Edoxaban in atrial fibrillation with PCI by ACS or stable CAD presentation: a pre-specified analysis of the ENTRUST-AF PCI trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Vranckx ◽  
M Valgimigli ◽  
L Eckardt ◽  
T Lewalter ◽  
P Laeis ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Stable Coronary Artery Disease ◽  
Coronary Intervention ◽  
Similar Efficacy ◽  
Cardiovascular Death ◽  
Funding Source ◽  
Private Company ◽  
P2y12 Inhibitor ◽  
Coronary Syndrome

Abstract Aim We aimed to compare the safety and efficacy of edoxaban in combination with P2Y12 inhibition in the setting of percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or stable coronary artery disease (SCAD). Methods and results This is a pre-specified sub-analysis of the ENTRUST-AF PCI trial. Participants were randomly assigned 1:1 to an edoxaban or vitamin K antagonist (VKA) based strategy and randomisation was stratified by ACS (edoxaban n=388, vitamin K n=389) vs. SCAD (edoxaban n=363, vitamin K=366). Participants received edoxaban 60mg once daily plus a P2Y12 inhibitor for 12 months; or VKA in combination with a P2Y12 inhibitor and aspirin 100mg (for 1–12 months). The primary bleeding endpoint, a composite of International Society on Thrombosis and Haemostasis (ISTH) major or clinical relevant non-major bleeding, at 12 months occurred in 59 (18.52%/year) vs 79 (26.21%/year) ACS patients (Hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.591–1.018, P=0.0631), and in 69 (23.11%/year) vs 73 (25.02%/year) SCAD patients (HR 0.94, 95% CI 0.676–1.305, P=0.7082) with edoxaban and VKA based therapies, respectively (P for interaction [P-int]=0.2741). The main efficacy endpoint (composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, or definite stent thrombosis) occurred in 33 (9.59%/year) vs 28 (8.21%/year) ACS-patients (HR 1.16, 95% CI 0.697–1.916) compared with 16 (4.84%/year) vs 18 (5.47%/year) SCAD-patients (HR 0.91, 95% CI 0.465–1.781) with edoxaban and VKA based therapy, respectively (P-int=0.5573). Conclusions An antithrombotic regimen consisting of edoxaban and a P2Y12-inhibitor without aspirin provides equal safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation with ACS or SCAD. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH

scholarly journals Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial

2020 ◽  
Vol 41 (47) ◽  
pp. 4497-4504 ◽  
Author(s):  
Pascal Vranckx ◽  
Marco Valgimigli ◽  
Lars Eckardt ◽  
Thorsten Lewalter ◽  
Ramunas Unikas ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
Similar Efficacy ◽  
Once Daily ◽  
P2y12 Inhibitor ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Trial Participants ◽  
Definite Stent Thrombosis

Abstract Aims  To compare the safety and efficacy of edoxaban combined with P2Y12 inhibition following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) presenting with an acute coronary syndrome (ACS) or chronic coronary syndrome (CCS). Methods and results  In this pre-specified sub-analysis of the ENTRUST-AF PCI trial, participants were randomly assigned 1:1 to edoxaban- or vitamin K antagonist (VKA)-based strategy and randomization was stratified by ACS (edoxaban n = 388, VKA n = 389) vs. CCS (edoxaban n = 363, VKA = 366). Participants received edoxaban 60 mg once-daily plus a P2Y12 inhibitor for 12 months, or VKA combined with a P2Y12 inhibitor and aspirin 100 mg (for 1–12 months). The primary bleeding endpoint at 12 months occurred in 59 (15.2%) vs. 79 (20.3%) ACS patients [hazard ratio (HR): 0.73, 95% confidence interval (CI): 0.59–1.02, P = 0.063], and in 69 (19.0%) vs. 73 (19.9%) CCS patients (HR: 0.94, 95%CI: 0.68–1.31, P = 0.708) with edoxaban- and VKA-based therapy, respectively [P for interaction (P-int) = 0.2741]. The main secondary endpoint (composite of CV death, myocardial infarction, stroke, systemic embolic events, or definite stent thrombosis) in ACS patients was 33 (8.5%) vs. 28 (7.2%) (HR: 1.16, 95%CI: 0.70–1.92), compared with 16 (4.4%) vs. 18 (4.9%) (HR: 0.91, 95%CI: 0.47–1.78) CCS patients with edoxaban and VKA-based therapy, respectively (P-int = 0.5573). Conclusions  In patients with AF who underwent PCI, the edoxaban-based regimen, as compared with VKA-based regimen, provides consistent safety and similar efficacy for ischaemic events in patients with AF regardless of their clinical presentation.

scholarly journals Antithrombotic Management for Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention or With Acute Coronary Syndrome: An Evidence-Based Update

2021 ◽  
Vol 8 ◽  
Author(s):  
Shujuan Zhao ◽  
Xuejiao Hong ◽  
Haixia Cai ◽  
Mingzhou Liu ◽  
Bing Li ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Vitamin K ◽  
Coronary Intervention ◽  
Vitamin K Antagonist ◽  
P2y12 Inhibitor ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Antithrombotic Management

Combined antithrombotic regimens for atrial fibrillation (AF) patients with coronary artery disease, particularly for those who have acute coronary syndrome (ACS) and/or are undergoing percutaneous coronary intervention (PCI), presents a great challenge in the real-world clinical scenario. Conventionally, a triple antithrombotic therapy (TAT), which consists of combined oral anticoagulant therapy to prevent systemic embolism or stroke along with dual antiplatelet therapy to prevent coronary arterial thrombosis (CAT), is used. However, TAT has been associated with a significantly increased risk of bleeding. With the emergence of non-vitamin K antagonist oral anticoagulants (NOACs), randomized controlled trials have demonstrated a better risk-to-benefit ratio of dual antithrombotic therapy (DAT) in combination of a NOAC and with a P2Y12 inhibitor than vitamin K antagonist-based TAT. The results of these studies have impacted the recommendations of current international guidelines, which favor a DAT with a NOAC and P2Y12 inhibitor (especially clopidogrel) in this clinical setting. Additionally, aspirin can be administered during the periprocedural period, while the treatment duration of TAT should be as short as possible. In this article, we summarize the up-to-date evidence regarding antithrombotic regimens for AF patients with PCI or ACS, with a specific focus on the optimal approach and critical discussions of key scientific data and future developments for antithrombotic management in these patients.

scholarly journals Assessment of atrial fibrillation in emergency department

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Manzo-Silberman ◽  
T Chouihed ◽  
L Fraticelli ◽  
A Peiretti ◽  
C Claustre ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Intensive Care Unit ◽  
Emergency Department ◽  
Intensive Care ◽  
Vitamin K ◽  
De Novo ◽  
Bleeding Event ◽  
Vitamin K Antagonist ◽  
Funding Source ◽  
Private Company

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

scholarly journals Cost-effectiveness analysis of apixaban versus vitamin K antagonists for antithrombotic therapy in patients with atrial fibrillation after acute coronary syndrome or percutaneous coronary intervention in Spain

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259251
Author(s):  
Simone Rivolo ◽  
Manuela Di Fusco ◽  
Carlos Polanco ◽  
Amiee Kang ◽  
Devender Dhanda ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Cost Effectiveness ◽  
Vitamin K ◽  
Treatment Strategy ◽  
Coronary Intervention ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Ischemic Events

Background/Objective AUGUSTUS trial demonstrated that, for patients with atrial fibrillation (AF) having acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), an antithrombotic regimen with apixaban and P2Y12 resulted in less bleeding, fewer hospitalizations, and similar ischemic events than regimens including a vitamin K antagonist (VKA), aspirin, or both. This study objective was to evaluate long-term health and economic outcomes and the cost-effectiveness of apixaban over VKA, as a treatment option for patients with AF having ACS/PCI. Methods A lifetime Markov cohort model was developed comparing apixaban versus VKA across multiple treatment strategies (triple [with P2Y12 + aspirin] or dual [with P2Y12] therapy followed by monotherapy [apixaban or VKA]; triple followed by dual and then monotherapy; dual followed by monotherapy). The model adopted the Spanish healthcare perspective, with a 3-month cycle length and costs and health outcomes discounted at 3%. Results Treatment with apixaban resulted in total cost savings of €883 and higher life years (LYs) and quality-adjusted LYs (QALYs) per patient than VKA (net difference, LYs: 0.13; QALYs: 0.11). Bleeding and ischemic events (per 100 patients) were lower with apixaban than VKA (net difference, –13.9 and –1.8, respectively). Incremental net monetary benefit for apixaban was €3,041, using a willingness-to-pay threshold of €20,000 per QALY. In probabilistic sensitivity analysis, apixaban was dominant in the majority of simulations (92.6%), providing additional QALYs at lower costs than VKA. Conclusions Apixaban was a dominant treatment strategy than VKA from both the Spanish payer’s and societal perspectives, regardless of treatment strategy considered.

scholarly journals Antithrombotic Strategies in Patients with Atrial Fibrillation Following Percutaneous Coronary Intervention: A Systemic Review and Network Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (4) ◽  
pp. 1062 ◽  
Author(s):  
Su-Kiat Chua ◽  
Lung-Ching Chen ◽  
Kou-Gi Shyu ◽  
Jun-Jack Cheng ◽  
Huei-Fong Hung ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Vitamin K ◽  
Antithrombotic Therapy ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Systemic Review ◽  
P2y12 Inhibitor ◽  
Percutaneous Coronary

Up to 10% of patients with atrial fibrillation (AF) undergo percutaneous coronary intervention (PCI). A systematic review and network meta-analysis were conducted by searching PubMed, Embase, and the Cochrane database of systematic reviews for randomized control trials that studied the safety and efficacy of different antithrombotic strategies in these patients. Six studies, including 12,158 patients were included. Compared to that in the triple antithrombotic therapy group (vitamin K antagonist (VKA) plus P2Y12 inhibitor and aspirin), thrombolysis in myocardial infarction (TIMI) major bleeding was significantly reduced in the dual antithrombotic therapy (non-vitamin K oral anticoagulants (NOACs) plus P2Y12 inhibitor) group by 47% (Odds ratio (OR), 0.53; 95% credible interval [CrI], 0.35–0.78; I2 = 0%). Besides, NOAC plus a P2Y12 inhibitor was associated with less intracranial hemorrhage compared to VKA plus single antiplatelet therapy (OR: 0.20, 95% CrI: 0.05–0.77). There was no significant difference in the trial-defined major adverse cardiac events or the individual outcomes of all-cause mortality, cardiovascular death, myocardial infarction, stroke or stent thrombosis among all antithrombotic strategies. In conclusion, antithrombotic strategy of NOACs plus P2Y12 inhibitor is safer than, and as effective as, the strategies including aspirin when used in AF patients undergoing PCI.

Antithrombotic treatment in patients with atrial fibrillation and acute coronary syndromes: results of the European Heart Rhythm Association survey

EP Europace ◽  
2019 ◽  
Vol 21 (7) ◽  
pp. 1116-1125 ◽  
Author(s):  
Deirdre A Lane ◽  
Nikolaos Dagres ◽  
Gheorghe-Andrei Dan ◽  
Javier García Seara ◽  
Konstantinos Iliodromitis ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Heart Rhythm ◽  
Dual Therapy ◽  
Coronary Intervention ◽  
Vitamin K Antagonist ◽  
Cardiac Events ◽  
University Hospitals ◽  
Antithrombotic Treatment ◽  
Coronary Syndrome

Abstract The management of an acute coronary syndrome (ACS) in a patient with existing atrial fibrillation (AF) often presents a management dilemma both in the acute phase and post-ACS, since the majority of AF patients will already be receiving oral anticoagulation (OAC) for stroke prevention and will require further antithrombotic treatment to reduce the risk of in-stent thrombosis or recurrent cardiac events. Current practice recommendations are based largely on consensus option as there is limited evidence from randomized controlled trials. Prior to the launch of the new European Heart Rhythm Association (EHRA) consensus document, a survey was undertaken to examine current clinical management of these patients across centres in Europe. Forty-seven centres submitted valid responses, with the majority (70.2%) being university hospitals. This EHRA survey demonstrated overall the management of ACS in AF patients is consistent with the available guidance. Most centres would use triple therapy for a short duration (4 weeks) and predominantly utilize a strategy of OAC (vitamin K antagonist, VKA or non-vitamin K antagonist oral anticoagulant, NOAC) plus aspirin and clopidogrel, followed by dual therapy [(N)OAC plus clopidogrel] until 12 months post-percutaneous coronary intervention, followed by (N)OAC monotherapy indefinitely. Where NOAC was used in combination with antiplatelet(s), the lower dose of the respective NOAC was preferred, in accordance with current recommendations.

Safety and Efficacy of Oral Anticoagulants Therapies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-Analysis

2020 ◽  
Vol 25 (5) ◽  
pp. 399-408
Author(s):  
Felipe F. Mainka ◽  
Vinicius L. Ferreira ◽  
Antonio M. Mendes ◽  
Gustavo L. Marques ◽  
Fernando Fernandez-Llimos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Vitamin K ◽  
Clinical Decision Making ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Coronary Intervention ◽  
P2y12 Inhibitor ◽  
Percutaneous Coronary

Background: Different antithrombotic treatments, from vitamin K antagonists to direct oral anticoagulants (DOACs), are available to reduce ischemic risks in patients with atrial fibrillation (AF) after percutaneous coronary intervention (PCI). Objective: To synthetize evidence about the benefit–risk ratio of antithrombotic treatments and their combinations in patients with AF and PCI. Methods: A network meta-analysis and a stochastic multicriteria acceptability analysis (SMAA) were performed including randomized controlled trials (RCT) that evaluate antithrombotic treatments in adults with AF and PCI. Searches were conducted in PubMed and Scopus (updated November-2019). Outcomes compared included bleeding, stroke, and death (Prospero registration: CRD42019146813). Results: Five RCTs were included (11 532 patients). Vitamin K antagonists + dual antiplatelet therapy was associated with major bleeding (odds ratio: 0.52 [95% CI: 0.32-0.86]) compared to DOAC + P2Y12. No statistical differences were found among DOAC regimens for the main outcomes, including bleeding, stroke, and death. Surface under the cumulative ranking curve analysis (SUCRA) and SMAA demonstrated edoxaban 60 mg + P2Y12 inhibitor as the worst option (28%). Apixaban 5 mg + P2Y12 inhibitor was the safest alternative (63%) in all scenarios. Conclusions: Insufficient evidence on the clinical superiority among anticoagulant regimens exists, although apixaban slightly stands out. Edoxaban was associated with more adverse events. To strength this evidence, well-designed, low risk of bias clinical trials are needed. Cost-minimization analyses are required to provide further information for clinical decision-making.

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