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.

Základní údaje

Originální název

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

Autoři

MIKULÍK, Robert (203 Česká republika, garant, domácí), J. ECKSTEIN (756 Švýcarsko), L. A. PEARCE (276 Německo), H. MUNDL (276 Německo), S. RUDILOSSO (724 Španělsko), V. V. OLAVARRIA (152 Chile), A. SHOAMANESH (124 Kanada), A. CHAMORRO (724 Španělsko), J. MARTI-FABREGAS (724 Španělsko), R. VELTKAMP (826 Velká Británie a Severní Irsko), S. OZTURK (792 Turecko), T. TATLISUMAK (752 Švédsko), W. F. PEACOCK (826 Velká Británie a Severní Irsko), S. D. BERKOWITZ (826 Velká Británie a Severní Irsko), S. J. CONNOLLY (124 Kanada) a R. G. HART (124 Kanada)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30103 Neurosciences

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

Impakt faktor

Impact factor: 7.914

Kód RIV

RIV/00216224:14110/20:00116031

Organizační jednotka

Lékařská fakulta

DOI

UT WoS

000544979200044

Klíčová slova anglicky

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

Štítky

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 17. 7. 2020 13:23, Mgr. Tereza Miškechová

Anotace

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.