Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source NAVIGATE-ESUS Trial
Por:
Mikulik, R, Eckstein, J, Pearce, LA, Mundl, H, Rudilosso, S, Olavarria, VV, Shoamanesh, A, Chamorro, A, Marti-Fabregas, J, Veltkamp, R, Ozturk, S, Tatlisumak, T, Peacock, WF, Berkowitz, SD, Connolly, SJ, Hart, RG
Publicada:
1 jul 2020
Resumen:
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.
Filiaciones:
Mikulik, R:
St Annes Univ Hosp, Int Clin Res Ctr, Brno, Czech Republic
St Annes Univ Hosp, Dept Neurol, Pekarska 53, Brno 65691, Czech Republic
Masaryk Univ, Brno, Czech Republic
Eckstein, J:
Univ Hosp Basel, Dept Internal Med, Basel, Switzerland
Mundl, H:
Bayer AG, Wuppertal, Germany
Rudilosso, S:
Hosp Clin Barcelona, Comprehens Stroke Ctr, Dept Neurosci, Barcelona, Spain
Olavarria, VV:
Univ Desarrollo, Clin Alemana Santiago, Dept Neurol & Psychiat, Fac Med, Santiago, Chile
Shoamanesh, A:
McMaster Univ, Populat Hlth Res Inst, Hamilton Hlth Sci, Hamilton, ON, Canada
Chamorro, A:
Hosp Clin Barcelona, Comprehens Stroke Ctr, Dept Neurosci, Barcelona, Spain
Marti-Fabregas, J:
Hosp Santa Creu Ist Pau, Barcelona, Spain
Veltkamp, R:
Imperial Coll London, London, England
Ozturk, S:
Selcuk Univ, Fac Med, Dept Neurol, Konya, Turkey
Tatlisumak, T:
Univ Gothenburg, Dept Clin Neurosci, Inst Neurosci & Physiol, Sahlgrenska Acad, Gothenburg, Sweden
Sahlgrens Univ Hosp, Dept Neurol, Gothenburg, Sweden
Peacock, WF:
Baylor Coll Med, Houston, TX 77030 USA
Berkowitz, SD:
Bayer US LLC, Pharmaceut Clin Dev Thrombosis, Whippany, NJ USA
Connolly, SJ:
McMaster Univ, Populat Hlth Res Inst, Hamilton Hlth Sci, Hamilton, ON, Canada
Hart, RG:
McMaster Univ, Populat Hlth Res Inst, Hamilton Hlth Sci, Hamilton, ON, Canada
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