Carlos Arturo Areán Martínez , Fernando Lanas , Ghazi Radaideh , Suleiman M. Kharabsheh , Marc Lambelet , Marco Antonio Lavagnino Viaud , Naser Samih Ziadeh , Alexander G.G. Turpie , on behalf of the XANTUS Investigators
{"title":"XANTUS-EL:一项在东欧、中东、非洲和拉丁美洲接受利伐沙班治疗的房颤患者预防卒中的现实世界、前瞻性、观察性研究","authors":"Carlos Arturo Areán Martínez , Fernando Lanas , Ghazi Radaideh , Suleiman M. Kharabsheh , Marc Lambelet , Marco Antonio Lavagnino Viaud , Naser Samih Ziadeh , Alexander G.G. Turpie , on behalf of the XANTUS Investigators","doi":"10.1016/j.ehj.2018.09.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>The prospective, observational XANTUS study demonstrated low rates of stroke and major bleeding in real-world rivaroxaban-treated patients with non-valvular atrial fibrillation (NVAF) from Western Europe, Canada and Israel. XANTUS-EL is a component of the overall XANTUS programme and enrolled patients with NVAF treated with rivaroxaban from Eastern Europe, the Middle East and Africa (EEMEA) and Latin America.</p></div><div><h3>Methods</h3><p>Patients with NVAF starting rivaroxaban for stroke prevention were consecutively recruited and followed for 1 year, at approximately 3-month intervals, or for ≥30 days after permanent rivaroxaban discontinuation. Primary outcomes were major bleeding, adverse events (AEs), serious AEs and all-cause mortality. Secondary outcomes included stroke, non-central nervous system systemic embolism (non-CNS SE), transient ischaemic attack (TIA), myocardial infarction (MI) and non-major bleeding. All major outcomes were centrally adjudicated.</p></div><div><h3>Results</h3><p>Overall, 2064 patients were enrolled; mean age ± standard deviation was 67.1 ± 11.32 years; 49.3% were male. Co-morbidities included heart failure (30.9%), hypertension (84.2%), diabetes mellitus (26.5%), prior stroke/non-CNS SE/TIA (16.2%) and prior MI (10.7%). Mean CHADS<sub>2</sub>, CHA<sub>2</sub>DS<sub>2</sub>-VASc and HAS-BLED scores were 2.0, 3.6 and 1.6, respectively. Treatment-emergent event rates were (events/100 patient-years, [95% confidence interval]): major bleeding 0.9 (0.5–1.4); all-cause mortality 1.7 (1.2–2.4); stroke/non-CNS SE 0.7 (0.4–1.2); any AE 18.1 (16.2–20.1) and any serious AE 8.3 (7.0–9.7). One-year treatment persistence was 81.9%.</p></div><div><h3>Conclusions</h3><p>XANTUS-EL confirmed low stroke and major bleeding rates in patients with NVAF from EEMEA and Latin America. The population was younger but with more heart failure and hypertension than XANTUS; stroke/SE rate was similar but major bleeding lower.</p></div>","PeriodicalId":44962,"journal":{"name":"Egyptian Heart Journal","volume":"70 4","pages":"Pages 307-313"},"PeriodicalIF":1.4000,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ehj.2018.09.002","citationCount":"17","resultStr":"{\"title\":\"XANTUS-EL: A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Eastern Europe, Middle East, Africa and Latin America\",\"authors\":\"Carlos Arturo Areán Martínez , Fernando Lanas , Ghazi Radaideh , Suleiman M. Kharabsheh , Marc Lambelet , Marco Antonio Lavagnino Viaud , Naser Samih Ziadeh , Alexander G.G. Turpie , on behalf of the XANTUS Investigators\",\"doi\":\"10.1016/j.ehj.2018.09.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>The prospective, observational XANTUS study demonstrated low rates of stroke and major bleeding in real-world rivaroxaban-treated patients with non-valvular atrial fibrillation (NVAF) from Western Europe, Canada and Israel. XANTUS-EL is a component of the overall XANTUS programme and enrolled patients with NVAF treated with rivaroxaban from Eastern Europe, the Middle East and Africa (EEMEA) and Latin America.</p></div><div><h3>Methods</h3><p>Patients with NVAF starting rivaroxaban for stroke prevention were consecutively recruited and followed for 1 year, at approximately 3-month intervals, or for ≥30 days after permanent rivaroxaban discontinuation. Primary outcomes were major bleeding, adverse events (AEs), serious AEs and all-cause mortality. Secondary outcomes included stroke, non-central nervous system systemic embolism (non-CNS SE), transient ischaemic attack (TIA), myocardial infarction (MI) and non-major bleeding. All major outcomes were centrally adjudicated.</p></div><div><h3>Results</h3><p>Overall, 2064 patients were enrolled; mean age ± standard deviation was 67.1 ± 11.32 years; 49.3% were male. Co-morbidities included heart failure (30.9%), hypertension (84.2%), diabetes mellitus (26.5%), prior stroke/non-CNS SE/TIA (16.2%) and prior MI (10.7%). Mean CHADS<sub>2</sub>, CHA<sub>2</sub>DS<sub>2</sub>-VASc and HAS-BLED scores were 2.0, 3.6 and 1.6, respectively. Treatment-emergent event rates were (events/100 patient-years, [95% confidence interval]): major bleeding 0.9 (0.5–1.4); all-cause mortality 1.7 (1.2–2.4); stroke/non-CNS SE 0.7 (0.4–1.2); any AE 18.1 (16.2–20.1) and any serious AE 8.3 (7.0–9.7). One-year treatment persistence was 81.9%.</p></div><div><h3>Conclusions</h3><p>XANTUS-EL confirmed low stroke and major bleeding rates in patients with NVAF from EEMEA and Latin America. The population was younger but with more heart failure and hypertension than XANTUS; stroke/SE rate was similar but major bleeding lower.</p></div>\",\"PeriodicalId\":44962,\"journal\":{\"name\":\"Egyptian Heart Journal\",\"volume\":\"70 4\",\"pages\":\"Pages 307-313\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2018-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.ehj.2018.09.002\",\"citationCount\":\"17\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Egyptian Heart Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1110260818300188\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Egyptian Heart Journal","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1110260818300188","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
XANTUS-EL: A real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Eastern Europe, Middle East, Africa and Latin America
Background
The prospective, observational XANTUS study demonstrated low rates of stroke and major bleeding in real-world rivaroxaban-treated patients with non-valvular atrial fibrillation (NVAF) from Western Europe, Canada and Israel. XANTUS-EL is a component of the overall XANTUS programme and enrolled patients with NVAF treated with rivaroxaban from Eastern Europe, the Middle East and Africa (EEMEA) and Latin America.
Methods
Patients with NVAF starting rivaroxaban for stroke prevention were consecutively recruited and followed for 1 year, at approximately 3-month intervals, or for ≥30 days after permanent rivaroxaban discontinuation. Primary outcomes were major bleeding, adverse events (AEs), serious AEs and all-cause mortality. Secondary outcomes included stroke, non-central nervous system systemic embolism (non-CNS SE), transient ischaemic attack (TIA), myocardial infarction (MI) and non-major bleeding. All major outcomes were centrally adjudicated.
Results
Overall, 2064 patients were enrolled; mean age ± standard deviation was 67.1 ± 11.32 years; 49.3% were male. Co-morbidities included heart failure (30.9%), hypertension (84.2%), diabetes mellitus (26.5%), prior stroke/non-CNS SE/TIA (16.2%) and prior MI (10.7%). Mean CHADS2, CHA2DS2-VASc and HAS-BLED scores were 2.0, 3.6 and 1.6, respectively. Treatment-emergent event rates were (events/100 patient-years, [95% confidence interval]): major bleeding 0.9 (0.5–1.4); all-cause mortality 1.7 (1.2–2.4); stroke/non-CNS SE 0.7 (0.4–1.2); any AE 18.1 (16.2–20.1) and any serious AE 8.3 (7.0–9.7). One-year treatment persistence was 81.9%.
Conclusions
XANTUS-EL confirmed low stroke and major bleeding rates in patients with NVAF from EEMEA and Latin America. The population was younger but with more heart failure and hypertension than XANTUS; stroke/SE rate was similar but major bleeding lower.
期刊介绍：
The Egyptian Heart Journal is the official journal of the Egyptian Society of Cardiology. It is an international journal that publishes peer-reviewed articles on all aspects of cardiovascular disease, including original clinical studies and translational investigations. The journal publishes research, review articles, case reports and commentary articles, as well as editorials interpreting and commenting on the research presented. In addition, it provides a forum for the exchange of information on all aspects of cardiovascular medicine, including educational issues.
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