Faculty Opinions recommendation of Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivaroxaban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study.

Author(s):  
Marc Vervloet
2021 ◽  
Author(s):  
Di Luo ◽  
Yanhong Liu ◽  
yue zhang ◽  
Gang Xu ◽  
Enzhao Liu ◽  
...  

Abstract Background: With the increasing number of aged population in China, the mortality and disability caused by atrial fibrillation (AF) and its complications lead to serious social burden and becoming more prominent. Due to the high false-negative rates of AF detected by routine ECG, the results on the recurrent rate and AF burden after cryoballoon ablation (CBA) in real world are inconsistent so far. Since the extension of monitoring time, the increased detection of AF in patients, insertable cardiac monitor (ICM) has its unique merits. Methods: Cryo-ICM AF study is a prospective, multicenter randomized controlled trial with 200 participants with paroxysmal atrial fibrillation from 4 centers. Monitoring AF load after CBA though two monitoring methods— ICM and 24 hours holter during the 1 years follow-up of the two groups. All data will be observed and recorded in baseline, 30th days and 3 th , 6 th , 9 th and 12 th months after CBA, which including incidence rates of postoperative complications and recurrence conditions, cardioelectrical indexes from 24-hours holter in all subjects and ICM in ICM group, UCG parameters about atrium/ventricular size and diastolic/systolic function, and biochemical indicators. Disucssion: This is the first study design to confirm the effectiveness of cryoballoon in real world, monitoring AF load with ICM in patients with paroxysmal AF after CBA.Trial registration: Chinese Clinical Trial Registry, No. ChiCTR1900026364. Registered 9 Oct 2019, http://www.chictr.org.cn/index.aspx


2021 ◽  
pp. 51-57
Author(s):  
I. S. Yavelov

The incidence of atrial fibrillation (AF) and coronary heart disease (CHD) increases with age. Obviously, this is largely due to the coincidence of risk factors for the occurrence and progression of AF and risk factors for the occurrence and progression of atherosclerosis, including coronary atherosclerosis. Vitamin K antagonists, which are necessary for stroke prevention in patients with AF, are also reported to be able to prevent thrombotic complications of coronary atherosclerosis. No studies specifically designed to compare direct oral anticoagulants (DOACs) and vitamin K antagonists in the prevention of coronary thrombosis have been conducted, However, analysis of the results of randomized controlled trials ARISTOTLE, AUGUSTUS, PIONEER AF-PCI, REDUAL PCI, RE-LY and ROCKET AF indicates that in general DOACs are not inferior to warfarin in the ability to protect patients with AF from myocardial infarction and stent thrombosis. Accordingly, in stable patients with non-valvular AF (who have not suffered an acute coronary syndrome in the next 1 year or planned coronary stenting in the next 6 months) they can be used as monotherapy, without simultaneous administration of antiaggregants. Taking into account the data obtained in patients with sinus rhythm who recently had acute coronary syndrome in the randomized controlled trial ATLAS-ACS 2, as well as with stable atherosclerotic disease in the randomized controlled trial COMPASS, the greatest evidence base in the prevention of coronary complications has been accumulated with rivaroxaban. At the same time, the results of the COMPASS study, as well as analysis of daily medical practice indicate its additional benefits in patients with peripheral atherosclerosis.


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