Initial anticoagulation experience with standard-dose rivaroxaban after Watchman left atrial appendage occlusion

Abstract

Background: Warfarin is now recommended as the standard anti-thrombotic regimen to allow complete endothelialization over the Watchman device post percutaneous left atrial appendage occlusion (LAAO).However, the need for frequent monitoring, narrow therapeutic range, dietary restrictions and multiple drug interactions associated with warfarin have contributed to increasing uptake of non-vitamin K oral anticoagulants (NOACs) worldwide. At present, the feasibility and safety of NOACs instead of warfarin post-LAAO is lacking.Methods: Patients who underwent successful Watchman device implantation between October 1, 2016 and September 30, 2017 were enrolled in a retrospective database. And only patients who received rivaroxaban in the periprocedural period were included in this study. Transesophageal echocardiography (TEE) followup was scheduled at 6 weeks, at 6 months, and at 12 months post-implantation to detect device-related thrombosis (DRT) or peri-device leak. Meanwhile, thromboembolic and bleeding events were also evaluated at the time of follow-up.Results: Totally, 57 Watchman devices were successfully implanted and 10 patients who were allocated to rivaroxaban at the dosage of 20 mg once daily were included. During the follow-up, none of the patients using rivaroxaban experienced DRT, peri-device leak, thromboembolic complications and major bleeding events, except for 2 patients who suffered minor bleeding during the 6 weeks follow-up.Conclusions: This study suggests that a short course of standard-dose rivaroxaban following Watchman LAAO is associated with low incidence of thrombotic complications and bleeding events, and might be a feasible alternative regimen in Chinese. Further randomized trials and large sample of real-world studies are needed to validate our finding.

Twice-daily rivaroxaban after percutaneous left atrial appendage closure for atrial fibrillation

“…Rivaroxaban at 20 mg once daily has been used to prevent thrombosis and stroke after LAAC ( Gu et al, 2020 ). The standard dose of rivaroxaban was determined by data from studies of deep vein thrombosis and exposure–response regression analysis, and subsequent studies of rivaroxaban for postoperative anticoagulation in patients undergoing LAAC followed this regimen ( Mueck et al, 2011 ).…”

“…Because the left atrial appendage (LAA) is the origin of most atrial thrombi, percutaneous LAA closure (LAAC) has been used for thromboprophylaxis in patients with AF ( Blackshear and Odell, 1996 ). Previous studies have evaluated once-daily dosing of rivaroxaban as a postoperative anticoagulation regimen in patients undergoing LAAC ( Bösche et al, 2015 ; Bergmann et al, 2017 ; Enomoto et al, 2017 ; Gu et al, 2020 ; Zhu and Xu, 2021 ) and have demonstrated a close correlation between pharmacodynamic effects and pharmacokinetic profiles ( Kubitza et al, 2005a ; Kubitza et al, 2005b ). However, the plasma concentration peaked as soon as 2–4 h after rivaroxaban administration, and Factor Xa activity and prolongation of prothrombin time returned to within 10% of baseline values at 24 h after rivaroxaban intake.…”

Meta-analysis of postoperative antithrombotic therapy after left atrial appendage occlusion

“…Thus, it could be deduced that NOACs have a critical role as antithrombotic therapies after LAAO, but this finding must be substantiated in larger clinical trials. 57 …”

Impact and predictors of device-related thrombus after percutaneous left atrial appendage closure

“…In this large sample the incidence of ischemic events was significantly higher in the group with DRT compared with those without [13.2% vs. 3.8%, odds ratio (OR): 5.27, 95% confidence interval (CI): 3.66À7.59; P < 0.001; 11 Other relatively small studies documented a poor association between cerebral ischemic events and DRT. [22][23][24][25][26][27][28][29] Søndergaard et al 30 compared two different drug regimens [antiplatelet therapy (APT) vs. oral anticoagulant (OAC)] in the overall population of PROTECT AF and PREVAIL trials, CAP, CAP2, ASAP and EWOLUTION registries and observed a higher DRT rates in the group of patients on the APT regimen compared with those on OAC, but it did not translate into a significant difference in terms of neurological events between the two groups. The 2-year follow-up data of the EWOLUTION registry in 1020 patients showed a lack of significant differences in the annual incidence of thromboembolic events in patients with or without DRT (respectively 1.7% vs.…”