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

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 Trends in initiation of direct oral anticoagulant therapies for atrial fibrillation in a national population-based cross-sectional study in the French health insurance databases

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e018180 ◽  
Author(s):  
Laetitia Huiart ◽  
Cyril Ferdynus ◽  
Christel Renoux ◽  
Amélie Beaugrand ◽  
Sophie Lafarge ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Multivariate Analysis ◽  
National Health ◽  
Oral Anticoagulant ◽  
Vitamin K Antagonists ◽  
Population Based ◽  
Administrative Database ◽  
Direct Oral Anticoagulant ◽  
Health Authorities ◽  
First Choice

ObjectiveUnlike several other national health agencies, French health authorities recommended that the newer direct oral anticoagulant (DOAC) agents only be prescribed as second choice for the treatment of newly diagnosed non-valvular atrial fibrillation (NVAF), with vitamin K antagonists (VKA) remaining the first choice. We investigated the patterns of use of DOACs versus VKA in the treatment of NVAF in France over the first 5 years of DOAC availability. We also identified the changes in patient characteristics of those who initiated DOAC treatment over this time period.MethodsBased on the French National Health Administrative Database, we constituted a population-based cohort of all patients who were newly treated for NVAF between January 2011 and December 2015. Trends in drug use were described as the percentage of patients initiating each drug at the time of treatment initiation. A multivariate analysis using logistic regression model was performed to identify independent sociodemographic and clinical predictors of initial anticoagulant choice.ResultsThe cohort comprised 814 446 patients who had received a new anticoagulant treatment for NVAF. The proportion of patients using DOACs as initial anticoagulant therapy reached 54% 3 months after the Health Ministry approved the reimbursement of dabigatran for NVAF, and 61% by the end of 2015, versus VKA use. In the multivariate analysis, we found that DOAC initiators were younger and healthier overall than VKA initiators, and this tendency was reinforced over the 2011–2014 period. DOACs were more frequently prescribed by cardiologists in 2012 and after (adjusted OR in 2012: 2.47; 95% CI 2.40 to 2.54).ConclusionDespite recommendations from health authorities, DOACs have been rapidly and massively adopted as initial therapy for NVAF in France. Observational studies should account for the fact that patients selected to initiate DOAC treatment are healthier overall, as failure to do so may bias the risk–benefit assessment of DOACs.

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