Dataset Information

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

ABSTRACT:

Aims

It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.

Methods and results

We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Consortium 2-5). A high-resolution brain magnetic resonance imaging (MRI) sub-study quantified acute brain lesions. Cognitive function was assessed by Montreal Cognitive Assessment (MoCA) at baseline and at end of follow-up. Overall, 674 patients (median age 64 years, 33% female, 42% non-paroxysmal atrial fibrillation, 49 sites) were randomized; 633 received study drug and underwent ablation; 335 undertook MRI (25 sites, 323 analysable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA {difference -0.38% [90% confidence interval (CI) -4.0%, 3.3%], non-inferiority P = 0.0002 at the pre-specified absolute margin of 0.075}, including 2 (0.3%) deaths, 2 (0.3%) strokes, and 24 (3.8%) ISTH major bleeds. Acute small brain lesions were found in a similar number of patients in each arm [apixaban 44/162 (27.2%); VKA 40/161 (24.8%); P = 0.64]. Cognitive function increased at the end of follow-up (median 1 MoCA unit; P = 0.005) without differences between study groups.

Conclusions

Continuous apixaban is safe and effective in patients undergoing atrial fibrillation ablation at risk of stroke with respect to bleeding, stroke, and cognitive function. Further research is needed to reduce ablation-related acute brain lesions.

SUBMITTER: Kirchhof P

PROVIDER: S-EPMC6110196 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

Kirchhof Paulus P Haeusler Karl Georg KG Blank Benjamin B De Bono Joseph J Callans David D Elvan Arif A Fetsch Thomas T Van Gelder Isabelle C IC Gentlesk Philip P Grimaldi Massimo M Hansen Jim J Hindricks Gerhard G Al-Khalidi Hussein R HR Massaro Tyler T Mont Lluis L Nielsen Jens Cosedis JC Nölker Georg G Piccini Jonathan P JP De Potter Tom T Scherr Daniel D Schotten Ulrich U Themistoclakis Sakis S Todd Derick D Vijgen Johan J Di Biase Luigi L

European heart journal 20180801 32

<h4>Aims</h4>It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.<h4>Methods and results</h4>We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Co ...[more]

PMID: 29579168

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Project description:BackgroundAblation is a widely used therapy for atrial fibrillation (AF); however, arrhythmia recurrence and repeat procedures are common. Studies examining surrogate markers of genetic susceptibility to AF, such as family history and individual AF susceptibility alleles, suggest these may be associated with recurrence outcomes. Accordingly, the aim of this study was to test the association between AF genetic susceptibility and recurrence after ablation using a comprehensive polygenic risk score for AF.MethodsTen centers from the AF Genetics Consortium identified patients who had undergone de novo AF ablation. AF genetic susceptibility was measured using a previously described polygenic risk score (N=929 single-nucleotide polymorphisms) and tested for an association with clinical characteristics and time-to-recurrence with a 3 month blanking period. Recurrence was defined as >30 seconds of AF, atrial flutter, or atrial tachycardia. Multivariable analysis adjusted for age, sex, height, body mass index, persistent AF, hypertension, coronary disease, left atrial size, left ventricular ejection fraction, and year of ablation.ResultsFour thousand two hundred seventy-six patients were eligible for analysis of baseline characteristics and 3259 for recurrence outcomes. The overall arrhythmia recurrence rate between 3 and 12 months was 44% (1443/3259). Patients with higher AF genetic susceptibility were younger (P<0.001) and had fewer clinical risk factors for AF (P=0.001). Persistent AF (hazard ratio [HR], 1.39 [95% CI, 1.22-1.58]; P<0.001), left atrial size (per cm: HR, 1.32 [95% CI, 1.19-1.46]; P<0.001), and left ventricular ejection fraction (per 10%: HR, 0.88 [95% CI, 0.80-0.97]; P=0.008) were associated with increased risk of recurrence. In univariate analysis, higher AF genetic susceptibility trended towards a higher risk of recurrence (HR, 1.08 [95% CI, 0.99-1.18]; P=0.07), which became less significant in multivariable analysis (HR, 1.06 [95% CI, 0.98-1.15]; P=0.13).ConclusionsHigher AF genetic susceptibility was associated with younger age and fewer clinical risk factors but not recurrence. Arrhythmia recurrence after AF ablation may represent a genetically different phenotype compared to AF susceptibility.

Project description:Background: Little is known about the prognostic value of nutritional status among patients undergoing atrial fibrillation (AF) catheter ablation (AFCA). We compared the risk of procedure-related complications and long-term rhythm outcomes of AFCA according to nutritional status. Methods: We included 3,239 patients undergoing de novo AFCA in 2009-2020. Nutritional status was assessed using the controlling nutritional status (CONUT) score. The association between malnutrition and the risk of AFCA complications or long-term rhythm outcomes was evaluated. We validated the effects of malnutrition using an external cohort of 360 patients undergoing AFCA in 2013-2016. Results: In the study population (26.8% women, median age: 58 years), 1,005 (31.0%) had malnutrition (CONUT scores ≥ 2); 991 (30.6%) had mild (CONUT 2-4) and 14 (0.4%) had moderate-to-severe (CONUT ≥ 5) malnutrition. The overall complication rates after AFCA were 3.3% for normal nutrition, 4.2% for mild malnutrition, and 21.4% for moderate-to-severe malnutrition. Moderate-to-severe malnutrition [odds ratio (OR) 6.456, 95% confidence interval (CI) 1.637-25.463, compared with normal nutrition], older age (OR 1.020 per 1-year increase, 95% CI 1.001-1.039), female sex (OR 1.915, 95% CI 1.302-2.817), and higher systolic blood pressure (OR 1.013 per 1-mmHg increase, 95% CI 1.000-1.026) were independent predictors for the occurrence of complications. In the validation cohort, malnutrition (CONUT ≥ 2) was associated with a 2.87-fold higher risk of AFCA complications (95% CI 1.174-7.033). The association between malnutrition and a higher risk of AFCA complications was consistently observed regardless of body mass index and sex. Malnutrition did not affect rhythm outcomes during the median follow-up of 40 months (clinical recurrence: 37.0% in normal nutrition vs. 36.5% in malnutrition). Conclusion: Malnutrition, which is common in patients undergoing AFCA, was associated with a substantially higher risk for complications after AFCA.

Project description:Background and objectivesThe relative efficacy and safety of apixaban compared with no anticoagulation have not been studied in patients on maintenance dialysis with atrial fibrillation. We aimed to determine whether apixaban is associated with better clinical outcomes compared with no anticoagulation in this population.Design, setting, participants, & measurementsThis retrospective cohort study used 2012-2015 US Renal Data System data. Patients on maintenance dialysis with incident, nonvalvular atrial fibrillation treated with apixaban (521 patients) were matched for relevant baseline characteristics with patients not treated with any anticoagulant agent (1561 patients) using a propensity score. The primary outcome was hospital admission for a new stroke (ischemic or hemorrhagic), transient ischemic attack, or systemic thromboembolism. The secondary outcome was fatal or intracranial bleeding. Competing risk survival models were used.ResultsCompared with no anticoagulation, apixaban was not associated with lower incidence of the primary outcome: hazard ratio, 1.24; 95% confidence interval, 0.69 to 2.23; P=0.47. A significantly higher incidence of fatal or intracranial bleeding was observed with apixaban compared with no treatment: hazard ratio, 2.74; 95% confidence interval, 1.37 to 5.47; P=0.004. A trend toward fewer ischemic but more hemorrhagic strokes was seen with apixaban compared with no treatment. No significant difference in the composite outcome of myocardial infarction or ischemic stroke was seen with apixaban compared with no treatment. Compared with no anticoagulation, a significantly higher rate of the primary outcome and a significantly higher incidence of fatal or intracranial bleeding and of hemorrhagic stroke were seen in the subgroup of patients treated with the standard apixaban dose (5 mg twice daily) but not in patients who received the reduced apixaban dose (2.5 mg twice daily).ConclusionsIn patients with kidney failure and nonvalvular atrial fibrillation, treatment with apixaban was not associated with a lower incidence of new stroke, transient ischemic attack, or systemic thromboembolism but was associated with a higher incidence of fatal or intracranial bleeding.PodcastThis article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_05_29_CJN11650919.mp3.

Project description:BackgroundA previous FDA study reported a favorable benefit risk for apixaban compared with warfarin for stroke prevention in older non-valvular atrial fibrillation (NVAF) patients (≥ 65 years). However, it remains unclear whether this favorable benefit risk persists in other populations including younger users. We examined if a similar benefit risk was observed in the Sentinel System and if it varied by age group.ObjectiveTo examine the risk of ischemic stroke, gastrointestinal (GI) bleeding, and intracranial hemorrhage (ICH) in apixaban users compared with warfarin users in Sentinel Distributed Database (SDD).Design and participantsA retrospective new user cohort study was conducted among patients, 21 years and older initiating apixaban and warfarin for NVAF, between December 28, 2012, and June 30, 2018, in the SDD.Main measuresCox proportional hazard regression was used to estimate the hazard ratios (HR) and 95% confidence intervals (95% CI) for each outcome (ischemic stroke, GI bleeding, and ICH) in propensity score matched apixaban users compared with the warfarin users. Subgroup analyses by age (21-64, 65-74, and 75+ years) were conducted.Key resultsAfter matching, 55.3% and 58.4% (n = 55,038) of the apixaban and warfarin users were included in the main analysis. GI bleeding was the most common outcome. The HR (95% CI) for GI bleeding, ICH, and ischemic stroke in apixaban users compared with warfarin users were 0.57 (0.50-0.66), 0.53 (0.40-0.70), and 0.56 (0.45-0.71) respectively. The reduced risk of these outcomes in apixaban compared with warfarin users persisted across age groups.ConclusionIn NVAF patients of all ages initiating either apixaban or warfarin for stroke prevention in the Sentinel System, apixaban was associated with a decreased risk of GI bleeding, ICH, and ischemic stroke compared with warfarin. Among patients less than 65 years of age, apixaban use was associated with a decreased risk of GI bleeding and ischemic stroke.

Dataset Information

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

Aims

Methods and results

Conclusions

Publications

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

Similar Datasets

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