title: Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures.
abstract: Using data from ARISTOTLE, we describe the periprocedural management of anticoagulation and rates of subsequent clinical outcomes among patients chronically anticoagulated with warfarin or apixaban. We recorded whether (and for how long) anticoagulant therapy was interrupted preprocedure, whether bridging therapy was used, and the proportion of patients who experienced important clinical outcomes during the 30 days postprocedure. Of 10 674 procedures performed during follow-up in 5924 patients, 9260 were included in this analysis. Anticoagulant treatment was not interrupted preprocedure 37.5% of the time. During the 30 days postprocedure, stroke or systemic embolism occurred after 16/4624 (0.35%) procedures among apixaban-treated patients and 26/4530 (0.57%) procedures among warfarin-treated patients (odds ratio [OR] 0.601; 95% confidence interval [CI] 0.322-1.120). Major bleeding occurred in 74/4560 (1.62%) procedures in the apixaban arm and 86/4454 (1.93%) in the warfarin arm (OR 0.846; 95% CI 0.614-1.166). The risk of death was similar with apixaban (54/4624 [1.17%]) and warfarin (49/4530 [1.08%]) (OR 1.082; 95% CI 0.733-1.598). Among patients in ARISTOTLE, the 30-day postprocedure stroke, death, and major bleeding rates were low and similar in apixaban- and warfarin-treated patients, regardless of whether anticoagulation was stopped beforehand. Our findings suggest that many patients on chronic anticoagulation can safely undergo procedures; some will not require a preprocedure interruption of anticoagulation. ARISTOTLE was registered at www.clinicaltrials.gov as #NCT00412984.
authors.affiliation: Division of Hematology, University of Washington, Seattle, WA;
authors.forename: David
authors.initials: D
authors.lastname: Garcia
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC;
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
authors.affiliation: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden;
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC;
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Wojdyla
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC;
authors.forename: Laine
authors.initials: L
authors.lastname: Thomas
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ;
authors.forename: Michael
authors.initials: M
authors.lastname: Hanna
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC;
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
authors.affiliation: University of Toronto, Toronto, ON, Canada;
authors.forename: Paul
authors.initials: P
authors.lastname: Dorian
authors.affiliation: New York, NY;
authors.forename: Jack
authors.initials: J
authors.lastname: Ansell
authors.affiliation: University of Cape Town, Cape Town, South Africa;
authors.forename: Patrick
authors.initials: P
authors.lastname: Commerford
authors.affiliation: University of Missouri, Columbia, MO;
authors.forename: Greg
authors.initials: G
authors.lastname: Flaker
authors.affiliation: Universidad de La Frontera, Temuco, Chile;
authors.forename: Fernando
authors.initials: F
authors.lastname: Lanas
authors.affiliation: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania;
authors.forename: Dragos
authors.initials: D
authors.lastname: Vinereanu
authors.affiliation: St. John's Medical College and Research Institute, Bangalore, India;
authors.forename: Denis
authors.initials: D
authors.lastname: Xavier
authors.affiliation: Boston University Medical Center, Boston, MA; and.
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Hylek
authors.affiliation: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden;
authors.forename: Claes
authors.initials: C
authors.lastname: Held
authors.affiliation: Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Freek W A
authors.initials: FW
authors.lastname: Verheugt
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC;
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC;
authors.forename: Renato D
authors.initials: RD
authors.lastname: Lopes
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000601:surgery; D004311:Double-Blind Method; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D065427:Factor Xa Inhibitors / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011720:Pyrazoles / Q000627:therapeutic use*; D011728:Pyridones / Q000627:therapeutic use*; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D014859:Warfarin