scholarly journals Effect of Direct Oral Anticoagulant, Patient, and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation Study

TH Open ◽  
2020 ◽  
Vol 04 (03) ◽  
pp. e255-e262
Author(s):  
Kira MacDougall ◽  
James D. Douketis ◽  
Na Li ◽  
Nathan P. Clark ◽  
Alfonso Tafur ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Clinical Outcomes ◽  
Oral Anticoagulant ◽  
Management Strategy ◽  
Perioperative Management ◽  
Elective Surgery ◽  
Direct Oral Anticoagulant ◽  
Significant Difference ◽  
Perioperative Anticoagulation

Abstract Introduction The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) Study assessed a standardized perioperative management strategy in patients with atrial fibrillation who were taking a direct oral anticoagulant (DOAC) and required an elective surgery or procedure. The aim of this substudy is to analyze the safety of this management strategy across different patient subgroups, according to four presurgical variables: (1) DOAC type and dose, (2) surgery/procedure bleed risk, (3) patient renal function, and (4) age. Methods Clinical outcomes analyzed included major bleeding (MB), arterial thromboembolism, any bleeding, and any thromboembolism. We used descriptive statistics to summarize clinical outcomes, where the frequency, proportion, and 95% confidence interval were reported. Fisher's exact tests were used for testing the null hypothesis of independence between the clinical outcome and patient characteristic, where the test p-values were reported. Results There were 3,007 patients with atrial fibrillation requiring perioperative DOAC management. There was no significant difference in bleeding or thromboembolic outcomes according to DOAC type/dose regimen, renal function, or patient age. The rate of MB was significantly higher with high bleed risk procedures than low bleed risk procedures in apixaban-treated patients (2.9 vs. 0.59%; p < 0.01), but not in dabigatran-treated patients (0.88 vs. 0.91%; p = 1.0) or rivaroxaban-treated patients (2.9 vs. 1.3%; p = 0.06). The risk for thromboembolism did not differ according to surgery/procedure-related bleed risk. Conclusion Our results suggest that in DOAC-treated patients who received standardized perioperative management, surgical bleed risk is an important determinant of bleeding but not thromboembolic outcomes, although this finding was not consistent across all DOACs. There were no differences in bleeding and thromboembolism according to DOAC type and dose, renal function, or age.

scholarly journals The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study for Patients on a Direct Oral Anticoagulant Who Need an Elective Surgery or Procedure: Design and Rationale

2017 ◽  
Vol 117 (12) ◽  
pp. 2415-2424 ◽  
Author(s):  
James Douketis ◽  
Alex Spyropoulos ◽  
Julia Anderson ◽  
Donald Arnold ◽  
Shannon Bates ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulant ◽  
Perioperative Management ◽  
Elective Surgery ◽  
Bleeding Risk ◽  
Patient Specific ◽  
Primary Study ◽  
Thrombin Time ◽  
Direct Oral Anticoagulant ◽  
Management Protocol

Background The perioperative management of patients who take a direct oral anticoagulant (DOAC) for atrial fibrillation and require treatment interruption for an elective surgery/procedure is a common clinical scenario for which best practices are uncertain. The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study is designed to address this unmet clinical need. We discuss the rationale for the PAUSE design and analysis plan as well as the rationale supporting the perioperative DOAC protocol. Methods PAUSE is a prospective study with three parallel cohorts, one for each DOAC, to assess a standardized but patient-specific perioperative management protocol for DOAC-treated patients with atrial fibrillation. The perioperative protocol accounts for DOAC type, patient's renal function and surgery/procedure-related bleeding risk. The primary study aim is to demonstrate the safety of the PAUSE protocol for the perioperative management of each DOAC. The secondary aim is to determine the effect of the pre-procedure interruption on residual anticoagulation when measured by the dilute thrombin time for dabigatran and anti-factor Xa levels for rivaroxaban and apixaban. The study hypothesis is that the perioperative management protocol for each DOAC is safe for patient care, defined by expected risks for major bleeding of 1% (80% power to exclude 2%), and for arterial thromboembolism of 0.5% (80% power to exclude 1.5%) in each DOAC group. Conclusion The PAUSE study has the potential to establish a standard-of-care approach for the perioperative management of DOAC-treated patients. The PAUSE management protocol is designed to be easily applied in clinical practice, as it is standardized and also patient specific.

scholarly journals Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant

2019 ◽  
Vol 179 (11) ◽  
pp. 1469 ◽  
Author(s):  
James D. Douketis ◽  
Alex C. Spyropoulos ◽  
Joanne Duncan ◽  
Marc Carrier ◽  
Gregoire Le Gal ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulant ◽  
Perioperative Management ◽  
Direct Oral Anticoagulant

Renal function in atrial fibrillation patients switched from warfarin to a direct oral anticoagulant

2016 ◽  
Vol 42 (4) ◽  
pp. 566-572 ◽  
Author(s):  
Anum S. Minhas ◽  
Qingmei Jiang ◽  
Xiaokui Gu ◽  
Brian Haymart ◽  
Eva Kline-Rogers ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant

scholarly journals Does body mass index influence clinical outcomes in patients with atrial fibrillation who receive direct oral anticoagulant therapy

2021 ◽  
Vol 16 (1-2) ◽  
pp. 67-67
Author(s):  
Ivana Jurin ◽  
Marko Lucijanić ◽  
Anđela Jurišić ◽  
Aleksandar Blivajs ◽  
Boris Starčević ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Mass Index ◽  
Clinical Outcomes ◽  
Body Mass ◽  
Anticoagulant Therapy ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Direct Oral Anticoagulant

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.

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.

scholarly journals Apixaban concentration variability and relation to clinical outcomes in real-life patients with atrial fibrillation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alenka Mavri ◽  
Nina Vene ◽  
Mojca Božič-Mijovski ◽  
Marko Miklič ◽  
Lisbeth Söderblom ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Thromboembolic Event ◽  
Real Life ◽  
Individual Variability ◽  
Blood Samples ◽  
Chromatography Tandem Mass Spectrometry ◽  
Significant Difference ◽  
Liquid Chromatography Tandem Mass ◽  
Peak Blood

AbstractIn some clinical situations, measurements of anticoagulant effect of apixaban may be needed. We investigated the inter- and intra-individual apixaban variability in patients with atrial fibrillation and correlated these results with clinical outcome. We included 62 patients receiving either 5 mg (A5, n = 32) or 2.5 mg (A2.5, n = 30) apixaban twice-daily. We collected three trough and three peak blood samples 6–8 weeks apart. Apixaban concentration was measured by liquid chromatography-tandem mass-spectrometry (LC–MS/MS) and by anti-Xa. Patients on A2.5 were older, had lower creatinine clearance, higher CHA2DS2VASc (4.7 ± 1.0 vs. 3.4 ± 1.7) and lower trough (85 ± 39 vs. 117 ± 53 ng/mL) and peak (170 ± 56 vs. 256 ± 91 ng/mL) apixaban concentrations than patients on A5 (all p < 0.01). In patients on A5, LC–MS/MS showed a significant difference between through levels and between peak levels (p < 0.01). During apixaban treatment, 21 patients suffered bleeding (2 major). There was no association between bleeding and apixaban concentrations or variability. Four patients who suffered thromboembolic event had lower peak apixaban concentrations than patients without it (159 ± 13 vs. 238 ± 88 ng/mL, p = 0.05). We concluded, that there was a significant intra- and inter-individual variability in apixaban trough and peak concentrations. Neither variability nor apixaban concentrations were associated with clinical outcomes.

Sign in / Sign up

Export Citation Format

Share Document