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Clinical Efficacy and Safety Comparison of Rivaroxaban and Dabigatran for Nonvalvular Atrial Fibrillation Patients Undergoing Percutaneous Left Atrial Appendage Closure Operation.

ABSTRACT: Objective: Due to the clinical complexity of warfarin, novel oral anticoagulation (NOAC) has been a feasible and safe alternative anticoagulant approach during left atrial appendage closure (LAAC). This study was designed to compare the efficacy and safety of rivaroxaban and dabigatran for nonvalvular atrial fibrillation patients undergoing percutaneous LAAC. Methods: One single and prospective cohort study was performed among patients who received anticoagulation with dabigatran or rivaroxaban. All patients were medicated with a 3-month course of NOAC to facilitate device endothelialization, followed by dual antiplatelet therapy until 6 months, then lifelong aspirin after discharge. Repeated transesophageal echocardiography was scheduled to evaluate thrombosis formation on occluders and thrombus dissolution ability. Results: A total of 262 consecutive patients were initially enrolled. A final number of 250 patients were analyzed; two patients were excluded due to procedure failure and 10 patients had a loss of follow-up; 97 were from the dabigatran group and 153 from the rivaroxaban group. Three patients (1.9%) in the rivaroxaban group and eight (8.2%) in the dabigatran group were experiencing device-related thrombosis (DRT) events during follow-ups. Cumulative Kaplan-Meier estimates showed that the incidence of DRT was lower under rivaroxaban medication during the 6-month follow-ups (p = 0.038*, OR = 3.843, 95%CI: 0.991-14.836). The transesophageal echocardiography (TEE) results showed that the average length and width of DRT in the rivaroxaban group was significantly lower compared with that in the dabigatran group (2.16 vs. 1.60 mm, p = 0.017*, and 1.71 vs. 1.30 mm, p = 0.003*, respectively). The thrombosis dissolved after the switch from dabigatran or rivaroxaban to warfarin within the target range, represented by the average length and width of thrombus with the cooperation of secondary TEE for the dabigatran and rivaroxaban groups (0.64 vs. 0.40 mm, p = 0.206, and 0.43 vs. 0.27 mm, p = 0.082, respectively). No significant difference was found between the two groups with respect to the levels of coagulation parameters, cardiac function, and bleeding events. Conclusion: Compared to dabigatran, post-procedural rivaroxaban anticoagulation might be advantageous in preventing DRT complications expected after LAAC, without increasing the risk of hemorrhage.

SUBMITTER: Li X

PROVIDER: S-EPMC8249758 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: The current post-procedure antithrombotic recommendation for left atrial appendage closure (LAAC) remains empiric. This study was designed to compare variations in platelet activation biomarkers and device-related thrombosis (DRT) under different antithrombotic regimens following LAAC. Methods: This study enrolled 105 consecutive patients with atrial fibrillation who underwent LAAC successfully and received post-procedure anticoagulation with either dabigatran (N = 33) or rivaroxaban (N = 72). After 3 months of anticoagulation treatment, thromboelastogram was used to evaluate thrombin receptor-activating peptide (TRAP)-induced platelet aggregation (PA). Measurements of platelet activation biomarkers, including thrombin-antithrombin complex (TAT), P-selectin, von Willebrand disease (vWF), and CD40L, were performed immediately before the LAAC procedure and after 3 months of post-procedure anticoagulation. Repeated transesophageal echocardiography was performed to evaluate DRT during follow-ups. Results: Three (4.2%) patients in the rivaroxaban and 4 (12.1%) patients in the dabigatran group experienced DRT events (odds ratio (OR) = 0.315, 95% confidence interval (95%CI): 0.066-1.489, p = 0.129) during follow-ups. The TRAP-induced PA was statistically significantly higher in the dabigatran group (62.9% vs 59.7%, p = 0.028*). Statistically significant increases in plasma concentration of TAT, P-selectin, and vWF were observed after 3 months of exposure to dabigatran when compared with rivaroxaban. An increased expression of platelet activation biomarkers was observed in DRT subjects compared with non-DRT subjects in terms of P-selectin and vWF (65.28 ± 13.93 ng/L vs 32.14 ± 12.11 ng/L, p = 0.037; 501.92 ± 106.48 U/L vs 280.98 ± 54.10 U/L, p = 0.045; respectively). Multivariate regression analysis indicated that the use of dabigatran might be an independent predictor of DRT (p = 0.022; OR = 4.366, 95%CI: 0.434-10.839). Furthermore, the CHA2DS2-VASc score (OR = 2.076, p = 0.016) and CD40L levels (OR = 1.015, p = 0.021) were independent predictors of increased D-dimer levels. Conclusions: Post-LAAC anticoagulation with dabigatran may increase the risk of DRT by enhancing platelet reactivity. In light of this potential increased risk in DRT, the authors recommend against using dabigatran for post-procedural anticoagulation in patients who have undergone LAAC.

Project description:Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used for prevention of stroke secondary to nonvalvular atrial fibrillation (NVAF). Increased use of NOACs is partially a result of simplified regimens compared with warfarin, which has been associated with poor adherence and persistence to therapy. Few studies have assessed adherence to NOACs, especially using contemporary data now that multiple NOACs are available.To evaluate adherence to NOACs in a cohort of newly diagnosed NVAF patients who are commercially insured.Incident, treatment-naïve NVAF patients were identified in 2013 from a large claims database. Patients were included who initiated rivaroxaban, dabigatran, or apixaban within 30 days after diagnosis. Subjects were required to have 12 months of pre-index information to assess demographic and clinical characteristics (comorbidities, CHA2 DS2-VASc, and HAS-BLED scores). Adherence to the index medication and adherence to any oral anticoagulant was assessed using proportion of days covered (PDC) at 3, 6, and 9 months. The number of switches and gaps in therapy were also evaluated. Analyses were stratified by stroke risk scores, and a logistic regression model was used to control for factors that may predict high adherence (PDC ? 0.80).A total of 3,455 rivaroxaban, 1,264 dabigatran, and 504 apixaban users were included with no major clinical or demographic differences between groups. At 3, 6, and 9 months of follow-up, dabigatran had lower adherence (PDC = 0.77, 0.67, and 0.62) compared with rivaroxaban (PDC = 0.84, 0.75, and 0.70; P < 0.001) and apixaban (PDC = 0.82, 0.75, and 0.71; P < 0.001), as well as nearly twice the number of switches to either other anticoagulants or antiplatelet therapy. At 9 months, 55.0% of rivaroxaban initiators had PDC ? 0.80, which was comparable with 56.8% for apixaban and significantly greater than 46.7% for dabigatran (P < 0.001). Adherence was higher overall as stroke risk increased and showed dabigatran had consistently lower adherence compared with the other NOACs. Overall adherence to any oral anticoagulants, allowing for switches to another NOAC or warfarin, was not dependent on the index medication (9-month PDC = 0.74, 0.71, and 0.74 for rivaroxaban, dabigatran, and apixaban initiators). Adjusted analyses showed that increasing age and comorbid hypertension and diabetes were associated with higher adherence. Compared with rivaroxaban, dabigatran initiators had nearly 30% lower odds of being adherent to their index medication, and no differences were observed between apixaban and rivaroxaban. At 9 months, there were no differences between NOACs for overall adherence to oral anticoagulants.In this real-world analysis of adherence to NOACs, rivaroxaban and apixaban had favorable profiles compared with dabigatran, and rivaroxaban appeared to have higher overall adherence among the NOACs. Clinicians and managed care organizations should consider the implications of lower adherence on clinical outcomes as well as quality assessment.The project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through grant number UL1TR000117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Brown reports receiving a training fellowship from Human and Pfizer. Study concept and design were contributed by Brown and Shewale. Talbert took the lead in data collection, along with Brown, and data interpretation was primarily performed by Brown, along with Shewale. The manuscript was written primarily by Brown, along with Shewale, and revised by all the authors.

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Clinical Efficacy and Safety Comparison of Rivaroxaban and Dabigatran for Nonvalvular Atrial Fibrillation Patients Undergoing Percutaneous Left Atrial Appendage Closure Operation.

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