Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source

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dc.contributor.authorMikulík, Robert
dc.contributor.authorEckstein, Jens
dc.contributor.authorPearce, Lesly A.
dc.contributor.authorMundl, Hardi
dc.contributor.authorRudilosso, Salvatore
dc.contributor.authorOlavarría, Verónica
dc.contributor.authorShoamanesh, Ashkan
dc.contributor.authorChamorro, Ángel
dc.contributor.authorMartí-Fàbregas, Joan
dc.contributor.authorVeltkamp, Roland
dc.contributor.authorÖztürk, Şerefnur
dc.contributor.authorTatlisumak, Turgut
dc.contributor.authorPeacock, W. Frank
dc.contributor.authorBerkowitz, Scott D.
dc.contributor.authorConnolly, Stuart J.
dc.contributor.authorHart, Robert G.
dc.date.accessioned2021-08-11T22:57:44Z
dc.date.available2021-08-11T22:57:44Z
dc.date.issued2020
dc.description.abstractBACKGROUND 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 mmHg (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 m2 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.es
dc.identifier.citationStroke, 2020, vol.51:2139–2147es
dc.identifier.urihttps://doi.org/10.1161/STROKEAHA.119.027995es
dc.identifier.urihttp://hdl.handle.net/11447/4292
dc.language.isoenes
dc.subjectBlood pressurees
dc.subjectEmbolismes
dc.subjectGlomerular filtration ratees
dc.subjectInfarctiones
dc.subjectRivaroxabanes
dc.titleFrequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Sourcees
dc.typeArticlees

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