A Comparative Prospective Observational Study on the Use of Direct Oral Anticoagulants after Cardiac Surgery for the Management of Atrial Fibrillation

Abstract

Purpose: Recently, guidelines recommended the use of direct oral anticoagulants (DOACs) for the management of non-valvular atrial fibrillation (NVAF). Postoperative atrial fibrillation (POAF) is the most common post-surgical complication of cardiac surgery, but the efficacy and safety of DOAC for POAF have rarely been investigated. We conducted a prospective observational study to investigate the efficacy and safety of DOAC administered immediately after POAF. Materials and Methods: In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC. Primary endpoints were either bleeding or thromboembolic events. Secondary endpoints included changes in hemoglobin (Hb), prothrombin time (PT), activated partial thromboplastin time (APTT), serum creatinine (sCr), estimated glomerular filtration rate (eGFR), and pleural/pericardial effusion. Results: Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivaroxaban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were significantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups. Conclusion: DOAC as anticoagulation therapy for the early intervention of POAF following cardiac surgery is associated with a low incidence of major bleeding; a favorable safety profile and excellent efficacy were demonstrated for DOAC. Furthermore, our results indicate that the safety and efficacy of apixaban and edoxaban are better than rivaroxaban.

Safety and Efficacy of Non–Vitamin K Oral Anticoagulant Use Early After Cardiac Surgery: A Systematic Review

“…The search yielded 822 articles from which we included 6 cohort studies (total n = 11 447 receiving NOACs), 17,[22][23][24][25][26] 1 RCT, 21 and 3 ongoing RCTs [27][28][29] (Figure 1); Tables 1 and 2 summarize key characteristics of included and ongoing studies. We excluded 2 studies available only as abstracts, 30,31 1 single-arm pilot study of 15 patients, 32 evaluated rivaroxaban 2.5 mg twice daily for coronary artery disease.…”

“…33 All included randomized and observational studies had high risk of bias in at least 1 domain (see Supplementary Table ). 17,[21][22][23][24][25][26]…”

“…Sezai et al 26 performed the only prospective observational study, with the aim of comparing NOACs early in the postoperative period at a single center. This Japanese study enrolled 135 patients who developed POAF after cardiac surgery (including mitral valve repair and ascending aorta and total arch procedures) and received apixaban (n = 31), edoxaban (n = 87) or rivaroxaban (n = 17) in a nonrandomized fashion, with 60-day follow-up.…”

“…22,24,25 Furthermore, bleeding outcomes were heterogeneous and poorly defined, which contributed to the wide range in reported event rates (0%-28.6%). 17,[21][22][23][24][25][26] Given the heterogeneity of the studies, no meta-analysis was done on the data. Apixaban was the most commonly used NOAC among studies that specified agents (43%, 121/283), whereas dabigatran was the least studied (n = 10).…”

“…One study used pericardial effusion size, another only included those requiring drainage or causing tamponade, and another combined pericardial and pleural effusions. 17,[22][23][24][25][26] For studies that specifically reported pericardial effusion, the incidence of pericardial effusion outcomes was 0% in the NOAC group and 1% to 2% in the warfarin group, with no significant difference between NOACs and warfarin in 2 large, multivariableadjusted cohort analyses. 17,22,24,25 Regardless, the available literature suggests that the risk of pericardial effusion should not preclude the use of NOACs in this setting.…”