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@article{1670643,
author = {Mikulík, Robert and Eckstein, J. and Pearce, L. A. and Mundl, H. and Rudilosso, S. and Olavarria, V. V. and Shoamanesh, A. and Chamorro, A. and MartiandFabregas, J. and Veltkamp, R. and Ozturk, S. and Tatlisumak, T. and Peacock, W. F. and Berkowitz, S. D. and Connolly, S. J. and Hart, R. G.},
article_location = {Philadelphia},
article_number = {7},
doi = {http://dx.doi.org/10.1161/STROKEAHA.119.027995},
keywords = {blood pressure; embolism; glomerular filtration rate; infarction; rivaroxaban},
language = {eng},
issn = {0039-2499},
journal = {Stroke},
title = {Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source NAVIGATE-ESUS Trial},
url = {https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.119.027995},
volume = {51},
year = {2020}
}
TY - JOUR
ID - 1670643
AU - Mikulík, Robert - Eckstein, J. - Pearce, L. A. - Mundl, H. - Rudilosso, S. - Olavarria, V. V. - Shoamanesh, A. - Chamorro, A. - Marti-Fabregas, J. - Veltkamp, R. - Ozturk, S. - Tatlisumak, T. - Peacock, W. F. - Berkowitz, S. D. - Connolly, S. J. - Hart, R. G.
PY - 2020
TI - Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source NAVIGATE-ESUS Trial
JF - Stroke
VL - 51
IS - 7
SP - 2139-2147
EP - 2139-2147
PB - Lippincott Williams & Wilkins
SN - 00392499
KW - blood pressure
KW - embolism
KW - glomerular filtration rate
KW - infarction
KW - rivaroxaban
UR - https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.119.027995
L2 - https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.119.027995
N2 - Background and Purpose: Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source. Methods: Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily. Results: During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7-4.3]), East Asia region (HR, 2.5 [95% CI, 1.6-3.9]), systolic blood pressure >= 160 mm Hg (HR, 2.2 [95% CI, 1.2-3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m(2)decrease, [95% CI, 1.0-1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin. Conclusions: Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk. Registration: URL:. Unique identifier: NCT02313909.
ER -
MIKULÍK, Robert, J. ECKSTEIN, L. A. PEARCE, H. MUNDL, S. RUDILOSSO, V. V. OLAVARRIA, A. SHOAMANESH, A. CHAMORRO, J. MARTI-FABREGAS, R. VELTKAMP, S. OZTURK, T. TATLISUMAK, W. F. PEACOCK, S. D. BERKOWITZ, S. J. CONNOLLY and R. G. HART. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source NAVIGATE-ESUS Trial. \textit{Stroke}. Philadelphia: Lippincott Williams \&{} Wilkins, 2020, vol.~51, No~7, p.~2139-2147. ISSN~0039-2499. Available from: https://dx.doi.org/10.1161/STROKEAHA.119.027995.
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