Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial

The Lancet ◽  
2019 ◽  
Vol 394 (10206) ◽  
pp. 1335-1343 ◽  
Author(s):  
Pascal Vranckx ◽  
Marco Valgimigli ◽  
Lars Eckardt ◽  
Jan Tijssen ◽  
Thorsten Lewalter ◽  
...  
Stroke ◽  
2019 ◽  
Vol 50 (8) ◽  
pp. 2125-2132
Author(s):  
Leonardo Knijnik ◽  
Manuel Rivera ◽  
Vanessa Blumer ◽  
Rhanderson Cardoso ◽  
Amanda Fernandes ◽  
...  

Background and Purpose— The optimal antithrombotic strategy to balance thromboembolic and bleeding events, especially acute stroke, for patients with atrial fibrillation following coronary stenting remains a matter of debate. We conducted a network meta-analysis to identify the antithrombotic regimen associated with the lowest rate of bleeding and thromboembolic events in atrial fibrillation after coronary stenting. Methods— PubMed, Scopus, and Cochrane Central were searched for randomized controlled trials and observational studies of patients with atrial fibrillation after coronary stenting. The outcomes of interest were stroke, myocardial infarction, major adverse cardiac events, mortality, and major bleeding. A network meta-analysis was performed comparing the available antithrombotic regimens in the literature. Results— Three randomized and 15 observational studies were included, with a total of 23 478 participants. Median follow-up was 2 years. Network meta-analysis demonstrated that vitamin K antagonist plus single antiplatelet therapy or direct-acting oral anticoagulant plus single antiplatelet therapy were the most effective regimens in preventing stroke. Direct-acting oral anticoagulant regimens were associated with lower major bleeding rates than vitamin K antagonist regimens. Regimens with dual antiplatelet therapy were associated with lower rates of myocardial infarction. Vitamin K antagonist plus dual antiplatelet therapy was associated with a lower mortality and low-dose direct-acting oral anticoagulants with decreased major cardiovascular adverse events. Conclusions— Direct-acting oral anticoagulant regimens were associated with less major bleeding and major cardiovascular adverse events, but vitamin K antagonists were associated with decreased mortality and stroke. These results suggest that the decision of antithrombotic therapy in patients with atrial fibrillation after percutaneous coronary intervention needs to be individualized.


2018 ◽  
Vol 40 (19) ◽  
pp. 1531-1537 ◽  
Author(s):  
Hee Tae Yu ◽  
Jaemin Shim ◽  
Junbeom Park ◽  
Tae-Hoon Kim ◽  
Jae-Sun Uhm ◽  
...  

Abstract Aims Although a recent expert consensus statement has recommended periprocedural uninterrupted (UI) non-vitamin K antagonist oral anticoagulants (NOACs) during catheter ablation of atrial fibrillation (AF) as a Class I indication, there have been no clear randomized trials. We investigated the safety and efficacy of UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs in patients undergoing AF ablation. Methods and results In this prospective, open-label, randomized multicentre trial, 326 patients (75% male, 58 ± 11 years old) scheduled for AF catheter ablation were randomly assigned in a 1:1:1 ratio to UI, SDS, and 24S at three tertiary hospitals. Bridging with low molecular weight heparin was carried out in the patients with persistent AF who were assigned to the 24S group. Dabigatran, rivaroxaban, and apixaban were assigned in order after randomization. The primary endpoint was the incidence of bleeding events within 1 month after ablation. The secondary endpoints included thrombo-embolic and other procedure-related complications. The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139). The incidence of major bleeding up to 1 month after ablation and a post-procedural reduction in the haemoglobin levels did not significantly differ among the treatment groups and different NOACs (P > 0.05). There were no fatal events or thrombo-embolic complications in all the three groups. Conclusion In patients undergoing AF ablation, UI NOACs and SDS or double dose skipped NOACs had a comparable efficacy and safety, regardless of the type of NOAC.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Manzo-Silberman ◽  
T Chouihed ◽  
L Fraticelli ◽  
A Peiretti ◽  
C Claustre ◽  
...  

Abstract Introduction Atrial Fibrillation (AF) is the most common arrythmia, especially in older adults. AF represents 1% of emergency department (ED) visits a third of which are de novo or recurrent. While the diagnosis is given quickly by reading the electrocardiogram (ECG), its management both remains complex. European guidelines have been published in 2016. Purpose Our study aimed to investigate guidelines implementation in French ED. Methods Prospective national multicenter study (clinical trials NCT 03836339) and core interpretation of ECG. Consecutive patients admitted in 32 French ED for AF confirmed by ECG were prospectively included. Clinical characteristics at admission were recorded by the physician. The 3-months telephone follow-up was ensured by one operator. Results From 1/10/2018 to 30/11/2018, 1369 patients with AF were included, of whom 295 (21.55%) had a de novo AF. Patients were 80 [65; 87] years old, 51.17% of men, 71.53% self-ruling, 91.53% living at home, 65.42% transported by firemen or by ambulances and 4,07% by a mobile intensive care unit. Twenty-six (8.84%) patients had a history of stroke or transient ischemic stroke and none of them on anticoagulants. CHA2DS2-VASC score was performed in 66.78% of patients and was 0 in 14 (7.11%) patients. HAS-BLED score = 2 [1; 3]. At admission 50.17% of patients received anticoagulants, of whom 49.32% a non-vitamin K antagonist oral anticoagulant, 0.68% Vitamin K antagonists, 50.68% UFH or LMWH. Beta-blockers were administered in 102 (24.01%) patients and amiodarone in 38 (12.89%). Cardiac echography has been performed in 20.34% of patients. Atrial fibrillation was the primary diagnosis in 42.71% of patients. It has been associated to a pneumopathy in 25.17% of patients, a pulmonary embolism in 4.76% and acute alcoholism in 1.36% of them. Precipitating factor was often undetermined. The discharge to the home concerned 18.64% of patients, 26.78% of patients were hospitalized in ED hospitalization unit, 23.05% in cardiology or intensive care unit. At 3 months, 49% of patients were on anticoagulants, of whom 90% on non-vitamin K antagonist oral anticoagulants, 95% of them didn't report any bleeding event and 41.77% of them were able to have a cardiology consultation within three months. Three-months mortality was about 22.09%, and rehospitalization rate about 22.89%. Conclusion It seems to be a reticence to initiate anticoagulation of patients admitted to ED with a de novo AF. It could be explained by both the advanced age of the patients and the lack of an organized access to a systematic cardiology consultation at discharge. Patients with chronic AF are subject to high mortality at 3 months and a significant risk of readmission. The application of the guidelines could be optimized by a better training program and the implementation of a dedicated pathway of care. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer


Author(s):  
Kuang-Tsu Yang ◽  
Wei-Chih Sun ◽  
Tzung-Jiun Tsai ◽  
Feng-Woei Tsay ◽  
Wen-Chi Chen ◽  
...  

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are more commonly used to prevent atrial fibrillation (AF) patients from thromboembolic events than vitamin K antagonists (VKAs). However, the gastrointestinal bleeding (GIB) risk in the Asian AF patients associated with NOACs in comparison with VKAs remained unaddressed. Materials and Methods: A systematic search of studies on NOACs and VKAs in the Asian AF patients was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov. The primary outcome was the hazard ratio (HR) of any GIB associated with NOACs versus VKAs. The secondary outcome was the GIB risks in different kinds of NOACs compared with VKAs. Results: This meta-analysis included two randomized controlled trials (RCTs) and four retrospective studies, comprising at least 200,000 patients in total. A significantly lower HR of GIB risks was found in all kinds of NOACs than VKAs in the Asian AF patients (HR: 0.633; 95% confidence interval: 0.535–0.748; p < 0.001). Additionally, the GIB risks of different NOACs were apixaban (HR: 0.392), edoxaban (HR: 0.603), dabigatran (HR: 0.685), and rivaroxaban (HR: 0.794), respectively. Conclusions: NOACs significantly reduced the risk of GIB in the Asian AF patients compared with VKAs. In the four NOACs compared with VKAs, apixaban probably had a trend of the least GIB risk. We need further head-to-head studies of different NOACs to confirm which NOAC is the most suitable for Asian AF patients and to know the optimal dosage regimen of different NOACs.


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