/pdf/2021-european-heart-rhythm-association-practical-guide-on-2pawim3hm9.pdf

2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation

The consensus of the Asia Pacific Heart Rhythm Society (APHRS) on stroke prevention in atrial fibrillation (AF) has been published in 2017 which provided useful clinical guidance for cardiologists, neurologists, geriatricians, and general practitioners in the Asia-Pacific region. In these years, many important new data regarding stroke prevention in AF were reported. The practice guidelines subcommittee members comprehensively reviewed updated information on stroke prevention in AF, and summarized them in this 2021 focused update of the 2017 consensus guidelines of the APHRS on stroke prevention in AF. We highlighted and focused on several issues, including the importance of the AF Better Care pathway, the advantages of non-vitamin K antagonist oral anticoagulants (NOACs) for Asians, the considerations of use of NOACs for Asian AF patients with single one stroke risk factor beyond gender, the role of lifestyle factors on stroke risk, the use of oral anticoagulants during the "coronavirus disease 2019" pandemic, etc. We fully realize that there are gaps, unaddressed questions, and many areas of uncertainty and debate in the current knowledge of AF, and the physician's decision remains the most important factor in the management of AF.

2021 Focused Update Consensus Guidelines of the Asia Pacific Heart Rhythm Society on Stroke Prevention in Atrial Fibrillation: Executive Summary.

4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation

Objectives This study sought to investigate clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs) in patients with high-risk atrial fibrillation (AF). Background LAAO has been shown to be noninferior to warfarin for stroke prevention in AF. However, anticoagulation with DOACs is now preferred over warfarin as thromboprophylaxis in AF. Methods Patients with AF enrolled in the Amulet Observational Registry (n = 1,088) who had successful LAAO with the Amplatzer Amulet device (n = 1,078) were compared with a propensity score–matched control cohort of incident AF patients (n = 1,184) treated by DOACs identified from Danish national patient registries. Propensity score matching was based on the covariates of the CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores for predicting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium ≥3), or all-cause mortality, and follow-up was 2 years. Results AF patients treated with LAAO had a significantly lower risk of the primary composite outcome as compared with patients treated with DOACs (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.49 to 0.67). Total events and event rates per 100 patient-years were (LAAO vs. DOACs) 256 vs. 461 and 14.5 vs. 25.7, respectively. The risk of ischemic stroke was comparable between groups (HR: 1.11; 95% CI: 0.71 to 1.75), while risk of major bleeding (HR: 0.62; 95% CI: 0.49 to 0.79) and all-cause mortality (HR: 0.53; 95% CI: 0.43 to 0.64) were significantly lower in patients treated with LAAO. Conclusions Among high-risk AF patients, LAAO in comparison with DOACs may have similar stroke prevention efficacy but lower risk of major bleeding and mortality.

Clinical Outcomes Associated With Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation.

Clinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.

Introduction The randomized PRAGUE-17 trial demonstrated non-inferiority of LAAC to NOAC for the prevention of major cardiovascular or cerebrovascular events. However, the LAA is an important source of natriuretic peptides and plays a role in left atrial reservoir function. Changes of HF biomarkers after LAAC compared to NOAC has not been studied. The aim of the study was to compare the changes in concentrations of heart failure (HF) biomarkers between left atrial appendage closure (LAAC) and non-vitamin K anticoagulants (NOAC) patients. Methods Of 402 patients randomized in the PRAGUE-17 trial, biomarkers were analyzed in 144 patients (73 in the NOAC and 71 in the LAAC group). Both groups had similar baseline characteristics. Serum concentration of NT-proBNP, NT-proANP, Galectin-3, and GDF-15 were measured at baseline (before the procedure in the LAAC group), at the 6-month (and at 24-month for NT-proBNP) follow-up timepoint. Results There were no significant differences in baseline, 6-month, and delta (δ = baseline - 6-month) concentrations of NT-proANP between the groups (NOAC: baseline 2.6 (0.5; 4.9), 6-month 3.1 (1.8; 4.8), p=0.068; LAAC: baseline 3.3 (1.1; 4.6), 6-month 2.6 (0.9; 5.3), p=0.51; p value for δ in concentrations between groups = 0.42). Similarly, there were no significant differences in baseline, 6-month, 24-monht and delta concentrations of NT-proBNP between the groups (NOAC: baseline 461.0 (113.5; 1342.0), 6-month 440.0 (120.5; 1291.5), 24-month 798 (274; 2236), p = 0.39; LAAC: baseline 421.0 (100.0; 1320.0), 6-month 601.0 (145.0; 1230.0), 24-month 855 (410; 1367), p=0.28; p value for δ in concentrations between groups = 0.73 at 6 months, and 0.58 at 24 months). Finally, no significant differences were present in baseline, 6-month, and δ concentrations of Galectin-3 and GDF-15 between the two groups. Conclusion LAAC did not significantly influence the levels of HF biomarkers 6 months after the procedure. This article is protected by copyright. All rights reserved.

The Effect of Left Atrial Appendage Closure on Heart Failure Biomarkers: A PRAGUE-17 Trial Sub-Analysis

Background: Percutaneous left atrial appendage closure (LAAC) has proven non-inferior to vitamin K antagonists (VKA) for preventing atrial fibrillation (AF)-related stroke. However, non-VKA oral anticoagulants (NOACs) have an improved safety profile than VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. 
 
Methods: In a randomized trial, we compared LAAC using commercially-available devices with NOACs in 402 high-risk AF patients. The primary composite outcome was stroke, transient ischemic attack (TIA), systemic embolism, cardiovascular death, clinically-significant major/non-major bleeding or procedure/device-related complications. The primary analysis of this noninferiority trial was by modified intention-to-treat. 
 
Findings: A high-risk patient cohort with CHA2DS2-VASc score = 4.7±1.5 was randomized to LAAC (n=201) or NOAC (n=201). LAAC was successfully performed in 181 of 201 (90%) patients. The most frequently used anticoagulant in the NOAC group was apixaban (192 of 201; 95.5%). After 20.8±10.8 months follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with NOACs (subdistribution HR = 0.84, 95% CI 0.53–1.31, p = 0.44; p=0.004 for noninferiority). There were no significant differences between groups for the major components of the composite endpoint: allstroke/TIA (subdistribution HR = 1.00, 95% CI 0.40–2.51), clinically-significant bleeding (subdistribution HR = 0.81, 95% CI 0.44–1.52), and cardiovascular death (subdistribution HR = 0.75, 95% CI 0.34–1.62). Major LAAC-related complications occurred in 9 (4.5%) subjects. 
 
Interpretation: Among high-risk patients with nonvalvular atrial fibrillation, LAAC was noninferior to NOACs in preventing major cardiovascular or neurological events. 
 
Clinical Trial Registration: NCT02426944. 
 
Funding Statement: Research grant from the Ministry of Health, Czech Republic (AZV 15-29565A). 
 
Declaration of Interests: V.Reddy reports consulting income and grant support from Abbott Inc and Boston Scientific Inc. He also has conflicts with other companies not related to this manuscript; a comprehensive list is included in the Supplement. P.Osmancik reports occasional speaking honoraria from Bayer and Abbott. P.Widimsky reports occasional honoraria from Bayer, Pfizer, and Boehringer Ingelheim. P.Kala´s disclosures with medical companies include Bayer (speaker bureau, advisory board), Boston Scientific (advisory board, consultancy). M.Poloczek reports speaking honoraria from Abbott. L.Haman reports speaking honoraria from Pfizer. M. Taborsky´s disclosures include Bayer and Pfizer (both advisory board). D.Zemanek reports speaking honoraria from Abbott and Bayer. All other authors report no conflict of interests. 
 
Ethics Approval Statement: The multicenter Ethics committee at University Hospital Kralovske Vinohrady, and Ethics committees at participating centers approved the protocol. All patients provided written informed consent.

Prague Trial Investigators

Papers

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.

The Effect of Left Atrial Appendage Closure on Heart Failure Biomarkers: A PRAGUE-17 Trial Sub-Analysis

Left Atrial Appendage Closure versus Non-Vitamin K Anticoagulants in High Risk Patients with Atrial Fibrillation: The PRAGUE-17 Trial