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

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          Abstract

          Is a standardized perioperative management approach safe for patients with atrial fibrillation who use a direct oral anticoagulant and require elective surgery or procedure? In this cohort study of 3007 patients with atrial fibrillation using apixaban, dabigatran, or rivaroxaban, the direct oral anticoagulant treatment was stopped and resumed before and/or after elective surgery or procedure using standardized protocols without heparin bridging. The 30-day postoperative rates of major bleeding were less than 2%, and the rates of stroke were less than 1%. In this study, in patients treated with a direct oral anticoagulant, a simple standardized perioperative management approach was associated with low rates of bleeding and stroke. Patients with atrial fibrillation (AF) who use a direct oral anticoagulant (DOAC) and request elective surgery or procedure present a common clinical situation yet perioperative management is uncertain. To investigate the safety of a standardized perioperative DOAC management strategy. The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) cohort study conducted at 23 clinical centers in Canada, the United States, and Europe enrolled and screened patients from August 1, 2014, through July 31, 2018. Participants (n = 3007) had AF; were 18 years of age or older; were long-term users of apixaban, dabigatran etexilate, or rivaroxaban; were scheduled for an elective surgery or procedure; and could adhere to the DOAC therapy interruption protocol. A simple standardized perioperative DOAC therapy interruption and resumption strategy based on DOAC pharmacokinetic properties, procedure-associated bleeding risk, and creatinine clearance levels. The DOAC regimens were omitted for 1 day before a low–bleeding-risk procedure and 2 days before a high–bleeding-risk procedure. The DOAC regimens were resumed 1 day after a low–bleeding-risk procedure and 2 to 3 days after a high–bleeding-risk procedure. Follow-up of patients occurred for 30 days after the operation. Major bleeding and arterial thromboembolism (ischemic stroke, systemic embolism, and transient ischemic attack) and the proportion of patients with an undetectable or minimal residual anticoagulant level (<50 ng/mL) at the time of the procedure. The 3007 patients with AF (mean [SD] age of 72.5 [9.39] years; 1988 men [66.1%]) comprised 1257 (41.8%) in the apixaban cohort, 668 (22.2%) in the dabigatran cohort, and 1082 (36.0%) in the rivaroxaban cohort; 1007 patients (33.5%) had a high–bleeding-risk procedure. The 30-day postoperative rate of major bleeding was 1.35% (95% CI, 0%-2.00%) in the apixaban cohort, 0.90% (95% CI, 0%-1.73%) in the dabigatran cohort, and 1.85% (95% CI, 0%-2.65%) in the rivaroxaban cohort. The rate of arterial thromboembolism was 0.16% (95% CI, 0%-0.48%) in the apixaban cohort, 0.60% (95% CI, 0%-1.33%) in the dabigatran cohort, and 0.37% (95% CI, 0%-0.82%) in the rivaroxaban cohort. In patients with a high–bleeding-risk procedure, the rates of major bleeding were 2.96% (95% CI, 0%-4.68%) in the apixaban cohort and 2.95% (95% CI, 0%-4.76%) in the rivaroxaban cohort. In this study, patients with AF who had DOAC therapy interruption for elective surgery or procedure, a perioperative management strategy without heparin bridging or coagulation function testing was associated with low rates of major bleeding and arterial thromboembolism. This cohort study examines the risk of bleeding and stroke associated with surgical procedures and the value of perioperative management among patients with atrial fibrillation who use anticoagulants.

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          Most cited references26

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          Prediction of Creatinine Clearance from Serum Creatinine

          A formula has been developed to predict creatinine clearance (C cr ) from serum creatinine (S cr ) in adult males: Ccr = (140 – age) (wt kg)/72 × S cr (mg/100ml) (15% less in females). Derivation included the relationship found between age and 24-hour creatinine excretion/kg in 249 patients aged 18–92. Values for C cr were predicted by this formula and four other methods and the results compared with the means of two 24-hour C cr’s measured in 236 patients. The above formula gave a correlation coefficient between predicted and mean measured Ccr·s of 0.83; on average, the difference between predicted and mean measured values was no greater than that between paired clearances. Factors for age and body weight must be included for reasonable prediction.
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            Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation.

            It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure. We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding.
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              Cohort Studies: Prospective versus Retrospective

              Cohort studies form a suitable study design to assess associations between multiple exposures on the one hand and multiple outcomes on the other hand. They are especially appropriate to study rare exposures or exposures for which randomization is not possible for practical or ethical reasons. Prospective and retrospective cohort studies have higher accuracy and higher efficiency as their respective main advantages. In addition to possible confounding by indication, cohort studies may suffer from selection bias. Confounding and bias should be prevented whenever possible, but still can exert unknown effects in unknown directions. If one is aware of this, cohort studies can form a potent study design in nephrology producing, in general, highly generalizable results.
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                Author and article information

                Journal
                JAMA Internal Medicine
                JAMA Intern Med
                American Medical Association (AMA)
                2168-6106
                August 05 2019
                Affiliations
                [1 ]Department of Medicine, McMaster University, Hamilton, Ontario, Canada
                [2 ]The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department of Medicine, Northwell Health at Lenox Hill Hospital, New York, New York
                [3 ]Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
                [4 ]L’Institut du Savoir Montfort, L’Hopital Montfort, Ottawa, Ontario, Canada
                [5 ]Department of Surgery, NorthShore University Health Systems, Evanston, Illinois
                [6 ]Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium
                [7 ]Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
                [8 ]Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
                [9 ]Department of Medicine, University of Toronto, Toronto, Ontario, Canada
                [10 ]Department of Medicine, Montreal General Hospital, McGill University, Montreal, Quebec, Canada
                [11 ]Department of Medicine, Université de Montréal, Montreal, Quebec, Canada
                [12 ]Department of Internal Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
                [13 ]Department of Anesthesiology, University of Manitoba, Winnipeg, Manitoba, Canada
                [14 ]Department of Medicine, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
                [15 ]Department of Medicine, Henry Ford Hospital, Detroit, Michigan
                [16 ]Department of Medicine, University of Calgary, Calgary, Alberta, Canada
                [17 ]Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
                [18 ]Department of Pharmacy, Kaiser Permanente Colorado, Aurora, Colorado
                [19 ]Department of Anesthesiology, University of Thessaly, Larissa, Greece
                [20 ]Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Location AMC, the Netherlands
                [21 ]Hamilton Regional Laboratory Medicine Program, McMaster University, Hamilton, Ontario, Canada
                [22 ]Department of Anesthesiology, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada
                [23 ]Department of Obstetrics and Gynecology, The First I.M. Sechenov Moscow State Medical University, Moscow, Russia
                Article
                10.1001/jamainternmed.2019.2431
                6686768
                31380891
                13f63a2a-b670-4862-8c53-289ac59500d9
                © 2019
                History

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