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Randomized Controlled Trial
. 2014 Dec 11;124(25):3692-8.
doi: 10.1182/blood-2014-08-595496. Epub 2014 Oct 15.

Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures

David Garcia  1 , John H Alexander  2 , Lars Wallentin  3 , Daniel M Wojdyla  2 , Laine Thomas  2 , Michael Hanna  4 , Sana M Al-Khatib  2 , Paul Dorian  5 , Jack Ansell  6 , Patrick Commerford  7 , Greg Flaker  8 , Fernando Lanas  9 , Dragos Vinereanu  10 , Denis Xavier  11 , Elaine M Hylek  12 , Claes Held  3 , Freek W A Verheugt  13 , Christopher B Granger  2 , Renato D Lopes  2
Affiliations
Randomized Controlled Trial

Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures

David Garcia et al. Blood. .

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.

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Figures

Figure 1
Figure 1
Periprocedural anticoagulation. (A) Bridging strategy suggested in the clinical trial protocol for low-risk patients. (B) Bridging strategy suggested in the clinical trial protocol for intermediate- and high-risk patients. INR, international normalized ratio; LMWH, low-molecular-weight heparin; POC, point of care; UFH, unfractionated heparin.
Figure 2
Figure 2
Diagram for inclusion of eligible patients and procedures.
See this image and copyright information in PMC

References

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