Abstract 13721: Is Single Dose Interruption of Direct Oral Anticoagulants Necessary Before Atrial Fibrillation Ablation? A Systematic Review and Meta-analysis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ali H Jafry ◽  
Khawaja H Akhtar ◽  
Amna M Chaudhary ◽  
Safi U Khan ◽  
Mohammad S Khan ◽  
...  

Background: In patients with atrial fibrillation taking direct oral anticoagulants (DOACS) and undergoing catheter ablation, it is unclear if interruption of a single dose of DOAC before the procedure is necessary. We assessed the peri-procedural adverse events between uninterrupted vs single-dose interrupted DOACS. Methods: A systematic review of Medline and EMBASE was conducted and all randomized controlled trials (RCTs) and observational studies that compared uninterrupted versus interrupted DOACS were included. Random effects model was used and risk ratios (RR) with 95% confidence intervals (CI) were reported using Mantel Haenszel method. All studies defined dose interruption as holding a single dose of DOAC before ablation. Separate analyses were conducted for RCTs and observational studies. Results: Eight RCTs with 2656 patients and 4 observational studies with 834 patients were included. In RCT restricted analysis, no significant difference was seen in major bleeding [RR 0.65 (CI 0.30-1.42)], minor bleeding [RR 0.98 (0.68-1.40)], stroke/transient ischemic attack/thromboembolism [RR 0.90 (CI 0.27-2.98)] and silent cerebral infarction [RR 0.51 (CI 0.14-1.89)]. In observational study restricted analysis, no significant difference was seen in major bleeding [RR 3.04 (CI 0.13-74.07)], minor bleeding [RR 0.88 (0.46-1.69)], stroke/transient ischemic attack/thromboembolism [RR 0.98 (CI 0.12-7.91)] and a statistically significant lower silent cerebral infarction [RR 0.45 (CI 0.31-0.67)]. Conclusion: Uninterrupted DOACS are safe for patients undergoing AF ablation and logistically easier for patients. Figure 1: Forest plot showing outcomes with uninterrupted vs interrupted direct oral anticoagulants in patients undergoing ablation for atrial fibrillation in randomized controlled trials.

2019 ◽  
Vol 8 (4) ◽  
pp. 554 ◽  
Author(s):  
Anneka Mitchell ◽  
Margaret C. Watson ◽  
Tomas Welsh ◽  
Anita McGrogan

Older people, are underrepresented in randomised controlled trials of direct oral anticoagulants (DOACs) for stroke prevention in atrial fibrillation (AF). The aim of this study was to combine data from observational studies to provide evidence for the treatment of people aged ≥75 years. Medline, Embase, Scopus and Web of Science were searched. The primary effectiveness outcome was ischaemic stroke. Safety outcomes were major bleeding, intracranial haemorrhage, gastrointestinal bleeding, myocardial infarction, and mortality. Twenty-two studies were eligible for inclusion. Two studies related specifically to people ≥75 years but were excluded from meta-analysis due to low quality; all data in the meta-analyses were from subgroups. The pooled risk estimate of ischaemic stroke was slightly lower for DOACs. There was no significant difference in major bleeding, mortality, or myocardial infarction. Risk of intracranial haemorrhage was 44% lower with DOACs, but risk of GI bleeding was 46% higher. Our results suggest that DOACs may be preferable for the majority of older patients with AF, provided they are not at significant risk of a GI bleed. However, these results are based entirely on data from subgroup analyses so should be interpreted cautiously. There is a need for adequately powered research in this patient group.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3672-3672 ◽  
Author(s):  
Yimin Pearl Wang ◽  
Rohan Kehar ◽  
Alla Iansavitchene ◽  
Alejandro Lazo-Langner

Introduction: The standard oral anticoagulant therapy administered to non-valvular AF patients has typically been Vitamin K Antagonists (VKA) particularly warfarin. In recent years, Direct Oral Anticoagulants (DOACs) including Direct Thrombin Inhibitors (DTI) and Direct Factor Xa inhibitors (FXa inhibitors) have become an alternative to warfarin. Randomized trials comparing warfarin and DOACs showed comparable effectiveness without significant additional major bleeding risk. However, bleeding events in RCTs may differ from those in daily use due to the routine exclusion of patients with a higher risk of bleeding from many studies. We aimed to assess bleeding risk between DOACs and warfarin in AF patients in observational studies and we also sought to determine differences between patients that were experienced or naïve to oral anticoagulants. Methods: A systematic literature search was conducted in the OVID MEDLINE® and EMBASE® electronic databases. Observational studies and randomized control trials (RCT) from 1990 to January 2019 were retrieved and examined by two independent reviewers. A pooled effect hazard ratio (HR) was calculated using a random effects model using the generic inverse variance method. Subgroup analyses according to previous exposure to anticoagulants, study type, funding type and DOAC type were conducted. The primary outcome was major bleeding risk. The secondary outcome was clinically relevant non-major bleeding. All studies must have used an established or validated definition of major bleeding. Results: The initial literature search identified 3359 potentially eligible citations. After primary screening, 150 articles were eligible for full text review and there were 35 studies including 2,356,201 patients that met the inclusion criteria. Overall, patients on DOACs were less likely to experience a bleeding event compared to warfarin (HR 0.78, 95%CI 0.71, 0.85, P<0.001). The results were consistent when analyzing patients receiving DTIs or FXa inhibitors (DTI: HR 0.76, 95% CI 0.67,0.87; FXa inhibitors: HR 0.79, 95% CI 0.69,0.89). However, among patients receiving factor Xa inhibitors, there was a significant difference in the risk of bleeding according to individual drug. Among patients receiving rivaroxaban the risk of bleeding was similar to warfarin (HR 0.98, 95%CI 0.91,1.06, p=0.60) whereas in those receiving apixaban there was a 40% reduction in the risk of bleeding compared to warfarin (HR 0.60, 95%CI 0.50,0.71, p<0.001) (Figure 1). Three studies reported information according to previous anticoagulant exposure. The overall pooled hazard ratio was 0.68 (95% CI 0.55, 0.82 p<0.001) in favor of patients on DOACs. In the subgroup analysis of previous anticoagulant use, the risk of bleeding was lower for DOACs compared to warfarin in both the experienced population (HR 0.70, 95%CI 0.51, 0.96) and the naïve population (HR 0.64, 95% CI 0.47,0.87). However, heterogeneity was moderate to high among both subgroups. Conclusion: This review and meta-analysis of observational studies including over 2.3 million patients showed that overall DOACs have a lower risk of major bleeding and clinically relevant non-major bleeding compared to warfarin. Most importantly, although the pooled effect estimate did not differ between DTIs and FXa inhibitors, among patients receiving FXa inhibitors there was a significant difference between individual agents. Patients on apixaban had a significantly lower risk of bleeding compared to warfarin in contrast to patients on rivaroxaban who had a similar risk. Disclosures No relevant conflicts of interest to declare.


Kardiologiia ◽  
2021 ◽  
Vol 61 (10) ◽  
pp. 81-88
Author(s):  
T. N. Novikova

This review focuses on issues of anticoagulant therapy in patients with atrial fibrillation (AF) associated with chronic kidney disease (CKD). Such patients are at high risk of stroke whereas the choice of an anticoagulant is difficult. A wealth of information about a negative effect of warfarin on the kidney function has accumulated. A need for an alternative therapy to warfarin for patients with stage 3-4 CKD has become imminent. In this regard, rivaroxaban seems to be an appropriate replacement for warfarin in such patients. In randomized, controlled studies that evaluated the efficacy of direct oral anticoagulants in comparison with warfarin, the efficacy and safety profile of a “kidney” dose in moderate disorders of kidney function has been studied only for rivaroxaban. Moreover, both randomized, controlled studies and studies performed in the conditions of clinical practice, have demonstrated a more favorable effect of rivaroxaban on kidney function compared to warfarin. Patients with AF associated with CKD require a comprehensive protection, which, according to results of clinical studies, may be provided by rivaroxaban. 


2021 ◽  
pp. 1-8
Author(s):  
Masaki Naganuma ◽  
Yuichiro Inatomi ◽  
Toshiro Yonehara ◽  
Makoto Nakajima ◽  
Mitsuharu Ueda

<b><i>Background and Purpose:</i></b> Anticoagulant drugs, including vitamin K antagonist (VKA) and direct oral anticoagulants (DOACs), can reduce stroke severity and are associated with good functional outcomes. Some patients are prescribed lower-than-recommended doses of DOACs; whether these have similar effects has not been clarified. <b><i>Methods:</i></b> We retrospectively evaluated 1,139 consecutive ischemic stroke and transient ischemic attack patients with atrial fibrillation. Patients were divided into 5 groups according to their preceding anticoagulant drug therapies: no anticoagulant therapy (AC<sub>n</sub>), undercontrolling VKA doses (VKA<sub>uc</sub>), recommended, controlling VKA doses (VKA<sub>rec</sub>), prescribed underdoses of DOAC (DOAC<sub>ud</sub>), and recommended doses of DOAC (DOAC<sub>rec</sub>). We investigated the associations between these anticoagulant drug therapies and patients’ initial stroke severity and 3-month outcomes. <b><i>Results:</i></b> Median National Institutes of Health Stroke Scale scores at admission were as follows: AC<sub>n</sub>: 16, VKA<sub>uc</sub>: 15, VKA<sub>rec</sub>: 9, DOAC<sub>ud</sub>: 5, and DOAC<sub>rec</sub>: 7. When the AC<sub>n</sub> group was used as a reference, regression analysis showed that VKA<sub>rec</sub> (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.01–2.21), DOAC<sub>ud</sub> (OR 2.84, 95% CI: 1.47–5.66), and DOAC<sub>rec</sub> (OR 1.83, 95% CI: 1.23–2.74) were associated with milder stroke severity, while VKA<sub>uc</sub> was not. Median 3-month modified Rankin Scale scores were 2 in the DOAC<sub>ud</sub> and DOAC<sub>rec</sub> groups and 4 in all other groups. After adjusting for confounding factors, DOAC<sub>ud</sub> (OR 3.14, 95% CI: 1.50–6.57) and DOAC<sub>rec</sub> (OR 1.67, 95% CI: 1.05–2.64) were associated with good 3-month outcomes while VKA<sub>uc</sub> and VKA<sub>rec</sub> were not. <b><i>Conclusions:</i></b> In patients with atrial fibrillation, recommended doses and underdoses of DOACs reduced stroke severity on admission and were associated with good 3-month outcomes.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Abdul Shokor Parwani ◽  
Daniel Blaschke ◽  
Alexander Wutzler ◽  
Martin Huemer ◽  
Phillip Attanasio ◽  
...  

Introduction: Thromboembolic events are the most feared complication of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). The traditional periprocedural anticoagulation approach is discontinuation of vitamin K antagonist and bridging with heparin. Newly procedures are done under therapeutic INR 2-3. Recent studies used periprocedural new direct oral anticoagulants (NOACs). Hypothesis: We evaluated the available evidence on the efficacy and safety of NOACs for periprocedural anticoagulation during RFCA of AF. Methods: Pubmed, Embase and Cochrane Central were searched. Retrospective and prospective studies published as peer-reviewed full-size articles were included if they reported embolic events and major and minor bleeding. Results: Fifteen studies were identified (14 observational studies, 1 small randomized trial). A total of 7050 patients were included (NOACs group: 2887 ). A total of 37 thromboembolic complications occurred (0,5%) with 17 events in the NOAC group (0,6%) and 20 in the warfarin group (0,5%) (odds ratio 0.97, 95% confidence interval (CI) 0.48 to 1.99). Major bleeding were numerically higher in the warfarin group compared to the NOACs group. However, the difference did not reach statistical significance (odds ratio 0.69, CI 0.43 to 1.10). Subgroup analysis did not reveal any differences in event rates. Conclusions: Our review suggests that dabigatran etexilate and rivaroxaban are as effective and safe as warfarin for periprocedural anticoagulation in patients undergoing RFCA of AF. However, it has to be acknowledged that the current evidence is mainly based on observational studies.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Poci ◽  
D Gjermeni ◽  
V Kuehlkamp

Abstract Background Catheter ablation of atrial fibrillation is known for the combining risks of thromboembolism (TE) and major bleedings. This urges a better understanding and optimization of the intraprocedural anticoagulation management. Differences in unfractionated heparin (UFH) requirements and anticoagulation time (ACT) levels between patients on different uninterrupted oral anticoagulation (OAC) agents have been studied. However, the clinical relevance, in terms of periprocedural TE and bleeding events, of UFH administration according to ACT monitoring among patients on different OAC agents, needs to be addressed. Objective To evaluate how the ACT monitoring and differences in intraprocedural UFH requirements among different anticoagulant agents, may translate to clinical outcome, in terms of periprocedural incidence of thromboembolic and bleeding events. Methods We retrospectively studied 1571 cases who underwent catheter ablation for atrial fibrillation between January 2011 and May 2017. Cases were on an uninterrupted oral OAC therapy of Vitamin K Antagonists (VKA)(713), Rivaroxaban (RG)(385), Dabigatran (DG)(260), Apixaban (AG)(192) and Edoxaban (EG)(21). First ACT measurements after the initial bolus of UFH (1ehz748.0610U), mean ACT measurements, total UFH doses/kg (Body Weight)/min (duration of procedure) and incidence of major periprocedural events were compared among the above OAC groups. Results The mean ACT (sec) was significantly lower in the AG and greater in the VKA (313,7±47 vs 340,5±49, p<0,001). Significantly lower UFH doses (U/kg/min) were required to reach the target ACT in VKA compared to RG, DG, AG and EG (0,69±0,4 vs 1,41±0,76; 1,42±0,7; 1,63±0,8; 1,37±0,4 respectively, p<0,001) The proportion of patients who achieved a target ACT value within 30 minutes after the fixed first UFH Bolus of 10 000 U was significantly lower in DG and AG compared to VKA, EG and RG group (51,5% and 49% vs 53%, 71,4%, and 61,8% respectively p=0,005). The incidence of periprocedural TE events and bleedings showed no significant difference among OAC groups. However, the 22 patients with a periprocedural TE event had significantly lower UFH doses (U)/ Duration of catheter ablation (min) compared to the ones without periprocedural TE (62,71±44,5 vs 94,4±66,4, p=0,026), despite equivalent mean ACT values between these two groups. Patients with a periprocedural TE had also a significantly older Age (69,6±10 vs 64±10 p=0,01, higher CHADSVASC Score (3,64±1,76 vs 2,63±1,7 p=0,006), longer duration of procedure (188,9±79,1 vs 144,9±57 p=0,0001) and higher pre-Ablation INR values (2,2±0,6 vs 1,7±0,6 p=0,002). Conclusions The average UFH doses required to reach the target ACT were lower in VKA than in NOAC- groups. The incidence of periprocedural TE events and bleedings was equivalent among OAC groups. Patients with TE showed a lower UFH requirement compared to no-TE group, with both groups having mean ACT ≥300 sec.


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