J 2020

Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source NAVIGATE-ESUS Trial

MIKULÍK, Robert, J. ECKSTEIN, L. A. PEARCE, H. MUNDL, S. RUDILOSSO et. al.

Basic information

Original name

Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source NAVIGATE-ESUS Trial

Authors

MIKULÍK, Robert (203 Czech Republic, guarantor, belonging to the institution), J. ECKSTEIN (756 Switzerland), L. A. PEARCE (276 Germany), H. MUNDL (276 Germany), S. RUDILOSSO (724 Spain), V. V. OLAVARRIA (152 Chile), A. SHOAMANESH (124 Canada), A. CHAMORRO (724 Spain), J. MARTI-FABREGAS (724 Spain), R. VELTKAMP (826 United Kingdom of Great Britain and Northern Ireland), S. OZTURK (792 Turkey), T. TATLISUMAK (752 Sweden), W. F. PEACOCK (826 United Kingdom of Great Britain and Northern Ireland), S. D. BERKOWITZ (826 United Kingdom of Great Britain and Northern Ireland), S. J. CONNOLLY (124 Canada) and R. G. HART (124 Canada)

Edition

Stroke, Philadelphia, Lippincott Williams & Wilkins, 2020, 0039-2499

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30103 Neurosciences

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

Impact factor

Impact factor: 7.914

RIV identification code

RIV/00216224:14110/20:00116031

Organization unit

Faculty of Medicine

DOI

UT WoS

000544979200044

Keywords in English

blood pressure; embolism; glomerular filtration rate; infarction; rivaroxaban

Tags

Tags

International impact, Reviewed
Změněno: 17/7/2020 13:23, Mgr. Tereza Miškechová

Abstract

V originále

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.