOACs during DCCV included a small percentage of patients with a body mass index (BMI) > 40 kg/m2. The purpose of this study is to evaluate the safety and effectiveness of DOAC use in obese patients with atrial arrhythmias who underwent DCCV.
Methods: In this IRB approved retrospective cohort study, we will identify patients 18 years of age or older presenting to a MaineHealth institution with a diagnosis of AF or atrial flutter for DCCV on guideline directed anticoagulation with a DOAC. Patients will be stratified based on their BMI, with the exposed group containing participants with a BMI > 40 kg/m2, and the control group with a BMI < 40 kg/m2. Demographic data to be collected will include age, sex, BMI, serum creatinine, hemoglobin, hematocrit, and sufficient information to calculate CHA2DS2-VASc and modified HAS-BLED scores. Participants will be followed for 30 days after DCCV with a primary composite endpoint containing ischemic/cardioembolic stroke or transient ischemic attack (TIA), arterial thrombosis, and International Society of Thrombosis and Haemostasis (ISTH) major or clinically overt bleeding. Secondary analyses will include compliance with manufacturer recommended dosing, concomitant medications that increase the risk of bleeding or thrombosis, such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, P2Y12 inhibitors, thalidomide, and estrogen products, as well as the presence of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) inhibitors or inducers. The individual components of the composite primary endpoint will also be analyzed as secondary outcomes, and a time to event analysis will be conducted for bleeding and thromboembolic events.
Results: In process
Conclusion: In process
Cox, Matt; Carlone, Brian; Gowen, Jaclynne; Rollins, Amber; and Zemrak, Wes, "A Retrospective Review of the Safety and Efficacy of Direct Oral Anticoagulants (DOACs) in Obese Patients who Underwent Electrical Cardioversion" (2020). Costas T. Lambrew Research Retreat 2020. 41.