P4750Uninterrupted and minimally-interrupted direct oral anticoagulant therapy in patients undergoing catheter ablation for atrial fibrillation. An updated meta-analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Ottoffy ◽  
P Hegyi ◽  
T Habon
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Major Bleeding ◽  
Clinical Benefit ◽  
Oral Anticoagulant Therapy ◽  
Meta Analysis ◽  
Thromboembolic Events ◽  
Significant Difference ◽  
Life Threatening ◽  
Net Clinical Benefit

Abstract Background Adequate anticoagulation in catheter ablation of atrial fibrillation (AF) is crucial in preventing both thromboembolic events and life-threatening bleeding. As clinicians gain more experience and reassurance with data from clinical trials, the usage of Direct Oral Anticoagulants (DOAC) in patients undergoing catheter ablation of AF has rapidly increased over the last years. The purpose of this updated meta-analysis was to assess the latest evidence and compare the safety and efficacy of uninterrupted and minimally interrupted periprocedural DOAC anticoagulation protocols with uninterrupted Vitamin K Antagonists (VKA) in this setting. Methods Randomized or prospective controlled observational studies comparing DOACs to VKAs were identified with multiple databases (Embase, PubMed, Cochrane, and Scopus). Uninterrupted and minimally interrupted DOAC (single dose of dabigatran or apixaban withheld) were distinguished, VKA therapy was always uninterrupted. The primary outcomes were stroke or transient ischemic attack (TIA), major bleeding, and net clinical benefit. Results 32 studies were included in the final analysis, encompassing a total of 19.437 patients. The incidence of thromboembolic events was rare (less than 0.2%), with no significant difference between groups. Occurrence of major bleeding and net clinical benefit were significantly improved in patients assigned to uninterrupted DOAC treatment compared to VKAs (1.5% vs 2.2%, POR: 0.74, CI: 0.56–0.98, I2=0,0% and 1.7% vs 2.4%, POR: 0.76; CI: 0.59–0.99, I2=0,0%, respectively). Net clinical benefit Conclusion This updated meta-analysis, based on a large database, showed that DOAC therapy is equally effective as VKA in preventing stroke and TIA. Minimally-interrupted DOAC therapy is a non-inferior peri-procedural anticoagulation strategy, however, uninterrupted DOAC therapy showed superiority when compared to VKA regarding major, life-threatening bleeding. Our findings showed that uninterrupted periprocedural DOAC therapy is a safe and preferable alternative to VKAs in patients undergoing catheter ablation for atrial fibrillation. Acknowledgement/Funding This study was supported by an Economic Development and Innovation Operative Programme Grant (GINOP 2.3.2-15-2016-00048).

scholarly journals Uninterrupted or Minimally Interrupted Direct Oral Anticoagulant Therapy is a Safe Alternative to Vitamin K Antagonists in Patients Undergoing Catheter Ablation for Atrial Fibrillation: An Updated Meta-Analysis

2020 ◽  
Vol 9 (10) ◽  
pp. 3073
Author(s):  
Máté Ottóffy ◽  
Péter Mátrai ◽  
Nelli Farkas ◽  
Péter Hegyi ◽  
László Czopf ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Meta Analysis ◽  
Thromboembolic Events ◽  
Direct Oral Anticoagulant ◽  
Significant Difference ◽  
Life Threatening

Adequate anticoagulation during catheter ablation (CA) for atrial fibrillation (AF) is crucial for the prevention of both thromboembolic events and life-threatening bleeding. The purpose of this updated meta-analysis is to compare the safety and efficacy of uninterrupted and minimally interrupted periprocedural direct oral anticoagulant (DOAC) protocols and uninterrupted vitamin K antagonist (VKA) therapy in patients undergoing CA for AF based on the latest evidence. Randomized controlled trials, prospective observational studies, and retrospective registries comparing DOACs to VKAs were identified in multiple databases (Embase, MEDLINE via PubMed, CENTRAL, and Scopus). The primary outcomes were stroke or transient ischemic attack (TIA), major bleeding, and net clinical benefit. Forty-two studies with a total of 22,715 patients were included in the final analysis. The occurrence of major bleeding was significantly lower in patients assigned to uninterrupted DOAC treatment compared to VKAs (pooled odds ratio (POR): 0.71, confidence interval (CI): 0.51–0.99). The pooled analysis of both uninterrupted and minimally interrupted DOAC groups also showed significant reduction in major bleeding events (POR: 0.70, CI: 0.53–0.93). The incidence of thromboembolic events was low, with no significant difference between groups. This updated meta-analysis showed that DOAC therapy is as effective as VKA in preventing stroke and TIA. Minimally interrupted DOAC therapy is a non-inferior periprocedural anticoagulation strategy; however, uninterrupted DOAC therapy showed superiority compared to VKA with regard to major, life-threatening bleeding. Based on our in-depth analysis, we conclude that both DOAC strategies are equally safe and preferable alternatives to VKAs in patients undergoing CA for AF.

P1564Atrial fibrillation and thromboembolic prophylaxis: focus on the frail oldest patient. how net clinical benefit influences anticoagulant therapy

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G I Greco ◽  
C Ninivaggi ◽  
A Graceffa ◽  
S Novello ◽  
F Bonfante ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Clinical Benefit ◽  
The Elderly ◽  
Thromboembolic Events ◽  
Intracranial Hemorrhages ◽  
Old Patients ◽  
The Difference ◽  
Net Clinical Benefit ◽  
Very Old Patients

Abstract Background Atrial fibrillation is highly prevalent among the elderly population, which is also frequently prone to thromboembolic complications. Anticoagulant prophylaxis is underused in the elderly due to fear of bleeding, which tends to be more frequent and severe within this group. Randomized controlled trials and several observational studies have shown the comparative effectiveness of direct oral anticoagulant (DOAC) against vitamin K antagonists (VKA), and their superior safety, at least in terms of intracranial bleeding. However, for patients aged 85 or older, there is still insufficient literature, leaving unanswered the question of which prophylaxis to use. Purpose The aim of the study is to compare the incidence of established outcomes and to investigate the net clinical benefit between DOAC and VKA in patients aged ≥85 years. Methods A cohort of 553 outpatients from the real world began treatment using DOACs at our clinic. The prospective follow-up on average lasted 1.97 years. Main endpoints were stroke and systemic thromboembolism, major hemorrhage, myocardial infarction and mortality for all causes. A sample of the 160 patients aged ≥85 years was compared with the remaining younger ones and with a second cohort of 298 outpatients aged ≥85 years. Retrospectively analyzed, with follow-ups at our center, who started VKAs; the average time was 2.03 years. The “net clinical benefit” of DOACs against VKAs was calculated as the difference between thromboembolic events with VKAs and with DOACs, minus the difference (weighted by 1.5) between spontaneous intracranial bleeding with DOACs and VKAs. Results In terms of thromboembolic events, DOACs and VKAs (2.43% p-y vs. 1.82% p-y, p=0.975) have shown comparable efficacy in a higher risk sample (CHA2DS2-VASc score: 5.2 vs. 4.5; p<0.001). There were no differences in spontaneous intracranial hemorrhages (0.81% p-y vs. 1.16% p-y; p=0.419). Major bleeding was more frequent in DOACs (10.11% p-y vs. 4.13% p-y, p<0.05), although they are comparable if we consider patients in VKAs achieving a time in therapeutic range (TTR) <60%. Mortality, in all cases similar (13.75% p-y vs. 9.92% p-y; p=0.778), but was reduced in patients with VKAs therapy, with a TTR ≥60%. The net clinical benefit of DOACs compared to VKAs is noticeable in patients with a previous stroke or with CHA2DS2-VASc score <6, while VKAs may be more beneficial to patients with vascular disease or with CHA2DS2-VASc score ≥6. Conclusions DOACs are as effective in very old patients with atrial fibrillation compared to very old patients receiving VKAs, but they are associated with increased major bleeding. The same is true when compared with younger DOACs users. TTR, representing quality achieved by the anticoagulation with a VKA, can influence the comparison with DOACs. Considering ischemic strokes and spontaneous intracranial hemorrhages, there is however a net benefit for DOACs use in specific categories of elderly patients.

Abstract 14648: Gender Differences in Procedural Complications Associated With Atrial Fibrillation Catheter Ablation: A Systematic Review and Meta-analysis of 244,353 Patients

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Martin L Campbell ◽  
John Larson ◽  
Talha Farid ◽  
Stacy Westerman ◽  
Michael S Lloyd ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Catheter Ablation ◽  
Gender Gap ◽  
Major Bleeding ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Vascular Complications ◽  
Increased Risk ◽  
Procedural Complications

Introduction: Women undergoing atrial fibrillation catheter ablation (AFCA) have higher rates of vascular complications and major bleeding. However, studies have been underpowered to detect differences in rare complications such as stroke/transient ischemic attack (TIA) and procedural mortality. Methods: We performed a systematic review of databases (PubMed, World of Science, Embase) to identify studies published since 2010 reporting AFCA complications by gender. Six complications of interest were: 1) vascular/groin complications; 2) pericardial effusion/tamponade; 3) stroke/TIA; 4) permanent phrenic nerve injury; 5) major bleeding & 6) procedural mortality. For meta-analysis, random effects models were used when heterogeneity between studies was ≥ 50% (vascular complications, major bleeding) and fixed effects models for other endpoints. Results: Of 5716 citations, 19 studies met inclusion criteria, comprising 244,353 patients undergoing AFCA, of whom 33% were women. Women were older (65.3 ± 11.2 vs. 60.4 ± 13.2 years), more likely hypertensive (60.6 vs. 55.5%) and diabetic (18.3 vs. 16.5%) and had higher CHA 2 DS 2 -VASc scores (3.0 ± 1.8 vs. 1.4 ± 1.4) (p<0.0001 for all comparisons). The rates of all 6 complications were significantly higher in women (Table). However, despite statistically significant differences, the overall incidences of major complications were very low in both genders: stroke/TIA (women 0.51 vs. men 0.39%) and procedural mortality (women 0.25 vs. men 0.18%). Conclusion: Women experience significantly higher rates of AFCA complications. However, the incidence of major procedural complications is very low in both genders. The higher rate of complications in women may be partially attributable to older age and a higher prevalence of comorbidities at the time of ablation. More detailed studies are needed to better define the mechanisms of increased risk in women and to identify strategies for closing the gender gap.

scholarly journals Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation: A systematic review and meta-analysis

2018 ◽  
Vol 261 ◽  
pp. 84-91 ◽  
Author(s):  
Marco Proietti ◽  
Giulio Francesco Romiti ◽  
Imma Romanazzi ◽  
Alessio Farcomeni ◽  
Laila Staerk ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Meta Analysis

scholarly journals Association of Oral Anticoagulation With Stroke in Atrial Fibrillation or Heart Failure: A Comparative Meta-Analysis

Stroke ◽  
2021 ◽  
Author(s):  
Catriona Reddin ◽  
Conor Judge ◽  
Elaine Loughlin ◽  
Robert Murphy ◽  
Maria Costello ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Treatment Effect ◽  
Oral Anticoagulation ◽  
Clinical Benefit ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Major Hemorrhage ◽  
Net Clinical Benefit

Background and Purpose: Atrial fibrillation and heart failure with reduced ejection fraction (HFrEF) are common sources of cardioembolism. While oral anticoagulation is strongly recommended for atrial fibrillation, there are marked variations in guideline recommendations for HFrEF due to uncertainty about net clinical benefit. This systematic review and meta-analysis evaluates the comparative association of oral anticoagulation with stroke and other cardiovascular risk in populations with atrial fibrillation or HFrEF in sinus rhythm and identify factors mediating different estimates of net clinical benefit. Methods: PubMed and Embase were searched from database inception to November 20, 2019 for randomized clinical trials comparing oral anticoagulation to control. A random-effects meta-analysis was used to estimate a pooled treatment-effect overall and within atrial fibrillation and HFrEF trials. Differences in treatment effect were assessed by estimating I 2 among all trials and testing the between-trial-population P -interaction. The primary outcome measure was all stroke. Secondary outcome measures were ischemic stroke, hemorrhagic stroke, mortality, myocardial infarction, and major hemorrhage. Results: Twenty-one trials were eligible for inclusion, 15 (n=19 332) in atrial fibrillation (mean follow-up: 23.1 months), and 6 (n=9866) in HFrEF (mean follow-up: 23.9 months). There were differences in primary outcomes between trial populations, with all-cause mortality included for 95.2% of HFrEF trial population versus 0.38% for atrial fibrillation. Mortality was higher in controls groups of HFrEF populations (19.0% versus 9.6%) but rates of stroke lower (3.1% versus 7.0%) compared with atrial fibrillation. The association of oral anticoagulation with all stroke was consistent for atrial fibrillation (odds ratio, 0.51 [95% CI, 0.42–0.63]) and HFrEF (odds ratio, 0.61 [95% CI, 0.47–0.79]; I 2 =12.4%; P interaction=0.31). There were no statistically significant differences in the association of oral anticoagulation with cardiovascular events, mortality or bleeding between populations. Conclusions: The relative association of oral anticoagulation with stroke risk, and other cardiovascular outcomes, is similar for patients with atrial fibrillation and HFrEF. Differences in the primary outcomes employed by trials in HFrEF, compared with atrial fibrillation, may have contributed to differing conclusions of the relative efficacy of oral anticoagulation.

scholarly journals Estimating the cost-effectiveness of treatment for prevention of thromboembolic events in at-risk adults with non-valvular atrial fibrillation

2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Marco Bellone ◽  
Lorenzo Pradelli ◽  
Mario Bo
Keyword(s):  
Atrial Fibrillation ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Major Bleeding ◽  
Clinical Benefit ◽  
Drug Acquisition ◽  
Adult Patients ◽  
Clinical Event ◽  
Clinical Events ◽  
Net Clinical Benefit

INTRODUCTION: The direct oral anticoagulants (DOACs) have demonstrated a more predictable effect and a more favorable risk-benefit ratio compared to the standard oral anticoagulant treatment for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF).AIM: To estimate the efficiency of DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban vs. warfarin), in the prevention of clinical events in adult patients with NVAF.METHODS: A deterministic incremental cost-effectiveness analysis was performed to evaluate the avoidance of a clinical event and the incremental cost per avoided clinical event, in a hypothetical population of 100,000 adult patients with NVAF, over 1-year period. In the absence of head-to-head comparison trials between DOACs, relative risks were derived from a network meta-analysis. Clinical events considered include stroke/systemic embolism (SE) and major bleeding. Only direct health costs related to the management of clinical events and drug acquisition costs were considered. Clinical event management costs were derived from literature and from the Diagnosis Related Group (DRG) tariffs. Net annual treatment costs were calculated based on the daily dose reported in the Summary of Product Characteristics (SPCs) and the ex-factory price of each drug.RESULTS: Among DOACs, apixaban was associated with the highest net clinical benefit with 1,064 avoided events over 1 year, compared to warfarin (728 major bleeding events and 336 strokes/SE). Furthermore, apixaban is the most efficient DOAC, with a cost per avoided event equal to € 16,672 vs. warfarin (€ 24,120 for edoxaban 60 mg, € 36,777 for dabigatran 150 mg).CONCLUSION: Apixaban has the highest potential net clinical benefit among DOACs for patients with NVAF and the least incremental cost per avoided event for the Italian National Health Service.

scholarly journals Prevention of ischemic stroke in atrial fibrillation from the point of view of a neurologist. Standards and real clinical practice

2021 ◽  
Vol 93 (10) ◽  
pp. 1240-1245
Author(s):  
Marina Yu. Maksimova ◽  
Andrei V. Fonyakin ◽  
Liudmila A. Geraskina
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Benefit ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Preventive Therapy ◽  
Individual Characteristics ◽  
Point Of View ◽  
Treatment Standards ◽  
Age Related ◽  
Net Clinical Benefit

The article outlines aspects of the current state of the problem of the priority choice of an oral anticoagulant for indefinite prevention of stroke and systemic thromboembolism in patients with atrial fibrillation. The advantages of direct oral angicoagulants over warfarin are presented, as well as a comparative analysis of the individual characteristics of the main direct oral angicoagulants from the point of view of personification of preventive therapy in accordance with modern treatment standards. The efficacy and safety of oral anticoagulant therapy has been reviewed in terms of the net clinical benefit. Particular attention is paid to the age-related aspects of choosing an anticoagulant for indefinite prophylaxis; an assessment of anticoagulants is presented in accordance with the FORTA concept, which regulates the use of drugs in elderly patients. In conclusion, recommendations are formulated for the choice of an anticoagulant in patients with atrial fibrillation in the most common clinical situations. As a general rule, the choice of a particular drug should be individualized based on risk factors, tolerability, net clinical benefit, patient preference, potential adverse interactions, and other clinical characteristics.

scholarly journals Discontinuation of oral anticoagulation therapy after successful atrial fibrillation ablation: A systematic review and meta-analysis of prospective studies

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253709
Author(s):  
Xue-Hui Liu ◽  
Qiang Xu ◽  
Tao Luo ◽  
Lei Zhang ◽  
Hong-Jun Liu
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Large Scale ◽  
Meta Analysis ◽  
Anticoagulation Therapy ◽  
Included Study ◽  
Af Ablation ◽  
Increased Risk ◽  
Significant Difference ◽  
Random Effects Modeling

Background The safety of discontinuing oral anticoagulant (OAC) therapy after atrial fibrillation (AF) ablation remains controversial. A meta-analysis was performed to assess the safety and feasibility of discontinuing OAC therapy after successful AF ablation. Methods PubMed and Embase were searched up to October 2020 for prospective cohort studies that reported the risk of thromboembolism (TE) after successful AF ablation in off-OAC and on-OAC groups. The primary outcome was the incidence of TE events. The Mantel-Haenszel method with random-effects modeling was used to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). Results A total of 11,148 patients (7,160 in the off-OAC group and 3,988 in the on-OAC group) from 10 studies were included to meta-analysis. No significant difference in TE between both groups was observed (OR, 0.73; 95%CI, 0.51–1.05; I2 = 0.0%). The risk of major bleeding in off-OAC group was significantly lower compared to the on-OAC group (OR, 0.18; 95%CI, 0.07–0.51; I2 = 51.7%). Conclusions Our study suggests that it may be safe to discontinue OAC therapy in patients after successful AF ablation. Additionally, an increased risk of major bleeding was observed in patients on OAC. However, the results of this meta-analysis should be interpreted with caution because of the heterogeneity among the included study designs. Large-scale and adequately powered randomized controlled trials are warranted to confirm these findings.

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