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.

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 FEIBA™ for Reversal of Direct Oral Anticoagulant Associated Major Bleeding

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1540-1540
Author(s):  
Joseph Shaw ◽  
Gregoire Le Gal ◽  
Melanie Tokessy ◽  
Nancy Cober ◽  
Elianna Saidenberg ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Vitamin K ◽  
Major Bleeding ◽  
Conservative Management ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Bleeding Events ◽  
Life Threatening ◽  
Bleeding Episodes

Abstract Introduction: Direct oral anticoagulants (DOACs) are indicated for the prevention of systemic embolism in patients with atrial fibrillation and for the prevention and treatment of venous thrombosis. Although DOACs offer advantages over the vitamin K antagonists, some hesitancy remains over their use given the lack of specific antidotes for management of life threatening bleeding events. In vivo studies, case reports and case series have shown that prothrombin complex concentrate (PCC) and activated PCC might potentially be used to control life threatening bleeding in patients with DOAC-associated bleeding episodes. Herein we describe management and outcomes of DOAC-associated life threatening bleeding events using an activated PCC (FEIBA™). Methods: A retrospective review of patients presenting with DOAC-associated (dabigatran, rivaroxaban or apixaban) life threatening bleeding to The Ottawa Hospital between January 2013 and June 2014 are included. Patients received 25 – 50 units/kg of FEIBA™. The primary outcome was adverse thrombotic and embolic events during follow-up. Secondary outcome was symptomatic control of bleeding. Results: Nine patients presented to hospital with life threatening bleeding episodes (post trauma: n=3; spontaneous bleeding: n=6). Spontaneous episodes included epistaxis or gastro-intestinal bleeding. Baseline characteristics are depicted in Table 1. A majority of patients had atrial fibrillation (n=8) and received rivaroxaban (n=5). The last dose of DOAC was taken within 24 hours of bleeding events for all patients. All patients received supportive management, interventions/procedures aimed at attaining source control of bleeding when possible, and transfusion of FEIBA™ for reversal of anticoagulant effect. Adverse events after receiving FEIBA™ were uncommon with one patient experiencing a TIA with expressive aphasia and visual field deficit on the evening of FEIBA™ transfusion; deficits resolved by the time of hospital discharge. Two patients with GI bleeding continued to have ongoing bleeding despite FEIBA™ administration and two patients died as a result of major bleeding. Conclusions: In this cohort of patients with major bleeding associated with DOACs, FEIBA™ administration, in addition to supportive care, was helpful in minimizing further complications of most bleeding events and associated with a low rate of adverse events. Prospective studies are needed to evaluate benefits and harms of FEIBA™ for management of DOAC associated major bleeding. Abstract 1540. Table 1: Patients with Life-threatening Bleeding Patient (Age and Gender) Indication for DOAC [AF(CHADS2); VTE] DOAC and Dosage Site of Bleeding Intervention/ Procedure Units of PRBCs Transfused Additional Treatment FEIBA™ Dose (IU)(1st/2nd) Adverse Events post-FEIBA™ Administration Survived Hospitalization 85 Male AF (2) Rivaroxaban 20 mg daily Epistaxis Nasal Packing 0 -- 3275 -- Yes 86 Male AF (2) Rivaroxaban 20 mg daily LGIB Angiogram, no embolization performed 10 Vitamin K 3159/ 2952 -- Yes 84 Male AF (2) Dabigatran 110 mg BID Orbital vitreous hemorrhage Surgical repair of ruptured globe 0 -- 1812 -- Yes 92 Male AF (6) Apixaban 5 mg BID Left hand Conservative management 1 Tranexamic acid 2718 TIA Yes 85 Male VTE Rivaroxaban 20 mg daily LGIB Conservative management 2 Vitamin K 1740 -- Yes 90 Female AF (5) Rivaroxaban 20 mg daily SDH Conservative management 0 -- 3275 -- No; died of major bleed 93 Female AF (6) Apixaban 2.5 mg BID LGIB Conservative management 4 -- 2241 -- No 93 Male AF (3) Rivaroxaban 15 mg daily UGIB Upper endoscopy, no intervention 4 Vitamin K 3000 -- No; died of major bleed and septic shock 81 Male AF (4) Dabigatran 110 mg BID LGIB Upper endoscopy and colonoscopy, no interventions 4 -- 3362 -- No AF = atrial fibrillation; BID = twice daily; CHADS = congestive heart failure, hypertension, age, diabetes, stroke; DOAC = direct oral anticoagulant; IU = international units; LGIB = lower gastrointestinal bleeding; PRBC = packed red blood cells; SDH = subdural hematoma; TIA = transient ischemic attack; UGIB = upper gastrointestinal bleeding; VTE = venous thromboembolism Disclosures Off Label Use: FEIBA is an activated prothrombin complex concentrate that was used during management of life threatening bleeding in patients with direct oral anticoagulant-associated bleeding episodes..

scholarly journals Prevention of Stroke in Atrial Fibrillation After Coronary Stenting

Stroke ◽  
2019 ◽  
Vol 50 (8) ◽  
pp. 2125-2132
Author(s):  
Leonardo Knijnik ◽  
Manuel Rivera ◽  
Vanessa Blumer ◽  
Rhanderson Cardoso ◽  
Amanda Fernandes ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Antiplatelet Therapy ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Observational Studies ◽  
Meta Analysis ◽  
Vitamin K Antagonist ◽  
Coronary Stenting ◽  
Direct Acting

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.

scholarly journals Az edoxabán véralvadásgátló hatásossága és biztonságossága nonvalvuláris pitvarfibrillációban

2018 ◽  
Vol 159 (12) ◽  
pp. 466-469
Author(s):  
Andrea Szegedi ◽  
Zoltán Csanádi
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Vitamin K ◽  
Oral Anticoagulant ◽  
Randomized Trials ◽  
Vitamin K Antagonists ◽  
Thromboembolic Events ◽  
Direct Oral Anticoagulant ◽  
Anticoagulant Drugs

Abstract: The significantly increased incidence of stroke and systemic embolisation caused by atrial fibrillation can be prevented by adequately adjusted anticoagulant therapy. Vitamin K antagonists effectively decrease the risk of thromboembolic events but this effect is influenced by many factors. The development of the new direct oral anticoagulant drugs (DOAC) in the last few years provided new opportunities for us to choose the suitable anticoagulant therapy. According to the results of the ENGAGE AF–TIMI 48 and ENSURE-AF multicenter, randomized trials, edoxaban, the recently introduced DOAC is equally effective as the traditional coumarin therapy, nevertheless, it ensures more tolerable anticoagulation for patients suffering from non-valvular atrial fibrillation. Orv Hetil. 2018; 159(12): 466–469.

Genotype-guided versus standard vitamin K antagonist dosing algorithms in patients initiating anticoagulation

2015 ◽  
Vol 114 (10) ◽  
pp. 768-777 ◽  
Author(s):  
Emilie Belley-Cote ◽  
Hasib Hanif ◽  
Frederick D’Aragon ◽  
John Eikelboom ◽  
Jeffrey Anderson ◽  
...  
Keyword(s):  
Vitamin K ◽  
Major Bleeding ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Vitamin K Antagonist ◽  
Random Effects Model ◽  
Thromboembolic Events ◽  
Clinical Algorithm ◽  
Significant Difference ◽  
Clinical Algorithms

SummaryVariability in vitamin K antagonist (VKA) dosing is partially explained by genetic polymorphisms. We performed a meta-analysis to determine whether genotype-guided VKA dosing algorithms decrease a composite of death, thromboembolic events and major bleeding (pri-mary outcome) and improve time in therapeutic range (TTR). We searched MEDLINE, EMBASE, CENTRAL, trial registries and conference proceedings for randomised trials comparing genotype-guided and standard (non genotype-guided) VKA dosing algorithms in adults initiating anticoagulation. Data were pooled using a random effects model. Of the 12 included studies (3,217 patients), six reported all components of the primary outcome of mortality, thromboembolic events and major bleeding (2,223 patients, 87 events). Our meta-analysis found no significant difference between groups for the primary outcome (relative risk 0.85, 95 % confidence interval [CI] 0.54–1.34; heterogeneity X2=4.46, p=0.35, I2=10 %). Based on 10 studies (2,767 patients), TTR was significantly higher in the genotype-guided group (mean difference (MD) 4.31 %; 95 % CI 0.35, 8.26; heterogeneity X2=43.31, p< 0.001, I2=79 %). Pre-specified exploratory analyses demonstrated that TTR was significantly higher when geno-type-guided dosing was compared with fixed VKA dosing (6 trials, 997 patients: MD 8.41 %; 95 % CI 3.50,13.31; heterogeneity X2=15.18, p=0.01, I2=67 %) but not when compared with clinical algorithm-guided dosing (4 trials, 1,770 patients: MD –0.29 %; 95 % CI –2.48,1.90; heterogeneity X2=1.53, p=0.68, I2=0 %; p for interaction=0.002). In conclusion, genotype-guided compared with standard VKA dosing algorithms were not found to decrease a composite of death, thromboembolism and major bleeding, but did result in improved TTR. An improvement in TTR was observed in comparison with fixed VKA dosing algorithms, but not with clinical algorithms.

scholarly journals Comparative Effectiveness and Safety of Non–Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients

Stroke ◽  
2021 ◽  
Author(s):  
Wengen Zhu ◽  
Zi Ye ◽  
Shilan Chen ◽  
Dexi Wu ◽  
Jiangui He ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Observational Studies ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Inverse Variance

Background and Purpose: Several observational studies have compared the effect of the non–vitamin K antagonist oral anticoagulants to each other in patients with atrial fibrillation. However, confounding by indication is a major problem when comparing non–vitamin K antagonist oral anticoagulant treatments in some of these studies. This meta-analysis was conducted to compare the effectiveness and safety between non–vitamin K antagonist oral anticoagulant and non–vitamin K antagonist oral anticoagulant by only including the propensity score matching studies. Methods: We systematically searched the PubMed and Ovid databases until May 2020 to identify relevant observational studies. Hazard ratios (HRs) and 95% CIs of the reported outcomes were collected and then pooled by a random-effects model complemented with an inverse variance heterogeneity or quality effects model. Results: A total of 17 retrospective cohort studies were included in this meta-analysis. Compared with dabigatran use, the use of rivaroxaban was significantly associated with increased risks of stroke or systemic embolism (HR, 1.16 [95% CI, 1.05–1.29]) and major bleeding (HR, 1.32 [95% CI, 1.24–1.41]), whereas the use of apixaban was associated with a reduced risk of major bleeding (HR, 0.78 [95% CI, 0.67–0.90]) but not stroke or systemic embolism (HR, 0.84 [95% CI, 0.56–1.28]). Compared with rivaroxaban use, the use of apixaban was associated with a decreased risk of major bleeding (HR, 0.63 [95% CI, 0.54–0.73]) but not stroke or systemic embolism (HR, 0.83 [95% CI, 0.67–1.04]). Reanalyses with the inverse variance heterogeneity or quality effects model produced similar results as the random-effects model. Conclusions: Current observational comparisons with propensity score matching methods suggest that apixaban might be a better choice compared with dabigatran or rivaroxaban for stroke prevention in atrial fibrillation patients.

scholarly journals Real-World Prevalence of Direct Oral Anticoagulant Off-Label Doses in Atrial Fibrillation: An Epidemiological Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Nan-Nan Shen ◽  
Chi Zhang ◽  
Ying Hang ◽  
Zheng Li ◽  
Ling-Cong Kong ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Oral Anticoagulant ◽  
Meta Analysis ◽  
Anticoagulation Therapy ◽  
Direct Oral Anticoagulant ◽  
Prevalence Data ◽  
Off Label ◽  
Significant Difference ◽  
Subgroup Analyses

Background: The use of direct oral anticoagulant (DOAC) off-label doses in atrial fibrillation (AF) patients may result in poor clinical outcomes. However, the true prevalence remains scarce. This study aims at estimating the prevalence of DOAC off-label doses in AF patients.Methods: Databases of MEDLINE, EMBASE, and COCHRANE were searched from inception through February 2020 for real-world studies that reported the off-label definition and prevalence data of AF patients using DOACs. The primacy outcomes were the overall prevalence of DOAC off-label doses and the corresponding underdose and overdose. The random-effects model was used for data synthesis. Variations on individual DOAC and different regions were examined by subgroup analyses.Results: A total of 23 studies involving 162,474 AF patients were finally included. The overall prevalence of DOAC off-label doses was 24% (95% CI, 19–28%), with 18% for dabigatran, 27% for rivaroxaban, 24% for apixaban, and 26% for edoxaban. The prevalence of underdosed DOACs was 20% (95% CI, 16–24%) with significant difference among individual anticoagulants (13% for dabigatran, 22% for rivaroxaban, 22% for apixaban, and 18% for edoxaban; Pinteraction=0.02). The prevalence of overdosed DOACs was 5% (95% CI, 3–7%), with the lowest prevalence observed in apixaban (2%). Subgroup analyses by regions demonstrated that the prevalence of DOAC off-label doses was higher in Asia (32%) than in North America (14%) and in Europe (22%), with underdose being predominant. Regardless of different regions, the prevalence of overdose was relatively low (4–6%).Conclusion: This study provides an estimation of DOAC off-label doses in the real-world setting. The prevalence rate of DOAC off-label doses in AF patients was relatively high, with underdose being predominant. Clinicians in Asia preferred to prescribe underdose of DOACs to AF patients. More evidence about the appropriateness of DOAC off-label doses in AF patients is urgently needed. Education programs concerning the appropriate prescription of DOACs within the drug labels and accepted guidelines are necessary to DOAC prescribers to ensure the safety and effectiveness of anticoagulation therapy for patients with AF.

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