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Novel oral anticoagulants and trauma: The results of a prospective American Association for the Surgery of Trauma Multi-Institutional Trial

Kobayashi, Leslie MD; Barmparas, Galinos MD; Bosarge, Patrick MD; Brown, Carlos V. MD; Bukur, Marko MD; Carrick, Matthew M. MD; Catalano, Richard D. MD; Holly-Nicolas, Jan MD; Inaba, Kenji MD; Kaminski, Stephen MD; Klein, Amanda L. MD; Kopelman, Tammy MD; Ley, Eric J. MD; Martinez, Ericca M.; Moore, Forrest O. MD; Murry, Jason MD; Nirula, Raminder MD, MPH; Paul, Douglas DO; Quick, Jacob MD; Rivera, Omar MD; Schreiber, Martin MD; Coimbra, Raul MD, PhD; the AAST Multicenter Prospective Observational Study of Trauma Patients on Novel Oral Anticoagulants Study Group

Journal of Trauma and Acute Care Surgery: May 2017 - Volume 82 - Issue 5 - p 827–835
doi: 10.1097/TA.0000000000001414
AAST 2016 Plenary Paper
Editor's Choice

BACKGROUND: The number of anticoagulated trauma patients is increasing. Trauma patients on warfarin have been found to have poor outcomes, particularly after intracranial hemorrhage (ICH). However, the effect of novel oral anticoagulants (NOAs) on trauma outcomes is unknown. We hypothesized that patients on NOAs would have higher rates of ICH, ICH progression, and death compared with patients on traditional anticoagulant and antiplatelet agents.

METHODS: This was a prospective observational trial across 16 trauma centers. Inclusion criteria was any trauma patient admitted on aspirin, clopidogrel, warfarin, dabigatran, rivaroxaban, or apixaban. Demographic data, admission vital signs, mechanism of injury, injury severity scores, laboratory values, and interventions were collected. Outcomes included ICH, progression of ICH, and death.

RESULTS: A total of 1,847 patients were enrolled between July 2013 and June 2015. Mean age was 74.9 years (SD ± 13.8), 46% were female, 77% were non-Hispanic white. At least one comorbidity was reported in 94% of patients. Blunt trauma accounted for 99% of patients, and the median Injury Severity Score was 9 (interquartile range, 4–14). 50% of patients were on antiplatelet agents, 33% on warfarin, 10% on NOAs, and 7% on combination therapy or subcutaneous agents.

Patients taking NOAs were not at higher risk for ICH on univariate (24% vs. 31%) or multivariate analysis (incidence rate ratio, 0.78; confidence interval 0.61–1.01, p = 0.05). Compared with all other agents, patients on aspirin (90%, 81 mg; 10%, 325 mg) had the highest rate (35%) and risk (incidence rate ratio, 1.27; confidence interval, 1.13–1.43; p < 0.001) of ICH. Progression of ICH occurred in 17% of patients and was not different between medication groups. Study mortality was 7% and was not significantly different between groups on univariate or multivariate analysis.

CONCLUSION: Patients on NOAs were not at higher risk for ICH, ICH progression, or death.

LEVEL OF EVIDENCE: Prognostic/epidemiologic study, level III.

From the Surgery Division of Trauma, Surgical Critical Care, t Burns and Acute Care Surgery, Department of Surgery (L.K.), University of California, San Diego; Department of Surgery (G.B.), Cedars Sinai Medical Center, Los Angeles, California; Division of Acute Care Surgery (P.B.), University of Alabama at Birmingham, Birmingham, Alabama; Dell Medical School (C.V.B.), University of Texas at Austin, Austin, Texas; Trauma Research (M.M.C.), Delray Medical Center, Delray Beach, Florida; University of North Texas Health Science Center (M.M.C.), Forth Worth; Medical Center of Plano (M.M.C.), Plano, Texas; Department of Surgery (R.D.C., J.H.N.); Division of Trauma and Critical Care, Department of Surgery and Emergency Medicine, (K.I.), University of Southern California, Los Angeles; Santa Barbara Cottage Hospital (S.K.), Santa Barbara, California; Department of Surgery (A.L.K.), Dell Medical School, University of Texas at Austin, Austin, Texas; Division of Burns, Trauma, and Surgical Critical Care (T.K.), University of Arizona Medical School-Phoenix, Phoenix, Arizona; SICU (E.J.L.), Cedars Sinai Medical Center; Trauma Services (E.M.M.), Chandler Regional Medical Center Grand Canyon University, Phoenix, AZ; Department of General Surgery, Trauma and Surgical Critical Care (F.O.M.), Chandler Regional Medical Center, University of Arizona College of Medicine; East Texas Medical Center (J.M.), Tyler, Texas; University of Utah (R.N.), Salt Lake City, Utah; Division of Trauma, Critical Care and Acute Care Surgery, Kettering Medical Center (D.P.D.), Kettering, Ohio; Division of Acute Care Surgery (J.Q.), University of Missouri, Columbia, Missouri; Division of Trauma and Critical Care (O.R.), University of Southern California, Los Angeles, California; Division of Trauma, Critical Care and Acute Care Surgery (M.S.), Oregon Health and Science University, Portland, Oregon; and Division of Trauma, Surgical Critical Care, Burns and Acute Care Surgery, Department of Surgery (R.C.), University of California San Diego, La Jolla, California.

Submitted: July 29, 2016, Revised: January 24, 2017, Accepted: February 8, 2017, Published online: March 15, 2017.

Presentations: This study was presented as a podium presentation at the 75th Annual Meeting of the American Association for the Surgery of Trauma and Clinical Congress of Acute Care Surgery in Waikoloa, Hawaii September 14, 2016.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.jtrauma.com).

Address for reprints: Leslie Kobayashi, MD, Division of Trauma, Surgical Critical Care, Burns and Acute Care Surgery Department of Surgery University of California San Diego 200 W. Arbor Dr. 8896 San Diego, CA 92103-8896; email: lkobayashi@ucsd.edu.

© 2017 Lippincott Williams & Wilkins, Inc.