Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban. Issue 2 (14th January 2015)

• Record Type: Journal Article
• Authors: Tamayo, Sally; Frank Peacock, W.; Patel, Manesh; Sicignano, Nicholas; Hopf, Kathleen P.; Fields, Larry E.; Sarich, Troy; Wu, Shujian; Yannicelli, Daniel; Yuan, Zhong
• Is Part Of: Clinical cardiology. Volume 38:Issue 2(2015:Feb.)
• Page Start: 63
• Page End: 68
• Publication Date: 2015-01-14
• Subjects: Cardiology -- Periodicals; 616.12005
• DOI: 10.1002/clc.22373
• Languages: English
• ISSNs: 0160-9289

Abstract

<abstract abstract-type="main" id="clc22373-abs-0001"> <title>ABSTRACT</title> <sec id="clc22373-sec-0001" sec-type="section"> <title>Background</title> <p id="clc22373-para-0001">In nonvalvular atrial fibrillation (NVAF), rivaroxaban is used to prevent stroke and systemic embolism.</p> </sec> <sec id="clc22373-sec-001a" sec-type="section"> <title>Objective</title> <p>To evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real‐world clinical setting.</p> </sec> <sec id="clc22373-sec-0002" sec-type="section"> <title>Methods</title> <p id="clc22373-para-0002">From January 1, 2013, to March 31, 2014, US Department of Defense electronic health care records were queried to describe MB rates and demographics. Major bleeding was identified using a validated algorithm.</p> </sec> <sec id="clc22373-sec-0003" sec-type="section"> <title>Results</title> <p id="clc22373-para-0003">Of 27 467 patients receiving rivaroxaban, 496 MB events occurred in 478 patients, an incidence of 2.86 per 100 person‐years (95% confidence interval: 2.61‐3.13). The MB patients were older, mean (SD) age of 78.4 (7.7) vs 75.7 (9.7) years, compared with non‐MB patients. Patients with MB had higher rates of hypertension (95.6% vs 75.8%), coronary artery disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%). Of MB patients, 63.2% were taking 20 mg, 32.2% 15 mg, and 4.6% 10 mg of rivaroxaban. Four percent of MB patients took warfarin within the prior 30 days. Major bleeding was most commonly gastrointestinal (88.5%) or intracranial (7.5%). Although 46.7% of MB patients received a transfusion, none had sufficient evidence of receiving any type of clotting factor. Fourteen died during their MB hospitalization, yielding a fatal bleeding incidence rate of 0.08 per 100 person‐years (95% confidence interval: 0.05‐0.14). Mean age at death was 82.4 years.</p> </sec> <sec id="clc22373-sec-0004" sec-type="section"> <title>Conclusions</title> <p id="clc22373-para-0004">In this large observational study, the MB rate was generally consistent with the registration trial results, and fatal bleeds were rare.</p> </sec> </abstract>